Pharma bio world june 2013

June 2013 

Vol. 11



Issue 11



Mumbai



Price ` 150

www.pharmabioworld.com PHARMA BIO WORLD JUNE 2013 VOL. 11 ISSUE 11 MUMBAI ` 150 B & R Ind.indd 1

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June 2013 

Vol.11



Issue 11



Mumbai



Price ` 150

www.pharmabioworld.com

Supply Chain Management Pharma Bio Pharma + Biotech South 2013 SOUTH 2013

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6 ď‚ƒJune 2013

Contents 2-4.indd 6

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FEATURES 10

Supply Chain Efficiency – A Lever for Enhanced Competitiveness – Manish Panchal, Siddharth Paradkar and Anirban Majumdar

16

Connecting the Dots in Pharma Supply Chain Management through Mobility and Auto-Id – G Ramesh

21

The ‘Whole’ Sale Story – Mahesh Kallayil

23

Addressing Contract Management Challenges in an Increasingly Complex Business Environment – Niranjan Umarane

26

Ensuring Product Quality for Pharmaceuticals – Joachim Baczewski

29

Highlights of ASCO Annual Meeting 2013 – ASCO

MARKET RESEARCH 31

Impact of recent Ranbaxy Fiasco on Indian Pharma Exports – Dr E Saneesh, Research Analyst, Business & Financial Services – Healthcare, Frost & Sullivan

NEWS UPDATE 33

Pharma News

34

Biotech News

CORPORATE AFFAIRS 54

Product Trends

58

Events Diary

BACKYARD 59

Bookshelf

60

AD Index Next Issue Focus: 11 th Anniversary Issue

8 June 2013

Contents 2-4.indd 8

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Supply Chain Efficiency – A Lever for Enhanced Competitiveness The opportunities for the Indian pharmaceutical industry are immense but increasing competition, increasing regulatory pressures and stringent price control means that companies need to constantly improve their costs and service levels. Supply chain efficiencies will play a crucial role going forward and will become the key differentiator for companies. Companies will therefore need to adopt an approach that encompasses strategic, tactical and operational interventions to remain competitive and create value for their customers.

Manish Panchal Practice Head - Chemical & Energy Tata Strategic Management Group

Siddharth Paradkar

I

Project Leader Tata Strategic Management Group 10 ď‚ƒJune 2013

Supply Chain Efficiency.indd 10

Pharma companies today face a number of supply chain challenges that could be an impediment in realising the company’s business objectives.

New Product Launches: To remain competitive and to differentiate from c ompetition, c ompanie s c o n tin u e to launch generic drugs in new dosages as well as various combination drugs. This increases the SKU spread for a company, which in turn increases the supply chain complexity. Also, with product launches that are phased out by geographies, the complexity only increases as diverse product portfolios have to be managed in different regions.

With many drugs going off-patent and India emerging as a low cost supplier of generics, the opportunities for the Indian Pharma generic companies are immense.

But there are numerous challenges too.

Global customers expect prices to be lower while at the same time demanding increased service levels. Already there is a price pressure in the generics market and operating margins are under stress.

This is also evident for major global players who have established their generic manufacturing base in India, as they experience year-on-year reducing margins in their India operations (Refer Figure 1 below).

For drugs coming off-patent, the 180-day exclusivity period for the first approved generic drug manufacturer also poses supply chain challenges. To maximise sales in the exclusivity period, some companies manufacture and stock the drug pre-approval. However, if approval is denied, the whole stock is wasted and has to be usually written off.

As competitive pressures intensify, organisations will need innovative products, novel processes and operational efficiencies to grow their business and sustain their profitability. Supply chain efficiencies can significantly improve operations and be a key differentiator for companies.

On the other hand, starting manufacturing post approval can lead to significant lost sales. The challenge for pharma supply chains is to find the right balance between these options. An agile supply chain with

49.2%

33.4%

32.9%

28.5%

27.9%

22.4% 40.7%

Principal Tata Strategic Management Group

Anirban Majumdar

Current & Potential Su p p ly Ch a in Challenges

ndian pharmaceutical industry today holds a distinctive position in the global market with high growth in generics, contract research and manufacturing services. The industry is the 3 rd largest in volume terms and 10 th largest in value, with current revenues of over USD 20 billion.

The industry has been growing at a brisk rate and is expected to reach between USD 55 to 70 billion by 2020.

14.6%

14.2%

27.0% 25.2% 17.9%

30.6%

29.2%

18.3% 23.8% 6.9%

20.2% 10.2%

GSK Pharma

Abbott India

FY 08

Sanofi

Novartis India

FY 10

Merck India

Astrazeneca

10.1%

Fulford -2.6%

FY 12

Figure 1: Operating Profit of MNC Pharma Companies (% of Net Sales) Source: Capitaline, Tata Strategic Analysis

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Figure 2: Distribution Costs of Pharma Companies (% of Net Sales) Source: Capitaline, Tata Strategic Analysis

a short turnaround time is the need of the hour.

Regulatory Guidelines: The industry has stringent regulations and guidelines in place to ensure that a safe drug is being delivered to the consumer. The industry works on GMP guidelines that mandate every process and product (final & intermediary) has to be tracked and validated for compliance. This makes the entire manufacturing system rigid and any changes usually require a long lead time.

Thus it becomes difficult to fully exploit short term opportunities like shortages of competitors’ products, break-out of diseases, etc.

While most companies acknowledge this issue, pharma companies find it difficult to align all partners by optimising the buffers across the supply chain. If managed effectively, enhanced responsiveness of the supply chain can become a significant competitive advantage for companies.

Impact of DPCO: The new Drug Price Control Order (DPCO) 2013, to take effect soon, brings 348 essential medicines or 652 medicine packs of various dosages and strengths under direct price control as against 74 bulk drugs earlier. As a result, the market will see a value erosion of ` 1600 crore, with revenues of MNC companies expected to take a hit of 18 per cent and revenues of domestic companies to go down by 9 per cent. Supply chain efficiencies 12 June 2013

Supply Chain Efficiency.indd 12

will therefore become extremely critical for companies looking to protect their bottom line.

have been traditionally high (3-5 per cent) when compared to other industries (1- 2 per cent) (Refer Figure 2 above).

Distribution Costs: Most formulation companies in India procure their API from companies that import their raw material.

Availability of quality raw material is often a challenge and delays are common, which impacts the production schedules of the formulators. This means that dispatches are often sent through air vis-à-vis ship or road. Special handling requirements (like sanitised environment, cold storage, limited transhipments, etc) and higher proportion of part truck loads (to avoid contamination) is typical of the industry, and this only adds to the transportation costs. Therefore, the distribution costs in the pharma industry

However, in the changing market scenario, with increasing competition in the generics space and the government and insurance companies continuing to apply cost pressures on the healthcare sector, it is imperative for pharma companies to critically review their logistics costs.

Operational Inefficiencies: Most pharma supply chains suffer from a high degree of month-end skew in their order patterns.

Many pharma companies have more than 50 per cent of their monthly sales in the last week, while some companies have even reported 60-75 per cent of sales on the last day of the month. A key reason for this is

• Network Design • Distribution Model • Supply Chain Partner Selection

STRATEGIC

OPERATIONAL • Route design

• Strategic Positioning

• Carrier Management • Analytics monitoring

and

TACTICAL

KPI

• Logistics Systems

Inventory Processes

&

Figure 3: Levers for Supply Chain Restructuring

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“

“

Supply chain executives in pharmaceutical companies must revisit their strategy to align it to current and potential supply chain needs.

that for most pharma companies, primary sales are “push sales” that are tracked in monthly buckets. As a result, ordering also tends to aggregate towards the month-end.

Consequently, physical dispatches often spill over into the next month, further skewing the order and replenishment cycle. In addition, distributors often wait till late into the month for the special month-end discounts that companies offer, which further accentuates the skew. This high skew puts an enormous amount of pressure on the company’s supply chain and makes it sub-optimal.

Introduction of GST: The current supply chain network of pharma companies is based on a state level tax optimisation mechanism instead of operational efficiencies. However, with the implementation of GST nearing reality now, decisions on selection of vendors and setting up of units will be determined by logistical considerations of costs and serviceability rather than tax saving priorities. For pharma companies it may imply restructuring of their logistic network to leverage efficiencies of scale and a complete revamp of existing distribution models and processes.

government regulations. Thus, it is imperative for companies to ensure that they have the right distribution network in place that not only makes them GST ready but also enables them to respond faster to the market in a cost effective manner.

It is also critical for companies to create distinct distribution models for different product categories. The current distribution model typically is a homogeneous one, operating on standardised lead times and service levels. This is in dissonance with the market reality, where customer tolerance time varies across products and geographies. A distinct supply chain will help ensure appropriate service levels and inventory for various categories/segments.

Considering that costs and service levels will be critical success factors in the industry, companies would also need to ensure that they have the right logistics partner to help them achieve these dual objectives. World class logistics partners can bring in best practices and help create significant competitive advantage.

Way Forward Going forward, improving service levels and enhancing customer value are going to be key differentiators for pharma companies. However, this will require a comprehensive approach to the Supply Chain that requires interventions at the strategic, tactical and operational levels.

1. Strategic Intervention – Pharma companies need to ensure that they have the right supply chain infrastructure in place to cater to the needs of the market and conform to 14 June 2013

Supply Chain Efficiency.indd 14

2. Tactical Intervention – With the right infrastructure in place, companies will also need to ensure that they have the right material at the right location at the right time. An effective inventory strategy will help companies not only to support their distinct distribution models but also ensure service levels are achieved at optimum costs.

imperative for the company to ensure that these processes and systems are aligned to the company’s supply chain objectives. This becomes more critical in a differential distribution model where multiple processes for different distribution models may be counter-productive if not designed and managed effectively.

3. Operational Intervention – Pharma companies will need to put in place strong checks and measures to ensure that supply chain operations meet their desired objectives. This may include monitoring adherence to milk routes, dynamic route optimization and strong contract management reviews for transporters and carriers. It will also be critical for companies to have a dashboard for daily monitoring of performance parameters, with early warning alerts and analysis paths.

Conclusion Increasing competition and the focus of the government on the healthcare sector would drive improvements in service levels and cost reduction in the future. Companies would need to revamp their supply chain as the classic way of supply chain operations may soon become untenable. Supply chain executives in pharmaceutical companies must revisit their strategy to align it to current and potential supply chain needs.

Successful implementation of strategic, tactical and operational interventions will drive supply chain efficiency as a key differentiator and help organisations protect margins and achieve sustainable competitive advantage. © Tata Strategic Management Group, 2013. No part of it may be circulated or reproduced for distribution without prior written approval from Tata Strategic Management Group.

This obviously has to be supported by a set of robust processes and systems.

While logistics service providers can bring in best practices, it is Pharma Bio World

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INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

Pharma Bio World has been bringing insights into innovations, novel technologies and business trends of the global pharmaceutical & biotech industries.

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Connecting the Dots in Pharma Supply Chain Management through Mobility and Auto-Id Pharmaceutical supply chain is faced with complex challenges. To meet challenges inherent in drug distribution, pharmaceutical companies need right strategies that will speed up efficiency and profitability of supply chain.

M

arket estimates project that global pharmaceutical market will reach nearly USD 1,100 billion by 2015. Indian pharmaceutical industry ra n k s 13 th in domes tic c ons umption value. The pharmaceutical industry is increasingly embracing the supply-chain as a competitive differentiator. Trends in the supply-chain management practices, and the route to market options, have begun to change the way business is done.

More and more pharmaceutical companies today outsource production globally.

Consequently, their products move through multiple layers of distribution before they are available at a pharmacy or a health care facility. As a result, logistics costs sometimes account for as high as 55 per cent of the costs in the pharma value chain.

There is also intense pressure on these companies to leverage their supply-chains to bring about a fast turnaround of supplies to meet market demand. This means that all stakeholders in the supply-chain need to work closely to enable faster and leaner operations.

Further, Pharma companies need to maintain regulatory compliance throughout their operations. Effective SCM, therefore, not only can ensure compliance and competitive advantage to each firm, it also helps in developing capabilities and utilising capacity as an industry in general.

G Ramesh Vice-President Supply Chain Management TAKE Solutions

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Connect the Dots in Pharma Supply Chain Management.indd 16

From a supply chain management stand-point this brings-up the following challenges that impact velocity: • Integrating compliance, especially product tracking and traceability, into all manufacturing processes and distribution touch-points.

• Removing latency of information without disrupting operations.

• Adopting best-practices to accelerate product flows in the supply-chain.

• Enabling newer and more efficient routes to market.

• Adopting innovative practices to drive product demand.

Like any other manufacturing company, a pharmaceutical company too looks to accomplish this while eliminating every wasted motion and potential bottleneck that can threaten its efficiency and profitability.

This is where mobility and auto-id technologies are making a difference.

Mobility eliminates wasted time hidden in its business processes — and speeds-up the entire supply-chain.

Integrating compliance without slowingdown operations in the supply-chain Pharmaceutical industry has to adhere to very specific and important mandates to ensure consumer safety – especially those relating to product tracking and traceability.

Counterfeiting, diversion, mishandling, mislabeling, and unintended or mistaken administration of prescription drugs are major concern areas. Ability to track and trace products – across all manufacturing processes and distribution touch-points, right from point-of-production to pointof-care – not only ensures product safety and security, but also supports efforts to improve productivity and profitability.

Automated track-and-trace systems, built around auto-id technologies like bar coding and radio frequency identification (RFID), now ensure products can be uniquely identified, with a serialised number that serves as a ‘fingerprint’ for only that particular bottle/package. Auto-ID technology allows the possibility of instant verification for any drug, at any location in the supply-chain. It also facilitates ‘notouch’ track and trace capabilities to support true pedigree information about drugs – and this information can be accessed by all supply chain partners. Industry experience indicates that these capabilities constitute strong barriers for potential counterfeiters to overcome.

Pharma Bio World

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Eliminating latency by taking enterprise systems to where the action is Many pharmaceutical companies today rely on their enterprise systems to help them make the smartest use of effort and resources, but the process of manually entering information into the appropriate forms can be a drain on productivity.

Workers – whether on the shop floor, in the warehouse, or on the shipping dock – must interrupt the flow of work to key information into a form, or wait until they have completed an activity to update the system.

Both approaches are error-prone and compromise the accuracy of the enterprise record. And because enterprise software can be difficult and expensive to customise, many companies are often forced to adapt their processes to fit existing functionality — jeopardising any competitive edge resulting from unique, innovative business practices.

With many companies relying on logistics service providers for physical distribution, the problem of latency acquires larger proportions on account of the varying levels of their IT savvy, and orchestrating collaboration across multiple organisations.

Rather than manually entering information into enterprise systems, with Enterprise Mobility Solutions, workers use handheld barcode and Radio Frequency Identification (RFID) scanners to collect information and complete transactions on the spot.

Rule-based guided put-away and picking enforce compliance with inventory policy and optimise warehouse traffic. Companies would also be able to use these solutions to streamline cycle counts, WIP pulls and labeling activity with advanced functionality that supplements existing enterprise system (ERP) capabilities — without costly modifications. Because workers can stay focused on the task at hand, such solutions also dramatically accelerate product flows and supply-chain throughput. At the same 18 June 2013

Connect the Dots in Pharma Supply Chain Management.indd 18

“

“

Companies are now using these technologies to easily refine dominant industry practices to embrace compliance – without slowing down operations in the supply-chain.

Moreover, these technologies also provide unprecedented control and efficiency for recalls, returns processing and inventory control.

Effective SCM not only can ensure compliance and competitive advantage to each firm, it also helps in developing capabilities and utilizing capacity as an industry in general.

time, companies make smarter use of available warehouse and manufacturing space, while reducing shipping errors.

Improving delivery times by making shipments instantly available for delivery Cross-docking is a popular strategy for Third-Party Logistics (3PL) providers and organisations with extensive distribution networks. The practice of immediately converting inbound deliveries to outbound shipments offers significant financial and operational advantages. Effective cross-docking requires continuous real-time visibility of shipments as they move from the factory to the end customer. Unfortunately, even with warehouse management modules supporting cross-docking installed, traditional enterprise resource planning (ERP) technology doesn’t offer the real-time visibility and accountability to optimise cross-docking efficiency.

Without the ability to track shipments on a real-time basis down to the level of individual bottle or package, companies can lose control over inbound and outbound materials, thereby increasing the potential for duplicate shipments, delayed shipments and other errors that can offset any gains in efficiency. This functional technology gap poses a significant challenge for 3PLs and distributors. Without tracking and tracing capabilities designed specifically for cross-docking, companies risk building up excess inventory and incurring the administrative overhead required to receive and process “rogue” shipments.

Auto-ID technologies coupled with mobile technologies allow drivers, shipping and receiving personnel to scan inbound and outbound shipments slated for cross-docking.

The handheld devices communicate directly with the tracking database in real-time via a wireless connection, or alternatively store

scanned information for batch uploads to the database at a later time. The devices also feature applications that enforce predefined receiving, delivery and cross-docking parameters designed to minimise shipping errors and subsequent returns.

Enabling alternative, efficient routes to market While most pharmaceutical companies rely on the traditional wholesale distribution channel, companies world-over have begun to leverage information technology to ship direct-to-pharmacy or even direct-to-patient.

A direct channel gives the company more control over the inventory — versus ceding inventory control to wholesale distributors — while helping reduce returns and keeping costs low. However, it also increases the administrative workload. Direct distribution requires increased real-time visibility and control across all nodes/touch-points in the supply-chain — and this again is enabled by auto-id and mobile technology capabilities.

Accelerating and enriching the demand generation process Some of the more successful Pharma companies are using mobile technologies to overcome the limited amounts of time that physicians are willing to spend with their sales representatives, enrich the interactions, and drive increased prescriptions for their products. These solutions help their sales personnel perform pre-sales planning, on-the-road preparation, and post-meet follow-up activities related to a meeting with a physician.

In addition to complex planning tasks like goal setting, calendar management, route planning, and researching customer issues, these solutions enable on-the-go look-ups for updated information about comparative drug efficacy, interactions, contraindications and adverse effects. Companies have also Pharma Bio World

6/21/2013 5:47:18 PM

Who’s Who th 14 Edition

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Integrating compliance without slowing-down operations

Accelerating the demand generation process

Better Supply Chain Management

Enabling new, efficient routes to market

Eliminating latency of information without disrupting operations

Adopting best-practices to accelerate product flows

extended capabilities to perform related activities like filing in meeting summaries and expense reports using these technologies.

These solutions are also helping in providing information that strengthens the personal bonding between the representatives and the physician, and enabling a new selling paradigm of collaborating with colleagues in real-time.

Conclusion Enterprise mobility and auto-id technologies are the missing link between a Pharma company’s operations in realtime and its business information systems.

Easy access to these technologies and mobile applications allow for much more functional capability on the shop-floor, in the field, and in the supply-chain.

It is generally true for all industry verticals that these technologies increase supply-chain velocity, but it will lead to a significant competitive advantage in the case of extremely competitive verticals like the pharmaceuticals industry.

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How Pharma Manufacturers can Simplify SOPs for Analytical Measurement

P

harmaceutical production is one of the world’s most regulated activities. Consequently, creating and maintaining documentation in a quality control system to satisfy regulatory requirements is a considerable task for drug companies. SOPs are an essential component of most quality control systems, and must document precisely all activities involved in drug production.

METTLER TOLEDO’s Intelligent Sensor Management (ISM ® ) is an innovative digital technology for analytical measurement solutions. ISM improves sensor handling and increases process reliability and production

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Connect the Dots in Pharma Supply Chain Management.indd 20

uptime, leading to greater productivity.

It also simplifies sensor-related SOPs. Kurt Hiltbrunner, pharmaceutical industry market specialist at METTLER TOLEDO, provided an example:

sensor diagnostics data is stored on the sensor. When an ISM sensor is connected to our iSense software, this information is automatically transferred to the software, which then updates its database for that particular probe."

“When a technician is calibrating a conventional ana log pH probe, they "iSense also displays the sensor must read the sensor’s serial number diagnostics, allowing technicians to printed on the sensor body and update easily see what, if any, maintenance the history for that probe in their data, the sensor requires or if it has for example, the number of exposures reached the end of its reliable lifetime. to CIP / SIP cycles, and operating hours. ISM therefore not only simplifies They then need to decide, based on sensor related SOPs by providing the sensor’s history, if the probe can sensor diagnostics, it also increases be used again or should be disposed process integrity.” of. ISM simplifies these operations as all relevant sensor data plus valuable Source: METTLER TOLEDO, Urdorf, Switzerland

Pharma Bio World

6/21/2013 5:47:33 PM

The ‘Whole’ Sale Story In an exclusive conversation with PBW, Chaitanya M Shah, Owner, CSC Pharma, leading pharmaceutical wholesaler, gives his views on Pharmaceutical wholesale market in India, constraints they face in supply chain and the future opportunities.

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ndian pharmaceutical market is going through a transformation. Recent developments like introduction of new pricing policy and compulsory licensing have accelerated this transformation.

Although India is growing with drug research & development and advanced infrastructure, pharmaceutical supply chain is still in the nascent stage.

Efficient supply chain management is essential for pharmaceutical Industry in India. The pharmaceutical supply chain is complex in nature, and calls for a lot of accountability in order to ensure the delivery of the right drug, at the right time and place, in the right condition - to the people in need of such drugs for fighting against the diseases.

The wholesalers play a critical role in the pharmaceutical supply chain. They ensure the delivery of right drug, at the right time and place, in the right condition.

Drug manufacturers increasingly rely on wholesalers to market and sell their product to an incredibly varied customer base.

The wholesalers not procuring drugs would mean a reduced supply to hospitals and smaller stockiest which eventually will lead to shortfall of drugs for the public.

Recently, Mumbai has witnessed acute drug shortage after wholesalers stopped purchasing fresh medicine stocks from manufacturers as a sign of protest against the new national pricing policy which they say will cut into their margins. This incident underlined the fact that how vital is the role of wholesalers in pharmaceutical supply chain.

a mediator in the supply chain. He supplies drugs to patients, hospitals, retailers, NGOs etc from where they are supplied to the end-users.

According to Chaitanya Shah there are two types of pharmaceutical wholesalers in India namely, authorised and unauthorised wholesalers. Those with formal agreements with drug makers are called authorised wholesalers.

“When a company appoints an authorised wholesaler, they have to get an NOC from Pharmaceutical Wholesalers Association (PWA). As a matter of practice, every company has a fixed number of distributors to a maximum of 11. Any increase beyond this requires approval from PWA. However, this rule is not applied to certain MNCs,” states Shah.

As per the provisions of Drugs and Cosmetics Act, for selling drugs one must be a qualified pharmacist or employ the services of qualified pharmacist. For Allopathic pharmaceutical marketing one has to get a wholesale drug licence from local licencing authorities along with Trade CST & VAT Nos. A pharmaceutical wholesaler should be a member of the Pharmaceutical Wholesalers Association.

Drug Distribution Channel Drug distribution in India is layered and regulated. Unlike in USA and EU, where a manufacturer can directly supply goods at the retail level, products in India move through a chain of intermediaries. Manufacturers can directly supply to institutions and hospitals, but never to a retailer.

Indian Wholesale Market

Compiled by: Mahesh Kallayil

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Pharmaceutical supply chain in India is highly fragmented. It would have been difficult for drug makers to cope with the highly fragmented distribution network without wholesalers. A wholesaler acts as

The manufacturer supplies drugs to wholesalers from whose premises drugs are routed to hospitals and retailers and chemist shops who then dispense the drugs to final consumers. This is the general scheme of drug distribution channel in India.

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Some drugs are not routed through this way.

Either patient directly approach distributor and buy it or they are distributed directly to hospitals. The prices of these drugs are depended on off-take. “There is a margin for wholesalers and retailers. Margin is fixed for drugs which are registered whereas there is no fixed margin for unregistered drugs.

The margin for unregistered drugs depends on competitor price. The unregistered drugs will not be available in any chemist shop. These drugs directly go to patients or hospitals. You can call it direct hospital marketing,” elaborates Shah.

Despite the pharmaceutical industry's notable contributions to human progress, there is a growing tension between industry and the common men. The relationship between pharmaceutical industry, doctors and common men is controversial. Unlike consumer products where the customer makes an independent decision to choose, in the case of medicines the doctors are the one who choose the product for the patient.

A doctor prescribes a certain brand of drug depending on a number of factors like his relationship with drug companies. Drug makers know this and exploit it to the fullest.

“There is no such thing as ethical market.

There are many brands for one particular product. It is difficult to differentiate which product is better. The companies bribe the doctor with mobile phones, luxury cars, expensive holiday packages etc in order to get them to prescribe their drugs,” says Shah.

Major Challenges for Wholesalers Pharmaceutical wholesalers are facing a wide variety of challenges. The main hurdles include the single channel distribution in some states, limited advancement in customs, regulatory reforms, lack of skilled pharmacists, counterfeiting practices, and such others. Lack of skilled pharmacists is a growing concern.

According to the Indian Retail Druggists and Chemists Association, in 1978, there were roughly 10,000 distributors and 125,000 retail pharmacies in India.

Today, the total number of stockists in India is around 65,000 and the number of 22 June 2013

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pharmacies is about 550,000, an increase of around six and four fold, respectively.

Despite the rapid increase in the number of stockists and pharmacies, there has not been a proportional increase in the number of qualified pharmacists. “In Mumbai itself there are 40000 chemist shops. How will every chemist shop have a registered pharmacist for 24 hours when there are not enough pharmacy graduates?” asks Shah.

Pharmaceutical products require careful climate control throughout their transit period especially in a country, such as India with diverse climatic conditions.

Products, such as vaccines, require cold chain management in the entire process of transportation in order to maintain the quality and efficacy.

“India is a geographically diverse country with extreme climates that make distribution a critical function. While transporting drugs, a uniform temperature has to be maintained. Lack of proper warehousing for drugs is the main challenge for wholesalers.

In Mumbai, there is no such warehouse which is meant only for pharmaceuticals,” Shah explains.

The infrastructure for pharmaceutical cold chain management is still developing in India. This situation has forced pharmaceutical wholesalers to consider alternate cold storage systems. The industry needs to ensure the development of cold storage facilities and other essential infrastructural facilities. Distribution of medicines directly from the manufacturers to the pharmacy or hospital, creating a single channel distribution in some states also needs to be addressed.

Another main challenge is while dealing with Indian retailers. “Retailers buy on credit and sell on cash. They sell drugs to patients on cash but they don’t pay wholesalers on time unless there is a monopoly of wholesalers. Because of competition, the drug manufacturers have come out with so many incentives and schemes to sell their products, but the retailers do not pass the benefit to the consumer which is not right,” Shah expresses.

Supply Chain Constraints Delay in Indian customs is the major constraint in the supply chain management.

For every shipment to be passed through Indian customs, it will take almost three days while in USA & EU it will take only two-three hours. Ease of working is much better there.

“Second thing is packaging. Packaging costs have a significant weightage in drug pricing. In India, we try to find cheaper methods of packaging in order to cut down the cost of drug. When you go to UK/USA, they have standard packaging methods. Obviously the price of drugs will be high in those countries. But, they don’t compromise in packing for price of the product,” Shah notes.

“Role of India in global pharmaceutical export market is negligible. Indian products are considered substandard oversees and many of Indian companies supply counterfeit products. The definition for counterfeit is changed now. Counterfeit doesn’t mean that you are copying a product. It means that even if your product is substandard or if it is doesn’t fall within the limited parameters then it is considered as counterfeit drug,” adds Shah.

Future for the Wholesalers The pharmaceutical wholesale market in India is very promising and not yet fully exploited so the opportunities are enormous.

“International wholesalers are increasingly seeking opportunities to supply drugs to Indian market. They are mulling to acquire the Indian wholesalers. They will try to upgrade the technology and service level which will in turn reduce the profit margin.

But, there will be a monopoly as they will acquire all the SMEs. It will be a loss for people in India in general,” Shah explains.

"Increasingly aging populations and rising incidences of lifestyle diseases, as well as the need to reduce healthcare costs, will open up market for new drugs and likewise, sales of existing drugs will also rise," he concludes.

Pharma Bio World

6/21/2013 5:54:56 PM

Addressing Contract Management Challenges in an Increasingly Complex Business Environment Pharmaceutical companies operate in one of the world’s most competitive, complex, and highly regulated markets. Effective management of all trading relationships as well as pricing and reimbursement strategies is vital to the overall health of the business. With contractual commitments translating into billions of dollars, relying on manual methods for contract management is no longer viable, exposes an organisation to legal and financial risk and the disadvantages accrued due to poorly administered contracts.

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he Pharmaceutical supply chain brings together a multitude of business partners and processes, as well as complex trading relationships. These include numerous inherent factors like price, quality, payment, discounts, shipment, rebate policies, to name just a few. With more than 80 per cent transactions now happening against contracts and an increased focus to reduce maverick spending and transactions, organisations will need to implement an enterprise wide contract management system and strategy. Companies also have to face complex government regulations and are required to maintain financial calculations adhering to government pricing programmes and increased auditor scrutinyor otherwise bear the burden of unbudgeted overheads incurred due to steep fines as a result of non-compliance.

Pharmaceutical business in particular needs to ensure that the contract strategy clearly defines the terms, pricing, discounts and compliance requirements supported by the right systems to ensure there is no undue risk and leakage during business operations. Organisations that manage contract processes without sufficient

control and visibility to their contracts bring in an element of risk through non-standard language, unfavorable term, lengthy contract creation and approval cycles etc leading to maverick contracting and loss of commercial opportunities.

To meet the emerging contract management requirements, the enterprises need to gear up and choose a system that best meets their requirements after identifying areas that have the potential for significant improvement. Some recommendations for process improvement are: • Enforcing standard clauses and terms in contract that are in line with business strategy and policies across enterprise wide contracts.

• Making sure all contracts go through the right review and approval process; the deviations are reviewed for risk and benefit analysis and have the requisite approval records before contract execution.

• Global visibility into contract information and key milestones. Automated alerts on renewals, expiries, contract obligation milestones to ensure that there are no unfavorable renewals and all possible

Niranjan Umarane Director – Product Management Icertis

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The increased scale and complexity of contracts in business today makes it impossible to meet the above requirements effectively if fragmented processes around contract management are not done away with. Leveraging the right technology tools and automation can significantly accelerate contract management improvements.

The following key contract management strategies can be enabled through adoption of right technology tools and contract management systems to deliver desired business results.

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actual performance. While such contracts may achieve the business objectives, the operational implications are significant since it will be difficult to automate such complex calculations for rebate purposes. Hence, it becomes imperative to internally collaborate with various functions and define a contract approach that is in line with business objectives and is also practical from a day to day operations perspective.

enforce an approval workflow on a contract transaction. This ensures that contracts are reviewed and approved by the right pair of eyes and for the company there is a clear view available centrally on all the deviations, risks and benefits that are associated with all the contracts that the company has executed.

Once the contract strategy is in place the next critical step is to translate this strategy into a contract language for terms and clauses. Contract Management systems can help setup a library of clauses, terms and templates essential for creating and executing contracts that are signed across the enterprise on a day to day basis and then enable enforcement of these standards on contract transactions.

Deviating from standard terms and clauses requires a close assessment of risks and associated benefits. Contract management system can help determine contractual risks across different risk categories of business, financial, legal, contractual, geography or counter party.

Each category can have multiple risk criteria to assess the risk score like terms, discounts, clauses, geography, counter party profile, history of relationship, prior business performance etc.

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re-negotiation opportunities are fully leveraged.

Ensure an enterprise wide contract record centre that can enable easy and quick access to any contract or related information.

Track all contractual obligations to ensure that there is no scope for noncompliance that may result in losses or penalties.

Monitor business transactions to ensure compliance against terms to fully leverage negotiated terms or ensure discounts/rebates and claims are processed after due validation against terms.

Ensure visibility and collaboration between the different internal functions for better negotiation capability and also with external counter parties for faster speed to contract.

Contract managment without sufficient control and visibility will bring in an element of risk through non-standard language, unfavorable term, lengthy contract creation and approval cycles etc.

Contract Strategy & Standardisation

Governance Model

One of the most significant challenges that organisations have to overcome is the effective integration of contract strategy with contract operations. An example of contract strategy that can be considered to understand this concern: Implementing performance-incentive contracts with distributors based on a market share baseline that is adjusted quarterly as measured by

One of the key tenets of enabling governance on the contract process is to enable an approval process driven by a contract management system that also has the ability to assess the risk and benefit resulting from a particular transaction.

The system not only looks at the contract type, template and the associated data but also the deviations and risk assessment to

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Addressing contract Management.indd 24

Contract Risk Management

System can also be leveraged to validate the contract transaction for compliance to certain terms and clauses based on contract data and this can then feed into the risk scores for the contract. Risk assessment is a dynamic process as things change during the negotiation process and during the lifecycle of the contract.

Once the risk assessment is done high risk contracts can be made visible to the right stakeholders and made to undergo a stringent review, as a result establishing a risk mitigation process.

Contract Automation and Global Repository A contract management system can automate the entire process of getting Pharma Bio World

6/21/2013 6:02:51 PM

A typical global deployment can also leverage the integration to electronic signature platforms for a complete p a p e r l e s s e n v i r o n m e n t . E ff e c t i v e collaboration between internal functions and with third parties is critical to ensure speed to contract. Complete automation a l s o e n s u re s t h a t d o cu m e n t ve rsio n management, single source of truth and data integrity is automatically maintained.

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contracts created, reviewed, approved and executed. Configurable workflow capability, effective task management, timely alerts and notifications can ensure the productivity of the entire process is optimised and improved significantly in stark contrast to the prevailing manual practices.

Contract management system can help determine contractual risks across different risk categories of business, financial, legal, contractual, geography or counter party.

Contract Compliance Management In most companies today contracts when signed are filed in cabinets to be accessed only closer to expiry or in case of some exception during the lifecycle. There is no way to proactively track and ensure that all contractual obligations are met by all contracting parties.

termination to avoid any undue charges or penalties. Contract compliance management can help pharmaceutical companies to minimise discounts/rebates paid, leverage account and contract information to increase the effectiveness of sales and marketing campaigns and significantly reduce leakages in claims.

Contract KPI Management

A global contract repository completely eliminates isolated islands of information w h e re i t i s d iff icu lt t o e ve n lo ca t e contracts let alone get proactive visibility and alerts.

A centralised contract repository enables companies to not only get quick access b u t o p e n s u p a w h o le n e w a re a o f consolidated contract health assessment for the enterprise where analytics can drive significant insights into contract performance, risks etc on a single contract or a portfolio of contracts. This becomes a potent negotiation tool during negotiations or dispute resolution or for audit compliance.

Contract compliance management helps abstract all such obligations from inside the document and setup on the system.

Escalation emails are sent in case of probable non-compliance and system can also help track commercial compliance by monitoring business transactions.

For example, contract management can track business done by distributor to compare with the contract terms of rebates and discounts and accordingly approve/ disapprove any claims from the distributor for incentive/discounts/marketing funds etc. Another example- before terminating a contract it is imperative to understand provisions of the contract in case of a

Contract management system also helps to monitor and manage the contract performance by measuring and reporting on KPIs. A large sized global organisation with thousands of contracts and users needs to continuously monitor the KPIs and statistics related to contracts to ensure that contracts are enablers of business and not a hindrance. Bottlenecks can be easily identified and resources allocated appropriately to overcome the constraints. Configurable dashboards with role based access provide the required visibility into contract performance across the enterprise for real time contract management and administration.

Some key benefits derived by adoption of a contract management system are; • 55 per cent Improvement in contract compliance.

• 40 per cent improvement in contract turnaround times.

• More than 50 per cent reduction in errors reducing substantial rework and review time.

• Reduction in contract administrative costs by 25-30 per cent.

• Reduction in leakages and improved discount/rebate claims.

Organisations that adopt comprehensive contract management systems stand to optimise their business relationships, overcome inefficiencies and reap significant benefits.

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6/21/2013 6:03:17 PM

Ensuring Product Quality for Pharmaceutical Production Process

Joachim Baczewski President, Bosch Packaging Technology KK (Japan) and Head of Inspection Technology 26 June 2013

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atient safety and product quality must come first in pharmaceutical manufacturing processes. The development of biotech products and anti-cancer treatment, for example, is rising rapidly, requiring highly sophisticated technologies to inspect these products at all levels. This is especially important for parenteral products filled in vials, ampoules, syringes and cartridges. Other liquid pharmaceuticals, as well as solid dosage forms such as tablets and capsules, also require thorough inspection. Technologies range from manual and semi-automated to fully-automated systems. They are used either for the detection of product-related contamination, cosmetic container defects, or both.

Product contamination occurs when particles or foreign matter are found within the pharmaceutical. Contaminated APIs (Active Pharmaceutical Ingredients), foreign matter or filling material might get into the product during manufacturing or filling. Other means of contamination are particles from fractioned containers or human intervention. Cosmetic container defects, on the other hand, can already be present at the beginning of the process, or they might occur during handling, either by human intervention or by incorrectly adjusted machinery.

Cracks in syringe flanges, or defects in the sealing integrity of ampoules are some examples of container defects.

Inspection methods applied depend largely on product consistency, and on form and size of the containers.

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Human Intervention Still Indispensable Manual inspection systems typically consist of a black and white background and fluorescent light. They require the operator to physically agitate each container to set the liquid and any contaminants into motion, and to carefully inspect each container. The human eye, however, is limited in its inspection possibilities, and depends on light intensity, distance, focus point, fatigue, performance variations, and many other factors. Subsequently, manual inspection systems are mainly used for small batch sizes, produced for customised applications, laboratory analyses, and stability surveys. Other important fields of operation are evaluation of test sets, re-work of ejects, and benchmarking of fully automated machines, where they are practically indispensable.

Semi-automated inspection systems reduce the need for manual handling; automatic feeding, sorting and discharging functions simplify the inspector’s manual work, enabling him to focus entirely on the quality control of containers. Thus, semi-automated machines achieve increased inspection accuracy and throughput rates.

Visual inspection systems require significantly less capital investment than fully automated systems. Covering a wider range of potential manufacturing flaws than automated equipment, they conform to regulatory standards. At the same time, they depend on human expertise and are subject to human errors that lie beyond the influence of the manufacturer. Yet,

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Strict optimising and monitoring of pharmaceutical production processes will reduce the risk of product recalls and protect consumers from contaminated medicine.

The ability to evaluate processes in real time, to detect and quantify process- or componentrelated defects and to take corrective actions is essential for process optimisation and, ultimately, product quality and patient safety. The author gives an overview of the regulatory guidance, and the different inspection methods available in the market.

Contaminated APIs, foreign matter that get into the product during manufacturing or filling, particles from fractioned containers or human intervention, etc are the means of contamination.

Pharma Bio World

6/21/2013 6:07:00 PM

Automated Inspection Systems Automated particle inspection systems have their origins in the 1970s. The “Static Division” (SD) technology derives its name from the ability to differentiate static from moving objects. It transmits light through the solution onto an optical SD sensor. Each container is inspected twice in real time. The container is rotated and then suddenly stopped. The liquid continues rotating in the immobile container. The insoluble foreign particles that now float inside the stationary container are depicted on the photo detector (SD head). Depending on the size and type of the particles, a portion of the transmitted light is blocked.

These particles cast a shadow which is detected by light-sensitive diodes. These changes in light intensity are only caused by moving particles, not by immobile objects, which significantly decrease the number of false rejects.

Since its introduction in 1975, the SD technology has undergone various improvements and currently inspects the majority of parenteral products in clear solutions in over 50 countries worldwide.

The new SDx sensor is equipped with many new software features. For instance, regressive testing software stores up to 1,000 images for off-line tuning and viewing on mobile computing devices.

Failed images can be saved in order to troubleshoot false rejects. To maintain the same number of inspection images for 300 and 600 ppm, the SDx technology is equipped with a newly developed oscillating drive system. Like most Pharma Bio World

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manual and semi-automated inspection systems remain in wide usage where the investment in automated machines would not pay off. The United States Pharmacopeial Convention (USP) requires that particulate and other foreign matter visible to the human eye shall not be present. As a point of reference, a human inspector can detect approximately 50 per cent of all particles sized 50 micron.

Some automated inspection systems are able to detect particles below the human capabilities.

The insoluble foreign particles float inside the container are depicted on the photo detector.

Depending on the size and type of the particles, a portion of the transmitted light is blocked.

fully automated inspection machines, those based on SD technology can be connected to filling and closing lines, other inspection machines, labelers, and cartoners. A smooth combination with other inspection methods is possible at any time.

Automated camera-based systems are used for both particle and cosmetic inspection. They also follow the principle of agitating the container and capturing images of light reflected from moving particles. While the containers are rotated by more than 360 degrees, cameras take a series of high-resolution images. By comparing these images, the system identifies particles stuck to the sidewall, cracks in syringe flanges, as well as crimp or sealing defects. Pre-programmed parameters determine whether the container is rejected or accepted. Today,

Figure 1: The computer-bound visual inspection unit examines vials, ampoules, syringes and cartridges for particle contamination and cosmetic container defects.

the capabilities of camera-based systems have greatly improved. Thanks to higher resolution and processing speeds, incorporation of artificial intelligence and neural networks, adoption of a Graphical User Interface (GUI), and high-quality CCD or CMOS cameras.

These machines have developed into high-performance systems The Challenges and Opportunities of Process Analytical Technology In 2004, the American Food and Drug Administration (FDA) issued its Process Analytical Technology (PAT ) guidance and caused considerable turmoil in the pharmaceutical industry. PAT is “a system for designing, analysing, and controlling manufacturing through timely measurement (ie, during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.” The main focus of PAT is “building quality into products”, instead of inspecting quality after the product has already been manufactured.

While some existing technologies (described above) inherently conform to these requirements, PAT guidance triggered the development of entirely new technologies for the in-line elimination of variable product quality, especially in the area of solid dosage forms.

Machines with x-ray technology offer comprehensive quality and weight control, for instance of capsules.

Software development and new imaging capabilities contribute to a rapid advance of these technologies. Most recently developed inspection units are able to simultaneously check all quality features like weight, foreign particles, deformation of capsule top and bottom, as well as length in real-time and at June 2013  27

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Figure 2: The Static Division (SD) technology, developed by Eisai Machinery, detects moving particles in pharmaceutical liquids by use of an optical sensor. The new SDx sensor has been significantly updated and is equipped with many new software features.

high throughput rates. Leak detection via high-voltage for the inspection of seal and container integrity also ranges among the technologies frequently used for glass containers of, for instance, ampoules.

inspection are used, the process should be validated and the performance of the equipment checked at intervals.

Results should be recorded.” How this recording is done, is up to each pharmaceutical producer.

Validating Inspection Processes

Within the validation process, the creation and maintenance of samples is crucial to ensure that the inspection machine is maintaining the validated state under dynamic conditions.

Furthermore, challenge set samples provide the basis for adjustment of inspection parameters.

Manual and semi-automated inspection tools are well suited to inspect these samples. It is a common misconception that an automated machine is the only possibility to get the required inspection results, because the inspection process largely depends on the product, the type of defect, and the volume of the batch requiring inspection. On the other hand, even the best-trained human inspector cannot keep up with the high speeds of all production types.

Compared to other pharmaceuticals, the production process of parenteral products is a lot more complex. It comprises mixing and filtering, followed by packaging into cleaned and pre-sterilised containers under sterile conditions. Parenterals are typically injected. They directly enter the bloodstream, and might cause adverse reaction to contamination and particulates. The steps and components involved in the manufacturing process contain numerous risks of contaminants entering both process and product. The EU Guideline to Good Manufacturing Practice, Annex 1 states that “filled containers of parenteral products should be inspected individually for extraneous contamination or other defects.

When inspection is done visually, it should be done under suitable and controlled conditions of illumination and background. Where other methods of 28 June 2013

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Combinations on the Rise The manufacture of parenterals and especially generic products is experiencing

enormous growth. Competition among manufacturers is increasing, leading to the use of more high-speed machines for high-volume production. Here, manual inspection is quickly stretched to its limits.

How can pharmaceutical manufacturers best respond to growing control requirements? An example from another product quality-related issue might come in useful: pharmaceutical counterfeiting is addressed by a multi-layer approach, including serialisation, authentication and tamper-evidence. What proves successful in one area can be transferred to another: depending on the volume and the type of pharmaceutical product and container, a combination of automated and manual inspection is sure to be most reliable.

The number of manufacturers integrating different inspection technologies into their production processes both in-line and end-of-line will further increase in the near future.

To ensure that inspection machines operate at their best, manufacturers must pay attention to validation requirements and perform regular maintenance activities. They must also carefully monitor the process and check new regulations and guidelines, as well as the availability of new technologies.

Depending on parameters such as volume, container type and size, as well as cost/benefit considerations, each manufacturer must determine the appropriate inspection method for his products. The possibilities of inspection technology are immense. So the decision for robust and reliable technologies is of utmost importance for high product quality. The keys to higher patient safety and minimised product recalls lies in knowing which inspection systems are available in the market – and in working with high-quality suppliers.

References - Michael de la Montaigne, Pedro. J. Mendez, Ryosaku Tagaya: Inspection of Parenteral Products.

Davis Healthcare International, 2009.

- h t t p : / / w w w. b o s c h p a c k a g i n g . c o m / eisaimachinery/ Pharma Bio World

6/21/2013 6:10:39 PM

Highlights of ASCO Annual Meeting 2013 Data at ASCO 2013 revealed some promising agents which are likely to emerge as key players in the oncology landscape in the near future. In addition, the focus on immunotherapy promises to change the way cancer is managed and provides hope of an elusive cure where prolonging survival is probably the only achievable goal at present.

Indegene Lifesystems Source: ASCO Annual Meeting 2013 May 31-June 4, 2013, McCormick Place, Chicago, Illinois

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SCO (Annual Society of Clinical Oncology) 2013 conference held at Chicago, Illinois generated a lot of buzz despite the absence of a truly paradigm changing data. The major headline that captured everyone’s attention was the recent developments in immunotherapy which promised significant clinical benefits and the possibility of durable remission. This report captures the key highlights from the five day conference that concluded recently.

Melanoma After ipilimumab in 2009, immunotherapy once again captured the centre stage with targeting of PD-1 and PDL-1 being the main topics of discussion. In continuation with the initial data at ASCO 2012, data from BMS’s PD-1 remains impressive.

The agent reported clinical benefit both as monotherapy and in combination with ipilimumab in advanced melanoma.

At Maximal Tolerated Dose (MTD), the combination of ipilimumab and nivolumab produced objective response in 53 per cent patients with advanced melanoma, all with tumor reduction of 80 per cent or more. Treatment-related grade 3 or 4 adverse effects occurred in 53 per cent of patients but were qualitatively similar to previous experience with monotherapy and were generally reversible. Combination was also reported to be active in patients progressing on ipilimumab.

Nivolumab monotherapy also demonstrated promising results with at least 30 per cent tumor shrinkage in 33 of the 107 advanced melanoma patients treated. The agent is currently in phase 3 trials for advanced melanoma, Non-Small Cell Lung Ca Cancer (NSCLC), and Renal Cell Carcinoma (RCC) and is likely to have a major impact on the oncology landscape. The mechanism of action is emerging as a key area of focus as multiple big pharma companies such as Merck and Roche looking to

develop agents. Merck is developing a PD-1 inhibitor, lambrolizumab, which has received FDA breakthrough therapy designation. Roche is in the race with its PDL-1 inhibitor MPDL3280A. Chronic Lymphocytic Leukemia (CLL) The good news continues for CLL. Ibrutinib was the star performer at ASH last year while impressive results were demonstrated by therapy with obinutuzumab as well as with idelalisib at ASCO 2013. Preliminary results from phase 3 trial of Roche’s novel, next-generation anti-CD20 monoclonal antibody obinutuzumab showed that the agent is potentially more efficacious than the blockbuster rituximab. In a 3-arm trial comparing chlorambucil alone versus chlorambucil in combination with either rituximab or obinutuzumab, investigatorassessed progression free survival served as the primary endpoint. Stage 1a compared chlorambucil with the obinutuzumab regimen, while stage 1b compared chlorambucil with the rituximabcontaining regimen. Median PFS rates reported for chlorambucil alone were 10.9 months in stage 1a and 10.8 months in stage 1b, compared with 23 months for obinutuzumab and 15.7 months for the rituximab-containing regimen.

Obinutuzumab was granted FDA breakthrough designation and Roche has completed the regulatory submission for approval for newly diagnosed CLL, both in EU and US. The other key agent in focus for CLL was Gilead’s PI3K delta inhibitor, idelalisib. A phase 2 study of idelalisib in combination with rituximab, showed significant clinical benefit in treatmentnaïve patients with CLL (≥65 years) including high risk cohorts; along with a favorable toxicity profile. An overall overall response rate (ORR) of 97 per cent was reported, along with an ORR of 100 per cent in the poor prognosis 17pdel/T53 mutation subset. Idelalisib is expected to emerge as a key player in the NHL landscape.

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6/21/2013 7:51:31 PM

Breast cancer Effectiveness of extended hormonal therapy in patients with early, HR+ve breast cancer has been an area of discussion for over a decade now. Two large trials, ATLAS and aTTom, were designed to answer the question and explore the usefulness of extended hormonal therapy with tamoxifen in these patients. Results from ATLAS trial were reported last year and showed 3-4 per cent fewer deaths due to breast cancer with 10 years of tamoxifen therapy versus 5 years. The results of aTTom trial presented at the plenary session during ASCO 2013 showed a significant 15 per cent reduction in the risk of recurrence and a significant 25 per cent reduction in the risk of breast cancer mortality starting at year 10 with 10 years of tamoxifen therapy.

The results were closely aligned with the findings from the ATLAS trial. The data adds to the evidence that longer hormonal therapy might be helpful, especially for high-risk patients.

Data from the aTTom trial adds to the evidence that longer hormonal therapy might be helpful, especially for high-risk patients Non-small Cell Lung Cancer Lung cancer is an area that has perhaps been due for a major breakthrough in emerging therapy for some time now. At ASCO 2013, immunotherapy with anti-PD therapy showed promise to provide that breakthrough in the near future in NSCLC while encouraging data was also presented from nintedanib’s pivotal trial LUMELung 1. Major development in NSCLC, reported at ASCO this year, included the promising activity of Roche’s anti-PDL-1 agent, MPDL3280A in this tumor type, as well as data on newer agents, nintedanib and LDK378 for for second line and ALKpositive NSCLC respectively. Data from phase 1 trial MPDL3280A, reported tumor shrinkage or stable disease in nearly half of a cohort 52 patients with heavily pretreated NSCLC. There was no MTD or dose limiting toxicities, and majority of adverse effects were grade 1 and 2. Stable disease of 24 weeks or longer was reported in 16 per cent patients with a 24-week PFS rate of 45 per cent. Activity was reported in both 30 June 2013

ASCO.indd 30

squamous and non-squamous histology with ongoing responses in all responders.

Association with tumor PDL-1 expression is being evaluated and expansion phase in various tumor types is ongoing. Boehringer Ingelheim’s nintedanib, in combination with docetaxel, showed an OS benefit of 2.3 months in second line treatment of NSCLC over treatment with docetaxel alone (12.6 vs. 10.3 months, respectively) in the phase 3 trial, LUME-Lung 1. The most common adverse effects were GI side effects and liver enzyme elevations which were manageable by supportive treatment or dose reduction. Withdrawal due to AEs was similar in both arms. Promising results from a phase 1 trial of LDK378, a second generation ALK inhibitor by Novartis, in patients with advanced ALK+malignancies, were also presented at ASCO 2013. Of the 130 patients enrolled, 122 patients had NSCLC. In the 114 evaluable NSCLC patients across all doses, Overall Response Rate (ORR) was achieved in 58 per cent patients. Response rates were similar in both Xalkori-resistant and Xalkori-naïve patients. Most common grade 3/4 toxicities included alanine aminotransferase (ALT) elevation, diarrhea, and aspartate transaminase (AST) elevation. The agent has received FDA breakthrough therapy designation, and phase 3 trials are scheduled to begin soon in both treatmentnaïve and pretreated patients.

Ovarian Cancer Maintenance therapy after first line may help which is used in ovarian cancer with the aim of extending PFS in these 1 st-line patients. Despite the acceptance of the concept of maintenance therapy in ovarian cancer for several years now, it has not yet been adopted uniformly into practice.

Pazopanib’s POIZE trial evaluated the agent as maintenance therapy in patients with advanced ovarian cancer. Results of the trial presented at the ASCO annual meeting reported that the agent met the primary endpoint of PFS improvement by 5.6 months compared to placebo (mPFS: 17.9 months versus 12.3 months). The OS results are not yet mature, but an interim analysis did not find any survival benefit with pazopanib. The incidence

of AEs was higher in the pazopanib arm.

Regulatory approval may be difficult if the OS trend continues and the trial fails to demonstrate OS benefit. Regulatory approval for pazopanib in maintenance setting for ovarian cancer may be difficult if the OS trend continues and the trial fails to demonstrate OS benefit.

Glioblastoma Multiforme (GBM) Bevacizumab is approved by FDA for treatment of recurrent glioblastoma and has been used off-label as firstline treatment in certain patients. The results of a phase 3 trial evaluating the addition of bevacizumab to first-line chemoradiation were presented during the plenary session at the conference and reported that the addition of bevacizumab failed to improve overall survival compared to chemoradiation alone.

Median OS was similar between the two groups (15.7 months vs. 16.1 months for bevacizumab and placebo, respectively).

Median Progression-Free Survival was 10.7 months in the bevacizumab arm compared with 7.3 months in the placebo arm. Results of a QoL analysis were in favor of the chemoradiation-alone group.

The findings do not support the use of bevacizumab in frontline management of GBM. Cervical Cancer According to a phase 3 study presented during the plenary session at ASCO 2013, the addition of bevacizumab to chemotherapy improved OS, PFS and clinical response rates in women with relapsed cervical cancer. Recurrent/ relapsed cervical cancer is an area of high unmet need. The current SoC of cisplatin plus paclitaxel extends survival for about 12 months or less, with no available options for non-responders or patients progressing on the SoC. Median OS was 17 months in the bevacizumab arm versus 13.3 months in the chemotherapy arm. The tumor shrinkage rate was reported to be higher in the bevacizumab arm.

This is the first study to demonstrate significantly prolongation of OS in women with relapsed cervical cancer.

Pharma Bio World

6/21/2013 7:52:22 PM

Market Research

Impact of Recent Ranbaxy Fiasco on Indian Pharma Exports

Last month, Ranbaxy had accepted US FDA charges of faking data and selling adulterated drugs in the US and agreed to pay USD 500 million as fine. Dr E Saneesh, Research Analyst, Business & Financial Services – Healthcare, Frost & Sullivan analyses the impact of this controversy on the Indian pharmaceutical exports.

T

he eight-year-long legal haul between Indian generic giant Ranbaxy Laboratories (Ranbaxy) and the United States Food and Drug Administration (FDA) has finally ended after the former pleaded guilty of violations related to Federal Drug Safety Law in May 2013. The legal battle dates back to 2008 when the FDA banned imports for over 30 generic drugs manufactured by Ranbaxy, after inspection at its Dewas plant and another plant at Paonta Sahib in Himachal Pradesh in India revealed non-compliance with Current Good Manufacturing Practices (CGMPs) at these plants. The ban was followed by further warnings and new charges that Ranbaxy had submitted false data in drug applications to the FDA, including backdating of tests and submitting of test data for which no test samples existed. These events led to filing of consent decree by the United States Department of Justice in January 2012 and since then Ranbaxy has been operating under the consent decree. The May 2013 announcement that Ranbaxy settled felony charges over violations in manufacturing practices and data submission with the US

“

“

Ranbaxy Sun Pharma Dr. Reddy’s Lupin Cipla

Figure 1: Performance of stocks of Leading Indian Pharma Companies (June 1 2012-June 11, 2013) Source: Capital IQ and Frost & Sullivan analysis

Department of Justice (DoJ) by agreeing to pay over USD 500 million as fine was climactic.

Though Ranbaxy has assuaged the criminal proceedings by paying a hefty fine, the nature and seriousness of these transgressions look to pose a potential pitfall for the generic manufacturer.

Though Ranbaxy has assuaged the criminal proceedings by paying a hefty fine, the nature and seriousness of these transgressions look to pose a potential pitfall for the generic manufacturer.

Pharma Bio World

MARKET RESEARCH.indd 31

Moreover, the inclusion of the company in the Application Integrity Policy (AIP) list will halt the existing and pending applications from those facilities under the scanner.

The plummeting stock price of Ranbaxy between June 1, 2012 and June11, 2013 has clearly reflected the turmoil. Exhibit 1 depicts the stock performance of leading Indian pharma companies from June 1, 2012-June 11, 2013.

On analysing Ranbaxy’s financials, it is clear that the gross margins have been reducing in the last 12 months (LTM) till March 2013. This is primarily attributed to the recall of Lipitor from the US market.

And, if FDA and the Indian regulators unveil any more new non-compliance issues by June 2013  31

6/21/2013 6:20:24 PM

However, the interest coverage ratios like Earnings Before Interest and Tax (EBIT)/Interest Expenses and Earnings Before Interest, Taxes, Depreciation, and Amortisation (EBITDA)/Interest Expenses are not in a very bad state, indicating that the company will be able to service its debt in the short term.

Exports by Indian pharma companies comprise a major chunk of the global generics market, which were close to USD 15 Billion in 2012 and almost 40 per cent of the exports were to the US. The immediate impact of the Ranbaxy incident on the Indian generics exporting is imminent but transient. So, the negative sentiments toward Indian generics in the US are expected to decimate their exports. This high-intensity violation will also increase the scrutiny on ANDAs (Approved New Drug Applications) and exports from India.

“

LTM Ending Dec 2010

LTM Ending Dec 2011

LTM Ending Dec 2012

LTM Ending Mar2013

Gross Margin

60.4%

61.3%

61.3%

56.5%

Net Margin

16.7%

(28.3%)

7.4%

(1.8%)

EBIT/Interest Exp.(Multiples) *

28.6x

34.3x

21.6x

14.3x

EBITDA/Interest * Exp.(Multiples)

33.2x

38.7x

23.8x

16.3x

Revenue Growth over prior year

18.0%

14.2%

21.8%

(4.5%)

Figure 2: Key Financials of Ranbaxy Laboratories Source: Capital IQ and Frost & Sullivan analysis; Key Financials of Ranbaxy Laboratories *Numbers in brackets indicate negative numbers *These ratios are multiples and ‘X’ means number of times

the Indian pharmaceutical industry to reach 18 per cent by 2016-2017. The domestic as well as international market has been taken into account, each contributing a projected growth rate of 21 per cent and 16 per cent, respectively. The industry now supplies 10 per cent of the global production, which comprises around 20 per cent of generics globally, and it has evolved from a developing industry to a major participant.

Over the years, the credibility of Indian generics among various stakeholders ranging from patients to regulators has improved. India has the highest number of approved manufacturing facilities outside the US. And, in 2012, out of 476 total Abbreviated New Drug Application (ANDA)

“

the company, then it is going to further stimulate the existing negative sentiments against Ranbaxy’s products. This will lead to more advisories against the prescription of Ranbaxy drugs. This may further reduce the overall sales inventory outstanding.

This expected scenario has made the Total Enterprise Value/Next Twelve Months (TEV/NTM) multiple to reduce from 1.71 times in March 2013 to 1.59 times in June 2013.

The immediate impact of the Ranbaxy incident on the Indian generics exporting is imminent but transient. So, the negative sentiments toward Indian generics in the US are expected to decimate their exports.

H o w e v e r, t h i s is n o t a n im m u t a b le s c e n a ri o d u e t o t w o m a jo r re a so n s.

Firstly, the historical nature of the case; and secondly, Ranbaxy is not a case to be seen in isolation.

This particular issue is nearly eight years old and both Ranbaxy and the Indian Generics export market have evolved since then. The Working Group on Drugs and Pharmaceuticals Industry’s report for the 12 th Five Year Plan pegs the growth rate for 32 June 2013

MARKET RESEARCH.indd 32

approvals by FDA, more than 35 percent applications originated from India.

Mounting pressure to reduce healthcare costs and expiring patents has enabled generic drugs to take center stage in the market. The use of generic drugs have increased over the years and is constantly increasing in the developing countries.

In 2011 more than 75 per cent of the prescriptions written in the US had generic

versions of branded drugs. In recent years, due to various reasons like increasing incidents of patient deaths from adverse effects, medication contamination, and counterfeit drugs, the regulatory bodies across countries have increased their scrutiny over pharma companies.

The Ranbaxy crisis cannot be viewed in isolation. Historically, even the big innovator pharma companies like Pfizer Inc, GlaxoSmithKline Pharmaceuticals Ltd, and Merck, have been made to pay fines for deviations from regulatory norms.

However, these companies were picked up by the regulator mostly for promotion of medicines for unapproved usage, unethical marketing of products, non-disclosure of health risks, etc, unlike non-compliance to CGMPs and fraudulent data submissions.

The FDA has also sent import alerts to other countries like China, Brazil, Canada, Italy, etc, stalling the import of their products to the US. Having said that the backlash due to this crisis will not last long in the industry, the recent reports of import alerts issued

by FDA on manufacturing facilities of Wockhardt Limited, another Indian generic major; and delay in FDA clearances for three of the facilities of Divis Laboratories is adding to the existing blow on the image of the Indian generics. To put it in a nutshell, this crisis situation should be taken as a call to action by industry participants to be increasingly transparent and ensure a higher level of compliance to regulatory requirements.

Pharma Bio World

6/21/2013 6:21:43 PM

PBW Marketing Initiative

In-Sight Vision System Guarantees Perfect Quality in Pharmaceutical Packaging This automated packaging system checks for complete packaging of the products, positioning them for the tattoo needles and does much more.

M

ost of the pharmaceutical products such as vials, clinical products, blister strips etc., for the small and medium-sized (SME) pharmaceutical and healthcare manufacturers are usually packed by external service providers. It has been proven many times that the cost of using these service providers sometimes prove to be unsustainable in the long run.

but large manufacturers can use it to meet requirements during high-demand periods.

The system is easily moved because it is on rollers, and it lets pharmaceutical and healthcare do their packaging in a minimum of space at maximum quality levels – at cycle rates of up to 45 units a minute and 40,000 units per day in minimal operational space.

And there is also the quality issue. To maintain the quality of the products, it is essential or advisable that manufacturers have their own units, which, would help them in producing high volumes and overcome the high costs. The challenge was to drive down large-scale packaging costs for a small-to-medium-sized pharmaceutical product manufacturer.

Compact Means Quick

The solution that was found out was to have a fully automated, compact packaging process featuring an In-Sight ® vision system to ensure the highest quality from a high-speed production line. Knoll VpA GmbH of Hüttisheim, Germany has developed a fully automated, compact packaging process to meet this challenge.

Knoll’s automated packaging system features intelligent quality control using a Cognex In-Sight ® vision system. Knoll‘s designed this system specifically for SMEs

Knoll’s compact blister packaging machine is suitable for clinical packaging operations, prototype packaging and small to medium production runs, as well as vials and blisters. It enables pharmaceutical and healthcare manufacturers to shape both hard and soft packaging materials such as PVC/ALU or ALU/ALU, to fill and seal them and to produce blister pack formats.

It feeds in the packaging film, heats and shapes it. It prints the foil seal and applies it before finally marking and stamping the product units.

Quality control is managed entirely by the In-Sight vision system, which checks the completeness of the packaged products as well as their shape and position and guarantees absolutely perfect quality.

Cognex In-Sight ® vision systems are self-contained, industrial grade vision systems that combine a library of advanced vision tools with high-speed image acquisition and processing.

Flexible Means Better The In-Sight vision system has also improved the positioning accuracy of modules for Knoll’s tattoo machines.

Despite the contrast difficulties caused by black plastic heads with integrated tattoo

Pharma Bio World

Cognex.indd 33

needles, the vision system determines the positioning using a small ink filling opening of only about 3x3 mm (0.119x0.119 inch).

This system also helps in finding out whether the needles that are used are round or broad versions. It is simple to test a wide range of tattoo modules using preconfigured settings.

The extensive Cognex image-processing library makes this quick and easy. The EasyBuilder ® configuration software is simple to use, a touch screen which helps in quickly enabling and controlling the highperformance Cognex image processing tools.

A Vis ionView ® v is ua lis a tio n s y s te m provides the user interface – monitoring the manufacturing processes and eliminating the need for a PC. The VisionView ® operator display panel provides a “plug-and-go” solution, a PC software version as well as a VGA adapter for monitoring the runtime operation of any In-Sight vision system on the network.

When used in larger system networks, it automatically detects any Cognex image processing system and can simultaneously display the data from up to nine vision systems.

Smaller is Smarter The 30x30x60 mm (1.18x1.18x2.36 inch) vision system delivers a complete image processing system. Flexible mounting options include a non-linear calibration tool that allows the system to be mounted at an angle of up to 45 degrees – even in tight spaces on robots and in difficult-to-access locations.

For further information, please contact: Piya D Banerjee: +91 9096699998

June 2013  33

6/21/2013 7:24:45 PM

pharma news DPCO 2013: What Awaits Drug Makers?

The Department of Pharmaceuticals, under the Ministry Of Chemicals and Fertilisers, Govt of India on the 15 th of May, 2013 announced the Drug Price Control Order 2013.

According to the Drug Price Control Order 2013, the cost of 652 drug formulations is going to be restricted replacing 74 bulk drugs and their formulations as per the earlier DPCO 2013 and includes 348 life-saving drugs in the National List of Essential Medicines 2011. The ceiling price will be calculated based on the average of all the brands and a 1 per cent market share. A 16 per cent margin for pharmacists is included in the calculation. The prices of formulations have been estimated to reduce drastically including anti-HIV drugs.

This will make the drugs more affordable for the consumers. For the first time that the multi-national companies will come under price control in India. The new policy will not affect the patented formulations and the bulk drugs. The scheduled formulations being sold at a price lower than the ceiling price will remain the same and will not be allowed to rise.

Industry and that the Industry must learn from this. She also adds that this is an eye opener and calls for the need to come up with stricter drug regulatory norms.

Meanwhile the Drug Controller General of India (DCGI) is scrutinising the legal documents of Ranbaxy filed in the US.

India’s Top Generic Drug Manufacturers Await the Patent Expiry of Top US Drugs The top generic players in India are now looking forward to generate profit from the US market as they await the patent expiry of top US drugs. A Supreme Court ruling has allowed for the selling of the drugs patented in other countries at a cheaper price in India making India a potential market for the generic drug makers.

According to analysts, the probable reason for the shift of interest of these companies to the US market in spite of the SC ruling could be the Drug Price Control Order 2013 which limits drug prices that cuts into their margin.

Merck Calls off Development of their ASLAN Pharma Announces Successful Anti Parkinsonian Drug Phase 2 Study with ASLAN001 Preladenant, an experimental drug to treat Parkinson’s disease was in the process of development by Merck.

The company decided to call off its further development due to insufficient evidence to prove its efficacy over a placebo based on the data obtained from three separate phase III trials. However, the company will continue to work on newer approaches to treat the disease.

A Lesson Worth Learning from Ranbaxy Soon after Ranbaxy pleaded guilty of violating the regulatory norms and selling their adulterated drugs in the US market, the whole Indian Pharmaceutical Industry was taken by surprise.

Daiichi Sankyo Co, a Japan-based pharmaceutical company which now holds the major shares of Ranbaxy has claimed that the former promoters of Ranbaxy, the Singh family had hidden vital information regarding US DOJ and FDA investigations. The Singh family has claimed these allegations as false saying that Ranbaxy settled on an agreement with the US FDA and DOJ according to which the company would cough up a large amount as penalty charges and that this was decided without consulting them. Following the Ranbaxy incident, Apollo Pharmacy (a chain of retail pharmacy stores) has issued a warning questioning the safety of Ranbaxy drugs. Mumbai-based Jaslok hospital has instructed its doctors against prescribing Ranbaxy drugs.

Biocon’s Chairman and MD, Kiran Mazumdar Shaw has termed the Ranbaxy issue a ‘wake-up call ‘for the Indian Pharmaceutical 34  June 2013

Pharma News.indd 34

ASLAN Pharmaceuticals announced the results of a phase 2 clinical trial with ASLAN001, a small-molecule pan-HER inhibitor, in gastric cancer. ASLAN001 reduced cell proliferation and cell survival in gastric tumours that were either coexpressing EGFR and HER2 or that were HER2 amplified. ASLAN001 was invented

by Array BioPharma Inc (NASDAQ: ARRY) and licensed to ASLAN in 2011.

“This is the first time a drug has shown activity in this patient population,” said Dr Alan Barge, ASLAN’s Chief Medical Officer.

“The burden of gastric cancer is particularly severe in Asia. It is the most prevalent cancer in males in China, where it is estimated to affect over half a million people.”

The phase 2, open-label, multicentre study was conducted at Seoul National University Hospital, South Korea, and was designed to evaluate the biological activity of ASLAN001 in patients with recurrent/metastatic gastric carcinoma whose tumours were HER2 amplified or coexpressing EGFR and HER2. 23 patients, who had previously failed on one or more rounds of chemotherapy and, where eligible, trastuzumab, each received 500mg of ASLAN001 orally twice daily as monotherapy for 28 days. Tumour biopsies taken before and after treatment were analysed using immunohistochemistry.

In this heavily pretreated population, ASLAN001 led to a downregulation of signalling pathways responsible for cell proliferation, and a reduction in cell survival and cell proliferation.

Toxicities observed were consistent with other drugs in this class and the previously reported profile of this compound.

Pharma Bio World

6/21/2013 3:17:51 PM

US FDA Rejects Valeant’s Anti-fungal Drug Nail fungal infections also known as onychomycosis infect the fingernails and toenails. Growth of the fungus occurs beneath the nails, making it difficult to reach and cure, at times. The fungus thrives in places that are warm, moist, and dark. Onychomycosis causes nails to deform, discolor, thicken, become brittle and split and separate from the nail bed.

Valeant Pharmaceuticals International, a Canada-based drug manufacturer said that the US FDA didn’t approve of the packaging units used to dispense the anti-fungal drug Efinaconazole used in the treatment of onychomycosis. According to this Canadian drug maker, the FDA didn’t question the efficacy or safety of the drug.

APDCA Seizes Spurious Drugs Worth ` 1.5 Crore The Andhra Pradesh Drug Control Administration has seized spurious drugs worth ` 1.5 crore since the past six months after the new Director General of APDCA, Dr B L Meena took charge.

Of the total 51049 inspections that were carried out in the state including drug manufacturing units and retail stores, around 3527 sales licences were suspended and 37 manufacturing licences were cancelled. 78 samples out of the 6127 analysed drug samples failed meet the quality requirements. Around 6 stop production orders have been passed by the state DCA. APDCA has employed 56 new inspectors who have been trained in analytical lab procedures and legal proceedings. In addition the DCA has also launched its new website that will facilitate easy issuance of drug licences that will also ensure transparency on their part.

To what extent these measures undertaken by the APDCA help to reduce fraudulent manufacturing and distribution is to watch out for.

Arzerra-Chlorambucil Combo may Treat Chronic Lymphocytic Leukaemia GlaxoSmithKline and Genmad declared their Phase III clinical trials of Arzerra (ofatumumab) in combination with chlorambucil rather than chlorambucil alone in patients with previously untreated Chronic Lymphocytic Leukaemia (CLL) to have shown positive results.

Dr Kathy Rouan, vice president BioPharmaceutical Development, GlaxoSmithKline, informed that their the aim of treating CLL, to maximise progression free survival and minimising side effects have been well met with.

Pharma Bio World

Pharma News.indd 35

The most common serious adverse effects as reported by the investigator within 60 days of last treatment were neutropenia [including febrile neutropenia] (five per cent), anaemia (four per cent), pneumonia (four per cent), and pyrexia (two per cent). Infusion reactions were mild to moderate in severity with three per cent of infusion reactions reported as serious. As such, no unexpected side effects were reported.

Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL. Ofatumumab is being developed under a co-development and commercialisation agreement between Genmab and GlaxoSmithKline.

Zydus Brings in the First Indian NCE, Lipaglyn The Zydus Group announced a breakthrough in its research efforts with Lipaglyn (Saroglitazar), a novel drug targeted at bridging an unmet healthcare need for treating Diabetic Dyslipidemia or L to R Dr Sharvil Patel-Dy MD, Hypertriglyceridemia in Type Pankaj Patel-CMD and Ganesh II diabetes, not controlled by Nayak-COO&ED, Zydus Cadila. statins alone. The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule, Lipaglyn is the first Glitazar to be approved anywhere in the world.

“Lipaglyn provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control,” said Pankaj R Patel, Chairman and Managing Director, Zydus Cadila.

Diabetic Dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the “bad” low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the “good” high-density lipoprotein (HDL) cholesterol concentration in the blood. Optimal LDL cholesterol levels for adults with diabetes are less than 100 mg/dL, optimal HDL cholesterol levels are equal to or greater than 40 mg/dL, and desirable triglycerides levels are less than 150 mg/dL. Lipaglyn, a non-thiazolidinedione, is the first therapy to be approved for this condition.

World over, it is estimated that 30 per cent of all deaths occur due to cardiovascular diseases (CVD). In India, one out of every five persons is at serious risk of developing CVD. Research has shown that diabetes is one of the major risk factors of CVD. India has a population of nearly 65 million diabetics and 77 million pre-diabetics.

85-97 per cent of the diabetes patients suffer from dyslipidemia or lipid abnormalities. Hence, addressing the problem of diabetes and dyslipidemia is crucial in tackling the health risk posed by CVD. June 2013  35

6/21/2013 3:19:43 PM

Vasa Pharmachem Bags the India SME 100 Award

production of high purity water. Developed taking into account the limitations of conventional EDI, the FEDI process improves the reliability of EDI for the production of high purity water.

Vasa Pharmachem Pvt Ltd, a pioneer in chemical and pharmaceutical raw material manufacturing, has added another feather to its cap by featuring in the elite list of top 100 Indian Small and Medium Enterprise. The India SME100 award is a recognition accord to Vasa Pharmachem Pvt Limited as the Achievers in growth and profit after scrutinising 42623 small and medium enterprises nominations received from all over India.

QUA develops, manufactures and markets advanced membrane products to treat challenging waters. Headquartered in the USA, the company also operates facilities in Europe and India. The company is committed to ongoing innovation, leveraging its deep roots in R&D and the expertise of staff that is highly experienced in water treatment technologies. QUA manages the entire lifecycle and manufacturing chain of its products from the initial concept to manufacturing according to the most rigorous quality standards.

QUA products are sold and serviced through a global network of qualified equipment manufacturers.

This is a prestigious award, instituted by the India SME forum, supported by Government of India (Ministry of MSME) and Bank of India for developing a culture of entrepreneurial spirit and building a robust SME space in India.This is an important milestone for us for having consistently delivered on our promise as well as providing business value through high impact, cost efficient products to our suppliers.

Vaishali Vasa, Joint Managing Director & Vrujal Vasa, Director received the award on 18 th April 2013 at Mumbai on behalf of Vasa Pharmachem Pvt Ltd.

QUA Launches “FEDI-Rx” Pharma Line of Electrodeionisation Products QUA, a leading-edge developer of advanced membrane products for water and wastewater treatment applications, has launched FEDIRx Fractional Electrodeionisation product range specially designed for applications in pharmaceutical, biomedical and laboratory applications where installations require hot water sanitisation to meet pharmacopoeia standards for Purified Water (PW) and Water For Injection (WFI).

“After successful acceptance of our industrial range of FEDI, we are now ready to service the pharma, medical, biomedical, cosmetics and laboratory arena with our innovative product range branded as FEDI-Rx. We are confident that our patented process of manufacturing ion exchange media will provide improved reliability of performance in these applications,” said V J Nathan, Technical Director, QUA Group.

In a short span of two years, the QUA Group’s FEDI has more than 25 global installations including various sites in USA, Europe and Asia. The company recently received the 2013 Frost & Sullivan New Product Innovation Award for Industrial Water & Wastewater Treatment Technology, North America, for FEDI Electrodeionisation and its Q-SEP Hollow Fiber Ultrafiltration Modules.

With patented dual voltage technology, QUA’s FEDI technology is the next generation of electrodeionisation (EDI) technology for the 36  June 2013

Pharma News.indd 36

4th Annual Clinical Trials Summit 2013 Held in Mumbai by Virtue Insight The 4 th Annual Clinical Trials Summit 2013 was held in Mumbai on the 7 th of June, 2013 by Virtue Insight which witnessed the presence of professionals involved in clinical trials and research. Some of the key issues addressed in the conference were ‘Updating towards guidelines and regulations in the Indian Clinical trial market’, ‘Discovering global opportunities in Clinical trials’, ’Sponsor-SiteCRO Relationships’.

The conference aimed to serve as a platform to shed light on the challenges that have emerged following the Drugs and Cosmetics (Third Amendment) Rules, 2013 and the future of Clinical Trials in India. The need to review the new amendment and measures to improve the opportunities of clinical trials in India were addressed in the discussions. The speakers and panellists for the discussions included experts from Clinical R&D and Regulatory Affairs, Regulatory Consultancies etc. The conference concluded with an optimistic note to bring India back on track in the Clinical trial scenario and establish it as a Global Clinical Trial Hub.

Eli Lilly to Bring its Insulin Delivery Device Soon to India Eli Lilly and Company, an US-based major drug maker aims to be among the top 20 pharma companies by 2020 in India from its current 50 th position and hopes to strengthen its presence in core segments like diabetes, oncology, cardiovascular and neuro sciences.

Diabetes is a strategic segment for the company and India has a huge population suffering from it. The company intends to launch “Savvio” in the Indian market which is its innovative insulin delivery system this August. Apart from India, the company said that Indonesia and Vietnam are the other high growth markets that the company will be argeting. “It is a very important country for the company. We see tremendous growth prospects here,” said Jannie Oosthuizen, president, Eli Lilly Asia Operations.

Pharma Bio World

6/21/2013 3:20:17 PM

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Eris Lifesciences Bags Frost & Sullivan’s Competitive Strategy Leadership Award Frost & Sullivan presented the 2013 Competitive Strategy Leadership Award, India to Eris Lifesciences Pvt Ltd in the Pharmaceutical Industry. The Award was received by Amit Bakshi, CEO, Eris Lifesciences Pvt Ltd. The Frost & Sullivan Competitive Strategy Leadership Award is bestowed upon the company that has demonstrated excellence by continually focusing on inventing a product portfolio based on newer opportunities and existing therapy gaps in each market after conducting market research.

Eris Lifesciences has focused on identifying therapy gaps and newer opportunities in the highly-competitive Indian pharmaceutical market. With high focus on customer satisfaction, Eris Lifesciences has achieved high prescription growth in therapy segments in which it operates.

The company has emerged as a key player in the Vitamin D market with a wide product portfolio. It has identified the potential for expansion of the Vitamin D market with global research indicating beneficial use of the dietary supplement in risk reduction for many diseases including liver and thyroid disorders.

Receiving the Award, Amit Bakshi, CEO, Eris Lifesciences, said, “We are thrilled to receive this award. The Indian pharmaceutical market is a challenging place for new entrants, to be recognised within six years of inception for competitive strategy leadership, which means we have been able to make visible impact on the market. Our team has put up incredible feat to bring this recognition to Eris and is committed to ensuring we stay on the growth track for years to come”.

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.

Global In Vitro Diagnostics Markets Outpace Pharma Industry Growth Despite global economic and industry challenges, in vitro diagnostics (IVD) markets are growing robustly at double the rate of the global pharmaceutical industry in some segments. Growth in emerging markets and next-wave emerging markets, particularly in the Asia-Pacific (APAC) region, are the most important factors in formulating future strategies.

New analysis from Frost & Sullivan’s Analysis of the Global In Vitro Diagnostics Market research finds the market size was USD 45.68 billion in 2012 and forecasts revenue to reach USD 64.65 billion in 2017. While the US and Western Europe are the largest IVD markets, APAC and Eastern Europe are projected to be the fastest growing. The research covers immunochemistry, Pharma Bio World

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clinical microbiology, tissue diagnostics, hemostasis, hematology, molecular diagnostics, Self-Monitoring Blood Glucose (SMBG), and Point Of Care Testing (POCT) segments.

“The APAC region holds the greatest number of next wave emerging markets, such as Indonesia, Vietnam and the Philippines,” noted the analyst, Frost & Sullivan. “This fast rising regional market must be part of every IVD company’s long-term strategy.”

The largest markets continue to be the US and Western Europe, which collectively represent nearly 60 per cent of the global IVD market. The anticipated outcome for these markets, however, varies.

“Such trends will act as a further spur for competitive IVD companies who have long recognised slowing growth in developed nations and have pursued emerging markets and other strategies,” said the analyst.

“Global IVD market participants will employ a diverse set of strategies rather than rely on comprehensive product portfolios to expand their businesses.”

GE Healthcare Launches “Mission on Wheels for a Healthier India” GE Healthcare, the USD 17 billion healthcare business of General Electric Company kicked off its first healthcare technology experiential lounge on wheels – “GE’s Mission on Wheels for a Healthier India”, a specially designed vehicle fitted with high end, affordable healthcare technologies.

Speaking on the occasion, S Ganesh Prasad Director Ultrasound, GE Healthcare South Asia said “Access to advanced diagnostic technology can make a huge difference in early detection and treatment of diseases and conditions. However, proliferation of such technologies has been dismal in India due to its high cost and low awareness. Mission Healthier India is an example of how we are at work for a healthier India. Our Mission will allow clinicians and public to experience GE’s advanced and affordable technologies at their doorsteps and learn how they can put these technologies to use for saving precious lives”.

The Mission aims to introduce high end technology to hospitals, nursing homes and clinics in 50 towns of Tamil Nadu at their doorsteps and to create awareness on the usage of technology in early detection of diseases and enablement of saving lives. The Mission also aims to create awareness amongst public through technology experience and information dissemination. Through this mission, GE Healthcare hopes to cover 5000 clinicians and 100,000 people in the two month tour of Tamil Nadu before embarking on similar tours in rest of India. The Mission Healthier India provides a closer view of technologies that can aid three key care areas that small towns and villages are challenged with – Women and maternal infant health, cardiac diseases and critical care.

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6/21/2013 3:22:17 PM

After US and EU, India Bans Dextropropoxyphene The manufacture, distribution and sale of dextropropoxyphene have been banned by the Union Health Ministry, Government of India.

Dextropropoxyphene is an opioid analgesic indicated for the relief of mild pain. This drug has been under the scanner since the last few years due to its potential addictive properties and other toxicities even at therapeutic doses. It was being misused by many addicts.

Wockhardt and Ranbaxy are some of the major manufacturers of dextropropxyphene in India.

The drug has already been withdrawn from the US market and the European Union following reports of cardiac arrhythmia and other adverse effects.

India awaits the ban on another analgesic Nimesulide, an NSAID which has been under scrutiny since long and has already been withdrawn in some countries.

Sun Settles Litigation with Wyeth and Atlanta Sun Pharmaceutical Industries Ltd announced that it together with its subsidiaries, have settled an ongoing litigation pending in the United States District Court, District of New Jersey regarding Sun Pharma subsidiary’s generic pantoprazole.

Under the terms of the litigation settlement between Sun Pharma, and Wyeth, (now a division of Pfizer Inc) and Altana Pharma AG, (now known as Takeda GmbH) the parties have dismissed all their claims. Sun Pharma will pay a lump-sum USD 550 million as a part of this settlement.

In 2005, Wyeth and Altana had filed a patent infringement suit against Sun Pharma after Sun Pharma filed its abbreviated new drug application for pantoprazole. Sun Pharma launched its generic pantoprazole in the US on January 30, 2008. In April 2010, a jury had determined that Altana’s patent is not invalid. On June 3, 2013, the Court began a jury trial to assess the amount of past damages that Sun Pharma owed for infringing Altana’s now expired patent.

This settlement now culminates the ongoing litigation.

Sun Pharma can continue to sell its generic pantoprazole in the US.

N a t i o n a l Conference on Evolving Roles of Ethics Committees in India Apollo Hospitals Educational And Research Foundation (AHERF) organised a ‘National Conference on Evolving Roles of Ethics Committees in India’ in Delhi with the objective of increasing awareness, aligning all stakeholders on current state, discussing and identifying key changes required on the regulatory and industry 40  June 2013

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front, identifying responsibility amongst stakeholders and charting out the roadmap to strengthen ethical conduct of clinical research in India.

In the recent past, India has witnessed great negativity around the conduct of clinical trials and the regulatory framework has been evolving to align itself with the changing scenario. There is obvious room for improvement in the framework and standards within which clinical trials are conducted in India.

One key element in this improvement is the role of ethics committees. The one and a half days long Conference provided a platform for the convergence of key stakeholders and facilitated an exchange of ideas through plenary sessions and panel discussions which resulted in a productive dialogue on ethics in clinical research.

Further, as part of the Conference, a hands-on workshop on Ethics Committee processes was conducted to impart education on ethics committee operations and best practices.

While the rapid expansion in the field of clinical research has been beneficial for the Indian population, it has also raised concerns that ethical conduct is often forgone when conducting clinical trials. The specter of unethical trials being frequently reported is a reflection of an ailing and substantially ineffective research regulatory system in India. The increasing awareness about ethical requirements in research, as well as the role of activists in questioning trial conduct when deemed exploitative, has resulted in a positive change to some extent. However, a lot still needs to be done. This requires a multi-faceted approach and involvement of all the stakeholders with an aim for more robust science, which incorporates a strong commitment to ethics.

Constella, the First Approved New Class of Treatment for IBS-C, Now in Europe Almirall, S.A. and Ironwood Pharmaceuticals, Inc announced the launch of Constella, the first approved prescription therapy in a new class of treatments for adults suffering from moderate to severe IBS-C1, in Europe. Constella is now available in Germany, the UK and Nordic countries and is expected to be launched in several other European countries in 2013. IBS is a functional, chronic and relapsing gastrointestinal disorder affecting over 10 per cent of the European population. Symptoms associated with IBS-C include abdominal pain and/or discomfort, bloating and constipation.

“The availability of linaclotide is excellent news for the one-third of adult IBS patients that have constipation. A targeted prescription treatment specifically for IBS-C is extremely welcome – for both appropriate patients and physicians alike who can now better manage this unpleasant, chronic condition”, said Professor Eamonn Quigley, Gastroenterologist.

Pharma Bio World

6/21/2013 3:23:26 PM

SOTAX Acquires Dr Schleuniger Pharmatron for USD 15 million

throughout North America, KLAS publishes approximately 60 performance and perception reports each year.

SOTAX Group, is a global leader in the development and manufacturing of high quality Dissolution Testing System, Composite Assay and Content Uniformity Workstation and Physical Tablet testing instrument for Pharmaceutical Industry acquires Dr Schleuniger Pharmatron in a USD 15 million deal. Dr Schleuniger Pharmatron is a leading manufacturer of physical test equipment for solid dosage and specialists in complete tablet hardness testing solution.

In a section of the report titled “Bottom Line on Vendors,” Carestream’s DRX-Evolution system is described as follows “Reliable unit with great patient throughput. Easy-to-use and intuitive GUI consistent across CR and DR offerings. Detector battery life is meeting needs. Switching detectors works well, with nearly 40 per cent using it.”

“The acquisition and integration of Dr Schleuniger Pharmatron is a further step towards ensuring sustainable growth by strengthening our innovation leadership. Dr Schleuniger Pharmatron brand stands for a long history of high quality and innovative technology. This will complement our existing product lines in an ideal way,” explains Thomas Pfammatter, CEO, SOTAX Group.

The DRX-Evolution is designed to move around the patient instead of positioning the patient based on the configuration of the X-ray equipment, which can help enhance care. The system’s wireless DRX-1 detector can be removed from the wall stand or table to easily handle difficult imaging studies, as well as exams for patients in wheelchairs or on stretchers. Digital images are sent over a secure wireless network and appear on the system console in seconds.

Dr Ramaswamy, Managing Director, SOTAX India Pvt. Ltd

SOTAX has an excellent international reputation as a specialist in the development and production of sophisticated test equipments and automated systems for tablet testing. They work with major pharmaceutical companies to develop customised hardware/ software solutions for their product. SOTAX also offers its know-how as a service to the pharmaceutical industry, including installations, maintenance and repair services as well as a comprehensive and careful validation service in compliance with FDA regulations.

Carestream DRX-Evolution X-ray System Rated Top by KLAS Carestream has again earned a top rating against major competitors for its digital X-ray systems that are based on its proven wireless DRX technology. As reported by KLAS in its just published “Digital X-Ray Performance 2013 – Impact of a Wireless Workflow,” the company’s CARESTREAM DRX-Evolution scored highest for overall performance.

In a survey of more than 200 radiology professionals, the report stated that “Carestream has built on their wireless detector success with the DRX-Evolution. Providers are taking advantage of moving detectors between different rooms or mobile X-ray systems. The DRX-Evolution wireless rooms are also meeting provider needs with an intuitive user interface, great image quality and reliability.”

Carestream also received the highest rating in three survey indicators which were “Implementation On Time,” “Usability” and “Quality of Training.”

KLAS is independently owned and operated, and has ratings on more than 250 healthcare technology vendors and over 900 products and services. Headquartered in Orem, Utah, with researchers Pharma Bio World

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The DRX-Evolution system can perform many different general radiology, trauma and emergency room X-ray procedures. Its ability to deliver rapid, high-quality images enables facilities to improve productivity and can help reduce radiology equipment expenses.

Abyrx ‘s New Absorbable Hemostatic Bone Putty Gets US FDA Nod Abyrx, Inc., a privately-held therapeutic device company, announced that the United States Food and Drug Administration has cleared its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the United States.

AHBP is provided ready-to-use (without requiring mixing or warming) and achieves hemostasis by mechanical tamponade.

Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery. Abyrx will offer AHBP in a multi-package configuration and in several sizes to accommodate hospital procurement requirements and to improve efficiency in a variety of surgical procedures across surgical specialties in which the product will be used.

AHBP complements Abyrx’s existing surgical hemostat product offerings which currently include Hemasorb and Hemasorb Apply.

With this new product, Abyrx is executing its strategy of vertically integrating within the surgical hemostasis marketplace.

Commenting on Abyrx’s portfolio approach to the marketplace, John J Pacifico, the Company’s President and Chief Executive Officer, stated, “Our team is committed to providing the most comprehensive bone hemostat product line in the operating room. AHBP and other products under development complement our Hemasorb products and will provide surgeons with more options to treat their patients and help enable hospitals to reduce costs.”

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6/21/2013 3:23:31 PM

Mexican Patent for Potentox Granted to Venus Remedies Venus Remedies Limited, a research-based global pharmaceutical company, has received another patent from Mexico for its novel antibiotic product Potentox. Granted by the Mexican Institute of Industrial Property (IMPI), the patent protects the composition of Potentox. Potentox is a novel antibiotic adjuvant entity effective against quinolones and aminoglycoside-resistant gram negative infections. The patent provides an exclusivity period for Potentox up to 2025. The drug is also protected by a number of other patents from various other countries, including USA, India, Australia, New Zealand, South Korea, South Africa, Canada and Ukraine.

Potentox is an antibiotic adjuvant entity (AAE), a drug effective in case of hospital-acquired pneumonia and febrile neutropenia infections, primarily caused by quinolones or aminoglycosideresistant microbes.

“The product is growing at a Compound Annual Growth Rate (CAGR) of 50 per cent since the past three years. To take this novel antibiotic adjuvant entity to Mexico, the company is already holding talks with some big pharmaceutical companies there for strategic tie-ups. The Common Technical Document (CTD) for Mexico is ready, and we will soon be filing it. But it will take us another two-three years to launch the product in this market,” said Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies Limited.

In Mexican Intensive Care Units (ICUs), the overall cost of one single healthcare-associated infection episode is USD 12,155. As per WHO statistics for Mexico, healthcare-associated infections are the third most common cause of death. Mexico spends about 70 per cent of its health budget on extra costs incurred due to hospitalacquired infections. Clinical trials conducted for Potentox on more than 500 patients have indicated a drop in cost of therapy by 20-30 per cent as compared to conventional therapies. Besides, studies conducted in hospitals across India have shown that Potentox is suitable for the treatment of infections caused by various resistant gram-negative pathogens in the ICU. Terming such global recognitions for novel research products as a matter of pride for the research team at Venus, Dr Manu Chaudhary, Joint Managing Director and Director, Research, Venus Medical Research Centre (VMRC), Venus Remedies Limited, said, “It will motivate us to keep working hard to bring to the world our greatest research breakthroughs that would help in bridging the gaps in the field of emerging antimicrobial resistance.”

Controller Redundancy with POWERLINK B&R is setting new standards with its redundancy solution for X20 control systems, a breakthrough that now allows the advantages of high availability to be enjoyed by smaller applications at much less cost. B&R’s solution is based on standard X20 controllers that can be reconfigured at any time with features that 42  June 2013

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reduce downtime using the Automation Studio software development environment. This eliminates the need for specialised redundancy controllers, which are generally very expensive due the small B&R makes it possible to design highquantities produced. availability systems using standard components, making redundancy E n g i n e e r i n g e ff o r t i s affordable for smaller applications with reduced to declaring lower downtime costs. the PLC a redundant unit and configuring communication parameters or failure criteria.

Switching in a matter of milliseconds- In B&R’s solution, one controller provides active control, while a second controller runs in the background in standby mode. All network functions are monitored continuously so that when the time comes, the backup controller can quickly take over all of the active PLC’s functions.

Whichever controller becomes active always uses the same IP address as its predecessor. The switching time of the system is a mere two task cycles – so all of this takes place in a matter of a few milliseconds.

Sagent Pharma Recalls All Lots of Vecuronium Bromide for Injection Sagent Pharmaceuticals, Inc announced the expanded voluntary nationwide recall of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent.

Sagent initiated a voluntary recall of Vecuronium Bromide for Injection to the user level for three lots on June 7, 2013 due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. Based on the results of additional analyses conducted since the initial recall, Sagent expanded its recall of Vecuronium Bromide for Injection, 10mg to the user level to include all lots manufactured between July 2011 and May 2012.

The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure.

Sagent is not aware of any adverse patient events resulting from the use of this product to date.

The subject lots were distributed to hospitals, wholesalers and distributors nationwide from August 2011 through May 2013.

Vecuronium Bromide for Injection is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied in a glass vial.

Pharma Bio World

6/21/2013 3:23:33 PM

AstraZeneca to Buy Pearl Therapeutics A v a n t o r N o w P r o d u c i n g c G M P AstraZeneca announced that it has entered into a definitive Pharmaceutical Chemicals in India agreement to acquire Pearl Therapeutics, a privately held company based in Redwood City, California, focused on the development of inhaled small-molecule therapeutics for respiratory disease.

The acquisition will give AstraZeneca access to a potential new treatment for chronic obstructive pulmonary disease (COPD), currently in late-stage development, and inhaler and formulation technology that provides a platform for future combination products. Pearl’s lead product, PT003, is a fixed dose combination of formoterol fumarate, a long-acting beta-2-agonist (LABA) and glycopyrrolate, a long-acting muscarinic antagonist (LAMA). LABA/ LAMA combinations are expected to become an important new class of treatment for COPD. A global Phase III programme has been initiated and will test the improvement in lung function in individuals with moderate to severe COPD in response to PT003. PT003 is delivered by inhalation via a pressurised metered dose inhaler (pMDI) using Pearl’s novel co-suspension formulation technology.

This technology platform will allow AstraZeneca to explore combinations of existing and novel technologies, including a triple fixed dose combination (LABA/LAMA and inhaled corticosteroid) which could be accelerated into Phase II clinical development.

Under the terms of the agreement, AstraZeneca will acquire 100 per cent of Pearl’s shares for initial consideration of USD 560 million payable on completion. In addition, deferred consideration of up to USD 450 million becomes payable if specified development and regulatory milestones in respect of any triple combination therapies and selected future products that AstraZeneca develops using Pearl’s technology platform are achieved. Salesrelated payments of up to a further USD 140 million are payable if pre-agreed cumulative sales thresholds are exceeded resulting in a total potential acquisition cost of up to USD 1.15 billion. The proposed transaction is subject to customary regulatory approvals and is expected to close in the third quarter of 2013.

GSK Receives Offer for its Thrombosis Brands and Related Manufacturing Site GlaxoSmithKline has received an offer for its thrombosis brands and Notre-Dame de Bondeville (NDB) site from Aspen Global Incorporated and Aspen Pharmacare Holdings Limited. A period of exclusivity has been agreed with Aspen and GSK will respond to the offer subject to consultation with employees and the relevant works councils.

The financial terms are confidential at this time, but the offer includes the transfer of the Arixtra ® and Fraxiparine ® (excluding China, India and Pakistan) brands to Aspen, along with the related manufacturing site and the majority of employees at NDB in France and certain dedicated commercial employees. The proposed transaction is aligned to GSK’s strategy of focusing on products with the most growth potential and the delivery of its pipeline.

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Avantor™ Performance Materials, a global manufacturer and supplier of high-performance chemistries and materials, is now producing pharmaceutical chemicals under current Good Manufacturing Practices (cGMP) from its new production facility in Panoli, India.

The Panoli plant manufactures and packages a wide range of Avantor’s Macron Fine Chemicals brand of salts and solvents for the production of pharmaceuticals, and high-purity solvents for use in chromatography separations for laboratory research, drug development and discovery.

Located in India’s Gujarat state, the new Avantor facility is ISO 9001:2008 certified and is approved by the Indian Food and Drug Administration.

In addition to cGMP manufacturing requirements, Macron Fine Chemicals products from Panoli are produced to Indian Pharmacopeia (IP), United States Pharmacopeia (USP), National Formulary (NF), European Pharmacopeia (EP), Japanese Pharmacopeia (JP) and British Pharmacopeia (BP) standards.

“The availability of cGMP chemicals from our Panoli facility demonstrates Avantor’s continued growth as a leading global manufacturer and supplier of high-quality performance materials,” said Paul Smaltz, Avantor ’s executive vice president of global pharmaceuticals.

First Approval of Roche’s Avastin for the Treatment of Glioblastoma Roche announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Avastin (bevacizumab) for the treatment of malignant glioma, including newly diagnosed glioblastoma (GBM) in combination with radiotherapy and temozolomide chemotherapy, and as monotherapy for treatment of recurrent GBM and certain other types of high grade glioma following prior therapy. Current treatment options for malignant glioma are limited, and Avastin represents the first new medicine approved worldwide for newly diagnosed glioblastoma, the most common and aggressive form of primary brain cancer, in the last eight years.

The approval was based on data from three clinical studies in GBM: The phase II BRAIN study, a Japanese phase II study (JO22506), the pivotal phase III AVAglio study, which demonstrated that when Avastin was added to standard treatment, patients lived significantly longer without their disease getting worse. Final results from the AVAglio study in newly diagnosed GBM patients were recently presented at the 49 th annual meeting of the American Society of Clinical Oncology in Chicago.

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6/21/2013 3:23:38 PM

Roselabs Launches First of its Kind Composite PFS Making Facility Roselabs Bioscience Limited and Roselabs Polymers Ltd, part of the Roselabs Group, have set up the first of its kind complete end-to-end Pre-Filled Syringes (PFS) making facility in the world.

The company has already invested more than Rs 400 crore in this unique new state-of-the-art facility near Ahmedabad. It is one of the few companies in the world which offers the complete PFS solution under one roof: from manufacturing of glass and polymer PFS, all required components, to making formulations that need to be put into the injectables.

Roselabs has recently got approval from the WHO-GMP and it has also initiated the process of getting other countries’ regulatory approvals. It is expecting to get regulatory approvals from 35-40 countries spread across South East Asia, Africa and Latin America in the coming months for its new project.

Explaining the uniqueness of their composite PFS set-up, Zameer Agarwal, Director of Roselabs Bioscience Ltd said, “Pre-filled syringe (PFS) is one of the most sophisticated medical devices in today’s world. There are only a handful of players in the world who make either glass or polymer PFS and they are dependent on a few other players for supply of other components. In turn, these companies then supply these complete empty syringes to the pharmaceutical companies to get the filling done. The unique selling proposition of Roselabs is that it offers a composite PFS solution under one roof. The existing and potential market for prefilled syringes in India and globally is huge. Nearly 95 per cent of PFS are imported into India which is one of the fastest growing markets for this sector.”

He further added that Roselabs is the only one of its kind facility in India which has commercialised 8 lanes of PFS filling with dedicated individual lanes as per therapeutic segments like peptide, recombinant, hormones, biotech, ophthalmic and others, along with manufacturing of complete empty devices.

Roselabs new ventures have already invested for more than ` 400 crore for a state-of-the-art PFS facility at Ahmedabad in the state of Gujarat which has a capacity to manufacture 8 lakh syringes a day.

Perrigo Acquires Ophthalmic Product Portfolio from Fera Pharmaceuticals Perrigo Company announced that it has signed a definitive agreement to acquire and has completed the acquisition of an ophthalmic sterile ointment and solution product portfolio from Fera Pharmaceuticals, LLC and its affiliates (Fera), a privatelyheld, Long Island, New York-based specialty pharmaceutical company. The acquired portfolio, including nine prescription ANDA products, generated more than USD 30 million in net revenues 44  June 2013

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during calendar year 2012. Terms of the transaction include an upfront cash payment of approximately USD 93 million along with potential contingent payments totaling approximately USD 36 million, certain of which relate to Perrigo securing additional product rights from Fera.

Additionally, Perrigo expects to receive a tax benefit as a result of the acquisition, the net present value of which is estimated to be approximately USD 20 million. This acquisition is expected to be more than USD 0.12 accretive to adjusted EPS for fiscal 2014 and more than USD 0.04 accretive to GAAP EPS after the inclusion of estimates for intangible amortisation, transaction and integration related expenses.

Perrigo Chairman, President and CEO Joseph C Papa stated, “I’m excited to announce the addition of Fera’s ophthalmic ointment and solution products to Perrigo’s Rx portfolio. The ophthalmic category has been one of high strategic interest to Perrigo as we continue to pursue opportunities that strengthen our leadership position within the niche Rx extended topical space. The breadth of the Fera portfolio allows us to become immediately relevant to patients and physicians across the country seeking cost-effective alternatives for the treatment of common ocular conditions. This acquisition serves as another example of our commitment to provide consumers everywhere with quality, affordable healthcare offerings.”

Glenmark Generics Gets Final ANDA Approval for Riluzole Tablets, 50mg Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Riluzole Tablets, 50mg. The Company will commence shipping immediately.

Riluzole is indicated for the treatment of amyotrophic lateral sclerosis. Based on IMS Health sales data for the 12 month period ending March 2013, Riluzole garnered sales of USD 64 million.

Glenmark’s current portfolio consists of 86 products authorised for distribution in the U.S. marketplace and 52 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America and developing an EU presence.

It primarily sells its FDF products in the United States and the European Union, as well as its oncology FDF products in South America. The Company supplies APIs to customers in approximately 80 countries, including the US, various countries in the EU, South America and India.

Pharma Bio World

6/21/2013 3:23:40 PM

J& J Announces Definitive Agreement to Acquire Aragon Pharmaceuticals Johnson & Johnson announced a definitive agreement to acquire Aragon Pharmaceuticals, Inc, a privately-held, pharmaceutical discovery and development company focused on drugs to treat hormonally-driven cancers.

The acquisition includes Aragon’s androgen receptor antagonist programme. Aragon’s lead product candidate is a second generation androgen receptor signaling inhibitor, ARN-509, in Phase 2 development for castration resistant prostate cancer (CRPC).

Under the terms of the agreement, Johnson & Johnson will make an upfront cash payment of USD 650 million, plus additional contingent payments of up to USD 350 million based on reaching predetermined milestones. The transaction is expected to close in the third quarter of 2013.

Prior to closing, Aragon will transfer all assets other than its androgen receptor antagonist program to a newly formed company, which Aragon will spin off. Johnson & Johnson will not have an ownership stake in the new company nor retain any rights to these products or programmes.

The closing is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, Aragon’s consummation of the spinoff of the newly created company, and other customary closing conditions. The boards of directors of both Johnson & Johnson and Aragon have approved the transaction.

“The acquisition of Aragon further enhances our leadership in prostate cancer drug development. ARN-509 complements ZYTIGA and provides the potential for exciting, novel approaches to treat prostate cancer patients,” said Peter F Lebowitz, MD, PhD, Global Therapeutic Area Head, Oncology for Janssen Research & Development, LLC. “Prostate cancer is one of our main areas of focus, and we are pleased to be adding ARN-509 to our portfolio.”

BMS, AstraZeneca Announce Successful result for Onglyza Phase 4 Clinical Trial Bristol-Myers Squibb Company (BMS) and AstraZeneca announced top line results of the Phase 4 SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin). In this study of adult patients with type 2 diabetes with either a history of established cardiovascular disease or multiple risk factors, Onglyza met the primary safety objective of non-inferiority, and did not meet the primary efficacy objective of superiority, for a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke, when added to a patient’s current standard of care (with or without other anti-diabetic therapies), as compared to placebo.These preliminary SAVOR-TIMI-53 data Pharma Bio World

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are being analysed and the study results will be submitted to the European Society of Cardiology (ESC) for potential presentation at the ESC Congress in September.

Onglyza is indicated as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults with type 2 diabetes mellitus in multiple clinical settings. Onglyza should not be used for the treatment of patients with type 1 diabetes mellitus or diabetic ketoacidosis (increased levels of ketones in the blood or urine), as it would not be effective in these settings. Onglyza has not been studied in patients with a history of pancreatitis.

Onglyza is contraindicated in patients with a history of a serious hypersensitivity reaction to Onglyza (eg, anaphylaxis, angioedema or exfoliative skin conditions). There have been post-marketing reports of acute pancreatitis and serious hypersensitivity reactions in patients taking Onglyza. If pancreatitis or a serious hypersensitivity reaction is suspected, promptly discontinue Onglyza and institute appropriate medical treatment. It is unknown whether patients with a history of pancreatitis are at an increased risk for development of pancreatitis while using Onglyza.

Teva Strengthens Respiratory Franchise with Acquisition of MicroDose Therapeutx Teva Pharmaceutical Industries announced that it has entered into a definitive agreement to acquire MicroDose Therapeutx, a privately-held pharmaceutical and drug delivery company focused on inhalation technologies and products for lung diseases and infections with the potential to dramatically improve efficacy and patient compliance.

With the addition of MicroDose’s technologies and products, Teva is taking a significant step toward expanding its respiratory pipeline. Teva will now have access to MicroDose’s proprietary technology including its multi-dose dry powder nebuliser device, which requires no preparation and can be administered in under 30 seconds. MicroDose’s current pipeline is anchored by MDT-637 for respiratory syncytial virus (RSV) - an inhaled, low dose, small molecule, fusion inhibitor which prevents viral replication, delivered via MicroDose’s technology.

Under the terms of the deal, Teva will acquire all of MicroDose’s outstanding shares for a payment at closing of USD 40 million, additional payments of up to USD 125 million upon achievement of regulatory and development milestones, plus sales-based milestones and tiered royalty payments upon commercialisation of MDT-637 and an earlier stage Asthma/COPD medicine.

Anand V Gumaste, President, CEO and Chairman of MicroDose, stated, “We believe this agreement provides a unique opportunity to advance MicroDose’s platform technology and development programs for the greatest benefit of patients. Teva has a strong and growing franchise in respiratory diseases, with extensive experience in both delivery mechanisms and novel therapeutic modalities.”

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Ambrx, Zhejiang Medicine to Develop and Market Ambrx’s ADC Ambrx and Zhejiang Medicine Co announced that they have formed a collaboration to develop and commercialise ARX788, Ambrx’s most advanced internally developed site-specific antibody drug conjugate (ADC) targeting Her2-positive breast cancer.

Under the agreement, Ambrx and ZMC will continue the development of ARX788, with ZMC bearing the ongoing development cost. ZMC will receive commercial rights in China while Ambrx retains commercial rights outside of China and receives royalties on sales of the product in China. ZMC will manufacture the product to world-class standards for clinical and commercial supplies on a global basis. WuXi PharmaTech will provide integrated services for ARX788, including the development and manufacturing of the toxin, antibody and ADC, pre-clinical development and clinical trials.

“We are excited to initiate this unique collaboration with ZMC and WuXi, which allows us to team up with China’s leading pharmaceutical and CRO companies to efficiently develop ARX788, our most advanced ADC therapeutic candidate for both breast cancer and gastric cancer indications,” said Lawson Macartney, PhD, Chief Executive Officer of Ambrx. “This collaboration allows Ambrx to further extend our pipeline of ADCs and gain access to the China market through our partnership with ZMC. Our experience with site-specific ADC technology has shown that we have the potential to create best-in-class therapeutic candidates, and we look forward to advancing ARX788 into the clinic to understand its full potential.”

Chunbo Li, Chairman of Zhejiang Medicine, commented, “We are honored to partner with Ambrx, a leading biotech company, in ADC drugs. We will work with WuXi PharmaTech to accelerate the development and commercialisation of ARX788 in China to bring benefits to Her2-positive cancer patients. The partnership will help ZMC undertake pioneering work in the development of monoclonal antibodies and ADCs. The partnership will also help ZMC establish long-term and mutually beneficial relationships with leading global companies and advance our position in the biopharmaceutical industry.”

InSite Vision, Merck File Joint Patent Infringement Lawsuit Against Mylan InSite Vision Incorporated announced that it will join Merck known as MSD outside the United States and Canada, and Pfizer Inc in filing a patent infringement lawsuit against Mylan Pharmaceuticals, Inc. Mylan recently filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking to market a generic version of AzaSite ® (azithromycin 1 per cent ophthalmic solution) before expiration of the patents covering AzaSite and its use. AzaSite is marketed by Merck in the US. 46  June 2013

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The Complaint will be filed in Federal District Court in Trenton, New Jersey.

Mylan filed an ANDA application for AzaSite with the FDA of which InSite received notice on May 2, 2013, and InSite has 45 days to file a patent infringement lawsuit. With this filing today, that time requirement has been met. This lawsuit also triggers an automatic stay, or bar, of the FDA’s approval of the ANDA for up to 30 months or until a final court decision of the infringement lawsuit, whichever comes first.

On May 26, 2011, InSite and Merck filed a similar patent infringement lawsuit against Sandoz Inc. A trial date for the Sandoz ANDA suit has been set for July 11, 2013. The companies have agreed that Merck will take the lead in prosecuting both lawsuits.

Each company will be responsible for their own legal costs, with InSite assuming a monitoring role.

Merck, with the assistance of InSite and Pfizer, will vigorously defend the five US patents related to AzaSite. InSite owns four US patents covering AzaSite and its use, and an exclusive license to a Pfizer-owned azithromycin patent.

Under the license agreement between InSite and Merck, Merck has the exclusive use of these patents in the US in return for a 25 per cent royalty payable to InSite based on AzaSite net sales. InSite believes that its four patents and the Pfizer patent were properly prosecuted with the US Patent and Trademark Office and are valid, and will provide AzaSite exclusivity until March 2019.

Cempra Inc Issued US Patent for Taksta Loading Dose Formulation Cempra Inc, a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases announced that the United States Patent and Trademark Office (USPTO) issued US Patent No. 8,450,300 on May 28, 2013 with claims directed to the company’s novel loading dose regimen for Taksta. The patent, entitled “Fusidic Acid Dosing Regimens for Treatment of Bacterial Infections,” provides protection until 2029, excluding possible patent term extensions.

“The issuance of this patent may add to the commercial value of Taksta as an important antibiotic candidate, currently in a Phase 2 clinical study in patients with prosthetic joint infections,” said Prabhavathi Fernandes, PhD, Chief Executive Officer of Cempra.

“Our now proprietary loading dose regimen for Taksta was a novel innovation designed so that the drug would rapidly reach therapeutic blood levels and minimise the risk of drug resistance. The patent provides protection in addition to the expected US market exclusivity obtained through Waxman-Hatch, the GAIN Act, pediatric testing and, possibly, the Orphan Drug Act.” Pharma Bio World

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biotech news Empire Genomics Launches a Genetic Test to Detect NEPC Majority of prostate cancers are adenocarcinomas and can be detected with Prostate Specific Antigen (PSA). However, Neuro Endocrine Prostate Cancer (NEPC) is a rare prostate cancer and NEPC cells do not make PSA. The cause for this cancer is not well-known. Currently, there is no good treatment that has shown efficacy in combating neuroendocrine cells.

Empire Genomics has acquired a biomarker licence for the diagnosis of NEPC from Cornell University and the company wishes to collaborate with other companies to develop and commercialise this technology which will benefit many.

OpGen and Applied Maths Partner to Launch New Bioinformatics Software OpGen, Inc, a leading innovator in rapid, accurate genomic and DNA analysis systems and services today announced the company has entered into a strategic collaboration with Applied Maths NV, the market leader in bioinformatics and analytical solutions for public health and research laboratories, to provide advanced software tools for microbial genomics and molecular strain typing.

Under the agreement, Applied Maths has incorporated a Whole Genome Mapping module into the company’s new BioNumerics 7 software suite, providing customers with seamless access to a new set of analytical tools for molecular typing and comparative genomics of microbial pathogens.

“The Applied Maths software and database analysis suite will provide a flexible, integrated solution that will enable broader adoption of Whole Genome Mapping.” said Douglas White, Chief Executive Officer of OpGen, Inc. “The efficient management of food-borne pathogen outbreaks through enhanced approaches for epidemiological surveillance requires the rapid detection of potential outbreaks and improved molecular typing solutions,” said Koen Janssens, Chief Executive Officer of Applied Maths.

New Updates for Roche’s LightCycler 96 and LightCycler Nano Systems Roche announced the global launch of new software updates, including advanced high-resolution melting analysis and qualitative detection modules for the LightCycler 96 and new support features for the LightCycler Nano system.

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research applications. It enables easy and fast detection of known and unknown gene mutations, including Single Nucleotide Polymorphisms, deletions and methylated regions.

The novel dedicated qualitative detection module for LightCycler 96 enables direct detection and validation of a target gene´s presence or absence. This module also employs a novel control concept and is designed mainly for customers doing research in the field of infectious diseases.

The new features of the LightCycler Nano include advanced gene expression analysis mediated by the import of external standard curves. It also offers an enhanced analysis method for highresolution melting experiments.

Roche launched the LightCycler 96 System in October 2012 with a variety of analysis methods including endpoint genotyping and absolute and relative quantification. Data generated by the system can be analysed directly or remotely for translation into publicationready results in line with MIQE* guidelines. With the new software it will also be possible to create PDF or HTML reports.

Rotavirus Vaccine Developed in India Proves Efficacious Positive results from a Phase III clinical trial of ROTAVAC, a rotavirus vaccine developed and manufactured in India showed an excellent safety and efficacy profile declared Department of Biotechnology (DBT), Government of India.

The clinical study shows that ROTAVAC developed together with Bharat Biotech under the Public-Private Partnership mode is efficacious in preventing severe rotavirus diarrhoea by more than half—56 per cent during the first year of life, with protection continuing into the second year of life. Moreover, the vaccine also showed impact against severe diarrhoea of any cause.

“This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year,” said DBT Secretary Dr K VijayRaghavan. “The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.”

ROTAVAC is an oral vaccine and is administered to infants in a three-dose course at the ages of 6, 10, and 14 weeks. It is given alongside routine immunisations in the UIP vaccines recommended at these ages. The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86.

Dr Raghavan said, Bharat Biotech had previously announced a price of USD 1.00/dose for ROTAVAC is soon to be a more affordable alternative to the existing rotavirus vaccines.

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Bionomics Completes Enrolment for BNC105 Phase II Renal Cancer Trial

The launch of SelexION Technology on the TripleTOF 5600+ System provides more confident identification and quantitation of molecules by delivering an additional level of separation between the Liquid Chromatography (LC) system and the mass spectrometer.

Bionomics Limited has completed enrolment into a randomised Phase II clinical trial, testing the combination of BNC105 plus everolimus (Afinitor) to treat patients with advanced renal cell carcinoma, the DisrupTOR-1 clinical trial.

This is the first and only randomised trial to test the combination of an mTOR inhibitor (Afinitor) with a vascular disrupting agent (BNC105) in renal cancer.

CEO and Managing Director, Dr Deborah Rathjen said, “The enrolment of 135 patients into this first Phase II clinical trial of BNC105 is an important achievement for Bionomics. It is particularly exciting to reach this milestone in a trial which has the potential to create a new paradigm for the treatment of renal cancer.”

Speaking about the effectiveness of BNC105 Dr José Iglesias, Chief Medical Officer of Bionomics said, “The mechanism of action of BNC105 provides an innovative approach to the treatment of solid tumours, including metastatic renal cell carcinoma, by attacking established tumour vasculature.

We believe that there is a strong scientific rationale for this combination, as well as compelling preclinical and Phase I data that support this approach. Afinitor and BNC105 work by different but complementary mechanisms of action. The vascular disrupting effect of BNC105 causes hypoxic stress and Afinitor concurrently blocks the mTOR driven recovery pathway of renal tumours.”

This Phase II trial was conducted at sites across the US, Australia and Singapore and enrolled 135 patients with advanced metastatic renal cell carcinoma. Patients, who had failed prior therapy with tyrosine kinase inhibitors such as Sutent, were randomised into one of two treatment arms: one arm to receive Afinitor, and the second arm to receive Afinitor plus BNC105. Once enrolled, patients are treated until disease progression or until adverse effects prohibit further therapy.

Bionomics is an Australian based international biotechnology company which discovers and develops innovative therapeutics for cancer and diseases of the central nervous system.

Ab Sciex Unveils 3 New Solutions for Biological Researchers Global leader in analytical technologies, Ab Sciex has launched three new solutions for biological researchers to improve identification and quantitation of proteins, peptides, metabolites and lipids. The company extended the applicability of SelexION Technology, Swath Acquisition and ProteinPilot Software for academic research in the field of systems biology.

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Dave Hicks, VP and GM Pharmaceutical and Academic Business Ab Sciex

This separation can be applied at the molecular level, the biological sub-class level or for the general removal of background interferences. The addition of SelexION Technology on the high-performing accurate mass-based system with high sensitivity and high resolution extends mass spectrometry performance with differential ion mobility, which enables a new dimension of separation and selectivity. Next-generation SWATH Acquisition improves data scoring and filtering with support for variable window acquisition, up to 5x speed and scale improvement and enhanced tools for visualisation and transfer of complex data sets.

“We continue to evolve our innovations to broaden their usefulness with additional features and functionality that provide greater confidence in results,” said Dave Hicks, VP and GM of the Pharma and Academic Business at Ab Sciex. “The development of these expanded versions of SWATH and SelexION are the direct result of feedback we received from customers who saw the potential to apply these breakthrough technologies to a wider range of analytical challenges.”

World’s First Vaccine for Enterovirus Enteroviruses affect millions of people worldwide each year, and are often found in the respiratory secretions and stool of an infected person. The enterovirus can cause hand, foot and mouth disease, especially in small children and even lead to deadly infections of the brain and spinal cord membranes.

The disease can be caused by several different germs, including a group called enterovirus and a specific form of this virus called the enterovirus71 (EV71). EV71 can cause sever disease in children that causes fever, blisters around the hands, feet and mouth and is transmitted by contact with fecal matter, blisters or saliva of an infected person. It sometimes leads to potentially fatalmeningitis and encephalitis.

Chinese researchers have developed world’s first vaccine against a strain of enterovirus. The research shows that the new vaccine protects against EV71. The study involved 10,245 children aged between six and 35 months who lived in four different places in China. The vaccine efficacy was 90 per cent against EV71associated hand, foot and mouth disease and 80.4 per cent against EV71-associated disease. The vaccine also demonstrated 100 per cent efficacy against EV71-associated hospitalisation.

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New Software for Efficient Molecular Sanofi Quadrivalent Flu Vaccine Gets Screening FDA Nod With an aim to offer flexible and powerful tool for efficient processing of molecular interaction data, GE Healthcare has launched Biacore T200 Software v.2.0. The new software facilitates label-free screening of low molecular weight compounds and low abundance proteins, giving detailed binding profiles on moleculedrug candidate mechanisms of action that ultimately assist in earlier lead selection and optimisation. It simplifies and speeds up the generation and transformation of raw label-free interaction data into high-quality information, reducing the time needed for screening and hit validation. The new software encompasses algorithms for efficient ranking and qualification of binders versus non-binders, and enables comparison of datasets through normalisation of sample responses by a number of means.

Stem Cells from Fat More Potent than those from Bone Marrow A research published in the current issue of Stem Cells Translational Medicine reveals that stem cells harvested from fat (adipose) are more potent than those collected from bone marrow in helping to modulate the body’s immune system. The study was conducted by scientists at the Department of Immunohematology and Blood Transfusion, Leiden University Medical Center, The Netherlands.

The research team, led by Dr Helene Roelofs, used stem cells collected from the bone marrow and fat tissue of age-matched donors. They compared the cells’ ability to regulate the immune system in vitro and found that the two performed similarly, although it took a smaller dose for the adipose tissue-derived stem cells (ATSCs) to achieve the same effect on the immune cells. When it came to secreting cytokines, the cell signaling molecules that regulate the immune system, the AT-SCs also outperformed the bone marrowderived cells. The finding could have significant implications in developing new stem-cell-based therapies, as AT-SCs are far more plentiful in the body than those found in bone marrow and can be collected from waste material from liposuction procedures.

Dr Roelofs said that Adipose tissue is an interesting alternative since it contains approximately a 500-fold higher frequency of stem cells and tissue collection is simple. Moreover, 400,000 liposuctions a year are performed in the US alone, where the aspirated adipose tissue is regarded as waste and could be collected without any additional burden or risk for the donor. This all adds up to make AT-SC a good alternative to bone marrow stem cells for developing new therapies.

Dr Anthony Atala, editor, Stem Cells Translational Medicine, and director, Wake Forest Institute for Regenerative Medicine, US, said that cells from bone marrow and from fat were equivalent in terms of their potential to differentiate into multiple cell types. The fact that the cells from fat tissue seem to be more potent at suppressing the immune system suggest their promise in clinical therapies.

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The US FDA has approved Sanofi Pasteur supplemental biologics license application (sBLA) for its four-strain influenza vaccine, Fluzone Quadrivalent, which is the newest addition to the Fluzone family. The vaccine is licensed for use in children six months of age and older, adolescents, and adults.

The 2013 influenza season will be the first in which quadrivalent influenza vaccines will be available in the US Until this year, seasonal influenza vaccines included only one B strain. Fluzone Quadrivalent vaccine includes two A strains and two B strains to help protect against influenza disease. Epidemics of influenza B occur every two to four years in all age groups. Influenza B is a common cause of influenza-related morbidity and mortality in children and has been associated with pneumonia andother respiratory illnesses, nervous system disease, muscle pain and inflammation, and other complications. In recent years, up to 44 per cent of influenza-associated deaths in children and adolescents 18 years of age and younger were due to influenza B.

Idera Pharma Initiates Phase 2 Trial of IMO-8400 Psoriasis Candidate Idera Pharmaceuticals has initiated dosing in a randomised, double-blind, placebocontrolled Phase 2 trial of IMO-8400 in patients with moderate to severe plaque psoriasis. IMO-8400, an antagonist of the Toll-like receptors (TLRs) 7, 8, and 9, is a lead clinical candidate in Idera’s autoimmune disease program. In a Phase 1 trial involving single escalating doses Sudhir Agrawal Chairman and CEO and multiple doses, IMO-8400 was well Idera tolerated and inhibited TLRs 7, 8, and 9-mediated immune responses. Data from the Phase 1 study will be presented at a scientific meeting in June 2013.

“This Phase 2 trial of IMO-8400 will enable us to evaluate over a 12-week treatment period the continued trajectory of Psoriasis Area Severity Index (PASI) score improvement that we observed in the previous 4-week study of our TLR 7 and 9 antagonist, IMO-3100,” said Robert Arbeit, MD, Vice President of Clinical Development at Idera. “We anticipate top-line data from the Phase 2 trial of IMO-8400 to be available by the end of 2013.”

“In our proof-of-concept study with IMO-3100 in patients with psoriasis, we observed PASI score improvement, which correlated with significant improvement in psoriasis disease-associated gene profile, including downregulation of the IL-17 pathway. We believe the inclusion of TLR8 activity with IMO-8400 would further enhance the clinical activity observed with IMO-3100 in patients with psoriasis,” said Sudhir Agrawal, DPhil, Chairman and CEO, Idera Pharmaceuticals.

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Medicago Initiates Phase II Trial for C a n g e n e B a c k s o u t M A A f o r H5N1 Vaccine Hemophilia Drug

Andrew Sheldon President and CEO of Medicago

Medicago Inc, a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced it has received clearance byHealth Canada to initiate its Phase II dose-sparing clinical trial for an H5N1 Avian Influenza VLP vaccine candidate. All clinical lots have been produced and the trial will commence with interim results expected in the summer of 2013.

“Securing Health Canada approval to conduct this trial is an important milestone in the advancement of our pandemic influenza vaccine,” said Andrew Sheldon, President and CEO of Medicago.

“This trial follows on from our recent positive phase I interim results which demonstrate that our vaccine candidate is in our opinion the best in class. Our ability to rapidly produce safe and efficacious vaccines is a key advantage over slower traditional methods of production. In the face of a pandemic, it will be essential for governments to deploy an effective vaccine within their borders as quickly as possible.”

Medicago’s H5N1 vaccine candidate was found to be safe and well tolerated and induced a solid immune response. A U.S. phase I study was recently completed using a 20 μg dose of the H5 VLP vaccine with or without the Alhydrogel (alum adjuvant) or the glucopyranosyl Lipid A (GLA-AF) adjuvant, given either intradermally (ID) or intramuscularly (IM).

Scientists Built Lyme Disease Detector Using Carbon Nanotube Sensor A team of researchers from both the physics and biology departments at the University of Pennsylvania has built a Lyme disease detector using a carbon nanotube sensor.

If not detected early, Lyme disease can cause permanent nerve damage. Currently available diagnosis tests tend to produce false positives. Researchers have been looking for a more accurate way to detect the presence of the bacteria that causes the disease.

In this new effort, the research team grew a large range of carbon nanotubes for use as sensors. Then with the help of a newly developed covalent-chemistry technique, antibody proteins are attached to the nanotubes. The antibodies attract and capture a type of protein found in the flagellum of bacteria that are the source of Lyme disease. The adhered protein causes a change in the nanotube sensors’ ability to conduct electricity. By measuring changes in voltage, the researchers can determine the presence of bacteria in a single drop of blood.

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Cangene Corporation (Cangene) announces its withdrawal of the Marketing Authorisation Application (MAA) for hemophilia compound IB1001 in Europe and intention to re-file the MAA with the additional clinical data requested by the European Medicines Agency (EMA).

In February 2013, Cangene acquired all rights to the development of the investigational hemophilia compound IB1001 from Ipsen and Inspiration Biopharmaceuticals Inc. IB1001 is a recombinant Factor IX (rFIX) product being developed for the treatment and prevention of bleeding episodes with hemophilia B. At the time of the acquisition, the asset was under regulatory review by the US Food and Drug Administration (FDA) and in the latter stages of review by the EMA. In May 2013, Cangene presented an Oral Explanation of IB1001 at the Committee for Medicinal Products for Human Use (CHMP). The EMA subsequently requested additional clinical data for IB1001 as part of the Marketing Authorisation Application’s Centralised Procedure. Given the results of the clinical study producing the data requested will not be available within the timeframe allowed in the Centralised Procedure, Cangene has notified the EMA of its withdrawal of the application at this time. Cangene intends to re-file the MAA for European Union licensure of this important product for hemophilia B patients when the additional clinical data is available.

Cangene continues to address the FDA issued Complete Response Letter (CRL) with a clearly defined path to approval in connection with the Biologics License Application (BLA).

Conatus Pharma Files for IPO to Fund Liver-disease Drug Conatus Pharmaceuticals Inc announced that it has filed a registration statement on Form S-1 with the US Securities and Exchange Commission (SEC) relating to the proposed initial public offering of its common stock. The number of shares to be offered and the price range for the offering have not been determined.

All shares of the common stock to be sold in the offering will be offered by Conatus.

Stifel and Piper Jaffray & Co are acting as joint book-running managers for the offering. JMP Securities LLC is acting as co-lead manager and SunTrust Robinson Humphrey, Inc is acting as co-manager for the offering. The offering will be made only by means of a prospectus.

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apceth in a First of its Kind C l i ni c al Tr ia l As the first biopharmaceutical company worldwide, apceth GmbH & Co. KG with its headquarters and manufacturing sites in Munich and Ottobrunn has received approval to conduct a clinical cancer trial with its genetically modified, adult mesenchymal stem cells. This is an entirely new approach for the treatment of advanced types of cancer for which there is currently no effective treatment available.

The multicenter, open-label trial will recruit patients suffering from advanced adenocarcinomas of the gastrointestinal tract.

This innovative therapy is based on mesenchymal stem cells harvested from the patient’s own (autologous) bone marrow, which are processed, genetically modified and re-infused into the patient. The stem cells thus modified specifically target the tumor and the cytotoxic gene product is selectively activated at the site of the tumor or its metastases to increase local efficacy and to reduce systemic toxicity, one of the main problems of systemic chemotherapy. This unique principle is also applicable to other cancer types.

This clinical trial will be initiated at the University Hospital Grosshadern in Munich shortly in collaboration with experts from the National Center of Tumor Diseases (NCT) in Heidelberg and the Karolinska Institute in Stockholm.

This to date unique and innovative approach in the treatment of cancer is part of apceth’s corporate strategy of developing sustainable cell-based therapeutics. Other clinical trials are already testing the treatment of advanced vascular diseases, while other cellular drugs are under development.

Besides its own internal research and development programmes, apceth also collaborates with international pharmaceutical and biotech companies, who are showing increasing interest in celland gene therapeutics as a next-generation treatment option and entering the emerging field of “regenerative medicine”.

New Method to Analyse High-throughput DNA Sequencing Data Scientists at A*STAR’s Genome Institute of Singapore (GIS) have developed a revolutionary method to quickly cut through noise and generate a unified and simplified analysis of high-throughput biological data from, for example, patient samples.

The technique, known as a pre-whitening matched filter, is well known in electrical engineering and widely used in cell phones and radar. This is the first time, however, computational scientists, led by Dr Shyam Prabhakar, Associate Director, Integrated Genomics, GIS, have adapted it to the analysis of high-throughput DNA sequencing data, with surprisingly accurate results.

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High-throughput DNA sequencing has revolutionized the study of molecular biology and human disease. The technology has yielded major insights into cancer, infectious diseases, Parkinson’s disease and many developmental disorders.

The difficulties facing this technique are the massive amounts of data that are generated. To add to that, it was generally believed that a different method of analysis was required for each type of sequence data. Hence, each new data type was treated as a completely new analysis problem, resulting in a tremendous number of different analytical methods to solve them.

Dr Prabhakar and his team at the GIS, however, discovered that by using the pre-whitening matched filter technique, the results were uniformly better than other existing algorithms at a whole range of analysis tasks. In essence, the technique was applied to accurately detect segments of the genome that stood out from the rest of the sequence data. This was possible because, as lead author Dr Vibhor Kumar quickly realised, the underlying mathematics to the solution of all these analysis problems was the same.

The team was also able to use a variant of the technique to accurately predict gene expression, from epigenomic data.

In other words, they could predict the activity levels of genes from data on chemical changes in the genetic material. This is significant especially in clinical settings, since gene expression is difficult to measure by conventional methods in old and degraded tissue samples.

BioMarin Starts Phase 3 Trial for PEG-PAL for the Treatment of PKU BioMarin Pharmaceutical Inc has initiated the Phase 3 program for PEG-PAL (PEGylated recombinant Phenylalanine Ammonia Lyase) for the treatment of phenylketonuria (PKU).

“In the Phase 2 trial, PEG-PAL was shown to dramatically reduce blood Phe levels, and we are hopeful that we will achieve the same outcome with the Phase 3 program,” stated Hank Fuchs, MD, Chief Medical Officer of BioMarin. “Adult patients with PKU and patients on the severe end of the disease spectrum still represent a very high unmet medical need. With PEG-PAL, it may be possible to provide a treatment benefit to this population.”

The Phase 3 study (165-301) is an open-label, multi-center study to assess the safety and tolerability of an induction, titration and maintenance dose regimen of PEG-PAL self-administered by approximately 90 naïve adult PKU subjects.

The primary objective of the 165-301 study is to characterise the safety and tolerability of PEG-PAL during induction, titration, and maintenance dosing. The secondary objective of the study is to evaluate blood Phe levels during induction, titration, and maintenance dosing.

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events diary India International Healthcare & Medical Diagnostics Expo Dates : 5 – 07 July 2013 Venue : Holly Hock Gardens, Jalandhar, Punjab India International Healthcare & Medical Diagnostics Expo is an important trade fair that will be held in Jalandhar, Punjab for the duration of three days. This promotional health expo will be providing detailed information about the offerings, medical products and services to enhance industrial growth. It will be holding conversations on medical topics like product development, finance, pharmacy, quality, disease and network management, community health and so on. This will be an international interactive forum that is intended to advance medical management strategies with more developed health care technologies.

Contact: Paramount Exhibitors # 679, Phase 7, SAS Nagar Mohali, Punjab, India Tel: +(91)-(172)-2274801/2274802/2274803 Fax: +(91)-(172)-2274803

Pharmac India Dates: 05 – 07 September 2013 Venue: HITEX Exhibition Centre, Hyderabad Hosting by Orbitz Exhibitions Private Limited for three days at HITEX Exhibition Centre, India, Pharmac India is recognised as a focused exhibition for Pharma & Health care industry. It is three day exhibition which is aiming towards highlighting varied related medical products. It will prove to be a large hub of reputed professionals from pharmaceutical formulation, herbal products, veterinary drug, medical & disposal, pharmaceutical machinery and many other sectors.

Contact: Orbitz Exhibitions Pvt Ltd 101, Navyug Indl Estate, Sewri (W), Mumbai Tel: +(91)-(22)-24102801/02/03/04/39504586 | Fax: +(91)-(22)-24102805 58 June 2013

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Pharma Bio South 2013 Dates: 9 – 11 October 2013 Venue: Chennai Trade Centre, Guindy, Chennai CHEMTECH announces CHEMTECH World Expo 2013 - SOUTH of its flagship event from 9th to 11th October 2013 in Chennai Trade Centre, Guindy, India. Pharma Bio World Expo & conferences will concurrently be organised during the Expo.

The international exhibition will have display of state-of-the-art technologies, equipment, accessories and services from national and international players in each sector. Concurrent International conferences EPC World Expo, ChemPetro World Expo, Industry Automation and Process Control World Expo and WaterEX World Expo will have deliberations on topical issues by industry leaders, experts and influencers and offer high level networking opportunities to take the businesses to newer heights.

Contact: Chemtech Secretariat 26, Maker Chambers VI Nariman Point, Mumbai 400 021 Tel: + (91)-(22)-40373737 | Fax: +(91)-(22)-22870502 E-mail: sales@jasubhai.com; conferences@jasubhai.com

India Diagnostic Expo Dates:21– 23 November 2013 Venue: HITEX Exhibition Centre, NAC campus, Madhapur Hyderabad India Diagnostic Expo is going to be held for a period of three days in Hyderabad, India. This expo will attract diagnostic labs, clinical lab professionals, chemists and biochemists from all over the world to discuss about the modern market trends and future market prospective associated with the diagnostic industry. By taking an active part in this expo technical and professional experts related to diagnostic industry will get a scope to share their expertise with the attendees.

Contact: SD (India) Corporation 14, Mall Road, 1 st Floor, Hudson Lane, GTB Nagar New Delhi Tel: +(91)-(11)-47034600/43003757 | Fax: +(91)-(11)-47056500 Pharma Bio World

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bookshelf Motor Control: Translating Research into Clinical Practices Authors: Anne Shumway-Cook and Marjorie H Woollacott Price: USD 88.34 No of pages: 656 pages (Hardcover) Publisher: Lippincott Williams & Wilkins; 4 th North American Edition About the book: Motor Control motor control research and its therapists to examine and treat and upper extremity function, clinical practice.

is the only text to bridge the gap between current applications to clinical practice. The text prepares patients with problems related to balance, mobility, based on the best available evidence supporting

This edition provides the latest research findings and their clinical applications in postural control, mobility, and upper extremity function. Drawings, charts, tables, and photographs are also included to clarify postural control and functional mobility, and laboratory activities and case studies are provided to reinforce key concepts.

Single-Case Research Designs: Methods for Clinical and Applied Settings Author: Alan E Kazdin Price: USD 74.32 No of pages: 464 pages (Paperback) Publisher: Oxford University Press, USA; 2 nd Edition About the book: This book provides a notable contrast to the quantitative methodology approach that pervades the biological and social sciences. While focusing on widely applicable methodologies for evaluating interventions -- such as treatment or psychotherapy using applied behavior analysis -- this revised edition also encompasses a broader range of research areas that utilise single-case designs, demonstrating the pertinence of this methodology in various disciplines, from psychology and medicine to business and industry. This updated text is ideal for practitioners, instructors, and students.

Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine (LANGE Clinical Science) Authors: Albert Jonsen, Mark Siegler and William Winslade Price: USD 41.06 No of pages: 240 pages (Paperback) Publisher: McGraw-Hill Medical; 7 th Edition About the book: Clinical Ethics teaches the widely-known Four-Topics Method to help you make the right choice when facing complex ethical questions and dilemmas encountered during everyday patient care. You will learn an easy-to-apply system based on simple questions about medical indications, patient preferences, quality of life, and contextual features that clearly explain clinical ethics and helps you formulate a sound diagnosis and treatment strategy. It goes beyond theory to offer a solid decision-making strategy applicable to real-world practice. Numerous clinical case examples link principles to everyday practice -- many new to this edition.

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R.N.I. No.: MAHENG/2002/8502 Date of Publication: 1’st of every month Postal Registration No: MH/MR/SOUTH-284/2011-13 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month.

Total Pages :- 62

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