PBW October 2013 by Pharma Bio World

October 2013 l

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October 2013 l

Vol.12

Issue 3

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6 ď&#x201A;&#x192; October 2013

Contents 6-8.indd 6

Pharma Bio World

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EXPERT’S TAKE 10

Access to Medicine: Moral Imperative and a New Consciousness - Part 4 – Jenik Radon, Maree Newson

INTERVIEW 16

The Biopharmaceuticals Doyen Speaks… – Dr Gautam Daftary

FEATURES 26

The Biosimilar Boom: Need for Robust Pharmacovigilance – Dr Rashna Cama

cGMP-Compliant Cleaning System Critical for Pharma and Biotech – Florian Uffinger

Regulatory Challenges and Complications in Development and Commercialisation of Biosimilars – Parminder Kaur

Co-Designing Modelling Approach – Sarabjeet Singh Sharad

Logistics of Biologics – Rajiv Sharma

Energy Savings in Process Air Treatment – Shridhar Gokhale

MARKET RESEARCH 51

Vaccines Market in India – Ananya Sen

NEWS FEATURE 53

Mobile Apps: A Game Changer for Pharma Industry – Mahesh Kallayil

Another 483? Again?! – Ananya Sen

NEWS UPDATE 56 64

Pharma News Biotech News

CORPORATE AFFAIRS 68 72

Product Trends Events Diary

BACKYARD 53

73 74

Bookshelf AD Index Next Issue Focus: Compititive Manufacturing

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Contents 6-8.indd 8

Pharma Bio World

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expert's take

Access to Medicine: Moral

Imperative and a New Consciousness

Part 4

Jenik Radon

Maree Newson

Associate (NZ Qualified) Radon Law Offices, New York

This series of articles looks at “access to medicine” as a human right, with a focus on what access to medication could look like in the real world. In the last issue, we discussed what illnesses might trigger that human right and what medicines are “essential”. In this issue, we explore who should pay for drugs when patients cannot afford them.

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he needs for access to medicine might be met through international private and public donations of medicines or money. But the time, quantity, and extent of these contributions are an unpredictable and not assured form of assistance. Accordingly, such help does not present a continuous or sustainable approach. Reports abound from NGOs that contributions are not adequate and from such international organisations as the UN that counties have not honored their support commitments. Although access to medicine is not the pharmaceutical industry’s sole responsibility, it does affect how the industry is viewed. It impacts its brand. Actively engaging in providing access to patented medicines can both improve a company’s image and thereby increase the value of the corporate brand and also allow a company to itself set the terms upon which that access is created. The Pharmaceutical Industry — A Standard Business or a Special Business? In the PMA case, the plaintiff pharmaceutical companies’ complaint was not just a

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Adjunct Professor of International and Public Affairs, Columbia School of International and Public Affairs

The fact that the pharmaceutical industry is the provider of some of the medical services that the governments are expected to make available alone may place it in a special situation and differentiate it from nearly all other industries.

10 October 2013

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public relations failure but also failure to understand that pharma products are not ordinary every-day commodities. The pharmaceutical industry seeks like any other business and industry to earn a profit for its shareholders and, in this regard, competes with all other businesses ranging from Microsoft to Chevron to Ford for investors. Yet the pharma industry is unlike these businesses as its products impact us very personally. They are consumed around the world by persons, who may include our parents, our children, and our friends, for one purpose only: to restore (or maintain) their health. Does focusing on health place any special responsibilities on the pharma industry? With the adoption of the UN Declaration of Human Rights in 1948, the right to medical care has received expanded recognition and is acknowledged as a human right under Article 25 of the Declaration. Admittedly political rights, as freedom from torture, as embodied in the 1966 International Covenant on Civil and Political Rights (“the Political Covenant”) have become the standard by which the United States and other western nations judge other nations human rights compliance. But political freedoms are literally a low-cost right as they do not impose any significant economic burdens on nations or their governments to ensure their compliance. Such an obligation can be described as a passive obligation as political freedoms require governments to refrain from Pharma Bio World

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“

Tiered pricing, which may appear unfair in its income price discrimination, ultimately delivers more drugs to more people and therefore provides an overall societal benefit.

certain actions such as the imposition of restrictions on press freedoms. Accordingly, compliance can be relatively easily monitored and determined.

However, the realisation of the human right to medical care as embodied in Article 12 of the Social Covenant imposes an affirmative obligation on the ratifying nation, namely financial commitments. The Social Covenant states that the ratifying nations, which still do not include the United States, “recognise the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” and specifically imposes on such nations the obligation to create the “conditions which would assure to all medical service and medical attention in the event of sickness.” The provision of such medical service, which includes pharmaceutical products, will invariably impose costs, even if only to the extent of the “maximum of [a nation’s] available resources,” on an individual government as it seeks to implement this obligation. Moreover, there is no obligation on the international community to assist another nation to meet its obligations other than to provide undefined economic and technical assistance. Accordingly, the pharma companies in the PMA case were effectively asking the South African government to ignore, if not violate or neglect, its international human rights obligations as embodied in the UN Declaration of Human Rights and the Social Covenant. Moreover, that approach failed to recognise that the public viewed the pharma business as comparable to that of hospital services. Consequently, the pharma industry has been subjected to a normative push that, like hospital services, drugs should be made available at least, in emergency 12 October 2013

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situations. Pharma companies are providers of some of the medical services that the governments are expected to make available. This fact alone may place pharma companies in a special situation and differentiates the pharmaceutical industry from nearly all other industries, admittedly not without controversy. But an articulation of the specifics of that special responsibility is still open to international public debate, as well national debate, especially in the US, which at times is emotionally charged and is certainly intense. Pharma Setting its Own Terms through Tiered Pricing A country’s government is the primary duty bearer for access to health care, but the pharmaceutical industry will inevitably carry some of the cost. How much of the burden private industry will bear is hard to predict based on international agreements alone, but if pharmaceutical companies proactively develop access programmes, they will at least have a role in setting those terms. The Doha Declaration and the 2005 amendment to TRIPS make clear that countries can compulsory license medicine when necessary and can import those medicines from another country if lacking its own manufacturing capability. TRIPS Article 31 lays out the rules for compulsory licensing, but its provisions are ambiguous about how these compulsory licensing will affect patients and pharma. As a result, developing countries have the opportunity to define for themselves when a public health need warrants breaking patent protections. Moreover, when a compulsory license is granted, TRIPS requires “adequate remuneration” to the patent owner but

does not specify a way to determine the amount of that remuneration. Furthermore, although a country with a health emergency can import medicine from another member country, countries may be reluctant to assume such a supporting exporting role. Countries, like Thailand as already noted, risk being branded intellectual property violators if they use compulsory licensing to address their own health problems. These potential exporting countries may be even more reluctant to grant compulsory license in order to address the needs of another country, although India, which has a significant pharma generic industry, does appear ready to accept such a role. TRIPS gives a country the power to provide patented medicines to its people at affordable prices, but it is unclear when a pharmaceutical company’s patent should be disregarded, how much the company will be paid, or, in some instances, where the medicines will be manufactured. Rather than rely on TRIPS, pharmaceutical companies can set their own prices and other terms for providing access to medicine. Tiered pricing, for example, allows drugs to be made available to different countries or different segments within a country at lower or higher prices depending on income. As a result, the poorest countries will pay the lowest prices. On the other hand, any loss of profit would have to be made up in the developed countries, thereby subsidising access to medicine by raising drug prices in wealthier countries, which may well ignite controversy in the future as the costs of providing medical care to aging societies continues to rise. Some economic studies have shown that tiered pricing, which may appear unfair in its income price discrimination, ultimately delivers more drugs to more people and therefore provides an overall societal benefit. One implementation of a tiered pricing strategy for AIDS medicine is worth noting in more detail. The pharmaceutical company, Gilead, holds patents to major HIV/AIDS antiretroviral drugs and has led the way in developing a model to deliver its medicines to low-income countries that Pharma Bio World

30-10-2013 10:47:01

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and sell at a relatively low price to a greater portion of a specific national market. But as discussed, it is not at all clear that a WTO member country with such production capacity would respond to another nation’s use of compulsory licensing by exporting AIDS medicine to that nation. Gilead, however, has assured the availability of its medicine at low or affordable prices and licensed generic manufacturers to produce it for sale to lowincome nations, which has the additional benefit that Gilead as licensor has a stake in ensuring production quality as the medicine is sold under the Gilead name.

In 2003, Gilead started a programme to increase access to medicines to make its products accessible to all patients who need them. This access programme both guarantees that the drugs will be available and allows the patent holder to set the price at which it will be compensated. Additionally, because the patent holder has control over the price of the drug in low-income countries, there is less of a need, if any, to raise prices in high-income countries. The Gilead access programme focuses on countries most affected by the HIV/AIDS epidemic and uses several strategies to increase access to its HIV medications. Its pricing is tiered and is based on a country’s economic status and its HIV prevalence. Gilead administers its programme by categorising countries as either low income or lower middle income. If a country has

“

a gross national income of less than USD 1,000, then it is deemed to be low-income, and in that case medicines are sold to local distribution partners at no profit. In lower middle-income countries, with a gross national income of more than USD 1,000 but less than USD 3000, medicines are sold to local distributors at a low profit. In all, Gilead sells its products through eleven distributors, reaching 130 countries. Gilead also encourages competition with its brand distributors by licensing to generic manufacturers. Gilead has licensing agreements with thirteen generic manufacturers in India for production and distribution in India and exportation to low-income countries.

In the next issue, we introduce a new framework for thinking about pharma corporate responsibility and the need for a new code of ethics.

In addition to selling vital drugs at a low price, Gilead’s model generates competition with generic manufacturers. As a result of this competition, the prices of both the generic drugs and the branded drugs are kept low.

“

is both sustainable and still creates profit where possible. Gilead’s first antiretroviral medicine was approved by the FDA in October 2001, six months after the PMA lawsuit was withdrawn.

Additionally, the Gilead model is of note because the drug developer shares in the modest profit made in middle-income countries instead of only the generic manufacturers. By adjusting prices on its branded medicines and encouraging generic v ers ions , G il e a d h a s ma d e significant progress toward creating a working and marginally profitable structure for selling HIV drugs to developing countries. But yet the Gilead model has not become an industry precedent, which is not to say that other pharma companies do not provide some form of access to medicine to people in developing nations. But a world-wide pharma industry access to medicine system is still lacking.

Arguably, generic companies could produce drugs under a compulsory license

Does focusing on health place any special responsibilities on the pharma industry?

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Pharma Bio World

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interview

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DR GAUTAM DAFTARY

The Biopharmaceuticals Doyen Speaks… The fact that most of our products continue to be the preferred product in crowded market is a testimony to our success.

In this Biopharmaceutical special issue of Pharma Bio World, Dr Gautam Daftary, Vice Chairman and Managing Director, Bharat Serums and Vaccine in an interview with Ananya Sen discusses product differentiation of biologics, their affordability, BSV’s product pipeline and more. How important according to you is product differentiation of Biopharmaceuticals and in what way? Not so long back, the area of Biopharmaceuticals had high barriers to entry – mainly being technology, scale and regulations. However, over the period of time, these traditional barriers to entry have been dismantled allowing more entrants to enter the area of Biopharmaceuticals. With more entrants in the markets, it is important to have some product differentiation which means that the customers perceive more value in our product and hence given a choice they opt for our product.

The way to look at product differentiation is to look at it from a strategic perspective and include product differentiation in each value chain business process – starting from drug development process and right up to marketing and sales of the product. I will cite a typical case of one of BSV’s successes. One of our earliest Biopharmaceutical drug developments was a novel monoclonal antibody product. There were other Biopharmaceutical products in the markets for the same indication – however, there were certain factors like threat of viruses, limited and disruptive supplies due to difficulties associated

Under the new competitive scenario where we have many players offering the same product, product differentiation is the only way to provide more value to the end customer, allowing the company to maintain the market share. The most simple, but unsustainable way, of product differentiation would be offering the product at a low price – however in the long run such strategy is neither good for the customers nor for the industry as it kills innovation and deprives customers with improved product. Pharma Bio World

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What would be the approaches to enable product differentiation? There could be various approaches to p r o d u c t d i ff e r e n t i a t i o n – h o w e v e r i n Pharma, we need to understand that given the high number of regulations, it is important to integrate such product differentiation approaches with the entire drug development process. Broadly, there could two categories of product differentiation – one from the front end perspective and second would be the back end perspective. From the front end perspective, product differentiation can be achieved through the right message and education of the medical fraternity on the product attributes. However longevity of such measures can be short lived if such messages are not backed with sound technical attributes (back end product differentiation), such measures are only good for mid term. The key to long term product differentiation is to incorporate such attributes as a part of drug development process. It is therefore important for the person, at the helm of the drug development, to always have the patient/unmet medical need in mind rather than the particular target molecule – this helps in envisaging all parameters and desirable product attributes to be listed out. I also think that Quality by design is one of the ways to achieve this. Again speaking from one of our successful drug development projects which is now being considered by the Government of India for the eradication of a vector borne disease, we had a product which is considered as a gold standard in a particular therapeutic area – however its use was limited severely by the side effects. We looked at the problem and practically redesigned the product to address the safety aspects of the product while 18 October 2013

final interview.indd 18

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with the active ingredient were some of the perceived risks with the products. Our approach of taking the monoclonal route addressed both the issues and translated into a long term competitive advantage to BSV. The product continues to be a market leader even after a decade of launch.

One cannot only rely on the reported risks with other similar products which may be in the market. Hence it is important to monitor all developmental data to highlight and note potential risks and have these put in the risk management plan.

maintaining the efficacy- the resultant product, patented globally, is proving to be game changer in this treatment regimen as it not only benefits the patients but also curtails the requirement of health care delivery for administration of such product. A well thought out and well planned drug development process ensures that your product stands out from competition. At BSV, we have always believed in this process and the fact that most of our products continue to be the preferred product in crowded market is a testimony to our success.

Do you feel the need to have risk management plans worked out before launching a product in the market especially biologics? Can you elaborate?

With the boom of Biosimilars, Biosuperiors and Personalised Medicines today, how close are the common Indian masses from gaining affordable access to these highly specific drugs? It’s a good question, a question which many in the industry, government and medical fraternity are asking. The way I would look at it is from two different perspectives – the technical capabilities of the industry at large and the evolution of regulation to establish guidelines to pave a smooth path for approval of such medicines. From an industry perspective and looking at the work that we do at BSV, I think the industry is now in a position to provide such drugs.

To put simplistically, a risk management plan articulates the potential risk, and mitigation of such risks, that a patient may have on administration of the product. It is a well established fact that all biologics products go through extensive drug development as no two biologics can be termed as generics. Hence specifically in terms of Biologics, one cannot only rely on the reported risks with other similar products which may be in the market.

However the challenges that industry is facing is the lag in the regulations to approve such drugs. There is an urgent need for a greater co-operation and discussions between the regulatory agencies and the industry to discuss and put in place such guidelines in a time bound manner.

Hence it is important to monitor all developmental data to highlight and note potential risks and have these put in the risk management plan. BSV has developed several biologics drugs – from equine sources (Anti Snake Venom, Anti Rabies Serum and Anti Thymocyte Globulin), from natural sources like urine ( fertility hormones, Ulinastatin) and recombinant p r o d u c t s ( f r o m C H O c e l l s ) . We h a v e a very wide and diverse experience in developing such drugs and putting such risk management plans prior to the launch of the drugs.

I foresee an interesting and challenging time ahead for the Indian biologics market. We are most likely to see pharma companies moving up the value chains. While we are going to see more entrants into this segment mostly into the biosimilar space, some of the existing companies will move on to the next challenge of Biosuperiors and novel Biologics.

How would you visualise the Indian Biologics market of the future?

At the same time, evolving regulations are going to raise the bar for entering the market – in terms of extent of studies which will have an impact on the resources Pharma Bio World

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required to come into the market. I can also talk from our experience in BSV. Our driving force for all development programmes has been providing a cost effective quality product for an unmet medical need. BSV has been unique in it approach as we saw the opportunity in Biologics more than a decade ago. Looking back, I can proudly say that we have been the only Indian company to initiate work on novel Biotech molecules and biosimilars –in late 1990’s and early 2000’s. We were amongst the first companies in India to commercialise and market a novel biotech compound in India more than decade ago. I should also mention here that this product continues to be a market leader in its segment. We expanded our Biotech research programme in early 2000’s to two Biosimilars and two novel Biotech molecules. While we already commercialised one biosimilar drug 5 years back, we are in the late stage development on two novel biotech molecules which would be for the first time in world. Our competencies in Biologics, therapeutic proteins isolated from natural sources, have also enabled us to provide path breaking therapies for unmet medical need. While we have been successful in bringing to market a novel biological compound for an unmet medical need of Sepsis and very shortly, we will be able to bring to the market another novel biological for treatment of stroke for the first time in India. What are the challenges involved in the clinical trials for biosimilars in your opinion? We see a lot of different clinical development requirements across countries which

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necessitate more than one clinical development programme if one aims for global market. In India itself, we have seen regulations evolve over a period of last few years with more extensive data requirements. The stricter requirements on the manufacturing scale of clinical supplies are also indirectly increasing the cost of such trials. The need to demonstrate the immunogenicity has made designing of such trial challenging and intricate. What was your vision when you started SIRO Clinpharm way back in the mid 90’s? As I always say, the starting of SIRO was more by default than by design. The actual start up was only for helping one of our German partners to generate some clinical data for their product. However, the way we executed the project led to more such trials being awarded to us, and before we knew, there were flood of offers from various global companies. It is at that time that we realised the need for a good quality clinical research organisation and I think what also helped was the fact that India was just emerging as a clinical trial destination. Which are the areas that BSV is currently working on? Could you update us on BSV’s product pipeline? Over the years, we have consciously built our competencies in three broad technology platforms - novel drug delivery systems, Biotechnology and Biologicals. Within BSV, we differentiate Biotech from Biologicals – we consider Biotech products to be the product which are made from recombinant Cell lines - whether bacterial or mammalian or any other cell lines, while we term Biologicals as therapeutic proteins which are isolated from natural sources.

While we recently launched a novel biological entity for Sepsis in the Indian market, we are in the late stage development of another novel biological entity for the Indication of stroke.

20 October 2013

final interview.indd 20

In terms of novel drug delivery molecules, BSV would be one of those very few companies which at global scale has global drug development programmes based on various technology platforms: liposomes, microsphere, implants, emulsions, etc. We have been very successful in development and commercialisation of such products and we will continue to focus in introducing more products in the Indian market on such platforms but also take a majority of these products to global scale. Our ability to patent such products on global scale and the immense interest shown by global companies are proof enough on the quality of work that we do. In Biotechnology, these are more long term projects with each product requiring at least 6 years to come in the Indian m a r k e t . A s I h a d m e n t i o n e d e a r l i e r, probably we were amongst the earliest to realise the potential of Biotechnology in India and commercialised novel Biotech entity in India more than a decade ago. In Biotechnology, we have been focused on limited Biotech molecules – 2 each in Biosimilar and Novel Biotech molecules – however the entire drug development right including cell line development, process development & scale up and clinical trials have been conducted in- house. We are in late stage clinical development of two novel Biotech molecules, which would be for the first time globally. In the near mid term, we should be able to provide these products to the Indian patients. On the Biological segment, we have a very successful product range of fertility hormones which have been entirely developed in house. We are amongst the very few companies in India to have a backward integration right up to the API stages for this class of products. While we recently launched a novel biological entity for Sepsis in the Indian market, we are in the late stage development of another novel biological entity for the Indication of stroke. The other major area of research for us is equine antitoxins and equine immunoglobulin – our cutting edge technology has enabled BSV to be amongst the largest producers of equine antitoxins globally. Pharma Bio World

30-10-2013 11:24:00

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8/5/2013 3:23:47 PM 30-10-2013 13:03:37

Ad Template 01.indd 25

30-10-2013 13:04:52

The Biosimilar Boom: Need for Robust Pharmacovigilance Biosimilars have tremendous potential to improve patient access to modern therapies and improve quality of life in both the developed and developing regions of the world, but the increased risks associated with immunogenicity highlight the need to focus on the pathways of patient care and robust pharmacovigilance legislation and practices.

Dr Rashna Cama

Associate Medical Director Quintiles Technologies Pvt Ltd 26 October 2013

The Biosimilar Boom.indd 26

s biologics worth more than USD 60 million go off-patent in the next decade, we are currently witnessing the blossoming of an era of Biosimilars. Unlike chemically synthesized molecules, “biologic” medicines are large complex molecules that are produced from living cells. The manufacture of biologics is a complex process involving multiple steps of production and purification. The complex structure of the molecule causes it to have different characteristics which may carry different risks. This together with a complex manufacturing process carries the risk of influencing the characteristics of the end product, and possibly the safety profile of the end product. The first biologic drug to receive approval in the US was recombinant insulin in 1982. Discovery of recombinant DNA techniques more than 25 years ago mushroomed into large-scale production of biologics, which resulted in important new treatments for a variety of chronic and sometimes lifethreatening diseases. Biologics are both therapeutically and economically important. More than 150 reference product biologics have been approved in the US and there appear to be more than 370 in clinical trials targeting a broad spectrum of diseases from cancers to Alzheimer’s, multiple sclerosis, vaccine preventable diseases, and AIDS. The expiration of patents of some biologics, like growth hormone, granulocyte colony-stimulating factor, and erythropoietin, makes it possible for pharmaceutical companies to produce socalled “biosimilars”, which are also called “subsequent entry biologics” or “follow-on biologics”. Hence, biosimilars are biologic medicines that though not identical to the reference product, are highly similar to the approved biologic, and may have minor differences in clinically inactive components. Biosimilars are defined by the European Medicines Agency (EMEA) as biopharmaceuticals claimed to be

similar to a reference medicinal product based on the demonstration of the similar nature of the two products, in terms of quality, safety and efficacy. Since 2007, biosimilars have been approved for use in patients in the European Union (EU) and other regions. According to a 2010 report from India, more than 40 biologics are marketed in India of which 25 are non-innovator biologics manufactured in India including epoetin, filgrastim, Rituximab, insulin and streptokinase. Regulatory Considerations The approval of Biosimilars in India today is governed by the ‘Guidelines on Similar Biologics’ issued by DBT and CDSCO in June 2012. Biosimilars cannot be authorised based on the same requirements that apply to generic medicines for chemically synthesised molecules. Even if a biosimilar and reference drug show similar efficacy, significant differences may exist in its safety profile in terms of type, seriousness or incidence of adverse reactions. As the data from pre-authorisation clinical studies normally are insufficient to identify all potential differences, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk-benefit assessment. A lack of similarity in complex drugs can lead to severe consequences, evident only when tested in long-term clinical trials. The CDSCO ‘Guidelines for Approval of Similar Biologics’ addresses post marketing surveillance requirements which may perhaps augment the pre-approval human clinical data and are in line with the EMEA and FDA requirements. The Guidelines mandate the submission of a post-approval ‘Risk Management Plan’ along with Marketing Authorisation Application. The risk management plan Pharma Bio World

30-10-2013 11:30:34

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for biosimilars is expected to focus on the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Thus, it should be designed to monitor and detect the known safety concerns of the biosimilar as well as detect unknown safety signals that may arise. The guidelines stress the need for at least one non-comparative post-marketing study with focus on safety and immunogenicity that will confirm that the biosimilar does not pose any safety concern to the subjects. The Indian guidelines emphasise that a pharmacovigilance plan must be prepared by manufacturer to further evaluate the clinical safety in all the approved indications in the post marketing phase. The pharmacovigilance plan should include the submission of Periodic Safety Update Reports (PSURs) on a six- monthly basis for the first two years after approval and on an annual basis for the subsequent two years to the DCGI office as per the Schedule Y. In Europe, the pharmacovigilance legislation which came into force in July 2012, has been upgraded to increase the scrutiny and robustness of the pharmacovigilance system. The European Directive 2010/84/EU requires that with regard to the reporting of adverse events, biologics must be identified by the trade name and batch number in addition to the International Nonproprietary Name (INN). The legislation recognises that biosimilars, and other biological medicinal products, present distinctive safety challenges and aims to guarantee their traceability after they have been dispensed, through the provision of product information and identification. Safety and Pharmacovigilance Though biosimilars are expected to behave like their reference biological product, differences in manufacturing and purification processes may induce differences in their safety and immunogenicity profile. As approval of Biosimilars is based on an abbreviated dossier based on equivalence in terms of pharmacokinetics (PK), pharmacodynamic 28 ď&#x201A;&#x192;October 2013

The Biosimilar Boom.indd 28

(PD), efficacy and safety data between the biosimilar and the reference product in a relatively small number of subjects, the importance of post-marketing studies and surveillance cannot be over-emphasised. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. The development of anti-drug antibodies and antibodies with cross-reactivity may affect the PK/PD characteristics of the biosimilar and may have potentially serious effect on its safety and efficacy profile. Hence the importance of post-marketing studies which must be appropriately designed taking into consideration the above factors. Continuing immunogenicity assessments post approval of a biosimilar are required as often the incidence of anti-drug antibodies and neutralising antibodies in controlled clinical studies may not reliably reflect that seen during the post-approval stage due to a larger numbers of exposed subjects, more concomitant medications, repeated drug re-exposures, and possibly reduced patient treatment compliance Strict post-marketing surveillance and potentially large post-marketing studies are necessary to provide reassurance regarding the safety of biosimilars. In June 2013 at ASCO, Hospira declared the results of the first ever post marketing study of their EPO biosimilar. This European prospective, observational study included 2,310 patients with solid tumors, lymphomas or myelomas who received their EPO biosimilar for chemotherapy induced anemia. The majority of patients (>80 per cent) enrolled in this study achieved a pre-defined haemoglobin response in a real-world clinical setting and the biosimilar was well tolerated in this study with an overall rate of thrombotic events at 3.5 per cent. In this observational study, no biosimilar-related deaths were reported. This post-marketing study reinforces the acceptability of biosimilars and reassures the treating physician regarding their efficacy and safety. Besides the safety and immunogenicity concerns regarding biosimilars, concern has also been expressed about using biosimilars in other indications on the basis

of extrapolation of efficacy and safety data, ie, in indications that are approved for the reference biological but for which the biosimilar has not been investigated. The efficacy and safety of biosimilars in these extrapolated indications can only be confirmed by robust post marketing surveillance studies. With increasing use of biosimilars, another concern which bears highlighting is that of switching among biosimilars or between the reference biologic and a biosimilar. It is possible that repeated switches between the biosimilar and the reference biological may increase immunogenicity with potentially negative effects on the safety and/or efficacy of the products. Data from large-scale robust post-marketing programs will ascertain the justification or otherwise of these concerns. Pharmacovigilance processes for biosimilars should be designed to adequately address the specificity of the respective type of medicinal product. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals and biosimilars should always be commercialised with a brand name or the INN plus the manufacturer's name, which can assist in tracing them back in case of adverse event. Some Pharmaceutical companies are working to improve patient safety by applying bar codes to all injectable drugs and intravenous solutions, and incorporating bar code-reading technology into several infusion devices, in order to help ensure that patients receive the right dose of the right medicine. Conclusion Post-marketing studies and pharmacovigilance of biosimilars are necessary tools to ensure their long-term safety and reassure the treating physician on their safety and efficacy in all the approved indications. (The author would like to thank Dr Charu Manaktala, Medical Director, Quintiles.) Contact: rashna.cama@quintiles.com Pharma Bio World

30-10-2013 11:31:11

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oday, pharmaceutical and biopharmaceutical companies are faced with the challenge of ensuring that their products are of consistently high-quality on a permanent basis. In fact, these are set out unambiguously in national and international regulations. In Germany, for example, the law stipulates that it is prohibited to manufacture or bring to market products or active ingredients whose quality is significantly reduced due to deviation from the recognised regulations. Combine this challenge with the monitoring process and, most importantly, the detailed documentation of every processing step in the chain of production. This includes the cleaning of the equipment and materials which are used. Hence, a validated washing process for production equipment, containers and machines is an essential prerequisite if one is to fulfil these quality requirements. Risk: The Human Factor Companies where production machines, other equipments, or containers are still cleaned by hand often find it difficult to meet the requirements of a consistently GMP-compliant production process, because carelessness or simple human error can impair not only the cleaning process itself, but also the necessary documentation. In situations such as this, the quality of the cleaning medium, various safety

Florian Uffinger Managing Director alphaphoenix GmbH 32 October 2013

Alphaphoenix.indd 32

“

aspects and in particular the human factor are so difficult to monitor that it is almost impossible for an efficient and safe cleaning process to be carried out with clearly reproducible results. There is no question that the complex Standard Operating Procedures (SOPs) cannot be met with manual cleaning, or can only be met subject to certain restrictions. However, these require a lot of training and are time-consuming. Using a special machine to standardize cleaning is therefore the logical conclusion, in order to structure the washing process in a safer and more effective way. By automating the entire procedure, a reproducible, documented cleaning process is achieved which will ultimately also increase product quality and safety, and result in less rejects. Thanks to its design, a washing machine always delivers the same results; and the machine itself also handles the documentation of the cleaning process, while providing seamless, traceable transparency for authorities and consumers. Costs and Processing Time Reduced In a cGMP-compliant cleaning system, all the important process parameters are monitored and documented, meaning that every step in the cleaning process is completely traceable and reproducible. For example, a system monitors the cleaning temperature and the time required for this process, or it can measure the conductivity of the water during the final rinse. With

“

The author emphasises on the necessity for the pharma and biotech industries to utilise equipments for the purpose of cleaning as also standardise this operation in order to comply with the current stringent cGMP norms.

Companies where production machines, other equipments, or containers are still cleaned by hand often find it difficult to meet the requirements of a consistently GMP-compliant production process.

Pharma Bio World

30-10-2013 12:20:56

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test”, and taking a sample of the water from the final rinse, which is tested in the laboratory for eventual residues. The “riboflavin test” checks whether all of the items’ surfaces to be cleaned are sufficiently wetted with the wash fluids with the help of a fluorescent substance. Considering the selected parameters such as cleaning elements, cleaning process or the geometry of a cleaning item a verification as to whether the test solution can be completely removed by the cleaning medium. If the predefined acceptance criteria is met in this test procedure, and confirmed that using the defined process relevant parameters always the same result is obtained, the process is validated. The PLC-controlled machine consistently grants reproducible and documented cleaning processes.

a cGMP-compliant cleaning system, the operator can rest assured that the same high-quality cleaning of production parts is being achieved from day-to-day. This is achieved through the self-draining pipe work and washing cabinet, through the surface quality of these, and through the crevice-free and dead-space-free design of the area that is in contact with the product, and of the entire cleaning cart. This type of construction optimises the cleaning process so that the desired cleaning result is achieved more quickly and with reduced water consumption. The cGMP-compliant system design of a cleaning unit ensures an efficient cleaning process with fewer cleaning steps, and therefore saves water, especially expensive ultra-pure water, in the final rinse. An example of such a system is the latest development of ACG Value Links’ partner alphaphoenix GmbH: the PW6474 34 October 2013

Alphaphoenix.indd 34

cleaning system which consumes as less as 32 litres of fluid per cleaning step. As ultra-pure water in particular (PW, WFI...) represents a significant cost factor, an economical use of this manufacturing resource will lower costs for the company. The reduced water consumption combined with a highly efficient drying system has another advantage as well - it reduces the overall processing time because the time taken for filling, heating and draining is reduced due to the smaller water volume, too.

Companies using validated cleaning units are therefore optimally equipped for the future. The automation of the cleaning process, by means of a cGMP-compliant cleaning system represents a solution which is convincing not only in terms of increased process reliability and reduced water consumption, but also because of its ease-of-use and smooth integration into existing production processes. For more information about pharmaceutical, biopharmaceutical and packaging solutions, visit ACG Value Links’ booth no. H34 + I34 in hall no. 5 at P-MEC India 2013. Contact: shivprasad.hiremath@acg-world.com

Validation Comes First In order to meet the cGMP requirements for cleaning, at the start of a wash process the entire process has to be validated in the automated cGMP-compliant cleaning system. This takes place with the help of various testing procedures, such as the so-called “riboflavin test”, the “swab Pharma Bio World

30-10-2013 12:22:12

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Regulatory Challenges and Complications in Development and Commercialisation of Biosimilars

iosimilars is a complicated classification in itself! Biosimilars are not molecularly identical to the originator reference product. It is therefore critical to understand what the differences are, how significant those differences a re, and whether thos e differenc es even matter? Biosimilar Market Opportunities Insulins, epoietins,G-CSF, interleukin-2 (IL-2) and interferons, and GH constitute a major biosimilar market today.However in the coming times, monoclonal antibodies will represent the largest sector of the biologics market in Europe. As a result, there will be a significant opportunity for biosimilars developers, driven by the rising incidence and prevalence of various life threatening diseases and the therapeutic success of these targeted therapies. Patents for top-selling monoclonal antibody drugs have either expired or will expire within the next decade, opening the door for biosimilar mABs. It is noteworthy that biosimilar versions of a monoclonal antibody (Infliximab) being developed by Celltrion Healthcare and Hospira, have recently been recommended for approval in the EU, opening a new chapter in the developing market for cheaper copies of mAB based medicines. Challenges If there is an opportunity then there is risk too! A risk-based approach for demonstrating the similarity between two

Parminder Kaur

Regulatory Affairs & PhV Consultant Regpak BioPharma Consulting 36 October 2013

Regpark.indd 36

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molecules is crucial. In order to minimise the need for extensive clinical evidence of similarity, similarity to the innovator biologic must be established in a stepwise process during development: 1. First step - quality comparability (physicochemical and biological comparability). 2. Second step - non-clinical comparability (comparative non-clinical studies). 3. Third step - clinical comparability (comparative clinical studies). According to the recently released revision of EMA guideline on developing biosimilar medicinal products, following aspects have been recognised that has a potential to create developmental challenges and must be taken into consideration to overcome the risks: • • • • •

risk-based approach for the design of non-clinical studies. use of pharmacodynamic markers for the demonstration of clinical comparability. study design. design of immunogenicity studies. extrapolation of efficacy and safety from one therapeutic indication to another.

On one hand where selection of relevant species for non-clinical studies pose to be a risk, on the other hand maximising patient recruitment and choosing the most sensitive patient population that is most likely to respond to therapy, while expediting clinical trials and minimising sponsor cost is a clinical challenge. Additionally, all biotechnology products,

“

From an industry and commercial perspective, the barriers to entry for biosimilar manufacturers are high compared with small-molecule-generic manufacturers due to different pricing structure. This article will tend to look into all these aspects, which may be challenging in development and commercialisation of biosimilars.

The budgetary implications of biological medicines have been growing over the years and managing their use has become more and more important for payers. Pharma Bio World

30-10-2013 12:32:04

Biosimilars are a small segment in the total pharmaceutical market but have growth rates greater than other market segments Pharmaceutical market breakdown (2), Sales, MAT to Q ending M6 2011, â&#x201A;Ź

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160

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1,500

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including biosimilars, have the potential to be immunogenic. Evaluating the comparative immunogenicity of the reference product and the biosimilar in a clinical study is a critical component of the safety assessment needed for marketing approval in the EU. It can be logistically challenging to obtain appropriate patient numbers, particularly if the incidence of immunogenicity is low. Cost Effectiveness or Price War? The budgetary implications of biological medicines have been growing over the years and managing their use has become more and more important for payers. Like the originator reference medicines, biosimilar medicines are generally more expensive to develop than small molecule generics. However, there are various develop biosimilars which is are becoming an interesting to even small generic players achieve big!

reasons to why these opportunity who aim to

Firstly, the availability of lower-cost alternatives to branded biologics can increase market access. According to a study conducted in mid-2011 by the firm 38 ď&#x201A;&#x192;October 2013

Regpark.indd 38

IMS, biosimilar medicines were a relatively small segment of the EU pharmaceutical market, but they have strong annual growth. This means that a greater proportion of the eligible patient population may receive biologic treatment which is a better choice than developing small molecules since it generates more revenue.

to successful product development and market penetration. References 1.

Secondly, from a governmental perspective, biosimilars provide an opportunity for the absolute saving since it will save thousands of Euros per year per patient. Therefore, biosimilars can potentially be promoted to larger number of people who could be benefitted from low cost. It will not be wrong to assume that biosimilars can effectively compete with brands and create a pricing war. Conclusion

European Medicines Agency, Guideline on similar biological medicinal products CHMP/437/04 Rev. 1 European Medicines Agency, Guideline on similar biological medicinal products co n t a in in g b io t e c h n o l o g y -d e ri v e d proteins as active substance: nonclinical and clinical issues. EMEA/CHMP/ BMWP/42832/2005 Rev. 1 EMA Press Release of 28 June 2013. European Medicines Agency recommends approval of first two monoclonal antibody biosimilars European Commission Consensus Information Paper 2013: What you need to know about Biosimilar Medicinal Products

Contact: pk@regpakconsulting.com

Biosimilar product development poses challenges at every level! However, careful planning in terms of regulatory strategic roadmap, appropriate clinical strategy and trial design, regulatory compliance with scientific advice received, as well as commercial and market access considerations can lead Pharma Bio World

30-10-2013 12:33:10

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Co-Designing Modeling Approach Co-Designing ensures the best route for an active pharmaceutical ingredient is in place whenever there is a new product to be launched through the commercial manufacturing processes.

he co-designing model proposes a framework whereby R&D and manufac turing work together clo s ely after pos s ible routes for the p roduc tion hav e been identified to ensure that the best process understandings are developed for that particular commercial process which will decrease both manufacturing cost and environmental impact. Earlier Route Modeling Approach

Companies were not accessing important information from num e r o u s s o u r c e s , ranging from paper notebooks to individual demands, as the earlier route design limited the access to this critical data which did nothing to improve the understanding of materials and waste impact on the cost of goods. Due to all these challenges Co-Designing Route Modeling Approach is being introduced, it has standardised

Materials and Processing Costs (USD/Kg) Figure 1 20%

% Material Cost to API (USD/Kg) figure 1.1

5% 5% Materials

Compound X

10%

Compound Y

Processing

Compound Z

Waste 78%

80%

Stepwise Yields

Current Optimized

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90%

Step D

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95%

Step E

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Overall Yield

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73%

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What are the Problems in Earlier Route Modeling Designing Approach?

Sarabjeet Singh Sharad Senior Research Analyst Beroe Consulting (I) Pvt Ltd

40 October 2013

Co-Designing Modeling Approach.indd 40

• This method could not provide sufficiently granular information on itemised costs or environmental factors which add great value to route selection for long-term manufacture. • It did not include information about disposal costs or relative production of waste per unit mass of product. • R&D side, processing costs were often projected without knowledge of actual cycle cost, it was based on the cost involved in processing step for producing per unit product, with some validation of cost as a function of annual production volume.

Other

template structure for the research and manufacturing spreadsheet approaches in an attempt to capture stepwise information and various route configurations. Co-Designing Route Modeling Approach Development through Co-Designing Approach by means of up gradation in analytical capabilities: For the improvement in the flow of work and information, departments are using electronic laboratory notebooks and electronic materials sourcing catalogues which are accessible to everyone in the co-design team. These electronic laboratory notebooks capture data and workflow, which mean the scientists accountable for assembling process development cost and environmental information, will update the data immediately which will automatically get stored in the central repository database. Co-Design approach has defined four sub categories describing the route like Pharma Bio World

30-10-2013 12:50:03

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Manufacturing Cost (USD/kg) API

Once all steps in defined route are populated (filled), the data are sent across the central device which has process development software which provides detailed analysis as an Excel report output based on a standard primary data. API Batch Process Manufacturing Cost and Green Chemistry Mix (Figure 2.1) 1500 $1,366 $1,185. $952 1000 50 500 37 28

80 60 40 20 0

0 Route A Route B Route C Manufacturing Cost

E-Factor

Cost (USD/kg) API

properties, materials, processing and comments and all the subcategories have defined set of deliverables for which data need to be added by employees, scientists at each level.

200

Commercial Route Step (Stepwise Processing Cost)

Stepwise Time Processing Cost (hr)

USD/kg API 140

Step K

150

Step D

150

100

Step E

120

180

Overall Cost

260

370

Note: All data shown in figures is hypothetical and for the purpose of demonstration

0 Step K

StepD

Step E

Conclusion What is the Benefits Co-Design Approach? Th rough this approac h c ompanies will be able to better select the best routes that will have the greatest cost and environmental advantages in commercial production. Using this refined cost of goods and environmental analysis companies can captures process development and scaleup history in a single platform rather than in multiple, customised spreadsheets.

It will improve the organisation data and results, through collaboration between divisions involved in route selection. This approach will make it easier to collect detailed material consumption data and project stepwise operating cycle times on manufac turing s c a le . Centralised materials databases with historical price information further improved the level of detail in the materials data used in the codesign analysis. Contact: sarabjeet.singh@beroe-inc.com

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Logistics of Biologics Biologics and clinical trials have in common their frequent need for closely controlled temperature ranges and existing of any kind temperature excursion is not acceptable at any cost especially when they are also being transported internationally.

he companies that succeed in bringing commercially viable biologics and cell-based therapies to the market are those that profoundly considered the cold chain and logistics requirements of their products from the very beginning of product development. It carries this message that in biologics business, logistics has to play an intensive role. No doubt that in today’s scenario, S u pply Chain’s bas k et has the world’s largest fleet of temperaturecontrolled air cargo containers, and the continuous investment in this sector is going on to meet the technology based logistics demand. Hence logistics of biologics is a science as it requires the understanding of the chemical and biological processes linked with perishability; it is a technology since it relies on physical means to ensure appropriate temperature conditions along the supply chain and it is a process since a series of tasks must be performed to prepare, store, transport and monitor temperature sensitive products. Both dry ice cooling and electric heating and cooling continue to grow across the increased number of temperature-sensitive products and geographical regions. Each technology has its own specific design that meets the various demands of the healthcare logistics industry. In addition, the wrinkle s from the forehead cannot go, without discussing the transportation of biologics.

To summarise •

• • • •

Think outside the package to understand the transportation environment. Develop a risk management plan for temperature-sensitive products. Limit supply chain handoffs. Ensure visibility of solutions provide actionable data. Create a transportation-specific quality agreement.

will not only help protect shipments, but also document the conditions the product will encounter as it moves through the supply chain. Therefore it is essential to select a partner with expertise and experience and agree upon a transportation protocol for the movements of shipments. It is also important to ensure the partner has quality control and assurance well in place to support compliance with the regulatory guidelines. The compliance of distribution environment is the need of the hour. Planning Process Framing a robust temperature sensitive supply chain as well as maintaining product integrity throughout transportation will meet the regulations and guidelines of relevant agencies. Contingency Planning

Challenges

Rajiv Sharma

General Manager- SCM/CRAMS Panacea Biotec 44 October 2013

Logistics of Biologics - New.indd 44

Although, challenges in pharmaceutical products and biologics are very similar and both aim to maintain product integrity till it reaches the final user and it can be said that both have same issue measures in quantity & quality. But on analysing quality challenges it presents a totally different perspective. Working with a transportation and distribution partner

Contingency planning means that the collaboration with transportation provider should be led in the light of the identification of potential problems. Carrying an alternative transportation plan is always a must in contingency planning. It becomes necessary to create pre-defined alternative routes. Contact: rajivsharma@panaceabiotec.com Pharma Bio World

30-10-2013 14:38:36

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30-10-2013 15:54:39

Energy Savings in Process Air Treatment This article discusses the different energy efficient options available for the process of dehumidification wherever required in the manufacturing of pharmaceuticals.

luid-bed coating process has been used for a number of purposes including improved stability and shelf life of products, controlled, sustained, or delayed release, taste or odour masking, dust control etc. The coating processes require evaporative removal of an organic solvent or aqueous vehicle as the film coat is deposited. The speed of a film coat application is related to the drying capacity of the process. Fluidbed film coating processes have a greater drying capacity than other coating systems due to a relatively high fluidising air volume that is used to both circulate particles and evaporate the coating vehicle. This increased drying capacity translates to more efficient film coat application making it a popular choice in many industries including pharmaceutical and food. Equilibrium Relative Humidity. Knowledge of the water activity of pharmaceutical solids (proteins, drugs,

and excipients) is essential to obtain a solid dosage form with optimal chemical, physical, microbial and shelf-life properties. Water activity (aw) influences the chemical stability, microbial stability, flow properties, compaction, hardness, and dissolution rate of dosage forms of pharmaceuticals, proteins, biopharmaceuticals, nutraceuticals and phytochemicals. The importance of the measurement of water activity has been long recognised by the food industry. The measurement of water activity is traditionally less common to the pharmaceutical industry. Water associated with a substance is classified as either free or bound. Free water (sometimes called mobile or unbound) is loosely adsorbed on the surface of the substance and has properties of bulk water. Bound water is directly or tightly associated with a material and is not readily available for chemical interaction with other species. Additionally, some water is less tightly bound, with properties reflecting a much higher level of structure

Shridhar Gokhale CEO United Humidifiers 46 ď&#x201A;&#x192;October 2013

Process Air Treatment.indd 46

Pharma Bio World

30-10-2013 14:57:37

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than bulk water but less than that of tightly bound water. Thus, the amount of free water rather than the amount of total water is critical to the chemical and physical stability of a drug substance that is moisture sensitive. Poor environmental control, particularly in respect of humidity, can directly or indirectly affect the pharmaceutical production output in a number of ways. For example tablet coatings with aqueous solutions require extremely tight control of air humidity to ensure that the coating does not dry too fast or too slowly. Unbound water in products is susceptible to change depending on the relative humidity it is exposed to. The process of drying requires the moisture to be removed contrary to this moisture addition may be necessary for some products. During moisture addition (absorption) or moisture removal (desorption) if products are processed at Equilibrium Relative Humidity (ERH) excessive wetness or dryness of products does not occur. The final moisture content of the product can be controlled accurately. Rejections are significantly reduced. Another benefit of

uniform processing is improved shelf life of products. At equilibrium, the water activity of a material is equal to the relative humidity (RH) of the atmosphere in which it is stored. Knowledge of whether water will absorb or desorb from a particular component is essential to prevent degradation, especially if one of the substances is moisture sensitive. For example, two separate materials (initially at different water contents and aws) stored at 25 per cent RH will reach a water activity of 0.25, although the final water content of the two materials will be different. If the materials are moved to a higher or lower RH then the water will increase or decrease, respectively until equilibrium is reached. Likewise, if two materials of differing water activities and the same water content are mixed together, then the water will adjust between the materials until an equilibrium water activity is obtained. Therefore, water activity over water content provides useful information for formulation design, manufacturing conditions and packaging requirements. The relationship between water content and water activity is complex. An increase in aw is almost always accompanied by an increase in the water content, but in a nonlinear fashion. These curves are determined experimentally. Many disciplines use water content calculations to regulate product quality, however, water content measurement can be inaccurate and timeconsuming, especially for pharmaceuticals. For example, a particular compound has a water content of 0.05 per cent and measuring water content in this range is difficult and requires a precision balance. For this compound, changes as small as 0.02 per cent in water content corresponded with a 0.2 change in aw. Clearly, the aw measurement permits much tighter control of the product's specifications. Stability Protein, enzyme and biopharmaceutical stability is influenced significantly by water activity due to their relatively fragile nature. Great care must be taken to prevent aggregation under pharmaceutically

48 ď&#x201A;&#x192;October 2013

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relevant conditions. Most proteins, enzymes and biopharmaceuticals also must maintain integrity to remain active. Maintaining critical water activity levels to prevent dissolution, aggregation and conformational changes from occurring is important to deliver the correct dosage. Water activity of powders affects the flow, caking, compaction and strength properties of solid dosage forms. Additionally, aw is used in the study of shelf-life, aging and packaging requirements. Air Handling System Air is required to be supplied to the process at a particular temperature and relative humidity depending on various factors like the heat sensitivity of the product, properties of the solvents or aqueous vehicle used for coating purpose, the Equilibrium Relative Humidity ( ERH ) of products being processed etc. Depending on the outside climatic conditions and those at which the air is required to facilitate the process the air is treated in the Air Handling System and the treatment would generally include most , if not all, of the following : i) Filtration ii) Cooling iii) Dehumidification iv) Heating v) Humidification As the process air is not recirculated the air treatment loads and energy costs are enormous. To achieve process efficiency and product consistency the equipment as well the control systems need to be matched correctly to ensure air is supplied at or near the required conditions. Usually the FBE equipment supplier is entrusted with the responsibility to supply the equipment as a complete package including the air handling system. However considering the criticality of the process it is advisable that a company specialised in the process air treatment be employed to ensure that the air treatment system developed is not only able to maintain constant supply air temperature Pharma Bio World

30-10-2013 14:58:13

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30-10-2013 15:59:58

“

Poor environmental control, particularly in respect of humidity, can directly or indirectly affect the pharmaceutical production output in a number of ways.

and humidity irrespective of outside air condition but is also energy efficient and meets the regulatory requirements of cGMP.

requires having proper slope in the drain tray towards the outlet and also adequate slope in the external drain line to facilitate quick removal of the condensate.

The World Health Organization Guide specifies that only steam humidifiers should be installed for the purpose of humidification due to risks involved with cold water humidifiers like spray, cold mist (ultrasonic) and evaporative type. However even with steam humidifiers it is essential to continuously remove the condensate from the air handling system. The air being supplied is in direct contact with product being processed for a long time and carries a much larger risk of contamination than SAY a standard Class M 6.5 product filling area where the product is exposed for a very short duration. Present practice followed in the industry is to inject steam in the AHU and drain out the condensate from the AHU.

This process of dehumidification when applied to such systems is not energy efficient. The air is first cooled down to the required dew point and then reheated to the desired temperature.

In most cases the humidification section is inadequate in length leading to additional steam condensation which not only adds heat to the air but also is waste of energy as the amount of steam absorbed is less than the amount supplied. Solution is to install a steam dispersion pipe or manifold having an integrated condensate removal arrangement. This ensures that condensate does not come in contact with the process air. Also if the humidification section is sufficient in length, the required amount of steam will be fully absorbed by the air increasing its moisture content or humidity while eliminating the above stated risks. Dehumidification using chilled water coils also carries a potential risk of contamination as cooling coils when used for dehumidification run wet. Condensate is collected in the drain pan and drained out. However effective condensate drain 50 October 2013

Process Air Treatment.indd 50

To resolve this desiccant dehumidifiers can be installed at the inlet of the AHU to remove moisture down to required dew point and the air can then be sensibly cooled or heated (as required) to the required temperature. This will ensure a dry coil operation completely eliminating the risk of microbial contamination. However care should be taken to choose the correct desiccant dehumidifier. The dehumidifier should have silica gel chemically bonded to the rotor wheel to ensure that silica gel dust is not carried over by the air as this can lead to contamination of the product. Additionally such a desiccant drier should also be bacteriostatic and washable. Energy Savings options Dehumidification A case study has shown a saving of 8.3 KW for a 3000 CMH system when the required conditions were 25 OC DB temperature and 8 OC Dew Point. Humidification Till a few years back cold water humidification was acceptable in pharmaceutical industry. Use of ultrasonic humidifiers was accepted as the energy requirement of such humidifiers is very low. However the new guidelines of World Health Organization (WHO) state

“4.9.9 Where humidification is required, this should be achieved by appropriate means such as the injection of steam into the air stream. A product-contamination assessment should be done to determine whether pure or clean steam is required for the purposes of humidification.” It further adds “4.9.11 Humidification systems should be well drained. No condensate should accumulate in air-handling systems.” And also states “4.9.15 Cold surfaces should be insulated to prevent condensation within the clean area or on air-handling components.” Whilst steam generation does require more energy than cold water generation it is a statutory requirement and must be followed. Self-generating electric steam humidifiers are available for smaller duties upto 40 Kg per hour. The power consumption would be 0.75 KW/ Kg of steam generated. Among the electric steam humidifiers resistive humidifiers are most suitable as they offer accuracy in control which can be as high as +/- 2 per cent if required, and do not have the maintenance and cylinder replacement expenditure like the electrode humidifier and most importantly steam can be generates using any water quality from untreated drinking water to Reverse Osmosis water. The electrode humidifier requires conductive water to pass current in order to generate steam. Process humidification duties are usually very high - more than 100 Kg of steam per hour even for smaller airflows like 3000 CMH. This of course depends on the RH to be maintained at a given temperature. As most pharmaceutical companies have process steam available it is more economic to generate pure or clean steam at atmospheric pressure for humidification purpose. The actual savings can vary depending on the electricity rates per unit at place of installation. Contact: unitedhumidifiers@gmail.com Pharma Bio World

30-10-2013 14:58:13

market research

Vaccines Market in India Pharma Bio World amalgamates the data available and crafts a picture of the Indian vaccines market. Ananya Sen

he small sized vaccines market contributing to a mere 2 per cent of the total pharmaceutical sector with just a handful of prominent players and small operators continues to flourish with new prospects. Vaccines have been known to uplift the grade of healthcare the world over but their capability of reducing the rate of mortality has not yet been channelised wholly in developing countries like India. The mortality of vaccine preventable deaths recorded in India is almost three times the size of that in the United States. The poor penetration of vaccines in the Indian market is evident from the size of Indian vaccines market that is about USD 500 million as against the global vaccines market size of USD 25 billion.

Vaccine Preventable Deaths

Vaccine Penetration

Under the Universal Immunisation Programme (UIP) launched in India in 1985-86, vaccines are made available free of cost for six vaccine preventable diseases: Tuberculosis, Diphtheria, Pertussis, Tetanus, Polio and Measles.

The developing countries still need vaccines to prevent diseases which have already been eradicated in the developing world. This poor market penetration can be principally attributed to the lack of awareness of vaccine preventable diseases. Another problem associated with this is that of access or affordability. Besides these, complications involved in distribution and supply also hamper the penetration of vaccines in India. The issue of cold chain still remains a grave and unsolved problem and adds to the difficulty of market penetration.

Vaccine Preventable Diseases: Number of Reported Cases The Government of India currently spends over ` 200 crore annually on the obtaining of the six UIP vaccines alone (excluding the Pulse Polio Immunisation Programme). However, it manages to immunise only about half of over 26 million children born every year.

Indian Vaccine Manufacturers: India currently has around twelve vaccine manufacturing facilities the major vaccine

Source: WHO vaccine-preventable diseases: Monitoring System 2013 global summary

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Pharma Bio World

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Disease

Name of Vaccine

Year of Launch

Launched by

Japanese Encephalitis

JENVAC

2013

Bharat Biotech

Typhoid

Typbar-TCV

2013

Bharat Biotech

Polio

Polprotec*

2012

Panacea Biotec

H1N1 Infuenza

NASOVAC

2010

Serum Institute of India

For Nigerian Market*

players being Serum Institute of India, Bharat Biotech, Panacea Biotec, Shantha Biotechnic. India meets 43 per cent of the total vaccine requirement with Serum Institute of India being the world’s largest producer of Measles vaccine. Recent launches by Indian Vaccine Manufacturers Recently in the month of October, Bharat Biotech announced the launch of JENVAC, its indigenously developed inactivated Japanese Encephalitis vaccine which came right after the launch of Typbar-TCV, their typhoid conjugate vaccine. In addition Bharat

Biotech had also declared the development of their vaccine against Rotavirus earlier this year in the month of May. For a Noble Cause… The Global Vaccine Action Plan (GVAP) ― endorsed by the 194 Member States of the World Health Assembly aims at saving lives through a rightful access to the existing vaccines for all globally by 2020. Some of the orgainsations that have actively participated in accomplishing this objective are WHO, UNICEF, the Bill & Melinda Gates Foundation and the GAVI Alliance.

The Bill & Melinda Gates Foundation works with special focus to countries such as India which have a large number of unvaccinated children. In India, this organisation works with specific attention in the countries of Bihar and Uttar Pradesh to increase immunisation coverage. The GAVI Alliance, is a global public-private partnership of scientists, health experts, government leaders, businesspeople, and philanthropic organisations whose goal is to vaccinate all the world’s children. GAVI provides funding to buy vaccines for and provide technical support to countries with the greatest needs. References: 1. Transforming India's vaccine market McKinsey & Company 2. WHO vaccine-preventable diseases: Monitoring System 2013 global summary 3. http://www.who.int 4. http://www.gatesfoundation.org

Bharat Biotech Launches JENVAC

enome Valley based Vaccine and Bio-Therapeutic Innovator Bharat Biotech announced the launch of its Verocell-derived purified inactivated JE vaccine “JENVAC” which received the manufacturing and marketing approvals by Drug Controller General of India (DCGI). It is a fully indigenous vaccine commercialised using strain, identified, characterised, manufactured and tested in India. The uniqueness of JENVAC is its strength to provide increased immunogenicity and long term protection as a result of unique manufacturing technologies. The virus strain for this vaccine was isolated in Kolar, Karnataka during the early 1980’s and characterised by the National Institute of Virology Pune and the strains were transferred to Bharat Biotech for further vaccine development. The vaccine candidate strain was adapted to verocell substrate and it is manufactured using novel purification,

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MARKET RESEARCH.indd 52

inactivation techniques with advanced bioreactor technology. The most significant benefit JENVAC brings over live attenuated vaccines is that it can be administered during disease epidemics because it is a highly purified and inactivated vaccine. Dr V M Katoch, Secretary Department of Health Research, Government of India, said "JENVAC “not only represents as a successful example of developing a totally Indian product of immense public health importance by public - private partnership but also will prove to be a good stimulus to ICMR institutes and other institutions to move fast with their leads to fully developed products by following this route" In the clinical trials JENVAC showed superior safety and immunogenicity, in head to head comparison with the live SA14 – 14 - 2 vaccine. JENVAC met all

its primary and secondary endpoints, in the age group of 1 to 50 years, after 1 or 2 doses of vaccination. Phase III trials showed 98.7 per cent sero - protection 28 days after the 1st dose and 99.8 per cent sero - protection 28 days after dose the 2nd dose. The results proved that JENVAC can be administered as a single dose during epidemics for mass vaccination campaigns and also as a 2 dose schedule during routine immunisation as part of the National Immunisation programme in endemic regions. The added benefit of JENVAC is its ability to provide long term sero - protection. Making the announcement after receiving the approval of JENVAC by the Drugs Controller General of India (DCGI) Dr Krishna M Ella, Chairman and Managing Director of Bharat Biotech, said “JENVAC” is a product of years of committed R&D. It is yet another clone to clinic milestone for the Bharat Biotech team.

Pharma Bio World

30-10-2013 15:38:10

news features

Mobile Apps: A Game Changer for Pharma Industry With the rapid rise in people’s access to smartphones and tablets, patients and physicians have become more netsavvy and started to depend on mobile phones for health information. This article tries to sketch the advent of mobile application in Indian pharmaceutical industry.

obile phones are always a happening topic. With the emergence of smartphones and mobile operating systems, it has transitioned into a hyper-productive business tool from an over-powered toy. A report says smartphone user base in India is expected to grow to 67 million this year and 382 million by 2016. Similarly, 3G subscriptions are also expected to rise to 56 million this year and touch 266 million by 2016. According to a report released last year by global accounting consultancy group PricewaterhouseCoopers, the mobile healthcare services will be a ` 3,000-crore market in India by 2017. The growing popularity of smartphones and tablets as well as the advent of mobile applications – which are mushrooming day by day – have spawned a new genre of marketing for businesses looking to grow. Pharmaceutical industry cannot afford not to be an active participant in this creative destruction of marketing. Pharmaceutical, like other businesses, realised the importance of digital marketing and started to invest more in mobile apps to improve patient and healthcare provider engagement. 53 October 2013

Mobile Apps.indd 53

Many pharmaceutical companies have even ventured into app development. Pharmaceutical apps are predicted to be the single largest category of mobile apps in the next few years. According to a report released last year by global accounting consultancy group PricewaterhouseCoopers, the mobile healthcare services will be a ` 3,000-crore market in India by 2017. Application in Pharmaceutical Industry Pharmaceutical apps can helpful in myriad ways. It offers a new channel to the pharmaceutical companies through which they can interact with end-users. A pharma mobile app – be it a product brochure or a patient diary – can improve the lives of patients. Hospitals are using apps to disseminate information. Then there are apps which will help doctors in diagnosis and treatment. At the same time, a properly designed app in the hands of a medical representative can accelerate sales and maximise organisational efficiency. Access to medical care is still a significant problem is most parts of the world. Especially in a developing country like India, hospitals and pharmacies are usually

located in cities and towns and villagers often need to travel far and wide to access basic healthcare. A Pharmacy locator app on the cell phone enable you to find your nearest pharmacy, drug store or chemist in just a single tap. Oleg Lola, CEO at MobiDev says that the mobile apps can help manage several pharmacies simultaneously; employing one pharmacist for several stores can be a cost-effective solution - especially when the store usually has a limited number of visitors. “Wherever the pharmacist is, he/she can always be in contact, receiving notifications. The technician, who is directly in the brick-and-mortar pharmacy, can still effectively communicate with the pharmacist, manage prescriptions, and hand the needed medicine in the customer's hands. The pharmacist must also be enabled to engage into private video chat conversations with the customers, and provide them with consultations. Apart from all that, the software has to keep track of patient history, details and prescriptions,” Adds Oleg Lola. Tackling the booming trade in counterfeit drugs been more of a concern in India where regulatory and enforcement systems for medicines are weak. Counterfeiters have become very adept at imitating even the most sophisticated packaging. It is in this place where pharma apps will make its biggest splash. In India, now we have many apps which allow consumers to scan and verify the authenticity of pharmaceutical drugs they purchase, directly from their mobile phone. Clinical trials search apps enables users to find, identify relevance and share information about clinical trials. Users can also find information on how to register as a participant in a trial. These few examples illustrate the potential for mobile apps to change the pharmaceutical landscape. Pharma Bio World

30-10-2013 17:52:20

“

Mobile application offers a new channel to the pharmaceutical companies through which they can interact with end-users.

Deployment of Pharma Apps “If someone wants to deploy pharma apps, first thing they need is the area they will operate in. Domain knowledge is essential. Then the product has to be good in design and easy to use. The team should have a product pipeline in mind for the next three years to come. Finally, the products have to get great reviews and should have the cash registers ringing,” explains Sandeep Saxena, Founder CEO, Acton Biotech. Mobile application developers are increasingly looking for a Mobile Application Development Platform (MADP) that can support their needs for both current and future projects. It's a broad field and vendors offer a wide array of capabilities. Choosing the appropriate operating system to develop a pharma application is really a big decision. You need to craft a strategy that should strike a balance between visibility and revenues. After all, the more visibility you get, the greater your chances of monetisation. The major platform providers are Apple's iOS platform and Google's Android. Other MADPs are Nokia with its Symbian OS, RIM with its Blackberry OS, and Microsoft with its Windows mobile OS family and the Latest being Windows Phone 7. “The real competition today is between I-phone and Android. Symbian died a couple of years ago. Blackberry is on its way out. We will need to give a little more time to Windows to catch up as today there are not enough users of windows mobile OS.” Says Saxena. According to Saxena, most apps when launched with a couple of features are free. As more and more featured are developed, the company launches newer versions of the app with many more featured and makes it paid. The free version still remains but lots of features do not work in the free version.

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Commenting on the average downloads of pharma apps, Saxena points out that the total number of monthly downloads in the pharmaceutical category is far far smaller than downloads in games or social categories. “If a pharma app gets 10,000 downloads per month it is doing very well. Apps like Runtastic, Endomondo, have over 1 crore lifelong downloads and are leaders in this category.” He says. “Pharma apps find it very difficult to stay on the top list of app market as games, social apps and productivity apps are very aggressive for the top slot. If a pharma app is able to stay on the top hundred lists for a week also is a great achievement,” adds Saxena. Side Effects Even though mobile apps revolutionised the pharmaceutical industry to a certain extent, many pharmaceutical experts issue a note of caution. One should not forget that an app is not a replacement for a physician but a value-added service. “These apps can be used as a replacement to a doctor. All apps say that the app should not be used in place of a doctor but very few people are reading those terms and conditions. Patients and consumers should be informed about the cases when the apps should be used and when the patient should visit a doctor,” tells Saxena.

risks to patients in case they do not work as they ought to work. Regulatory Aspects Saxena opines that pharma apps can be classified as medical device. “Some apps for blood pressure monitoring and pulse rate monitoring should be classified as a medical device. And it should be regulated. There are lots of such apps which give wrong reading. The regulators should ban such apps. Other apps which give diet tips, drug information are not medical devices,” Saxena explains further. Not all smartphone and tablet apps, such as a programme reminding patients about an appointment, need to be regulated. All mobile apps that qualify as medical devices - such as a smartphone-based ultrasound and mHealth application for smart phones and tablets that allows doctors to view medical images and X-rays - warrant regulation in the first place. “In the US there are some regulations for mobile apps. A couple of other countries are catching up. In India, I don't think the regulators even know about pharma apps,” concludes Sandeep Saxena. Recently the Insurance Regulatory Authority of India (IRDA) had come out with draft regulations to regulate the functioning of web aggregators of Insurance services in India. In the same vein, we can expect similar regulations for mobile medical apps from Indian authorities as well. - Mahesh Kallayil

The biggest risk of pharma apps is the partial or wrong information display. Drugs are complex and there may be lots of warnings - interaction warnings, dosage warnings, patient warnings. If somebody reads partial information, they could miss something critical. Pharma apps cannot hope to bring relief to a critically ill patient. Moreover, some medical applications could cause serious Pharma Bio World

30-10-2013 17:52:35

news features

Another 483? Again?! Penalties, warning letters, import alerts and 483s not only taint the long standing reputation of an organisation but also cause it to run into losses. Is there a way they can be avoided? Ananya Sen seeks answers from industry experts.

s the Pharma companies remain under constant USFDA surveillance, ’compliance’ today has almost become impossible complain industry insiders. With the USFDA warning letters and Form 483 doing the rounds, the head honchos of the pharma industry have been spending sleepless nights. Indian drug manufacturing giant, Ranbaxy Laboratories has been under the USFDA scanner for quite a while now only to be served with a notice of a ban on its Mohali plant after Dewas and Paonta Sahib plants. On account of the import ban on its Mohali plant, it has become difficult for the company to export their products timely to the US. Wockhardt is another drug manufacturer where major quality violations were cited in its Chikhalthana plant following observations of urine spillage. Earlier this year a warning letter was issued to its Waluj plant with a complete ban on this facility. Other companies which made news this year for non compliance include USV, Posh Chemicals and Promed Exports. But what is it that the inspectors look for in a company? Usually it is the process that is scrutinised rather than the product itself. So more often than not a flaw in the procedure to obtain the final product will 55 October 2013

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draw more interest of the inspector. The result obtained usually should guarantee the validation of the process. Often changes in vendor or specification for equipments or reagents are not thoroughly revalidated. The regulators look out for Quality Control samples which need to be segregated and stored. At the time of inspection, failure to justify the cause of out-of-specification batches can invite a lot of trouble. The regulators try to understand how well a company is able to address the deficiencies in their processes. It is the company’s commitment for quality which is put to test! Unlike the way it used to be earlier where companies were given a lot of time prior to the regulator’s inspection, now companies have to be prepared any time for a quality check and hence the increasing need to abide to the Good Manufacturing Practices. An important thing experts warn that can land a company in a soup for sure is fudging with data. It is advisable that a company remains absolutely transparent with all its operations and documentations as far as possible. Manipulation will ensure that a company is up for trouble and can culminate in the company shelling out a handsome amount of penalty or worse a complete ban on its manufacturing facility. Tampering with data can create huge goof ups and therefore should never be attempted.

Industry experts suggest a few measures that can be undertaken by Pharma companies to combat compliance issues. First of all it is very important to have a clearly defined and well established written procedure/Standard Operating Procedure (SOP) and the personnels carrying on the operations as per the SOP must be adequately trained to strictly comply with it. Some of the other secondary steps that have been advised to ensure compliance are encouraging Whistle Blower Policy within the organisation that can help resolve many problems internally before the external inspections. When adopting the Whistle Blower Policy, it is essential to have provisions for the protection of the whistle blower. Vendor due diligence is also of utmost importance in order to mitigate risks and safeguard compliance. Background checks and screening of employees before hiring should also be considered. It is therefore advisable to stick to the ever evolving and advancing Good Manufacturing Practices called current Good Manufacturing Practices in order to live up to the 'Gold Standard' of this highly regulated industry. References www.fda.gov www.usdm.ilinc.com - Ananya Sen

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any condition that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company’s management of objectionable conditions. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously. The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist. FDA Form 483s are discussed with a company’s management at the conclusion of the inspection. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.

Pharma Bio World

30-10-2013 15:59:22

pharma news Chhattisgarh CM & HMRI Inaugurate 104 Health Information Helplines Piramal Foundation’s primary healthcare initiative, Health Management and Research Institute (HMRI) and Dr Raman Singh, the Chief Minister of Chhattisgarh inaugurated the 104 Health Balaji Utla presenting the memento Information Helpline. The to the Chief Minister ceremony witnessed the presence of Amar Agarwal - Health Minister, Ramesh Bias, MP – Raipur, Brij Mohan Agarwal - Minister of Education, Kiranmayee Nayak –Raipur Mayor, M K Raut (IAS) - Prl Secretary – Health, Pratap Singh (IFS) - Commissioner HM & FW, Dr K P Singh – DHS. The 30 seater Health Information Helpline would operate on 24x7, throughout the year. The call centre is located in Raipur and can handle a call volume of 2,500 calls a day. The call center is equipped with well trained paramedics, counselors, doctors, specialists and uses HMRI’s algorithm and disease summary. The paramedics aid in providing basic medical advice whereas the doctors provide expert advice at the call centre. Advice is also provided for long-term illness conditions such as diabetes, heart issues, cancer, common ailments and chronic & acute medical issues. The team also shares much needed information during local epidemics and health scares, rehab counseling (alcohol, drugs, smoking) and psychological counseling (anxiety, depression, suicidal tendencies, chronic diseases like cancer etc). Experts address issues related to family planning, stigmatised diseases (HIV, AIDS, and leprosy), birth disorders like cleft lip and club foot among the new born, childcare, pregnancy and safe birth practices as well as sickle cell anemia. In the future, the Raipur health helpline can be connected further to telemedicine node that would access and be connected to medical colleges and district hospitals. Other services offered by the Piramal Foundation led HMRI initiative are 104 health helplines in Assam, Rajasthan, Maharasthra and Karnataka in partnership with the respective state Governments and has served over 66 million callers till date. Recently, HMRI has won the bid for the helpline in the state of Jharkhand. HMRI is poised for a growth with ambitious footprint plans across States. Piramal Foundation strongly believes that there are several untapped innovative solutions that can address India’s most pressing problems. Piramal Foundation plays an impactful role in implementing and facilitating such projects. Each social project that is chosen to be funded and nurtured by the Piramal Foundation fits into one of the four 56  October 2013

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broad areas – healthcare, education, livelihood creation and youth empowerment. The Foundation strives to develop transformative, scalable and replicable solutions to address issues that are critical roadblocks towards unlocking India’s economic potential.

Glenmark Receives Final ANDA Approval for Desoximetasone Ointment 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 Desoximetasone Ointment USP, 0.25 per cent their generic version of Topicort by Taro Pharmaceuticals USA Inc and shipping will commence immediately. Desoximetasone Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses. According to IMS Health sales data for the 12 month period ending June 2013, Desoximetasone Ointment garnered annual sales of approximately USD 40 million. Glenmark’s current portfolio consists of 89 products authorised for distribution in the US marketplace and 54 ANDA’s pending approval with the US 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.

Piramal Bags BSC Five Star Safety Ratings Award Piramal Enterprises achieved the British Safety Council (BSC) Five-Star Safety Award for the Digwal pharma solutions’ site, near Hyderabad. Piramal is the only Indian pharmaceutical company this year to achieve such a prestigious rating. This award recognises the company’s adherence to world-class safety and compliance with the best industry practices worldwide. Commenting on the appreciation Vijay Shah, Executive Director & COO, Piramal Enterprises said: “At Piramal, Environment, Health & Safety (EHS) is embedded in our very philosophy of business. The Digwal site underwent a stringent 4 day audit from 12 th to 16 th August, 2013 led by a delegate from British Safety Council (BSC), UK. I am happy to note that the audit results declared on 10 th September, 2013 scored Digwal site at a commendable 94.58 per cent. The Five Star Award of BSC, is highly reputed and is awarded in recognition of world class safety practices. We are the only Indian Pharma company this year to have received this prestigious award. This indeed is noteworthy.” Among many other areas of strength in Piramal’s safety management systems, the BSC auditor commended the management’s commitment and efforts to achieve excellence in occupational health and safety. Pharma Bio World

30-10-2013 16:17:32

Frost & Sullivan Hosts 5th Annual India Healthcare Excellence Awards 2013 Frost & Sullivan hosted its 5 th Annual India Healthcare Excellence Awards in Mumbai, by recognising distinguished achievers from the Healthcare Industry. Over the past five consecutive years, these awards have become an industry benchmark and have recognised the innovative growth strategies and solutions adopted by top companies to excel in the healthcare industry. Sandeep Sinha, Director, Healthcare and Life Sciences, Frost & Sullivan, South Asia and Middle East, stated, “In our annual Healthcare Awards, we utilise the opportunity to choose and recognise an individual whose singular contribution has made a positive impact not only on the industry, but also on society at large. While the Corporate Awards are identified by our team and ratified by an eminent panel, Special Awards are conferred by Frost & Sullivan on thought leaders who have dedicated themselves toward addressing India’s pertinent healthcare challenges, making an indelible impact in this field.” “This year, we have added new categories in Healthcare Delivery Services related to IVF and Hair Restoration services. New categories in Medical Technology include Medical Consumables and Dialysis Solutions. For Biotech and Pharma section, the new categories are Oral Anti-Diabetic and Pharmaceutical Brand of the year. All these new categories assume great importance and relevance in the current Indian healthcare scenario,” added Sinha. With nominations invited from healthcare companies across India, the award process was launched in June 2013. Detailed evaluation of each shortlisted company was based on actual market performance indicators, which were measured on predefined parameters. A few specific measurements were applied to certain categories. These findings were then presented to a panel of esteemed jury members, comprising leading doctors, technologists, CEOs, and investors, who selected the most deserving companies in each category.

Indus Health Plus Conferred with Best Wellness Service Provider Award Frost & Sullivan honored Indus Health Plus (P) Ltd with the Wellness Service Provider Company of the Year Award at its recently concluded 5 th Annual India Healthcare Excellence Awards. The awards are based on a structured research process and evaluate performance of a company’s services. A decade ago, Indus Health Plus entered the preventive health care segment. Currently, the company has 82 centers across 38 cities in 9 states in India, facilitating preventive health package at affordable prices. The company has conducted 3.8 lakh health check-ups in association with reputed healthcare institutions. Pharma Bio World

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The company through its innovative marketing campaigns has been able to reach 80lakh families. Keeping in mind the importance of marketing and awareness of preventive health check-ups, the company conducts regular media activities, publishes news articles, and conducts various conferences to create awareness about the importance of preventive health checkup and benefits of early detection of any disease. With a large volume of patients, Indus Health has been able to reduce substantially the price of health check packages. Congratulating Indus Health Plus (P) Ltd on the award, Sandeep Sinha, Director, Healthcare and Life Sciences Practice, Frost & Sullivan said, “With growing mandatory corporate check-ups and increasing number of cases of lifestyle diseases like Diabetes, Hypertension, Chronic Lung disease and Asthma, the scope for preventive healthcare check-ups is increasing in India. These diseases often remain undetected for a long time due to lack of awareness about preventive health check-ups.” On the occasion, Amol Naikawadi, Joint Managing Director, Indus Health Plus, said, “I am extremely happy and glad that we have been bestowed such a prestigious award. On behalf of the entire Indus family, we would like to thank the jury members for selecting us as the winner in this category. Indus drives the need to spread the awareness of practicing prevention in everyday life to live healthy. With life taking non-communicable diseases taking a toll in India, it is the need of the hour to know one’s health statistics and follow a healthy schedule. Our endeavor is to reach a larger spectrum of the populace.”

Revised METTLER TOLEDO Sensor Product Guide Saves Time METTLER TOLEDO announced the launch of the latest version of its interactive, web-based Electrode ValueBox. This downloadable electrode identification and troubleshooting toolkit, which features a revised electronic Sensor ProductGuide, will help METTLER TOLEDO customers choose the right electrode in less time, enabling easy optimisation of delicate values such as pH. Particularly for pH measurements, subtle electrode composition shifts capture electron transfer in various solution types. Electrodes must also often withstand acids/caustic solutions and/or meet hygienic design requirements. Sub-optimal selection increases the possibility of inconsistency, rework, and additional cost. The guided ability to choose the right electrode and combine it with appropriate housing, cables, and transmitters helps analysts ensure products adhere to specification while prolonging the electrode’s useful life, keeping costs in check. Available in 27 languages, the Sensor ProductGuide is easily downloaded for use on PC or iPad, enabling convenient browsing in nearly any environment. Conductivity, pH, DO, ORP or cable guides can be accessed via product name or technical search/ application criteria. October 2013  59

30-10-2013 16:18:26

Indegene Launches IndegeneConnect Indegene, a leading provider of R&D, commercial and marketing solutions to top global pharmaceutical and healthcare organisations, announced the launch of IndegeneConnect — a cloud-based digital asset production, collaboration, and workflow management platform. The platform enables global teams to significantly reduce wasteful creative and design costs arising from duplication, lack of information, and conflicting communication between stakeholders during the digital production lifecycle. IndegeneConnect increases productivity across the existing ecosystem comprising numerous Agencies of Record (AoR), local agencies, and brand teams that are managed across multiple geographies. Global pharmaceutical companies commonly work with multiple global agencies, and this often results in significant duplication of efforts in creating assets; errors following brand guidelines; reduced visibility throughout the production process; limited knowledge and access to assets created in other markets that can be reused; and decreased productivity. In addition, meaningful data and analytics that can drive process improvement efforts and satisfy audit-trail requirements are typically missing, incomplete, or challenging to obtain. IndegeneConnect creates a catalytic ecosystem through which a brand or a digital factory can manage all of its creative assets, the entire production workflow including internal and external stakeholders, promote collaboration and sharing, and cut wasteful cost from the budgets, all the while maintaining regulatory and audit compliance. Dr Rajesh Nair, President, Indegene, said “IndegeneConnect is a revolutionary way to effectively manage digital production at the enterprise level, while significantly empowering local and regional teams. This represents a significant addition to Indegene’s intellectual property portfolio.”

Tr a j e n t a R e c o g n i s e d a s t h e ‘Pharmaceutical Brand of the Year’ Boehringer Ingelheim has been presented with the Pharmaceutical Brand of the Year – New Launch 2013 award for its most appreciated product Trajenta at the Frost & Sullivan India Healthcare Excellence Awards 2013 held in Mumbai. Trajenta is an original research product of Boehringer Ingelheim launched in 2012 post robust clinical trial programmes conducted in India, the United States, the European Union and Japan among other countries. Trajenta is a first-of-its-kind anti-diabetic drug with a one-dosefor-all solution for diabetics in India, where dose adjustment is not required irrespective of any degree of renal or hepatic 60  October 2013

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dysfunction in the patient. The coveted Frost & Sullivan India Healthcare Excellence Awards commended Boehringer Ingelheim for superior planning and execution of the product launch, distribution strategy, technological innovation and customer services. Congratulating Boehringer Ingelheim on the award, Jayant Singh, Associate Director, Pharma and Medical Technology, Healthcare Practice, Frost & Sullivan, said, “Trajenta has established itself in a short period of time in the highly competitive diabetes market. Though being a late entrant in its drug class, the brand achieving a substantial market share within nine months of its launch, speaks volumes for its success. The brand has received tremendous response from the treating physicians due to its efficacy and safety profile and has exhibited highest sales and growth rate amongst the innovative brands launched in FY2012 which has led to the brand being recognised as the best launch of the year.” Commenting on the award, Sharad Tyagi, Managing Director, Boehringer Ingelheim India, said, “This award is a recognition of Boehringer’s ongoing commitment to address patients’ unmet needs amidst the growing Indian diabetes pandemic. This appreciation marks an important milestone in our journey and will significantly inspire our robust and unique alliance with Lilly to serve many more patients and play a leading role in fighting diabetes in India.” Trajenta emerged as one of the best-in-class drug for treatment of type 2 diabetes owing to the exemplary efficacy and safety profile and the robust field force, gaining a substantial market share of 10.6 per cent (June MAT, 2013).The product is widely marketed by BI-Lilly alliance and is available on prescription in pharmacy outlets across the country.

US FDA Approves Teva’s Generic TOBI Teva Pharmaceutical Industries Ltd announced that the US Food and Drug Administration has granted approval of the generic equivalent to TOBI (Tobramycin Inhalation Solution USP) in the United States. Pursuant to an agreement with Novartis on this product, Teva expects to launch this product in late November. Marketed by Novartis, TOBI had annual sales of approximately USD 350 million in the United States, according to IMS data as of June 30, 2013. Teva Pharmaceutical Industries Ltd is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached USD 20.3 billion in net revenues in 2012. Pharma Bio World

30-10-2013 16:18:45

Acacia Pharma Reports Positive NICE Issues Second Draft Guidance Phase II Results with APD515 on Cell Therapeutics’ PIXUVRI Acacia Pharma, a pharmaceutical company specialising in the development of drugs for supportive care, announced positive results from its Phase II study of APD515 for the treatment of xerostomia (dry mouth) in advanced cancer patients. The study showed that APD515 significantly reduced the symptoms of dry mouth (the primary Julian Gilbert, CEO endpoint) compared to placebo. APD515 is Acacia Pharma an optimised oromucosal (liquid) formulation of a currently marketed muscarinic agonist for the completely new, patent-protected use of treatment of xerostomia. Dr Julian Gilbert, Acacia Pharma’s CEO commented, “We are delighted with these results. Dry mouth is a common and distressing issue in advanced cancer patients that is significantly underrecognised. It is associated with a wide range of oral and systemic complications and can contribute to a greatly reduced quality of life. Our market research indicates that a locally delivered, liquid formulation of a suitable salivary stimulant would be of major benefit to many cancer sufferers, and these data indicate that APD515 should meet this profile.” The randomised, double-blind, placebo-controlled, cross-over trial was conducted in 11 centres in the UK and Denmark, and enrolled 32 patients with advanced cancer and a persistently dry mouth. Patients received a week of APD515 treatment and a week of placebo, in a randomly assigned order, with a week’s washout in between. Patients graded their symptoms before and after treatment and were asked to record which treatment week they preferred. Patients’ unstimulated salivary flow was measured before and after each treatment period. The study met its primary endpoint of a significant improvement in the subjective scoring of mouth dryness after one week of treatment with APD515 compared to placebo. Subjective scoring was done on a standard 100mm visual analogue scale, where 0 represented no dryness at all and 100 the worst dryness possible. The average score for mouth dryness was 26.01 after treatment with APD515 and 43.52 after placebo (p=0.0005). Other subjective scores, for oral comfort, difficulty speaking and difficulty swallowing, all showed a significant improvement for APD515 over placebo. The overall number of adverse events was low, with no significant difference between APD515 and placebo. The study also assessed whether the blinded treatment had made patients’ symptoms better, worse or unchanged. There was a highly significant difference in favour of APD515, with 17 out of 27 patients judging that their dry mouth had improved after APD515, compared to only seven after placebo. When asked for their treatment preference on a blinded basis at the end of the study, 19 subjects preferred APD515 and only one preferred the placebo. Pharma Bio World

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Cell Therapeutics Inc announced that the National Institute for Health and Care Excellence (NICE), a non-departmental public body of the Department of Health in the United Kingdom (UK), issued second draft guidance on PIXUVRI (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL). NICE’s independent Appraisal Committee met on September 11, 2013, to consider the cost effectiveness of pixantrone taking into consideration CTI’s initial patient access scheme that was approved by the Department of Health in July 2013. The result is a second appraisal consultation document, or ACD, whereby the Committee concluded that this scheme does not overcome the uncertainties in the evidence for pixantrone’s (PIXUVRI) clinical effectiveness and once again requests that consultees, including CTI, healthcare professionals and members of the public, comment on the draft guidance via the NICE website. The ACD consultation will close on November 4, 2013, and any comments received will be considered by the NICE appraisal committee to enable them to develop the next stage of guidance. It should be noted that this is not NICE’s final guidance on pixantrone and that a third Appraisal Committee meeting is expected to be held on November 13, 2013, where subject to approval, CTI hopes the Committee will consider an ‘enhanced’ patient access scheme to demonstrate the cost effectiveness of pixantrone for use by the NHS in the UK.

Dynavax Starts First Human Trial in Asthma Programme Dynavax Technologies Corporation announced the start of dosing in the first human clinical trial in its asthma programme. Dynavax is conducting the trial under its collaboration agreement with AstraZeneca. The Phase 1 study will assess the safety of AZD1419, a proprietary TLR9 agonist developed by Dynavax on behalf of the collaboration. Up to approximately 45 healthy subjects will receive inhaled doses of AZD1419 or placebo in single and multiple ascending doses in the first part of the study, followed by up to approximately 24 patients with mild asthma in the second part of the study. Safety data from the first part of the study is expected in mid-2014. AZD1419 was selected as a clinical candidate based on extensive preclinical studies conducted by Dynavax and AstraZeneca. These include a demonstration that AZD1419 can produce long lasting disease-modifying effects in a mouse model of atopic asthma. Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. Dynavax’s lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. October 2013  61

30-10-2013 16:18:46

Boehringer Ingelheim Seeks EU Approval Argenta, Genentech Extent Drug for Nintedanib Discovery Collaboration Boehringer Ingelheim announced the submission of a Marketing Authorisation Application to the European Medicines Agency for the approval of its oral triple angiokinase inhibitor nintedanib, in combination with docetaxel, for the treatment of patients with locally advanced, metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy. Nintedanib, when added to chemotherapy, is the first lung cancer treatment that extended patient survival beyond one year in a broad population of adenocarcinoma patients, after initial chemotherapy had failed. “Improving patients’ lives remains at the forefront of Boehringer Ingelheim’s commitment to evidence based progress in the treatment of cancer.” said Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “We are proud that nintedanib, a compound out of our innovative oncology research programme, is the second compound in our portfolio to be filed with the European Medicines Agency.” Lung cancer causes more deaths than any other cancer and only approximately one out of six patients survive 5 years from diagnosis. Adenocarcinoma is the most common type of lung cancer and more than two-thirds of patients are diagnosed at a late stage when curative treatment is no longer feasible. Ultimately, all patients with advanced adenocarcinoma will progress and require second-line treatment. The EU Marketing Authorisation Application for the approval of nintedanib is based on the international, double-blind, Phase III LUME-Lung 1 trial, which was the first trial to show a survival benefit of an add-on treatment in a broad second line adenocarcinoma patient population versus an active comparator (standard-of-care/chemotherapy).

Argenta announced a three-year extension of its integrated contract drug discovery agreement with Genentech, a member of the Roche Group. This is the fourth such extension since the agreement was first announced in December 2005. The agreement covers a portfolio of projects that utilises Argenta’s wide-ranging drug discovery expertise to discover new chemical entities acting against undisclosed drug targets defined by Genentech. Dr John Montana, Managing Director of Argenta, commented, “We are delighted that our long-standing and highly valued client, Genentech, has once again chosen to extend its collaboration with Argenta. We believe that this further extension is a testament both to the close working relationship that has been established between our companies over the years and the high level of success delivered by Argenta to Genentech in terms of pre-clinical candidate compounds, four of which are currently in clinical trials.” Argenta is a fully-integrated drug discovery services provider and a trusted partner for many world-leading pharmaceutical and biotechnology companies including AstraZeneca, Genentech, Janssen and Zafgen. Argenta combines a comprehensive range of discovery services with multiple disease area expertise including respiratory, oncology, pain and inflammatory disease, providing a compelling combination of scientific excellence, a full in vitro and in vivo pharmacology and DMPK capability, cutting edge medicinal chemistry thinking and cost-effectiveness.

Sagent Pharma Launches Zoledronic Acid Injection 5 mg in a Premix Bag

In this trial in advanced NSCLC patients, the combination of nintedanib plus docetaxel demonstrated a statistically significant prolonged Progression-Free Survival (PFS), versus placebo (3.4 vs. 2.7 months, respectively) regardless of tumour histology, reducing the risk of renewed tumour growth by 21 per cent. Overall survival was significantly prolonged in adenocarcinoma patients treated with nintedanib plus docetaxel versus placebo plus docetaxel (12.6 vs. 10.3 months respectively).1 The results demonstrated that patients with adenocarcinoma who have failed initial treatment with chemotherapy received on average a 20 per cent extension of overall survival. In addition, the data demonstrated that the earlier adenocarcinoma patients failed first line chemotherapy, the bigger the benefit nintedanib provided, as patients who progressed within 9 months (T<9 months) after start of their first-line treatment, achieved a median overall survival benefit of 3 months (10.9 vs. 7.9 months). 62  October 2013

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Jeffrey M Yordon, CEO & Chairman of the Board, Sagent

Sagent Pharmaceuticals, Inc announced the launch of Zoledronic Acid Injection 5 mg, the generic form of the bisphosphonate Reclast, in a ready-to-use premix IV bag presentation. As with all products in Sagent’s portfolio, Zoledronic Acid features Sagent’s PreventIV MeasuresSM packaging and labeling, designed to help reduce medication errors.

“Sagent is pleased to offer our customers Zoledronic Acid Injection 5 mg in an enhanced packaging option, a ready-to-use premix bag, which can help reduce the risk of contamination and reconstitution errors,” said Jeffrey M Yordon, Chief Executive Officer and Chairman of the Board of Sagent. Zoledronic Acid 5 mg is indicated for the treatment of Paget’s disease of bone in men and women. Pharma Bio World

30-10-2013 16:18:46

STEER’s Innovative Excellence through Vertical Integration STEER continues to develop proprietary “task specific” processing technology, where energy and functionality target specific attributes such as improving conveying efficiency for difficult-to-handle materials, or providing the precise nature of work/energy input for specific melting or mixing requirements. This allows for more efficient utilisation of the process section of an extruder, which in turn results in lower process temperatures, higher throughput, and improved quality. It can also enable the extruder to operate at high screw speeds and higher throughput rates for heat and shear sensitive compounds than cannot be attained by using conventional conveying elements and kneading blocks. STEER’s technological progress has been very evident in the processing of bio-composites. This year STEER has provided production extruders for the compounding of Cellulosic Fibers, Feather Fiber and Jute Fiber supporting the growing biocomposites market. STEER low energy Dynamic Stir Element (DSE) and “Shovel” style side feeder conveying elements enable the achievement of high capacity with these materials. DSEs are also finding new uses for low energy melting of thermoplastics and improved devolatilisation performance through enhanced surface renewal. In the K 2013, STEER is introducing a new line of extruders that would offer the best power utilisation making it truly a mixing vessel that can operate at full power at different speeds. STEER displays a versatile 50mm MEGA SPECIAL PLUS extruder with new technology to utilise full motor power of 160 kW at screw speeds of 625 rpm, 750 rpm, 1000 rpm and 1200 rpm. The “MEGA SPECIAL PLUS” shares the “General Purpose” Do/Di of 1.55 with earlier MEGA models, with the added features of a Continua shaft for improved safety and reliability apart from the availability of STEER proprietary line of conveying and mixing elements. STEER’s OMEGA line of extruders features a process section with a Do/Di of 1.71 with the tightest and most optimised screw to screw gaps in the industry.

Sonoco ThermoSafe Opens New Site in Germany Sonoco ThermoSafe, a unit of Sonoco, has opened its newest site in Duren, Germany, at an existing Sonoco facility. This strategically located facility will manufacture insulated shippers and serve as the primary distribution and warehousing hub for Western Europe and the Middle East. “Along with our plant in Ireland, Sonoco ThermoSafe’s new facility in Duren, Germany gives us the flexibility to serve our customers out of multiple locations in Europe,” said Niall Lehane, General Manager, Sonoco ThermoSafe Europe. “In addition to manufacturing Pharma Bio World

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insulated shippers, we can warehouse and distribute to customers throughout Europe, the Middle East and Asia. This facilitates justin-time delivery and reduces costs for our customers.” Lehane continued, “With Sonoco’s global footprint of 347 facilities, we now have the ability to serve our customers at almost any of these locations. Our new Duren facility demonstrates our capability and commitment to providing local solutions to our global customers.” The new Sonoco ThermoSafe manufacturing site is ISO9001:2008 certified. The facility is located within an existing Sonoco location where the Company manufactures tubes and cores. Sonoco ThermoSafe is the leading global provider of temperature assurance packaging for the safe and efficient transport of pharmaceuticals, biologics, vaccines and other temperature sensitive products. Sonoco ThermoSafe shipping solutions mitigate risk for customers and ensure product efficacy throughout the extremes of a supply chain. With operations in North America, Europe, Asia and South America, the Company has a vast product offering featuring industry leading technology that encompasses refrigerated, frozen or controlled-room-temperature applications.

Bexion Presented with SBIR Bridge Award by NCI Bexion Pharmaceuticals has been awarded a Small Business Innovation Research (SBIR) “Bridge Award” by the National Cancer Institute (NCI). The award of USD 2.9 million over three years will help Bexion further its clinical development of BXQ-350. BXQ-350 is an innovative proteo-lipid nanovesicle intended for use as an anticancer agent. This funding will enable Bexion to complete a Phase I First-in-Human clinical trial. NCI’s SBIR “Bridge Award” is intended to accelerate the development of promising new cancer therapies, imaging technologies and diagnostics of previously supported SBIR projects. To date, Bexion is only one of five recipient companies developing a therapeutic, since the Awards were initiated in 2009. Dr Ray Takigiku, CEO & Co-founder, Bexion

Monies from this award will specifically help fund a Phase I clinical trial evaluating the use of BXQ-350 nanovesicles as a therapy for certain brain tumors. This could be the first step in developing a more targeted, less invasive treatment for an aggressive brain cancer known as Glioblastoma multiforme. “Bexion is gratified to have been given this prestigious award. The NCI follows an exacting and extremely detailed process to assess applicants, which involves deep scientific assessment by a select group of leading scientists and drug development experts,” stated CEO and Co-founder of Bexion, Dr Ray Takigiku. October 2013  63

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biotech news MannKind Resubmits AFREZZA NDA for US FDA Approval MannKind Corporation announced the resubmission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the marketing and sale of AFREZZA (insulin human [rDNA origin]) Inhalation Powder with an indication to improve glycemic control in adults with type 1 or type 2 diabetes. The Alfred Mann resubmission is based on the entire data Chairman & CEO MannKind Corporation set from the extensive AFREZZA clinical development programme and particularly the positive results from two recent Phase 3 trials, one in patients with type 1 diabetes (study 171) and one in patients with type 2 diabetes (study 175). “We designed the recent studies with input and guidance from the FDA, and both achieved their primary efficacy endpoints and safety objectives,” said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “I am very proud of our team for completing an extensive submission on a very ambitious schedule. We will continue to work with the FDA to bring AFREZZA to market for the millions of diabetes patients in the United States who might benefit from this novel product.” AFREZZA (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy developed by MannKind Corporation to improve glycemic control in adult patients with type 1 or type 2 diabetes. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA Inhalation Powder dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45-90 minutes for injected rapid acting insulin analogs and 90150 minutes for injected regular human insulin.

Zydus, Pieris to Jointly Develop Novel Anticalin Therapeutics Zydus Cadila, an innovative global pharmaceutical company, and Pieris AG, a next generation therapeutic protein R&D company, have entered into an alliance for development and commercialisation of multiple novel Anticalin based protein therapeutics. The collaboration combines Pieris’ drug discovery and early development capabilities with Zydus’ expertise in biologics development, regulatory affairs and biologics manufacturing. Under the terms of the agreement, Zydus will take the lead in advancing Anticalin drug candidates through formal pre-clinical development and into clinical development, undertaking drug development in accordance with ICH guidelines. Zydus has been 64  October 2013

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granted exclusive marketing rights in India and several other emerging markets, while Pieris retains exclusive marketing rights in key developed markets. Anticalin are recombinantly engineered versions of human lipocalins, low-molecular weight polypeptides that naturally bind, store and transport a wide spectrum of molecules. Pankaj R Patel, chairman and managing director, Zydus group, said, “Collaborating with established biotech companies on differentiated drug candidates is an important component of Zydus’ ongoing transformation into an innovation-led global healthcare provider, and we are pleased to add Anticalins to our novel biologics pipeline.” Stephen Yoder, CEO of Pieris, said, “With Zydus state-of-theart manufacturing facilities and seasoned drug development team, this collaboration will allow Pieris to unlock value on a global scale in a cost-effective manner, significantly expanding the number of proprietary Anticalin programmes we can advance into clinical trials.” The most advanced programme in the collaboration is PRS-110, an Anticalin specific for c-Met, a target becoming increasingly validated across a broad spectrum of tumours PRS_110, which is a pure antagonist due to its monovalent target engagement, has demonstrated the ability to inhibit both ligand-dependent and independent c-Met activity in a variety of animal models.

KineMed, Amgen to Develop Kinetic Biomarkers of Brain Proteinopathies KineMed, Inc announced an agreement with Amgen to apply KineMed’s mass spectrometric Dynamic Proteomics platform to the study of brain protein homeostasis linked to neurodegenerative diseases. KineMed’s biomarker platform will allow Amgen to track synthesis and clearance rates of pathogenic proteins in the brain that drive neurodegeneration. “Normal brain aging and neurodegenerative diseases, including Alzheimer’s, Parkinson’s and Huntington’s diseases, are characterised by the accumulation of misfolded proteins in the brain. Diagnostic tests have not previously been available that reflect the underlying dynamics of the proteins believed to play a causal role in neurodegeneration. This has been a major obstacle in developing drugs that slow the accumulation of these misfolded proteins,” said Dr Patrizia Fanara, Vice President of Neuroscience at KineMed and Principal Investigator on this study. Neurodegenerative disease is a significant health burden worldwide with few effective treatment options available to patients; according to the Harvard NeuroDiscovery Center, without the development of new treatments, in 30 years’ time more than 12 million Americans may be suffering from some form of neurodegenerative disease. The growing number of patients underscores the urgent need to build new tools to guide and accelerate the development of effective treatments for neurodegenerative disease. Pharma Bio World

30-10-2013 16:21:39

Trovagene to Evaluate Oncogene Mutation

Antonius Schuh CEO, TrovaGene

Trovagene, Inc, a developer of cell-free molecular diagnostics, announced that it will collaborate with a pharmaceutical company to evaluate Trovagene’s proprietary, urine-based, cell-free DNA technology for the detection of certain Epidermal Growth Factor Receptor (EGFR) mutations associated with lung cancer.

“We are pleased to launch a pharmaceutical clinical study collaboration to further evaluate the use of cell-free DNA in urine as a systemic sample for monitoring of individual patients’ mutational status,” said Antonius Schuh, PhD, Chief Executive Officer of Trovagene. “The ability to non-invasively monitor real-time EGFR mutations changes in lung cancer patients represents the potential to obtain greater guidance for treatment decisions.” Lung cancer is the most prevalent cancer in the United States, with more than 225,000 new cases diagnosed annually. EGFR mutations are present in 10 to 35 per cent of lung cancers, and these mutations frequently occur during the course of therapy, affecting response to treatment and/or prognosis. “This study will help us further evaluate Trovagene’s technology as an alternative for mutation monitoring in lung cancer, where tissue biopsies are often challenging to obtain,” said Mark Erlander, chief scientific officer of Trovagene. Trovagene is committed to a clinical study programme with the objective to demonstrate that cell-free DNA specimens from urine samples provide an effective and reliable alternative to monitoring patients’ therapeutic response and the emergence of drugresistance mutations, thereby offering the potential to improve outcomes and patient care.

SSB and BD Diagnostics Ink Microbiological Diagnostics Deal

Dominique Baly Member of the Sartorius Group Executive Committee

Sartorius Stedim Biotech (SSB), a leading international pharma and biotech supplier, and BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced a collaboration to develop, manufacture and market various ready-to-use, prefilled media products for microbiological applications in pharmaceutical, biotech and research laboratories.

“Through our agreement with BD, we have created an excellent collaboration. BD is known worldwide for its expertise in Pharma Bio World

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manufacturing and filling of microbial media. BD’s expertise combined with Sartorius Stedim Biotech’s know-how in polymeric technologies and applications will help us further extend our expert capabilities in the field of microbiological monitoring,” says Dominique Baly, member of the Sartorius Group Executive Committee. Based on its many years of expertise in the development of membranes, SSB offers high-quality, single-use filter products for concentration of microbial contaminants in the lab. As part of this strategic collaboration, BD will fill special SSB single-use products with BD culture media and supply these to SSB as prepackaged products. In addition, the companies are exploring options of extending their existing business relationship by pursuing further innovative solutions in the field of microbiological diagnostics. “The products we plan to develop under our agreement with Sartorius Stedim Biotech will enhance laboratory efficiencies for our pharmaceutical, biotech and research customers with these unique product offerings,” said Bob Ferguson, Vice President and General Manager, BD Diagnostics – Diagnostic Systems, Industrial Microbiology. “By combining Sartorius Stedim Biotech’s bioprocessing and filtration expertise with BD’s microbiological media capabilities, customers will benefit from improved lab productivity and standardisation of sample processing.”

Constellation, UPSOM Get Cystic Fibrosis Foundation Research Grant Constellation Pharmaceuticals, Inc, a clinical-stage biopharmaceutical company in the field of epigenetics, announced that it has been awarded a research grant in collaboration with the University of Pittsburgh School of Medicine (UPSOM) from the Cystic Fibrosis Foundation to explore the potential use of BET bromodomain inhibitors for the control of inflammation in cystic fibrosis. “This research grant will facilitate the study of the epigenetic control of inflammation, an area of active research at Constellation, in the context of a disease for which the treatment options are very limited,” commented Jose Lora, PhD, executive director of preclinical sciences at Constellation. Through the grant, Constellation Pharmaceuticals will collaborate with the laboratory of Jay Kolls, MD, director, Richard King Mellon Foundation Institute for Pediatric Research at Children’s Hospital of Pittsburgh of UPMC, and professor of pediatrics and immunology at University of Pittsburgh School of Medicine. Dr Kolls’ laboratory is a pioneer in the mechanistic understanding of cystic fibrosis, and has made fundamental contributions to the concept of inflammation as a key component of the pathophysiology of this disease. The research supported by this grant will test the preclinical efficacy of novel anti-inflammatory compounds to reduce potential lung-damaging inflammation in people with cystic fibrosis. The Cystic Fibrosis Foundation is the world’s leader in the search for a cure for cystic fibrosis and funds more cystic fibrosis research than any other organisation. October 2013  65

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Vivaldi Buys Clinical-Stage Influenza Vaccine Assets Biotechnology company Vivaldi Biosciences Inc (Vivaldi) has acquired research and development assets, including intellectual property, clinical data, know-how and materials, for LAIVs in which the gene for influenza nonstructural protein 1 (NS1) has been fully deleted from Baxter Healthcare SA (Glattpark, Switzerland). These assets previously were owned by AVIR Green Hills Biotechnology AG (Vienna, Austria). NS1 is a multifunctional virulence factor of influenza. The NS1 gene is highly conserved in influenza type A, B and C viruses. LAIVs with fully deleted NS1 (known as delta-NS1 LAIVs) have been evaluated in 160 volunteer recipients in four clinical trials conducted at the Medical University of Vienna by AVIR Green Hills Biotechnology. In a phase 1 clinical study of a delta-NS1 LAIV for highly pathogenic avian influenza A(H5N1) (“bird flu”), two phase 1 studies of delta-NS1 LAIVs for seasonal H1N1 influenza strains, and a phase 1/2 study of a trivalent delta-NS1 LAIV for seasonal influenza, the candidate vaccines were well tolerated and generated positive immunogenicity data in a dose-dependent manner. The vaccines evaluated in the four clinical studies were produced using Vero cell substrate technologies. The acquired assets complement and substantially broaden Vivaldi’s LAIV platform and product development opportunities in pandemic preparedness and seasonal influenza. Vivaldi’s platform uses proprietary reverse genetics and plasmid rescue technologies to engineer a specific truncation in the NS1 gene, generating LAIVs with partially-deleted NS1 that are attenuated for safety and provide a potent, protective immune response, including cross-protection against unmatched strains, as demonstrated in preclinical studies.

CMC Biologics Bags DKMA Authorisation for cGMP Commercial Manufacturing CMC Biologics has received renewal of its manufacturing and importation authorisation (MIA) for Good Manufacturing Practice (cGMP) production of clinical and commercial manufacturing from the Danish Medicines Agency (DKMA), a division of the Danish Health and Medicines Authority. The DKMA inspected CMC Biologics’ optimised manufacturing and testing facilities in Copenhagen, Denmark in late May, and issued the certificate based on the positive outcome of the inspection. “This important regulatory milestone helps drives our strategy to satisfy our customers’ growing clinical and commercial cGMP manufacturing requirements, and takes this site to the next level as a global leader in commercial production of protein therapeutics,” said Patricio Massera, General Manager of CMC Biologics Copenhagen. “We are committed to the highest 66  October 2013

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quality standards and extremely pleased with the results of the agency’s inspection.” CMC Biologics made an important capital investment in its biopharmaceutical manufacturing facility which optimises segregation of unit operations and improves flow of materials and personnel. The enhanced layout now maintains a fully unidirectional return corridor and exit airlocks to achieve exceptional manufacturing quality standards. Massera adds, “Our vision is to be considered the global market leader of customer satisfaction for contract biopharmaceutical process development and manufacturing services. This facility expansion and successful regulatory inspection represents another step toward making that vision a reality.”

HMP, Eli Lilly Collaborate on Cancer Therapy Hutchison MediPharma Limited (HMP), an R&D company majority owned by Chi-Med, has entered into a licensing, co-development, and commercialisation agreement with Eli Lilly and Company in China for Fruquintinib (HMPL-013), a targeted oncology therapy for the potential treatment of various types of solid tumors. Fruquintinib, a selective Christian Hogg, CEO inhibitor of the Vascular Endothelial Growth Hutchison China MediTech Factor (VEGF) receptor tyrosine kinases, was discovered by HMP and is currently in phase II testing in China. Under the terms of the agreement, the costs of future development of Fruquintinib in China, to be carried out by HMP, will be shared between HMP and Lilly. HMP will potentially receive a series of payments of up to USD 86.5 million, including upfront payments, and development and regulatory approval milestones. Should Fruquintinib be successfully commercialised in China, HMP would receive tiered royalties starting in the mid-teens percentage of net sales. Additional terms of the agreement were not disclosed. Christian Hogg, chief executive officer of Chi-Med said, “Our belief is that Fruquintinib has potential activity against multiple tumor types with high incidence rates and may benefit patients with significant unmet medical needs in China. The collaboration with Lilly will allow for Fruquintinib to be developed across various tumor types in China and at a far greater speed than if we went alone.” “We are excited to collaborate with Hutchison MediPharma in the development of this potential new cancer therapy,” said Jacques Tapiero, Lilly Senior Vice President and President of Emerging Markets. “In Lilly’s emerging markets business, we are focused on providing patients with innovative medicines from our own pipeline and through collaborations with respected science-based companies such as HMP. Together, we are committed to help meet the medical needs of oncology patients in China.” Pharma Bio World

30-10-2013 16:22:00

Medimmune Completes Acquisition of Amplimmune AstraZeneca announced that on 4 October MedImmune, its global biologics research and development arm, completed its acquisition of Amplimmune, a privately-held, US-based biologics company focused on developing novel therapeutics in cancer immunology. As previously announced, the acquisition bolsters MedImmune’s oncology pipeline by obtaining multiple early-stage assets for its immune-mediated cancer therapy (IMT-C) portfolio, including AMP-514, an anti-programmed cell death 1 (PD-1) monoclonal antibody. AMP-514 is currently in late-stage preclinical development with the aim of an investigational new drug (IND) filing before the end of 2013. Other Amplimmune assets include multiple preclinical molecules targeting the B7 pathways. MedImmune, with its clinical stage programmes – tremelimumab, mOX40 mAb and MEDI-4736 (anti-PD-L1 mAb) - and a robust pre-clinical pipeline, is building one of the most comprehensive programmes in IMT-C. IMT-Cs are being designed to empower the immune system to counteract the tactics employed by cancer cells to avoid detection and attack the body. Upon completion of the acquisition, MedImmune acquired 100 per cent of Amplimmune’s shares for an initial consideration of USD 225 million and deferred consideration of up to USD 275 million based on reaching predetermined development milestones.

The phase 3 trial is designed to evaluate overall survival with IMA901 in combination with sunitinib (Sutent, Pfizer), the current standard first-line therapy, compared with sunitinib alone in patients with metastatic and/or locally advanced RCC. The trial has completed inclusion of 339 patients at sites in the US and Europe. Interim overall survival results are expected in 2014, with final data in 2015. The phase 3 trial builds on the positive phase 2 study with IMA901 in advanced RCC patients. The trial showed that patients who produced an immune response to two or more of the TUMAPs contained in IMA901 had a significantly longer survival, as published in Nature Medicine in 2012. Paul Higham, CEO of immatics, said: “We are pleased that our existing investors have demonstrated their continued confidence in immatics and the novel cancer vaccines that we are able to generate using our unique, rational TUMAP-based approach to cancer immunotherapy. This financing will allow us to complete the full phase 3 development of IMA901 and prepare regulatory submission packages for the US and Europe. There is a clear need for novel cancer therapies that can deliver prolonged survival while maintaining a good quality of life. We remain hopeful that IMA901 will deliver a significant improvement for patients with renal cell cancer.”

immatics Completes EUR 34 Mln Vital Therapies Files Registration Series D Financing Statement for Proposed IPO immatics biotechnologies GmbH, a clinical-stage biopharmaceutical company developing advanced multi-peptide cancer vaccines that are active against cancer, announced that it has closed a EUR 34 million Series D financing round. The funding round was supported by existing investors including dievini Hopp Biotech holding, Wellington Partners, MIG-advised funds and AT Impf GmbH. Under the terms of the fundraising, immatics will receive the first EUR 12 million tranche of funding immediately. Paul Higham, CEO immatics

The new funds will enable immatics to conclude the development of its lead vaccine IMA901, including completing all of the activities necessary to prepare for regulatory filings in the US and Europe. IMA901 – a cancer vaccine comprising 10 different tumor-associated peptides (TUMAPs) that are found to be highly over-expressed in the majority of patients suffering from renal cell carcinoma (RCC) – is in a pivotal phase 3 trial. It has orphan drug designation in the US and Europe for the treatment of RCC in HLA-A 02 positive patients. Pharma Bio World

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Vital Therapies, Inc, a biotherapeutic company developing a cell-based therapy targeting the treatment of acute liver failure, announced that it has filed a registration statement with the US Securities and Exchange Commission (SEC) relating to a proposed Initial Public Offering (IPO) of shares of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Credit Suisse Securities (USA) LLC and William Blair & Company, LLC are acting as joint book-running managers for the offering. Cowen and Company, LLC and Canaccord Genuity Inc are acting as co-managers for the offering. A registration statement relating to these securities has been filed with the Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. Vital Therapies, Inc is a biotherapeutic company developing a cellbased therapy targeting the treatment of acute liver failure. The company’s lead product-candidate, ELAD, is an extracorporeal bio-artificial liver currently in phase 3 clinical trials. Vital Therapies, Inc. is based in San Diego, California. October 2013  67

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Combustible Dust Hazards Testing Lab Fauske & Associates, LLC (FAI) offers services related to characterizing, preventing and mitigating combustible dust explosions and fire hazards. FAI’s lab capabilities provide testing per ASTM and European (CEN) standards, which include common tests like the Explosion Severity Test - (KSt, Pmax and (dP/dt)max), Minimum Ignition Energy, the Minimum Explosible Concentration and Limiting Oxygen Concentration. These standards are the basis of NFPA codes for combustible dust as well as the OSHA Combustible Dust National Emphasis Program (NEP). Combustible dust hazards have gained additional exposure due to the OSHA Combustible Dust (NEP) which was re-issued as a result of the fatal accident at Imperial Sugar. FAI conducts comprehensive plant evaluations. FAI’s Nuclear Systems Group helps its customers enhance the availability and reliability of their operating plants while maintaining regulatory compliance, extending plant life and reducing operation/maintenance costs.

Laboratory PEF System A pulsed electric field (PEF) laboratory system that features PLC controls to let users automatically test numerous treatment conditions is available from Diversified Technologies, Inc, USA. The system is totally integrated and features PLC controls to let users examine the utilistion of pulsed electric fields over a wide range of products and treatment conditions. Capable of applying 40 kV/cm across a fluid at conductivities up to 10 mS, including 10 kV/cm into seawater, once a process is evaluated using this laboratory system; it can be scaled into a process production system. Washdown capable, the system is designed for performing R&D experiments, batch tests and process development at up to 50 LPH, depending upon the application. PEF processing works through a process of electroporation in cells, which destroys the cell membranes by applying short, very high voltage pulses. Applications include food sterilization and the extraction of intracellurlar materials from algae.

For more information, please contact:

Fauske & Associates 16W070 83rd Street Burr Ridge, IL 60527, U.S.A. Tel: 630-887-5213 E-mail: afauske@fauske.com

Diversified Technoligies, Inc 35 Wiggins Ave, Bedfor MA 01730-2345, U.S.A. Tel: 275-9444 x211; Fx: (781) 275-6081 E-mail: kempkes@divtecs.com

Desiccant Dehumidifiers As producer of quality pharma products, one must be familiar with the effect of high seasional humidity on the overall quality, chemical composition and the shelf life of final product. High seasonal humidity demands additional dehumidification to maintain recommended conditions and the ideal solution for short-term requirement is dehumidifier rental. TDS provides desiccant dehumidifiers on rent to maintain recommended humidity in processing (powder milling, compounding of tablests, tablet compression, tablet coating, glandular/liver extracts); manufacturing (effervescent tablets, cough drops, penicillin, soft gelatin capsules); packaging (dry powder/vial filling, strip packaging, drug packaging area); and storage (refrigerated cold rooms, hospital pharmacy). For more information, please contact: Technical Drying Srvices (Asia) Pvt Ltd Plot No: 2274/3, Shiv Vihar, Rajiv Nagar, Nr Old CRPF Camp B/h Birla White Cement Godown, Bus Stand Road, Gurgaon, Haryana 122 001 Tel: 0124-4012851, 3201104, 3200571 E-mail: tdsmarketing@pahwa.com

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Triple Screw Pumps UTPSL offers range of triple screw pumps as per BORNEMANN Germany design acquired by virtue of previous JV partnership. These pumps are manufactured in different combination of casing materials with replaceable cartridge assemblies. The pumps are available in different designs of mounting arrangements to meet specific requirements of customers for replacement of existing pumps without disturbing already laid out pipelines. These pumps find applications for transfer and pressure boosting in systems handling lubricating oils and light and heavy fuel oils and turbine governing oil systems, boiler feed systems in different industries. UTPSL triple screw pumps are available in capacity range of 2,200 LPM and pressure range up to 80 bars.

Skid-mounted Fire Protection Systems Grundfos Pumps India Pvt Ltd (Grundfos India) offers the factory assembled fire protection systems. This pre-packaged system complies with local National Building Code and Tariff Advisory Council guidelines and can be delivered to the site as pumping systems with the necessary pipework, valves, control systems, wiring assembled and mounted on a skid. This system can also be offered in an insulated steel enclosure as a containerized system or tailor made to customer requirements. Engineered from a broad selection of pumps, motors, diesel engines, controls and high quality accessories, this latest solution is a plug-and-douse system suitable for high rise commercial buildings, hotels and resorts, residential apartments, multiplexes and general industry.

For more information, please contact:

UT Pumps & Systems Pvt Ltd 14/7 Mathura Road, Faridabad. Haryana 121 003 Tel: 0129-4045831, 2274861, 2258588, 3299731. Fax: 91-0129-2258584, 2275877. E-mail: sales@utpsl.in

Grundfos Pumps India Pvt. Ltd 118 Old Mahabalipuram Road Thoraipakkam, Chennai 600 097 Tel: 044-45966800; Fax: 91-044-4596 6969 E-mail: mahathi@grundfos.com

Power Meter Schneider Electric today offers the PowerLogic PM5000 Series power meter. This newest addition to the PowerLogic portfolio of power and energy meters is engineered on a compact and high performance platform. A range of models cover the full spectrum of buildings and industrial applications, within a wide range of value propositions. The highly-accurate, reliable meters are compliant with IEC 61557-12, IEC 62052/53 and IEC 61053-22 metering standards: PM5100 and PM5300 models are Class 0.5S while PM5500 models are Class 0.2S. Each meter in the PowerLogic PM5000 Series offers combinations of features intended to fully complement the requirements of energy cost management applications. Essential features such as different communication and I/O options, a batterybacked real-time clock, alarms, multiple tariff schedules, MID compliance and data and event logging ensure the PM5000 Series has the capabilities to perform energy cost allocation and tenant metering/sub-billing. These high performance meters directly connect to networks rated up to 690 V L-L without potential transformers. Internal memory stores key information and data logging capacities enable energy management dashboards. The range-topping PM5500 models provide a fourth current input, onboard web pages for viewing real-time and stored information, enhanced harmonics capabilities and dual Ethernet ports to daisy chain meters together without the need for an additional hub thereby saving costs. For more information, please contact: Schneider Electric India Pvt Ltd DLF Building No: 10, Tower C, 9 th Floor DLF Cyber City, Phase II, Gurgaon, Haryana 122 002 Tel: 0124-3940 400; Fax: 91-0124-4222 036

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Hot Water Generator

Side Channel Blowers & Vacuum Pumps

Aero Therm Systems Private Limited, Ahmedabad, Gujarat, offers custom-built units for higher temperature and heat output ratings fitted with fully automatic oil/gas burners. Fuel consumption is based on NCV of 10,200 kcal per kg for LDO; 9,650 kcal per kg for RO and 8,400 kcal per m 3 for natural gas. Features independent drive for fuel pump 1,440 RPM; no scale formation; easy and economical operation; etc.

Vacunair Engineering Company Private Limited, Ahmedabad, Gujarat offers side channel blowers and vacuum pumps. Side channel blower from Vacunair Engineering Company Private Limited, Ahmedabad, Gujarat, works on the following principle. In the chambers, set in the periphery of the impeller, air is accelerated due to centrifugal force created as the impeller turns and is thrown into the next chamber and is again similarly accelerated thus continuously increasing compression as the impeller turns until it reaches the outlet port.

For more information, please contact:

Aero Therm Systems Pvt ltd Plot No: 1517, Phase III, GIDC Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-25890158; Telefax: 91-079-25834987 E-mail: contact@aerothermsystems.com

Vacunair Engg Co Pvt Ltd Nr Gujarat Bottling, Rakhial Ahmedabad, Guja rat 380 023 Tel: 079-22910771; Fax: 91-079-22910770 E-mail: info@vacunair.com

Morphologi G3 to Troubleshoot Particle Sizing Methods The Morphologi G3 delivers statistically relevant particle size and shape data that enable the investigation of factors that can have an effect on particle size measurement such as dispersion state and crystal shape. Running automated particle imaging alongside laser diffraction particle sizing using the Mastersizer 2000 supports the development of truly robust test methods that may be applied to characterize products from developmental through to commercial scale manufacture. Laser diffraction is a fast and efficient technique used routinely across the pharma industry for particle sizing. Sample preparation for laser diffraction is often rapid but appropriate dispersion of the test sample is essential in order to obtain meaningful results. As with many other sizing techniques, including sieving and sedimentation, laser diffraction results can be influenced by particle shape. Using automated imaging alongside laser diffraction is an efficient way of detecting problems with dispersion since it allows multi-particle agglomerates to be visually distinguished from primary, dispersed particles. A change in shape resulting from a change in feed source or process scale-up may also be efficiently detected. For more information, please contact: Malvern Aimil Instruments Pvt Ltd Naimex House, BSEL Tech Park, B Wing â&#x20AC;&#x201C; 906 Sector 30A Opp: Vashi Railway Station, Vashi, Navi Mumbai 400 705 Tel: 022-3918 3596; Fax: 91-022-3918 3562 E-mail: Stuart.Wakefield@malvern.com

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High-power Servo Motors The highly efficient motors in the 8KS Series provide up to 140 kW of power and stall torque up to 555 Nm. Available in two sizes with speeds up to 3,000 RPM, 8KS motors open up new possibilities for applications in a wide range of industries. In addition, these servo motors are available with either axial or radial fans, water cooling and optional mounting feet. This motor Series is also the perfect complement for implementing high-powered yet energy-efficient servo hydraulic drive solutions together with B&R’s servo pump control. The variant with reinforced bearings, eg, makes it possible to set up high-torque belt feed axes for electric injection moulding machines. The servo motors in this series come equipped with a resolver interface, an optical encoder with EnDat interface and an embedded parameter chip, ensuring seamless compatibility with ACOPOS multi drives and easy integration into B&R’s entire system landscape.

Track & Trace - E-PEDIGREE Serialization modules, aggregation systems and a complete software suite = the complete line of mission critical machines compliant to the current and upcoming regulation on serialization, aggregation and e-pedigree. National Regulators have pursued the need for stringent drug tracking regulations in an effort to combat this risk of counterfeit, illegally imported or stolen drugs and to fight reimbursement system frauds. A complete track and trace process, made of serialization and aggregation, represents the best possible control as it could tell the whole history of a given product from the manufacturer to the point of dispensing. Antares Vision developed the Antares Tracking System to respond to the current and upcoming regulations on traceability and e-pedigree The ATS is designed to assure the utmost flexibility, future expandability and complying with evolving requirements from State Authorities (Turkey, US, France, Brazil, Korea, China, Italy).

For more information, please contact:

B&R Industrial Automation Pvt Ltd 8, Tara Heights, Mumbai-Pune Road Wakdewadi, Pune, Maharashtra 411 003 Tel: 020-41478999; Fax: 91-020-41478998 E-mail: shyam.padwal@br-automation.com

Jay Instruments & Systems Pvt Ltd E-16 Everest Building Tardeo Road, Mumbai 400 034 Tel: 022-23526207, 23526208; Fax: 91-022-23526210 E-mail: marketing@jayinst.com

Vapour Pressure Testing AMETEK Grabner Instruments offers a new automatic tester for low-volatility measurements. Grabner developed the MINIVAP VPXpert-L to automate the manual ASTM D2879 Standard Test Method for Vapour Pressure by Isoteniscope used by the chemical industry. The analyser measures gasoline, jet fuels, solvents and chemicals as well as food, flavour and fragrance products with vastly improved precision. The analyzer is optimized for a pressure range from 0.1 to 100 kPa and shows a measuring repeatability better than 0.1 kPa.. The MINIVAP VPXpert-L is the first completely automatic analyzer that accurately tests fuels and chemicals down to 0.1 kPa vapour pressure in a temperature range from 0 to 120°C. The pressure range of this new tester is limited to 100 kPa, which results in an optimized measuring repeatability of less than 0.1 kPa. The instrument requires only 1 mL of sample per test, eliminates the need for vacuum pump and manual filling, and yields results within minutes. The MINIVAP VPXpert-L includes all standard vapour pressure methods for testing fuels and incorporates new static methods for testing chemical compounds. These new VOC-methods measure the absolute vapour pressure based on the static Triple Expansion Method and yield results equivalent to the static ASTM D2879 Isoteniscope method. For more information, please contact: GRABNER Instruments Messtechnik GmbH Dr Otto Neurathgasse 1, A-1220 Vienna, Austria T +43 1 282 16 27-0 | F +43 1 280 73 34 E-mail: sales.grabner-instruments@ametek.at

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events diary 5th Pharmacovigilance Congregation 2013

CPhI India 2013

Dates: 20 November 2013 Venue: Kohinoor Continental Hotel, Mumbai, India

Dates: 3 – 5 December 2013 Venue: Bombay Convention and Exhibition Centre, Mumbai, India

5 th Pharmacovigilance 2013 will discuss the pressing concerns confronted with regard to drug safety, addressing the risks, time line, budget constrains, effectively tackling key challenges, overcoming trial agreement and site contract negotiation hurdles. Top pharmaceutical, biotech, and regulatory representatives will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development. The Conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.

CPhI India is a sister brand of CPhI Worldwide - the “must attend” event in the international pharmaceutical industry. Into its 6 th year, CPhI India and its co-located events are the largest and most comprehensive pharmaceutical industry events in South Asia.

Contact: Deepak Raj Virtue Insight, Plot No – 07, 2 nd Floor Ekambaram Industrial Estate, Alapakkam, Porur Chennai – 600 116 Tel: +(91) 44 65515693 | Mob: +(91) 9171350244 E-mail: deepak@virtueinsight.com

BioPharma India Convention 2013 Dates: 25 – 26 November, 2013 Venue: Hyatt Regency, Sahar Airport Road, Mumbai BioPharma India is the region’s leading biopharmaceutical event. This year more than 300 manufacturing, clinical trials and supply chain stakeholders from India and beyond will come together to identify innovation and partnership opportunities as well as best business and operationally effective practices. This year the conference will be made up of three seperate conference tracks as well as a global exhibition. You only need to purchase 1 pass and you can attend the whole event. Contact: Terrapinn Pte Ltd 1 Harbourfront Place, #18-01 Harbourfront Tower 1 Singapore – 098633 Tel: +(65) 6222 8550 | Fax: +(65) 6226 3264 E-mail: enquiry.sg@terrapinn.com 72 October 2013

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Contact: India CPhI Exhibitor query Kumudini Bodha UBM India Pvt Ltd Times Square Unit No 1 and 2, B Wing, 5 th Floor, Andheri Kurla Road, Marol Andheri (East) Mumbai - 400 059 Tel: +(91) 22 61727163, 61727272 Fax: +(91) 22 61727273 Email: kumudini.bodha@ubm.com

P-MEC India

Dates: 3 – 5 December 2013 Venue: Bombay Convention and Exhibition Centre, Mumbai, India P-MEC India will give you an unprecedented insight into the future of pharmaceutical equipment and machinery. The event highlights latest knowledge and trends in the industry. It is the best place for you to source quality machinery and equipment at competitive prices. Contact: Rahul Deshpande UBM India Pvt Ltd Times Square Unit No. 1 and 2, B Wing, 5 th Floor, Andheri Kurla Road, Marol Andheri (East) Mumbai - 400 059 Tel: +(91) 22 61727165 Fax: +(91) 22 61727273 Email: rahul.deshpande@ubm.com

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bookshelf The Oxford Handbook of the Economics of the Biopharmaceutical Industry [Hardcover] Authors: Patricia M Danzon (Editor), Sean Nicholson (Editor) Price: USD 122.98 No of pages: 624 pages About the book: This book examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the FDA and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialised countries, and in developing countries.

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing [Hardcover] Authors: Hamid Mollah (Editor), Harold Baseman (Editor), Mike Long (Editor) Price: USD 106.98 No of pages: 416 pages About the book: This book features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authorsâ&#x20AC;&#x2122; firsthand experience. With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Biopharmaceutical Production Technology [Hardcover] Author: Ganapathy Subramanian (Editor) Price: USD 445.93 No of pages: 944 pages About the book: Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

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R.N.I. No.: MAHENG/2002/08502. Date of Publication: 1â&#x20AC;&#x2122;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:- 76

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