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4 June 2017
Pharma Bio World
INTERVIEWS 08
Raising Awareness in the Fight to Cure Rare Diseases - Vi n e e t S i n g h a l , C o u n t r y H e a d , B a x a l t a B i o s c i e n c e India Pvt Ltd
FEATURES 14
Novel Approaches in Preclinical Research, Pharmacogenomics, Drug Design and Drug Delivery -Satish Wagh
8 21
Novel Research in Pharmaceuticals and BioPharmaceuticals -Ketan Zota
24
A Practical Approach to Successfully Navigate the Safety and Regulatory Continuum for Mature Products -David Balderson
28
nSMOL - A Novel Approach to Quantification of Therapeutic Monoclonal Antibodies -Ashutosh Shelar
14
30
Good Clinical Practices: Challenges and the Road Ahead
32
Novel Approaches in Medical Diagnostics
-Bhavik Narsana, Pavi Jain -Aparna Dhar MARKET RESEARCH 34
Pharma’s 4Q Debacle -Amey Chalke, Siddhant Mansukhani NEWS UPDATE
21
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6 June 2017
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interview
Vineet Singhal
Raising Awareness in the Fight to Cure Rare Diseases “Our purpose is to enable people with lifealtering conditions to lead better lives,� Says Vineet Singhal, Country Head, Baxalta Bioscience India Pvt Ltd (Now part of Shire). In an exclusive interview with Mahesh Kallayil, he further talks about potential oppor tunities in rare disease market, ensuring affordability of specialty medicines, business strategies and much more.
Can you briefly explain about Shire's vision and its focus areas in India? Shire is a leading global biotechnology company committed to serving people affected with rare diseases and other highly specialized conditions. These diseases (many of which are genetic) are often misunderstood, undiagnosed, and potentially life-threatening. Shire keeps patients at the centre of everything we do. In India, we are focused on two therapeutic categories, one being Hematology with our portfolio covering antihemophilia factors. Hemophilia is an X-linked congenital bleeding disorder caused by a deficiency of coagulation factor VIII (FVIII) Hemophilia A or factor IX (FIX) Hemophilia B. The deficiency is the result of mutations of the respective clotting factor genes. The second broad franchise in India is Immunology where we sell high-quality albumin and immunoglobulins, which are used under critical care by leading hospitals across India. We have widened our reach across the country and are present in every state.
8 ď‚ƒJune 2017
How do you see rare disease market in India? The biggest challenge that we see is that awareness and understanding of most rare diseases remains limited in India. Therefore our primary focus will be on three areas: the first is to increase awareness of these conditions amongst the medical community. Our second focus will be to improve the means of diagnosis for rare diseases. Thirdly and most importantly we want to make therapies accessible to patients. We are making a concerted effort to nurture an ecosystem that supports patients in rare diseases and ensure these specialized conditions can be treated. The good news is that there is a fair level of awareness about some rare conditions like Hemophilia across the country. Various efforts by the Government, patient bodies and healthcare companies have been instrumental in driving this awareness. It is thanks to these collective efforts by various stakeholders that the disease is addressed in a holistic manner. Pharma Bio World
interview There has been an increase in funding for Hemophilia around the country from three states 10 years ago to 21 states as of today. The Government has played a pivotal role in this journey by ensuring that patients do not suffer from a lack of access clotting factors. Going forward, Shire is committed to supporting the Government in its effort to increase awareness of rare diseases, LSD (Lysosomal Storage Disorder) and specialized conditions. What are the potential opportunities you see for Shire in India? Given the current scenario of rising incidences of disease-burden in Hemophilia and other rare diseases it is an imperative and a responsibility for Shire to be able to bring therapies to India that can help patients lead a better quality of life. From our experience of having played the role of enablers providing access to the diagnosis and treatment of Hemophilia, we plan to play a similar role in the treatment of LSD. Shire's extensive portfolio means we have the potential to help thousands of patients who need treatments , not yet available within the country. We want to make therapies accessible to patients so that they can start leading a near normal life. We also plan to bring our Oncology portfolio into the country, including a first in line treatment for Acute Lymphoblastic Leukemia. For Shire, it's critical we are a catalyst in creating an environment that supports Rare Disease patients with a comprehensive program that will encompass awareness, education, diagnosis, and infrastructure to provide the right treatment options. We believe the only way to make this possible is through meaningful partnerships that bring together policy makers, patient bodies, patient communities and other stakeholders 10 ď‚ƒJune 2017
around a common agenda, promoting awareness and accessibility to therapies. At Shire, we ensure we build a sustainable platform for future innovation and growth. Keeping in mind the current scenario, the company has a significant role to play in building awareness among all these stakeholders. Can you give us a brief overview of the Indian pharmaceutical sector and growth potential of biotechnology? The pharmaceutical market in India is growing at a double-digit rate. Having said that, it is difficult to benchmark any specific data for the biotechnology market, although it has the potential to grow at a much faster rate than the mass pharma market. With rising in awareness levels and Government initiatives, we feel that the biotechnology industry will continue to grow, comprising bio-pharmaceuticals which will can contribute to the overall growth of the economy. What steps have been taken by Shire to address the affordability of medicines of these highly specialized conditions? Shire is dedicated to developing innovative treatments for rare diseases and specialized conditions, which make a difference to the lives of patients and their caregivers. Developing innovative medicines, particularly for rare diseases, is not easy. For every successful therapy that is brought to the market, there are many failures. We are committed to pricing our treatments in a way that is responsible and sustainable for healthcare systems around the world and also ensures that our company makes a return on investment enabling us to develop the next generation of treatment for patients with high unmet needs. To support decision makers, Shire generates evidence, both before and after our therapies
are approved, to demonstrate the impact our treatments make to the lives of patients, their caregivers and to the healthcare system. We are solution-focused, actively seeking ways to engage constructively with healthcare providers, payers and policy makers to achieve together the best possible outcomes for patients from the resources available. At Shire, we never lose sight of our focus on patients and our drive for high-impact. Our goal is to ensure that all patients prescribed a Shire therapy have access to it and that they have the support they need to achieve the best possible results for them. Shire has programs to support patients along their treatment journey offering early, supported or charitable access. We believe our commitment to advancing innovation for rare disease and specialized conditions is how we are making a significant contribution to society through the impact we have on the lives of patients, their families and caregivers. Shire has a very strong focus towards both global and domestic partnership. What are the basic criteria for partnership and how do you ensure success? Shire's journey over the past few years has seen the company strengthened its position through partnerships and mergers, which in turn have helped us to achieve our mission. We are constantly seeking out new opportunities through strategic partnerships and our approach to business . We have a good track record of partnerships with other organisations to develop innovative therapies which build on our existing rare disease portfolio. These partnerships help to combine the best of both companies and contribute to making Shire, a nimble, performance-driven organization through a collaborative approach with the patient at the centre of it all. Pharma Bio World
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interview How important has the Baxalta acquisition been for Shire?
24,000 employees and expanded geographic reach across more than 100 countries.
Our combination with Baxalta has been an important step to help us achieve our goal of being the leading global biotech for rare diseases, bringing us an expanded portfolio and increased capabilities that enhance the impact we can have on patients around the world with significant unmet needs. Shire and Baxalta's complementary portfolios mean that our global therapeutic areas now include Hematology, Immunology, Neuroscience, LSD, Gastrointestinal / Internal / Endocrine, HAE, and a small but growing franchise in Oncology. Globally, our two biggest franchises are Hemophilia (a Baxalta legacy) and LSD (a Shire legacy).
What are the major challenges you are facing and how are you gearing up?
Following our combination, we have an expanded 37 programs in clinical development, our most robust pipeline in history. The combined company has nearly
12 ď‚ƒJune 2017
From an India standpoint, our biggest challenge is the lack of awareness of rare diseases and specialized conditions. To overcome this, it is important to create more conversations at various levels, including patients, doctors, the medical community and policy makers. We have been working continuously with all stakeholders through patient outreach, awareness programs for the medical community and engagement with doctors and policy makers to increase awareness of these life affecting conditions. What would be your business strategy for the current financial year?
and our strategy is to create and grow longterm value based on improved diagnosis and providing high impact medicines and therapies. We believe our commitment to advancing innovation means we are making a significant contribution to society through the positive impact we have on the lives of patients, their families and caregivers. We c ontinue to foc us on c o mme r c ia l execution and new product launches, including geographical expansions to extend access to our portfolio. Our intent is to expand leadership therapeutic areas by enhancing our commercial capabilities, increasing our global footprint and broadening our portfolio of best-inclass products. Also, we want to focus on the effective execution of our late stage clinical development pipeline to support future growth.
Shire strives to support patients with rare diseases and other specialized conditions,
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Novel Approaches in Preclinical Research, Pharmacogenomics, Drug Design and Drug Delivery Novel approaches in rug iscovery are reuire as they may reuce cost of D improve safety an efficiency This article highlights novel approaches in rug iscovery ith particular emphasis on preclinical research pharmacogenomics rug esign an rug elivery
Satish agh Chairman Basic Chemicals, Cosmetics & Dyes Export Promotion Council (Chemexcil) 14 June 2017
D
rug discovery is the process by which new chemical entities are discovered. Historically, drugs were discovered by studying and identifying the active component from traditional remedies. Some have been discovered by serendipity. Later in the classical pharmacology methodology chemical libraries of synthetic small molecules, natural products or extracts were screened in vitro or in vivo to identify substances that have a desirable therapeutic effect. Since the recent past pharmacogenomics has gained lot of significance wherein human genome sequencing is the basis and collated with the pharmacology. In the modern drug design process High throughput screening is carried out on large compounds libraries against isolated biological targets which are hypothesized to be disease modifying. Hits are then tested in cells and then in animals for efficacy. In the drug development cycle, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. On average, only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug. Drug delivery studies have come a long way and have reached very advanced levels of research in drug administration such as thin film, magnetic, self microemulsifying , acoustic , neural .
The Drug Discoery Cycle Modern drug discovery involves the identification of screening hits, and optimization of those hits to increase the affinity, selectivity, efficacy/potency, metabolic stability, and oral bioavailability. The identified compound then undergoes the process of drug development prior to clinical trials. Some steps may involve computer-aided drug design. Modern drug discovery is a capitalintensive process. However despite advances in technology and understanding of biological systems, drug discovery is still a cumbersome process with low chances of new therapeutic discovery. A singIe new molecular entity (NME) cost was approximately USD 2.0 Billion. Drug discovery is done by pharmaceutical companies, with research assistance from universities. The drug requires very expensive Phase I, II and III clinical trials, and most of them fail. Small companies have a critical role, often then selling the rights to larger companies that have the resources to run the clinical trials. Discovering drugs that may be a commercial success, or a public health success, involves a complex interaction between investors, industry, academia, patent laws, regulatory exclusivity, marketing and the need to balance secrecy with communication. A drug discovery process ends up in a patent on the potential drug. The Drug Discoery Techniues The modern era in pharmacology began with the idea that the effect of a drug in the human body is mediated by specific interactions of the drug molecule with Pharma Bio World
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Figure 1: Drug Discovery Cycle biological macromolecules, (proteins or nucleic acids in most cases) led scientists to the conclusion that individual chemicals are required for the biological activity of the drug. Thus pure chemicals, instead of crude extracts, became the standard drugs. Morphine, the active agent in opium, and digoxin, a heart stimulant originating from Digitalis lanata are Examples of drug compounds isolated from crude preparations. Organic chemistry also led to the synthesis of many of the natural products isolated from biological sources. In Classical pharmacology, forward pharmacology or phenotypic drug discovery. historically substances, whether crude extracts or purified chemicals were screened for biological activity without knowledge of the biological target. Only after an active substance was identified was an effort made to identify the target. Small molecules were synthesized to specifically target a known physiological/pathological pathway, rather than adopt the mass screening of banks of stored compounds. This led to great success, such as the work of Gertrude Elion and George H. Hitchings on purine metabolism, the work of James Black on beta blockers and cimetidine, and the discovery of statins by Akira Endo. 16 ď‚ƒJune 2017
Another champion of the approach of developing chemical analogues of known active substances was Sir David Jack at Allen and Hanbury's, later Glaxo, who pioneered the first inhaled selective beta2-adrenergic agonist for asthma, the first inhaled steroid for asthma, ranitidine as a successor to cimetidine, and supported the development of the triptans. Gertrude Elion, working mostly with a group of fewer than 50 people on purine analogues, contributed to the discovery of the first anti-viral; the first immunosuppressant (azathioprine) that allowed human organ transplantation; the first drug to induce remission of childhood leukaemia; pivotal anti-cancer treatments; an anti-malarial; an anti-bacterial; and a treatment for gout. Cloning of human proteins made possible the screening of large libraries of compounds against specific targets thought to be linked to specific diseases. This approach is known as reverse pharmacology and is the most frequently used approach today. Thus a paradigm shift has occurred in the drug design methodology. The drug target is usually the naturally existing cellular or molecular structure involved in the pathology of interest that
the drug-in-development is meant to act on. There are two types of drug targets, established and new. "Established targets" are those for which there is a good scientific understanding, supported by a lengthy publication history, of both how the target functions in normal physiology and how it is involved in human pathology. target is fully understood. Rather, "established" relates directly to the amount of background information available on a target, in particular functional information. The process of gathering such functional information is called target validation in pharmaceutical industry parlance. Established targets also include those that the pharmaceutical industry has had experience mounting drug discovery campaigns against in the past; such a history provides information on the chemical feasibility of developing a small molecular therapeutic against the target and can provide licensing opportunities and freedom-to-operate indicators with respect to small-molecule therapeutic candidates. "New targets" are all those targets that are not "established targets" but which have been or are the subject of drug discovery campaigns. These typically include newly Pharma Bio World
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discovered proteins, or proteins whose function has now become clear as a result of basic scientific research.
chemists will attempt to use structureactivity relationships (SAR) to improve certain features of the lead compound:
The majority of targets currently selected for drug discovery efforts are proteins. Two classes predominate: G-proteincoupled receptors (or GPCRs) and protein kinases.
•• increase activity against the chosen target
In this decade to date an estimated 435 human genome products were identified as therapeutic drug targets of FDAapproved drugs.
This process will require several iterative screening runs, during which, it is hoped, the properties of the new molecular entities will improve, and allow the favored compounds to go forward to in vitro and in vivo testing for activity in the disease model of choice.
1) High Throughput Screening The process of finding a new drug against a chosen target for a particular disease usually involves high-throughput screening (HTS), wherein large libraries of chemicals are tested for their ability to modify the target. For example, if the target is a novel GPCR, compounds will be screened for their ability to inhibit or stimulate that receptor (see antagonist and agonist): if the target is a protein kinase, the chemicals will be tested for their ability to inhibit that kinase. Another important function of HTS is selectivity ie to show how selective the compounds are for the chosen target. To this end, other screening runs will be made to see whether the "hits" against the chosen target will interfere with other related targets - this is the process of cross-screening. Cross-screening is important, because the more unrelated targets a compound hits, the more likely that off-target toxicity will occur with that compound once it reaches the clinic. It is more often observed that several compounds are found to have some degree of activity, and if these compounds share common chemical features, one or more pharmacophores can then be developed. At this point, medicinal 18 June 2017
•• reduce activity against unrelated targets •• improve
the drug likeness or ADME properties of the molecule.
While HTS is a commonly used method for novel drug discovery, it is not the only method. It is often possible to start from a molecule which already has some of the desired properties. Such a molecule might be extracted from a natural product or even be a drug on the market which could be improved upon (so-called "me too" drugs). Other methods, such as virtual high throughput screening, where screening is done using computer-generated models and attempting to "dock" virtual libraries to a target, are also often used. 2) Drug Design Another important method for drug discovery is drug design, whereby the biological and physical properties of the target are studied, and a prediction is made of the sorts of chemicals that might (e.g.) fit into an active site. One example is fragment-based lead discovery. Novel pharmacophores can emerge very rapidly from these exercises. In general, computer-aided drug design is often but not always used to try to improve the potency and properties of new drug leads. Once a lead compound series has been established with sufficient target potency and selectivity and favorable drug-like
properties, one or two compounds will then be proposed for drug development. The best of these is generally called the lead compound, while the other will be designated as the "backup". 3) Combinatorial Chemistry Combinatorial chemistry was a key technology enabling the efficient generation of large screening libraries for the needs of high-throughput screening. However, now, after two decades of combinatorial chemistry, it has been pointed out that despite the increased efficiency in chemical synthesis, no increase in lead or drug candidates has been reached. This has led to analysis of chemical characteristics of combinatorial chemistry products, compared to existing drugs or natural products. The chemo-informatics concept chemical diversity, depicted as distribution of compounds in the chemical space based on their physicochemical characteristics, is often used to describe the difference between the combinatorial chemistry libraries and natural products. The synthetic, combinatorial library compounds seem to cover only a limited and quite uniform chemical space, whereas existing drugs and particularly natural products, exhibit much greater chemical diversity, distributing more evenly to the chemical space. The most prominent differences between natural products and compounds in combinatorial chemistry libraries are the number of chiral centers (much higher in natural compounds), structure rigidity (higher in natural compounds) and number of aromatic moieties (higher in combinatorial chemistry libraries). Other chemical differences between these two groups include the nature of heteroatoms (O and N enriched in natural products, and S and halogen atoms more often present Pharma Bio World
in synthetic compounds), as well as level of non-aromatic unsaturation (higher in natural products). As both structure rigidity and chirality are both well-established factors in medicinal chemistry known to enhance compounds specificity and efficacy as a drug, it has been suggested that natural products compare favorable to today's combinatorial chemistry libraries as potential lead molecules.
Many drugs that are currently available are "one size fits all," but they don't work the same way for everyone. It can be difficult to predict who will benefit from a medication, who will not respond at all, and who will experience negative side effects (called adverse drug reactions). Adverse drug reactions are a significant cause of hospitalizations and deaths in the United States.
4) Structural Elucidation
With the knowledge gained from the Human Genome Project, researchers are learning how inherited differences in genes affect the body's response to medications. These genetic differences will be used to predict whether a medication will be effective for a particular person and to help prevent adverse drug reactions.
The elucidation of the chemical structure is critical to avoid the re-discovery of a chemical agent that is already known for its structure and chemical activity. Mass spectrometry is a method in which individual compounds are identified based on their mass/charge ratio, after ionization. Chemical compounds exist in nature as mixtures, so the combination of liquid chromatography and mass spectrometry (LCMS) is often used to separate the individual chemicals. Databases of mass spectras for known compounds are available, and can be used to assign a structure to an unknown mass spectrum. Nuclear magnetic resonance spectroscopy is the primary technique for determining chemical structures of natural products. NMR yields information about individual hydrogen and carbon atoms in the structure, allowing detailed reconstruction of the molecule's architecture. Pharmacogenomics Pharmacogenomics is the study of how genes affect a person's response to drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to a person's genetic makeup. Pharma Bio World
The field of pharmacogenomics is still in its infancy. Its use is currently quite limited, but new approaches are under study in clinical trials. In the future, pharmacogenomics will allow the development of tailored drugs to treat a wide range of health problems, including cardiovascular disease, Alzheimer disease, cancer, HIV/AIDS, and asthma. Preclinical Research Each class of product may undergo different types of preclinical research. For instance, drugs may undergo;
Most preclinical studies must adhere to GLPs in ICH Guidelines to be acceptable for submission to regulatory agencies such as the Food & Drug Administration in the United States. Typically, both in vitro and in vivo tests will be performed. Studies of a drug's toxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction. Animal Testing The information collected from these studies is vital so that safe human testing can begin. Typically, in drug development studies animal testing involves two species. The most commonly used models are murine and canine, although primate and porcine are also used. Choice of Species The choice of species is based on which will give the best correlation to human trials. Differences in the gut, enzyme activity, circulatory system, or other considerations make certain models more appropriate based on the dosage form, site of activity, or noxious metabolites. Depending on a drug's functional groups, it may be metabolized in similar or different ways between species, which will affect both efficacy and toxicology.
••
pharmacodynamics (what the drug does to the body) (PD),
••
Pharmacokinetics (what the body does to the drug) (PK),
Importantly, the regulatory guidelines of FDA, EMA, and other similar international and regional authorities usually require safety testing in at least two mammalian species, including one non-rodent species, prior to human trials authorization.
••
Absorption, distribution, metabolism, and excretion, (ADME),
NOAEL
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Toxicology testing.
This data allows researchers to estimate a safe starting dose of the drug for clinical trials in humans.
Based on preclinical trials, No Observable Adverse Effect Levels (NOAEL) on drugs are established, which are used to determine initial phase 1 clinical June 2017 19
trial dosage levels on a mass API per mass patient basis. Generally a 1/100 uncertainty factor or "safety margin" is included to account for interspecies (1/10) and inter-individual (1/10) differences. Drug Deliery This refers to approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body to safely achieve its desired therapeutic effect safely as needed . Drug delivery is often approached via a drug's chemical formulation, but it may also involve medical devices or drug-device combination products. The concept of drug delivery is in synchronization with dosage form and route of administration Drug delivery technologies modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well as
patient convenience and compliance. Drug release is from: diffusion, degradation, swelling, and affinity-based mechanisms. Most common routes of administration include the preferred non-invasive peroral (through the mouth), topical (skin), transmucosal, (nasal, buccal / sublingual, vaginal , ocular and rectal)and inhalation routes. Many medications such as peptide and protein, antibody, vaccine and gene based drugs, in general may not be delivered using these routes because they might be susceptible to enzymatic degradation or can not be absorbed into the systemic circulation efficiently due to molecular size and charge issues to be therapeutically effective. Many protein and peptide drugs have to be delivered by injection or a nano needle array precisely for this reason Current efforts in the area of drug delivery include the development of targeted
delivery in which the drug is only active in the target area of the body (for example, in cancerous tissues), sustained release formulations in which the drug is released over a period of time in a controlled manner from a formulation, and methods to increase survival of peroral agents which must pass through the stomach's acidic environment. In order to achieve efficient targeted delivery, the designed system must avoid the host's defense mechanisms and circulate to its intended site of action. Types of sustained release formulations include liposomes, drug loaded biodegradable microspheres and drug polymer conjugates. Survival of agents as they pass through the stomach typically is an issue for agents which cannot be encased in a solid tablet.
Contact Chairmanchemexcil.gov.in
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Pharma Bio World turns 15 this July. Our sincere thanks go out to all of you who have helped make the magazine a success over the years. Over the past decade, we has been catering to the strategic information needs of senior professionals in the pharmaceutical and biotechnology industries, covering the best manufacturing and management practices, technological developments, new markets and cutting edge products and services. In this anniversary edition, we intend to explore information of latest ideas, current trends, cutting-edge technologies and innovations shaping the future of pharmaceutical and biotech industries. To ensure Pharma Bio World continues to meet your needs, we would appreciate your feedback. Please feel free to write to us at mahesh_kallayil@jasubhai.com if you think we can serve you better.
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Novel Research in Bio-Pharmaceuticals
Pharmaceuticals
P
revailing Research is a versatile associate investigated that gives generous amount of understanding into the methods of biopharmaceutical medication declaration and its effect on the act of solution. The focal point is on the immeasurable dispersal of late advancements and growth in biotechnological instruments and equipments and the approach and expansion of the novel pharmaceutical medications, treatments and aids. Pharmaceutical biotechnological reviews into incorporates contemplates on the utilization of microbiology, recombinantDNA innovation, mechanical biotechnology, genomics and proteomics. The extent of the wraps inquire about the evolution in bio-sub-atomic flow, building models in biomedicine, biomedicine strategies, cell designing and sub atomic, bio mechatronics and pharmaceutical building. The Pharmaceutical Biotechnology The ongoing research additionally further administrates authentic copies exhibiting late diagnosis on microarray advances, atomic evolution, cell frameworks and sub atomics, bio nanotechnology, phylogeny and frameworks biotechnology. Besides distributes discoveries and evolution on the component of moment of medications, medication targets, cell based therapeutics, radio pharmaceuticals science, nucleic corrosive and pharmacokinetics. Pharmaceutical Design and Adancement
etan ota Chairman - ota ealthcare Pharma Bio World
The path toward getting other pharmaceutical medication once an advanced compound has been esteemed through the transactions of medication disclosure and enhancing strategies in medication epiphany is called Pharmaceutical Design and Advancement.
and
Prudent medication contour creates less mixes of contrast with high-throughput screening. In any case, these mixes are positive to the objective and utilize computer based displaying to accomplish this specificity. Pharmaceutical Adancement Tranquilize Advancement Medication disclosure is the way toward discriminating another concoction or dynamic pharmaceutical fixing which is appropriate for evaluating a specific sickness is called as medication revelation. Amid medication revelation, is an escalated seek follows to advancement of a medication like little or small particle or natural therapeutic, generally named as an advancement challenger , that will advance into preclinical, and if fruitful, into clinical enhancement and eventually be a showcased prescription. Bio Molecular Dynamics Bio Molecular component replications are vital instruments for interpreting the substantial assertion of the structure and capacity of organic macromolecules. Biomolecular Dynamics underpins key research in the ranges of molecular biochemistry molecular biophysics and metabolic biochemistry. The group underlines the contact between structure, capacity, and progression in investigations of individual metabolic pathways, macromolecules andmacromolecular complexes. Molecular pansion Atomic development is a hypothesis, expressing that whenever of disparity between qualities, proteins, or genealogies can be dated just by measuring June 2017 21
the quantity of changes between arrangements. Atomic development raised in the 1960s as specialists looked to comprehend revelations encompassing the transformative examples, structure and capacity of nucleic acids and protein and also the utilization of these particles in investigations of biogeography, populace hereditary qualities, phylogenetics, and different territories of research at various levels of natural association. Molecular Bio Technology Atomic evolution is a hypothesis, exhibit that whatever time of dissimilarity between elements, proteins, or ancestries can be dated essentially by calculating the quantity of changes between successions. Atomic advancement or evolution was grown in the 1960s as analysts tried to comprehend publication byencompassingthe life-changing examples, structure and capacity of nucleic acids and protein and in addition the utilization of these particles in
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investigations of phylogenetics, populace hereditary qualities, biogeography, and different ranges of research and at various levels of natural federation. Genomics Study Genomics is an inspection inside the hereditary qualities that worries the investigation and sequencing of a creature's gens. Genomics-based exploration is as of now empowering by medicinal scientists to create enhanced diagnostics, more compelling restorative techniques, confirm based methodologies for exhibiting clinical adequacy, and better basic leadership devices for patients and suppliers. It seems inescapable that medications will be customly fitted to a patient's specific genomic cosmetics. Along these lines, the part of transmitted qualities in human services is beginning to change significantly and the primary cases of the time of genomic pharmaceutical are upon us.
Framework of Bio Technology Frameworks bio technology covers the ideas and strategies utilized as a changeable part of frameworks level cross examination of biomedical frameworks. Frameworks science has been the way organic and biotechnological investigation is performed. Presently, frameworks natural methodologies can be taken to create bioprocesses for the generation of profitable medications, item and fine chemicals, powers, and polymers and different materials and components. Computer Assist Drug Design (CADD) CADD attempt an inside and out communication of the computer helped systems used to find, outline, and improvement of new, powerful, and safe medications. Techniques for CADD change contingent upon the degree of basic and other data reachable, in regards to the objective (catalyst/receptor) and the ligands. Computer helped
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Pharmacodynamics Study
medicate plan (CADD) is an energizing and different train where different parts of connected and fundamental research blend and empower each other. In the early phase of a medication revelation prepare, scientists might be confronted with practically zero structure movement relationship (SAR) data Phylogenetic Rehabilitation Phylogenetic propagating is a quickly evolving field that is enhanced by various perceptible methodologies and by explorations and applications in an expansive scope of natural zones. Phylogeneticreproduction strategies have enormously profit by late improvements in sub-atomic science and sequencing innovations with various intense techniques having been created particularly to construe Phylogenetic from macromolecular information. Biopharmaceuticals Biopharmaceuticals are corrective medications that are plans by utilizing biotechnology. Microarray variation might be symbolized as a high-throughput and flexible innovation utilized for parallel quality expression and investigation for a many great element of known and obscure capacity, or DNA homology examination Pharma Bio World
for distinguishing polymorphisms and changes in both prokaryotic and eukaryotic genomic DNA.
Pharmacodynamics is an investigation and study of physiological impacts and biochemical impacts of medications in an individual. Just characterized as what a medication does to the human body. The pharmacodynamic measures interprets every one possessing thoseissues and worried with the pharmacological activities of a medication, regardless of whether they are expected parts of the restorative impact (adequacy). Initially, pharmacodynamics was the essential enthusiasm of patient reviews, against the fact that viability assessment has turned out to be deliberately essential in stage 1 ponders. Pharmacokinetics
Micro-Array Technology It is an innovation which is utilized to benchmark the expression levels of vast quantities of genotype numerous districts of a genome or qualities at the same time. Microarray innovation might be characterized as a high-throughput and adaptable innovation utilized for parallel quality expression examination for a huge number of qualities of known and obscure capacity, or DNA homology investigation for identifying polymorphisms and changes in both prokaryotic and eukaryotic genomic DNA.
Pharmacokinetics is the investigation of medication assimilation, dispersion, digestion, and discharge in the body. Basically portrayed as what the body does to a drug. Pharmacokinetics is fundamentally worried with the examination of focus and rate of medication accessibility to the required receptor site. Pharmacokinetic examination is not normally restricted to the parent medicate atom itself, additionally recognized metabolites, regardless of whether dynamic or inert.
Bio-Nanotechnology Bio-Nanotechnology is a bureau of nanotechnology which utilizes organic beginning components and is applies in solution or uses natural plan or biotechnology. Bio-Nanotechnology has turned into an energizing pasture of research and a region of innovation advancement, exceptionally since the length scale nanotechnology can get to increase with the length size of essential natural structures and basic organic segments.
Contact: infoariapr@gmail.com June 2017 ď‚„ 23
A Practical Approach to Successfully Navigate the Safety and Regulatory Continuum for Mature Products ature harmaceutical roducts are those that are long ast their mareting eclusiity eriod but are still sold in substantial olumes because of their ellestablished effectieness and safety in certain medical conditions. ature roducts hae a significant role in the healthcare for many atients both in the deeloed and deeloing orld. The maority of the large harma comanies hae a sieable ortfolio of mature roducts, hich are in the final stages of their lifecycle although they may be mareted or sold for many years to come. These roducts can still lay a crucial role in the comanys strategy, more so in emerging marets than in innoationfocused, deeloed marets.
W
hile development of promising new products is an obvious area of focus for biopharmaceutical companies, maintenance of already established marketed products is a critical activity that cannot be ignored. Ensuring regulatory compliance and reducing product risk whilst still working within the cost constraints presents unique challenges to companies in managing established products and requires innovative and cost-effective approaches that can help ensure patient safety and compliance while continuing to meet ever-increasing and complex regulatory demands. Rather than handling all products in the same way, marketing authorization holders (MAHs) have an opportunity to look at managing the more stable mature products differently and more efficiently, allowing them to consider the benefits of an integrated safety, regulatory and benefit-risk model.
for individual market needs, innovating the formula, dosage forms or packaging for optimal results, or expanding geographically. Yet, due to increasingly stringent drug regulations in emerging markets, the documentation needed to remain compliant for mature product maintenance has risen dramatically in the last decade. Pharmacovigilance (PV) activities must be continued, while maintaining regulatory dossiers and managing labels is all required to uphold licenses. on-compliance can result in critical regulatory penalties, with significant financial implications. The most significant financial impact for any manufacturer is when blockbuster drugs pass their patent exclusivity, requiring most companies to look carefully at minimizing costs to sustain their profitability. A Pragmatic Approach to Managing Mature Products
The Importance of Mature Products Mature products, those that are still sold substantially but are long past their marketing exclusivity, have a significant role in the healthcare industry in both the developed and developing world. Mature products make up a large portion of many pharmaceutical organizations portfolios these are likely to be sold well into the future despite being in the final stages of their lifecycle.
Daid alderson Global Vice President - Safety Operations Sciformix Corporation 24 June 2017
Established products have proven effectiveness and safety profiles making them even more important in emerging markets compared to newer products. However, since the cost of maintaining mature products is usually significantly lower than launching newer ones, pharma companies can focus on tailoring them
Organizations have the opportunity to manage their mature products differently from others in their portfolio by focusing on efficiency to free up resources. Mature products, by nature, are typically more stable with a predictable revenue stream, thus, the reduced amount spent on managing the product can increase profitability. A more pragmatic approach can be taken to streamline processes making it less resource intensive. In some aspects, such as the frequency of Periodic Safety Update Reports (PSUR) production, the regulations also support a more streamlined approach and although aspects such as signal detection activities need to be maintained, there are opportunities to take a more pragmatic approach by reducing the frequency of many routine activities. Pharma Bio World
Figure 1. The Safety Continuum There are three main areas to traverse when managing mature products, namely, safety and risk management, labeling and regulatory. Taking an integrated approach for these three areas is vital to efficient management. Yet, often these functions can act independently within organizations which can result in overlapping and duplicative work or in worse case scenarios some elements being missed completely, due to fragmented processes and oversight. Furthermore, with the evolution of Good Pharmacovigilance Practices (GVP) in Europe and many other regions following suit, more rigorous standards need to be upheld. This requires a substantially skilled manpower pool who are knowledgeable of each region's regulations, which often means stretching the same resources between mature product portfolios and new products. Pharma Bio World
The Safety Continuum Whilst mature products are often much more stable and well defined than new ones, safety activities are still required, although usually under less scrutiny. These are done to ensure the product remains safe and effective for patients. PV is a central function to supporting the safety of a product and ensuring the benefits out-weigh the risks of using the drug. It is acknowledged that some products, across multiple classes that have been on the market for a long time, still require extensive support from a PV perspective. These include clozapine, thalidomide, isotretinoin, and leaner approaches to managing these products are not applicable. However, even the majority of the stable mature products can still go through many changes due
to increasing exposure, differences in physician practices, new or untested drug interactions and pharmacogenetic variations as they are introduced to new patient populations. A variety of activities are therefore still required, along with risk management plans that may go beyond routine PV. These activities from single adverse event processing to signal identification and risk management are part of the safety continuum, which is illustrated in the figure below. Signal Management Signal management can be defined as the activities performed to identify new risks or changes in character or severity of a known risk. It remains an essential component in assuring the safe use of a drug throughout its lifecycle. Avoiding and minimizing risks can be done through alerting patients and June 2017 ď‚„ 25
Figure 2. The integrated safety, regulatory and labeling continuum. healthcare providers to the identification of a new risk or change in a known risk. This requires discussion with regulators, changes to labels and occasionally direct communications. This can often include a spectrum of teams in an organization from PV, to clinical development, to regulatory affairs and medical information, especially if the communications become urgent. Even for mature products, signal management remains an essential part of the safety continuum and product lifecycle.
and, at times, essential information to regulators, patients and HCPs, regarding the safe use of a product. Label changes are also a complex procedure involving cross-functional processes, requiring written safety practices and high level expertise. For mature products there is normally a large amount of safety data that needs to be managed efficiently. In order to complete a safety driven label change, an organization must have written practices in place to organize the different functional groups with the required expertise.
Signal Detection to Implementation of the Label
The Regulatory Continuum
A label change is an example of a truly collaborative and cross-functional process which has a high degree of operational complexity and is often an outcome from signal management, subsequent to the validation of a safety signal. The label change communicates formally important
Regulatory submissions are often time intensive and require multiple teams and stakeholders to fulfil, but for mature products the strategy for filing is often managed regionally or locally, requiring an understanding of the local environment. However, in order to manage the
regulatory activities, the local regulatory resources still require documentation and support from central regulatory experts who are often unable to dedicate time to supporting mature products as the focus is on the new product portfolio. With this and the increasing pressure to be cost and time efficient, new operating models and adapted standard operating practices (SOPs) need to be considered. Typically these allow local or regional regulatory professionals to manage activities themselves by re-purposing documents that have been created centrally. Dossier Repurposing
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When maintaining mature products, some key strategies allow for expedited safety labeling and regulatory procedures. The first of these is dossier repurposing, which consists of reusing and reformatting the existing dossier submitted in highlyPharma Bio World
regulated countries to then meet regionspecific requirements. Obtaining regulatory approval of new uses for existing drugs is an important part of innovating mature products. Sections of existing dossiers can be repurposed, along with the creation of any additional content needed to meet the specific requirements in order to file applications for mature products with wellestablished safety and efficacy profiles. This includes changes from prescription to over the counter drugs.
Mature Product Lifecycle Management
License Maintenance and Renewals
Outsourcing regulatory and safety activities for mature products is a viable option and can streamline the process while minimizing costs. A partner can employ a centralized approach and is able to communicate with multiple teams globally and efficiently manage data to fully coordinate operations. Ideally a partner should manage the end-to-end safety and regulatory deliverables to support mature products, however, a flexible model can be employed if required. A dedicated and integrated team is able to proactively manage risks, including generating risk management plans and risk mitigation strategies. They are also able to track regulatory commitments, such as US FDA annual reports and PSURs, and ensure all deliverables are submitted on time.
MAHs of pharmaceutical products are responsible for validating the effects of any manufacturing or product quality (generally CMC) related changes to the identity, strength, quality, purity, and potency of the drug as these factors can affect the safety or efficacy of the drug. CMC changes are a significant source of license maintenance activity and are inevitable due to many reasons including continuous process improvement in manufacturing and quality of the product, changing business needs, or implementation of regulatory authority stipulations. Deviations or violations from filing such documentation can result in regulatory actions such as warning letters and import alerts. License renewals are also required periodically to continue marketing a drug. In order to keep a continuous supply of product these activities must be managed ahead of drug license expiration dates and site registrations. An Integrated Safety, Regulatory and Labeling Continuum for Mature Product Maintenance Organizations should consider the merits of an integrated safety, regulatory and labeling service model for mature product maintenance with a flexible structure that promotes continuous improvement, whilst lowering the costs and maximizing product value. The figure below illustrates an example matrix of the different activities that need to be managed within an integrated framework. Pharma Bio World
A meaningful way to address the challenges in today's complex regulatory environment is to focus on an integrated team approach to product lifecycle management. Most pharmaceutical companies suffer from building virtual walls between functional silos, along with data and processes being separated, thus, making it difficult for cross-functional information to flow quickly and securely.
Furthermore, for generic products the regulatory intelligence capabilities of an outsourced vendor can be leveraged to track and implement updates to the reference label.
was implemented at a large generics company to manage their product portfolio. With the client's products being manufactured at various locations worldwide, and teams located in different geographies, the main challenge was to manage the data generated across the different locations and coordinate regulatory submissions. A dedicated crossfunctional team with in-depth knowledge of the product portfolio, various regulatory information management systems, and publishing tools was assigned to the project. Data was collated into a single repository that allowed for early identification of potential risks, the ability to quickly address emerging problems, improved efficiency, and reduced the need for regulatory oversight from the client. The reliance on input from the client has reduced over time and they are being successfully supported through this integrated model. Conclusion Whether product lifecycle activities are managed internally or by a service provider, creating a structure in which all elements (people, process and technology) are integrated is critical to being able to successfully manage mature products efficiently. This allows all stakeholders to be aligned and companies can streamline tasks and free up resources to focus on other activities.
As with any outsourced model, internal resources would still be required to manage relationships with the vendor and provide access to necessary data, over time this will diminish and the provider will be able to manage the safety and regulatory activities to support the entire mature product portfolio in a much more independent manner. An integrated regulatory, safety, risk management, and product labeling model
Contact:David.Balderson@Sciformix.com June 2017 ď‚„ 27
nSMOL - A Novel Approach to Quantification of Therapeutic Monoclonal Antibodies!
28 June 2017
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Good Clinical Practices: Challenges and the Road Ahead Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. This article depicts clinical research scenario in India and historical perspective on Good Clinical Practices, challenges and future of clinical research in India.
hai arsana Partner ifesciences and Healthcare and the Corporate M&A and PE eam haitan & Co.
Pai ain Senior Associate ifesciences and Healthcare and the Corporate M&A and PE eam haitan & Co 30 June 2017
I
ndia has a robust platform and an equal potential to contribute meaningfully towards the global clinical research and drug development. India presents an attractive platform with a vast population and patient-pool, minimal research costs and quality skill sets in the form of medical practitioners. However, despite the previously targeted growth projections and expansion reports, growth of Indian clinical research has not materialised due to several challenges. he past two decades have seen the rise and fall of clinical trials in India. he Indian clinical trial market grew by 20.3 per cent compound annual growth rate (CAGR) between 2005 and 2010 and decreased by - 14.6 per cent CAGR between 2010 and 2013 1. he slowdown in the clinical trial market was a result of the unprecedented regulatory framework, slow regulatory approval process, unwarranted and negative media coverage along with activist engagement, lack of awareness in the public and recuperative initiatives.
serious adverse events 2. On the other hand, compliance with Indian GCP guidelines are only recommended and does not have a statutory status.
Indian Clinical rial raewor
he genesis of GCP surfaces from the aftermath of World War II, when the importance of protecting participants in clinical research was recognised and the first code addressing the ethical conduct of biomedical research, the uremburg Code, 1947 was released. In fact, the Declaration of Helsinki was developed using principles of the uremburg Code and the Declaration of Geneva. GCP is now considered the international ethical and quality standard for the design, recording, performance, monitoring, auditing, recording, conduct and reporting of clinical trials that involve participation of human subjects. 3 Internationally, the International Conference on Harmonization (ICH) GCP guideline is being revised to keep pace with the scale and complexity of clinical trials. he primary responsibility of maintaining GCP
he Indian clinical trial set-up is mainly governed by: (a) regulations of Schedule Y along with rules 122A, 122, 122D, 122DA, 122DAC and 122E of the Drugs and Cosmetics Act, 1940 (D&C Act); (b) the Ethical Guidelines for iomedical Research on Human Subjects prescribed by the Indian Council of Medical Research; and (c) the Indian Good Clinical Practice (GCP) guidelines. Per law, it is mandatory that all clinical research that falls under the ambit of Schedule Y complies with the necessary requirements, which inter -alia comprises of formats for clinical trial protocols, informed consent forms, responsibilities of the sponsors, investigators and monitors, templates for independent ethics committee (IEC) approval and format for reporting of
GCP Genesis GCP is a standard for clinical studies or trials that encompasses the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies. It ensures that the studies are implemented and reported in such a manner that there is public assurance that the data from clinical trials is credible, accurate and that the rights, integrity and confidentiality of the subjects are protected. he guidelines seek to establish two cardinal principles: (i) protection of the rights of human subjects; and (ii) authenticity of biomedical data generated. he Indian GCP guidelines have been prescribed by the Central Drugs Standard Control Organisation (CDSCO).
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lies on the sponsors, clinical investigators, ethics committees, institutional review boards, contract research organizations, monitors etc. Regulatory Concerns and Changes Currently, to conduct a clinical trial in India one needs: (a) permission of the Drugs Controller General, India and permission of the new drug advisory committees consisting of sector experts; (b) approval from ethics committee; and (c) mandatory registration on the ICMR maintained website www.ctri.in. Following the judgment of the Supreme Court in Swasthya Adhikaar Manch 4 and in response to the 59 th report of the Parliamentary Standing Committee, the Indian regulators passed several amendments to Schedule Y of the D&C Act, many of which lead to immediate fall out of pharmaceutical industry sponsored clinical trials. While mandatory registration of clinical research organisations 5 is a welcome change, the other amendments like structure of the ethics committee, tougher site selection process, audio video recording of informed consent process and the reporting deadlines for serious adverse events were taken as adverse. Amongst the various steps being taken by the government to give an impetus to the clinical trial industry after the slowdown in 2010-2013, the government has brought a fresh slew of reforms including: (a) CDSCO's recently launched new tool (called SUGAM) for online applications as part of efforts to increase accountability, transparency, and efficiency of processing applications with speed 6; (b) taking away the restriction of only 3 trials per principal investigator; and (c) removing the restriction of minimum 50 bedded hospital requirement for conducting clinical trials, which now can instead be decided by the ethics committee.
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Some of the issues faced by this industry, which if dealt, with will lead to greater protection and participation under a clinical trial, include providing protection to, and ensuring a fair treatment for, the clinical trial subjects, particularly, the vulnerable class such as illiterate and poor people and fair compensation and insurance structure. Differences between ICH-GCP and Indian GCP Indian GCP is largely based on the ICH-GCP, has certain areas stricter than the ICH-GCP and endorses all the internationally endorsed principles. Certain Indian GCP requirements are more progressive and stringent as compared to those formulated at the international level, for example registration of IEC 7, clinical trials with the registry and usage of language to encourage participants diverse cultural and economic backgrounds 8. Conclusion Good clinical practices are important for quality products, safety of patients and also general good health of the industry. Although, lot needs to be done, with the recent amendments and progressive changes to the conduct of clinical trial process, the government is taking the right steps in promoting and encouraging clinical trials in India. India is primarily known for its generics capability and with the right changes, India has the capability, and can do well, as a drug innovator also.
2. G o g t a y N J , R a v i R , T h a t t e U M . Regulatory requirements for clinical trials in India: What academicians need to know. Indian J Anaesth 2017;61:192-9. 3. G o o d C l i n i c a l P r a c t i c e R e s e a r c h Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators: Second Article in a Series. Journal of Oncology Practice. 2008;4(5):233235. doi:10.1200/JOP.0854601. 4. Swasthya Adhikar Manch And Anr. v Union of India (UOI) and Others (WP(C)No. 33/2012 with WP(C)No. 79/2012) 5. B a b u G . C e n t r e r e l e a s e s d r a f t rule for chedule Y-1 mandating registration of CROs? Pharmabiz.com, Mumbai. 2009. Jul 11. Available from: http://pharmabiz.com/NewsDetails. aspx?aid=51414&sid=2 . 6. Notice by CDSCO; 05 October 2016 (CDSCO/IT/2015-(48)). Available from: http://www.cdsco.nic.in/writereaddata/ notice%20-dated05-10-2016.pdf. 7. B u r t T , S h a r m a P , D h i l l o n S , Manchanda M, Mittal S, Trehan N. Clinical Research Environment in India: Challenges and Proposed Solutions. Journal of clinical research & bioethics. 2014;5(6):1-8. doi:10.4172/2155-9627.1000201. 8. P a n d e y A , A g g a r w a l A R , M a u l i k M, Gupta J, Juneja A, et al. The upgraded Clinical Trials Registry India: a summary of changes. Indian J Med Ethics. 2011;8:186
References 1. B u r t T , S h a r m a P , D h i l l o n S , Manchanda M, Mittal S, Trehan N. Clinical Research Environment in India: Challenges and Proposed Solutions. Journal of clinical research & bioethics. 2014;5(6):1-8. doi:10.4172/2155-9627.1000201.
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June 2017 33
Market Research
Pharma’s 4Q Debacle - Amey Chalke and Siddhant Mansukhani, HDFC Securities Institutional Research
4
QFY17 was a disastrous quarter for many Pharma majors, with most of them missing guidance by a wide margin. Although there are arguments that this pain is structural (hence more permanent) in nature, with high pricing erosion in generics products, we believe otherwise. While there can be no denying the shift in the mechanics of the US business (which we have highlighted in our note: Truth vs Hype), in our opinion, these issues are transitory in nature and were in the spotlight owing to the absence of crucial capacities for many of these companies. We believe that once the Indian Pharma companies come up the curve in terms of regulatory compliance, their progress in more lucrative spaces such as complex generics and specialty will be unencumbered, and the sector multiple is likely to re-rate. Quality of pipeline remains crucial. •
Price erosion has been everpresent in the generics business model. However, it has historically always been offset by new product launches. Companies like SUNP, DRRD and CDH faced US FDA bans
• •
•
on the very facilities that were meant to be their key growth drivers. Others such as ARBP and TRP faced capacity constraints. FY17 ended up being a confluence of negatives, especially for SUNP, DRRD and CDH. These companies did not receive significant product approvals, and hence had limited power to deal with the base business erosion. This resulted in a decline in the US business and erosion of margins. Going ahead, once the companies have their facilities cleared and capacities available, new product launches will quickly follow and the US business will bounce back. We also believe that post the warning letters, companies have significantly de-risked their business by spreading their filings across various facilities. A case in point is CDH, which has already received 10 approvals YTD in CY17 vs 9 in the whole of CY16. The first approval from its Moraiya facility has also been received in Jun-17. While CDH's Moraiya facility was
•
•
cleared in the re- inspection, SUNP and DRRD received serious observations which will need more time to be resolved. We do not expect these clearances to happen in the near-term, and hence the outlook for FY18 is soft for SUNP and DRRD. However, both companies have strong R&D capabilities, and we believe that there are enough opportunities in their respective pipelines to revitalise the businesses post FY18E. We prefer companies with a strong growth outlook in the US business in FY18E and no current regulatory overhang � CDH, LPC, (Ex-gGlumetza and gFortamet) and GNP. Companies focussed on the domestic market like ALKEM, TRP and CIPLA will experience some difficulties in 1HFY18, owing to the impending GST implementation and resultant channel disruption. Hence, we believe that 2HFY18 will provide a good entry point for : SECTOR UPDATE these PHARMA stocks. Prefer ALKEM.
Comparison To Bloomberg Estimates beat
ev. e overall nt in all es,
%+) US base NP and
CDH terms
Sun Pharma Lupin Limited Cadila Cipla Dr. Reddy's Labs Aurobindo Alkem Labs Glenmark Pharma Torrent Pharma Divi's Labs Alembic Pharma Granules India
Net Sales (Rs bn) EBITDA (Rs bn) EBITDA Margin (%) APAT (Rs bn) 4QFY17 4QFY17 4QFY17 4QFY17 4QFY17 4QFY17 Var 4QFY17 4QFY17 Var Var (%) Var (%) Actual Est. Actual Est. Actual Est. (bps) Actual Est. (%) 68.3 78.9 (13.5) 15.5 23.5 (34.1) 22.7 29.8 (711) 12.2 15.3 (20.0) 42.5 45.4 (6.3) 7.8 12.1 (35.4) 18.4 26.7 (828) 3.8 6.5 (41.5) 24.2 26.2 (7.7) 4.9 5.3 (7.5) 20.3 20.2 4 3.9 3.7 4.2 34.9 38.5 (9.4) 5.1 6.9 (26.6) 14.5 17.9 (340) -0.6 3.3 (118.7) 35.5 37.1 (4.2) 5.8 8.3 (29.7) 16.4 22.4 (596) 3.1 4.3 (26.5) 36.0 40.1 (10.2) 7.2 9.3 (22.4) 20.0 23.2 (317) 5.1 5.9 (12.7) 12.5 14.0 (10.6) 1.5 2.5 (40.3) 11.9 17.9 (593) 1.4 1.9 (27.9) 24.2 31.3 (22.5) 5.0 11.1 (55.3) 20.5 35.5 (1,500) 0.2 6.9 (96.9) 13.8 15.2 (9.1) 3.0 3.5 (15.7) 21.4 23.0 (166) 2.1 2.3 (10.4) 10.7 11.9 (10.4) 3.9 4.3 (9.1) 36.7 36.1 53 2.9 3.3 (12.6) 7.4 8.6 (14.2) 1.3 1.7 (20.8) 18.2 19.8 (153) 0.9 1.2 (19.1) 3.6 3.8 (6.5) 0.8 0.7 3.3 21.8 19.7 206 0.5 0.4 7.7
Source: Bloomberg, HDFC sec Inst Research
34 June 2017
Pharma Bio World
Market Research 4QFY17: Company-Wise Snapshot
Company
4QFY17
Management commentary ••
Sun Pharma
Rev. YoY %: (6.8) EBITDA M: 21.7% PAT YoY %: (13.6)
•• •• •• •• ••
Lupin
Rev. YoY %: 2.0 EBITDA M: 18.4% PAT YoY %: (34.6)
•• •• •• •• ••
Cadila
Rev. YoY %: 6.2 EBITDA M: 19.8% PAT YoY %: (32.1)
••
•• Rev. YoY %: •• (5.4) EBITDA M: 16.4 •• Dr. Reddy's % Labs PAT YoY %: •• 9 318.
••
Cipla
Rev. YoY %: 8.1 EBITDA M: 14.1 PAT YoY %: N/A (PY loss)
Pharma Bio World
••
Our view
Single-digit top-line decline in FY18E. Want to accelerate ANDA approvals. Taro: 4Q is the new reality and see similar challenges in FY18E. No updates on the DoJ case. Will remain on the lookout for inorganic growth opportunities.
••
Muted top-line growth in FY18E and double-digit growth in FY19E. EBITDA margins to be 26-28% in FY18E. US price erosion is in the high single- digit range. Will focus on operating efficiencies going forward, in order to boost profitability. Indore 483 observations are not serious.
••
US base biz erosion was US$ 8-10mn sequentially (high singledigit %). Moraiya warning letter expected to be lifted soon, post which there will be 30-40 approvals in FY18, including two transdermals. 6 approvals are in the US$ 30-40mn size range (includes Lialda). Good growth visibility in FY18E.
•• •• •• ••
10+ launches in the US in FY18 (fromearlier guidance of 15+). Price erosion in the US is high single-digit to low double-digit. gCopaxone TAD is in 6 months.
•• •• ••
•• •• •• ••
•• •• ••
•• Near double-digit revenue growth in FY18 Expect 10-11 • • ANDA launches. Visibility on at least 1 important launch every quarter 2QFY18 •• onwards. R&D in FY18E to be 8-9% of sales. Capital allocation strategy has changed - less focus on in-house biosims and • • greater impetus on specialty and respiratory.
Margin headwinds to continue, with steeper price erosion in the Taro business, lack of approvals from Halol and increased spend on specialty. We believe that this quarter more or less forms a new base for Sun Pharma. While there is likely to be some recovery in margins, scaling up to historical levels of 3334% will be a significant challenge. Downgraded to NEUTRAL in 4QFY17. Adjusted for the legal provision, forex losses and the surprise on R&D costs, the EBITDA margin was 28.8%, which is extremely healthy. When compared to peers, delivered strong growth in the domestic market. FY18 outlook: On the revenue front, we believe that 1HFY18 will be modest, as sales from gGlumetza will continue to erode. However, 2HFY18 onwards, we should see some uptick in the US biz, on the back of new product launches and a scale up in controlled substances and topicals. Maintain BUY. As expected, 4QFY17 numbers were weak. FY17 formed a low base on which CDH should report strong growth. FY18 outlook: Very strong, on the back of the Moraiya reinspecition. Approvals will begin to flood in once the warning letter is lifted, which we expect is imminent. Upgraded to BUY in 4QFY17.
On the revenue front, we believe that4QFY17 would be the base to judge DRRD, going forward. With the overhang of the Duvada warning letter unlikely to go away any time soon, visibility on launches in FY18 is low. gCopaxone launch, if it happens, could be a strong trigger for the stock to move up from here (still 6 months away). Maintain NEUTRAL.
There were various one-offs in the quarter, such as an Rs 570mn provision for losses on certain assets, and a ~Rs 2.1bn impairment charge for InvaGen. FY18 outlook: On the now high base (InvaGen included), it will be a challenge to maintain high double-digit growth in FY18 in the US. Maintain NEUTRAL.
June 2017 35
Market Research 4QFY17: Company-Wise Snapshot
Company
4QFY17
Management commentary ••
Rev. YoY %: (2.7) EBITDA M: Aurobindo 20% PAT YoY %: (4.7)
•• •• •• ••
••
Alkem
Rev. YoY %: 9.0 EBITDA M: 11.9% PAT YoY %: 58.1
•• ••
••
Torrent Pharma
Rev. YoY %: (4.6) EBITDA M: 20.6% PAT YoY %: (27.5)
••
••
•• ••
Glenmark
Rev. YoY %: 11.5 EBITDA M: 20.5% PAT YoY %: 88.9
•• ••
••
36 June 2017
Our view
Believes ARBP is uniquely •• placed to combat price erosion, as dependence on any single product is minimal. Base business erosion is 7-8%. Injectables to maintain growth •• momentum in the US. Status quo on DoJ case. Limited business with Walmart, •• hence minimal impact of pending merger. Sees mid-to-higher single- •• digit price erosion in general (not for ALKEM specifically). 1QFY18 expected to be soft, •• owing to GST de-stocking Believes margin expansion will be a challenge in FY18E, owing to various headwinds GST, OTC investment and •• higher R&D The US base business erosion is in high singledigits. Looking to launch 8-10 products in the US market in FY18, some of which will be "significant". Important lessons learned from the failure to launch approvals in hand, will be more capable in this regard going forward. Guided for 12-15% top-line growth in FY18 (despite gZetia in the base). gZetia sales will be towards the lower end of the initial guidance of US$ 200-250mn. 4QFY17 base business price erosion was ~15%. Expect 1015% in FY18. 10 to 15 product launches in the US market in FY18. 1QFY18 should be strong, with growth returning to the business FY18 EBITDA margin will sustain at current levels. R&D guidance remains at 11-12%.
••
••
••
••
••
•• ••
While ARBP is now evolving into a complex generics player, this transformation still has some way to go. Also, being a pure generics player, ARBP's business model remains very susceptible to the buyer consolidation and competitive pressures in the US market. FY18 outlook: Expect higher single-digit growth in FY18E. Margins expansion will be limited due to increasing R&D investments. Maintain BUY, as valuations are extremely attractive. The fourth quarter is a seasonally weak quarter for ALKEM, and 4QFY17 was no different. With the added stress of GST disruption, the 9% top-line growth was reasonable FY18 outlook: 1QFY18 is expected to be soft, owning to the GST de-stocking. However, the US business should continue to witness good growth, with the Lidocaine launch in 1QFY18. Expect profitability to be under pressure, with the increased R&D investments and higher effective tax rate for the year Maintain NEUTRAL (see a good entry point after GST disruption). 4QFY17 is more or less a fair representation of TRP's top-line (putting aside some domestic business pressure on account of GST), and we believe that this will be the base to assess growth, going forward. TRP's pipeline build-up programme is likely to gain momentum in FY18/FY19. TRP's focus remains on filing more products in derma, oncology and ophthalmology in the US market. With 10 to 12 launches every year from FY18, the US base business (ex- Abilify) is likely to expand faster. Maintain BUY.
4QFY17 was a one-off quarter with significantly higher R&D spends, write-off of some older intangibles and the Venezuel cash adjustment. Net debt too was optically higher, with the Venezuela cash adjustment of ~Rs3.25bn. FY18 outlook: GNP received only 1 approval in 2HFY17. The approval pace has now picked up, and the growth momentum is likely to sustain, aided by the 3-4 derma launches in FY18. The specialty story will also begin to play out in 2HFY18. Maintain BUY.
Pharma Bio World
Market Research 4QFY17: Company-Wise Snapshot
Company
4QFY17
Management commentary ••
Divi's Labs
Rev. YoY %: (3.3) EBITDA M: 36.7% PAT YoY %: (10.9)
•• •• •• •• •• •• ••
••
Alembic Pharma
Rev. YoY %: 17.9 EBITDA M: 18.2% PAT YoY %: 2.2
•• •• ••
••
Single-digit growth on the top-line in FY18. Margins to be maintained at FY17 levels. Capacity expansion at Unit I and II is underway, some of which will be utilised in FY18. Remediation measures undertaken at Unit II have been implemented in Unit I as well. Work on the new facility will only start in 2HFY18.
Our view ••
••
•• •• ••
FY17 fell short of launch targets. Expect to launch 8 to 10 products •• in the US in FY18. Filings will increase in FY18 (2030), as will R&D costs. 4 facilities coming on stream in •• FY18. Generic generic prescription order does not stop the use of brands. Industry associations are talking to the govt. on this. Substantial price cut in Azithral •• had a significant impact.
••
Granules India
Rev. YoY %: (4.2) EBITDA M: 21.8% PAT YoY %: 38.5
••
••
FY18-20 will be revolutionary •• years in the history of Granules India with all key investments playing out. •• The management expects ~20% top- line and ~25% profit growth in FY18. ••
Reported a minor revenue decline and maintained margins in 4Q. We believe that the full impact of the import alert will be seen in 1QFY18, as it came into effect towards the end of Mar-17. FY18 outlook: We have conservatively assumed a slight decline on the top-line in FY18, as well as ~175bps margin contraction in order to factor in the possible remediation costs. The key monitorable for the year would be the outcome of the probable Unit I inspection. Largely contrary to the current trend, management commentary was encouraging and the business represents good value at current prices. Maintain BUY.
We believe that 4QFY17 is a reasonable base to judge ALPM's business going forward, with very low gAbilify sales reported during the quarter. There were also no one-offs in the P&L. FY18 outlook: Is likely to be the final year of ALPM's investment phase. Margins expansion will be limited, as R&D costs rise and staffing for the new facilities gets completed. However, top-line growth should start to show in 2HFY18, as some of ALPM's filings from FY17 begin to fructify. Maintain BUY.
We believe that GRAN will see a strong spurt of growth starting 2HFY18, on the back of expected ANDA approvals for the US market, core business capacity expansion kicking in and a continued ramp- up in the Omnichem JV. However, the full impact of these forces is likely to be visible only from FY19E. Overall, we expect GRAN to report ~20% revenue CAGR, ~23% EBITDA CAGR and ~26% PAT CAGR over FY17-19E. Maintain BUY.
The impact of regulatory issues is evident, with approvals taking a big hit post the inspections of these key facilities Pharma Bio World
June 2017 37
PHARMA : SECTOR UPDATE
Previous FY18 New FY18 Expectation Expectation* Previous FY18 New FY18 SUNPCompany 25,545 (34.7) (25.3) 147,263 115,517 4QFY17 YoY (%) QoQ (%) Expectation Expectation* LPC 19,007 (13.2) (12.6) 87,014 78,999 SUNP 25,545 (34.7) (25.3) 147,263 115,517 CDH 9,851 2.5 11.1 49,655 48,217 LPC 19,007 (13.2) (12.6) 87,014 78,999 DRRD 15,349 (19.0) (7.5) 72,648 68,689 CDH 9,851 2.5 11.1 49,655 48,217 CIPLA 6,460 32.9 (2.4) 33,366 31,333 DRRD 15,349 (19.0) (7.5) 72,648 68,689 ARBP 16,432 0.6 (5.8) 80,142 73,893 CIPLA 6,460 32.9 (2.4) 33,366 31,333 ALKEM 2,907 19.4 (14.1) 16,163 15,326 ARBP 16,432 0.6 (5.8) 80,142 73,893 TRP 2,810 (45.3) (9.4) 17,375 15,033 ALKEM 2,907 19.4 (14.1) 16,163 15,326 GNP 10,004 53.4 (18.7) 43,941 43,118 TRP 2,810 (45.3) (9.4) 17,375 15,033 ALPM 1,902 28.6 (9.1) 13,155 10,286 GNP HDFC Sec Inst Research 10,004 53.4 (18.7) 43,941 43,118 Source: *The now lower base of FY17 and the appreciation of the28.6 rupee have played a significant role in reduced ALPM 1,902 (9.1) 13,155 revenue expectations. 10,286 Company Decline Underlines 4QFY17 US Market YoY (%) Sequential Stress
QoQ (%)
Change (%) (21.6) Change (%) (9.2) (21.6) (2.9) (9.2) (5.4) (2.9) (6.1) (5.4) (7.8) (6.1) (5.2) (7.8) (13.5) (5.2) (1.9) (13.5) (21.8) (1.9) (21.8)
Source: HDFC Sec Inst Research
*The now lowerGrowth base of FY17 and theInappreciation of the rupee have played a significant role inDRRD reduced revenue expectations. US Revenue: Returns FY19 SUNP, CDH And Approval Rate (CY) YoY Growth (%)
Cadila
49.8 US Sales (Rs bn) 44.9
Source: Company, HDFC sec Inst Research
2017*
2017*
2016
2016
2015
2015
2014
2014
2013
2013
2012
2012
2011
2011
2010
2010
0
2007
Source: Company, HDFC sec Inst Research
FY19E
5
FY19E
FY15
FY15
408
FY18E
FY14
FY14
321
515 010
FY18E
FY13
222
FY13
148
FY12
107
5.3 3.9 15.6 515 535 618 5.3 3.9 489 515 535 618
489
FY17
408
FY17
321
FY16
222
FY16
148
FY12
20.0 107
Dr Reddy's Labs
1525 1020
15.6
2009
20.0
2009
27.0
Sun Pharma
2535 2030
27.0
30.1
Dr Reddy's Labs
35 3040
44.9
38.3
Cadila
40
2008
30.1
49.8
YoY Growth (%)
2008
38.3
Sun Pharma
SUNP, CDH And DRRD Approval Rate (CY)
2007
US Sales (Rs bn)
US Revenue: Growth Returns In FY19
FY11
atory th latory big hit ith of these big hit s of these
PHARMA : SECTOR UPDATE
US Performance In 4QFY17 Sequential Decline Underlines US Market Stress US Performance In 4QFY17
FY11
ked our e facility aked andour me facility arly FY19 P and early FY19
Market Research
Source: Company, HDFC sec Inst Research * DRRD’s Duuvada facility was inspected between Feb and Mar-15. **CDH’s facility was between Aug and Sep-15. Source:Moraiya Company, HDFC secinspected Inst Research *** SUNP’s Halol facility was inspected in * DRRD’s Duuvada facility was inspectedSep-14. between Feb and Mar-15.
**CDH’s Moraiya facility was inspected between Aug and Sep-15. *** SUNP’s Halol facility was inspected in Sep-14. Page | 9
Page | 9
•
Not a sinlgle company beat estimates in 4QFY17
•
A big miss on the US rev. expectations led to the overall top-line disappointment in all USfocussed companies,except CDH
•
Significant erosion (10%+) was witnessed in the US base businesses of SUNP, GNP and DRRD
•
Only GRAN, DIVI and CDH were largely in-line in terms of EBITDA margins
38 June 2017
Pharma Bio World
PHARMA : SECTOR UPDATE
PHARMA : SECTOR UPDATE Market Research
Domestic Performance In 4QFY17 Domestic Performance In 4QFY17 GST Disruption Causes 4Q Jitters GST Disruption Causes 4Q JittersPrevious FY18 4QFY17 YoY (%) 4QFY17 YoY (%) 19,164 6.1 19,164 6.1 8,788 8,788
13.8 13.8
CDH CDH DRRD DRRD CIPLA CIPLA
8,402 8,402 5,711 5,711 11,970 11,970
8.9 8.9 8.4 8.4 (4.1) (4.1)
ALKEM ALKEM
8,563 8,563
7.0 7.0
TRPTRP GNPGNP ALPM ALPM
4,670 4,670 5,769 5,769 2,860 2,860
3.53.5 6.96.9 6.36.3
Source: HDFC Sec Sec InstInst Research Source: HDFC Research
Coverage Domestic Rev: In-Line With IPM Coverage Domestic Rev: In-Line With IPMGrowth Growth Domestic Rev.Rev. (Rs(Rs bn)bn) Domestic
GST In FY18 FY18 GSTTo ToImpact ImpactAcute-Heavy Acute-Heavy Companies Companies In
YoYYoY Growth (%) Growth (%)
Acute Acute(%) (%)
28.4 28.4
12.3 12.3
12.512.5
9.79.7
60 60
12.8 12.2 12.8 12.2
40 40
TRP TRP
LPC LPC
SUNP SUNP
GNP GNP
CIPLA CIPLA
CDH CDH
DRRD DRRD
FY19E FY19E
FY18E FY18E
FY17 FY17
FY16 FY16
FY15* FY15*
FY14 FY14
FY12 FY13 FY13
FY11 FY12
Source: Company, HDFC sec Inst Research Source: Company, HDFC sec Inst Research significant jump is largely on account of the acquisition of *The*The significant jump is largely on account of the acquisition of Ranbaxy by Sun Pharma Ranbaxy by Sun Pharma
ALPM ALPM
20 20
00 FY11
Chronic(%) (%) Chronic
80 80
17.217.216.416.4 15.315.3
Source: Company, HDFC sec Inst Research Source: Company, HDFC sec Inst Research
PHARMA : SECTOR UPDATE Page | 10 Page | 10
Valuation Matrix
Sun Pharma Lupin Cadila* Dr Reddy's Cipla Aurobindo Alkem Labs Torrent Pharma Glenmark Divis Labs Alembic Pharma Granules India
Sub-chronic Sub-chronic (%)
100 100
ALKEM ALKEM
LPC LPC
New FY18 Change Other comments Previous FY18 Expectation New FY18 Change Expectation (%) Other comments Expectation Expectation (%) 90,869 86,286 (5.0) 90,869 86,286 (5.0) While still below expectations, LPC was the only While stillinbelow expectations, LPCdouble-digit was the only 44,070 43,499 (1.3) company our coverage to show 44,070 43,499 (1.3) growth company in our coverage to show double-digit in 4QFY17. 36,639 36,539 (0.3) growth in 4QFY17. 36,639 36,539 (0.3) 27,058 25,675 (5.1) 27,058 25,675 (5.1) 65,310 60,830 (6.9) CIPLA’s performance was particularly poor. 65,310 60,830 (6.9) CIPLA’s performance was particularly poor. Considering the seasonality in ALKEM’s domestic Considering the seasonality in ALKEM’s domestic portfolio and the GST impact, 7% growth was 49,160 48,075 (2.2) portfolio and the GST impact, 7% growth was 49,160 48,075 (2.2) reasonable. Expect GST disruption to play a reasonable. Expect GST disruption to play a major strong for forALKEM. ALKEM. majorrole roleas as 1H 1H is is seasonally seasonally strong 39,516 37,501 (5.1) 39,516 37,501 (5.1) 26,682 26,148 (2.0) 26,682 26,148 (2.0) 14,671 14,321 (2.4) 14,671 14,321 (2.4)
IPM IPM
Company Company SUNP SUNP
Mcap (Rs bn)
CMP (Rs/sh)
Reco
TP
1,239 525 507 434 426 347 236 205 183 164 101 32
515 1,167 494 2,555 530 593 1,977 1,213 650 618 537 141
NEU BUY BUY NEU NEU BUY NEU BUY BUY BUY BUY BUY
650 1,800 550 2,685 495 740 2,050 1,525 1,100 705 675 190
Adj EPS (Rs/sh) P/E (x) RoE (%) FY17P FY18E FY19E FY17P FY18E FY19E FY17P FY18E FY19E 26.0 22.6 30.5 19.8 22.8 16.9 17.9 13.9 16.4 59.4 62.6 81.9 19.7 18.7 14.2 21.8 19.3 21.3 14.5 17.5 22.8 34.0 28.3 21.7 23.5 23.4 25.3 72.7 115.2 147.3 35.2 22.2 17.3 9.5 14.5 16.3 15.7 19.4 24.7 33.8 27.3 21.5 10.5 11.8 13.5 39.3 41.7 46.4 15.1 14.2 12.8 27.6 23.2 21.0 74.6 74.9 97.2 26.5 26.4 20.3 21.9 18.6 20.7 51.2 56.7 76.2 23.7 21.4 15.9 22.1 20.3 23.1 29.6 39.4 53.6 22.0 16.5 12.1 18.1 19.9 21.7 39.9 37.5 44.0 15.5 16.5 14.0 22.0 17.5 18.4 21.4 25.7 33.8 25.1 20.9 15.9 23.0 23.2 25.1 7.2 8.3 11.7 19.6 17.0 12.0 21.0 19.3 22.8
Source: HDFC sec Inst Research *We have raised our earnings multiple for CDH to 24x from 22x, owing to the number of near-term triggers for the stock. We arrive at a revised TP of Rs 550/sh. June 2017 39 Pharma Bio World
marketing initiative
Advanced service functions for machinery and equipment B&R further expands mapp Technology framework B&R continues to expand its mapp Technology software framework. The new mapp Tweet function allows a machine application to send information via text message or email. The increased intelligence boosts machine availability Automated text messaging
The new software block mapp Tweet allows a machine application to send text messages and emails triggered by specific events. Set up with just a few clicks, mapp Tweet can easily be connected to other mapp components. This enables the mapp AlarmX component, for example, to automatically notify a maintenance technician when an alarm requires immediate action. mapp Tweet can supplement the message with addi-tional information, such as troubleshooting instructions that allow the technician to quickly and efficiently resolve the cause of the alarm. This is
an effective way to achieve a targeted reduction in machine down-time.
automatic notifications that enable advanced maintenance concepts.
Fast maintenance response times
About B&R
If the service technician isn't on site, they can quickly connect via B&R's remote maintenance solution in order to run diagnostics, adjust parameters and resolve the error-all in a matter of moments. The solution utilizes the latest IT and security standards and allows for significant savings with low investment costs.
B&R is an innovative automation company with headquarters in Austria and offices all around the world. As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With industrial fieldbus communication standards like POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations.
B&R continues to expand its mapp Technology software framework. Functions are now available for sending
For details Contact : B&R Industrial Automation
Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com 40 ď‚ƒJune 2017
Pharma Bio World
marketing initiative
Boost productivity with anti-sloshing Transport liquids faster without spills With B&R’s industrial transport system, it is now possible to transport liquids quickly with no spills. SuperTrak is the only system on the market to offer anti-sloshing technology. This technology suppresses the formation of oscillations on free surfaces to prevent liquids from spilling over container edges during transport. No spills from open containers
The term slosh is used to describe the behavior of liquids in moving containers. Specially designed move-ment profiles prevent the development of positive feedback loops on the surface of the liquid so that it remains calm during transport. This minimizes downtime and increases productivity when handling open containers. Higher production speeds
Minimizing oscillations on the surface of liquids is particularly important in
the packaging industry. The better you are able to control sloshing, the faster the products can be transported. B&R's sophisticated anti-sloshing technology also prevents the formation of air bubbles and foam. The downtime otherwise required to allow the liquid to settle is reduced drastically or eliminated entirely for a substantial improvement in packaging line productivity. As the only system on the market, SuperTrak offers anti-sloshing technology that suppresses the formation of surface oscillations to prevent liquids from spilling during transport.
About B&R
B&R is an innovative automation company with headquarters in Austria and offices all around the world. As a global leader in industrial automation, B&R combines stateof-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With industrial fieldbus communication standards like POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations.
For details Contact : B&R Industrial Automation
Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com Pharma Bio World
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Corning in India and BharatNet, Corning will continue adopted by leading Indian customers to innovate and provide future- for various applications. proof solutions in India'soptical communications space. Corning Life Sciences offers a comprehensive range of innovative, Corning'smaterials and process high-quality labware products and expertise has contributed to the solutions for life science research and campaign for clean air for more than bio production. Corning provides the 25 years in India. As an inventor of world'smost comprehensive line of cellular ceramic substrates and filters drug discovery tools to support Indian for emissions-control products, Corning biotechnology researchers in their Corning entered the India market in has been a dedicated partner to the quest to minimize the time and cost late 1980s to produce cathode ray Indian automotive industry, providing being spent on the development of emissions control new medicines. With India'spopulation tube (CRT) glass for the TV industry. cutting-edge This local production of CRT TV technology. Indian'svehicle market expected to reach 1.4 billion in glass supported the advancement of growth, coupled with tighter emission 2022 (per the 2015 UN Report on affordable TV ownership across the regulations such as India'sClean Air World Population), this growing region. Corning then established a legislation is driving the increased population demands not only large liaison office in India in 1988. Since then, demand for high-quality emission scale production of vaccines but also Corning has been actively participating products. Corning'scommitment to research for newer vaccines relevant in India'sdevelopment, working with clean air solutions continues through a to India. Corning'sbioprocessing tools local expertise to develop and apply global network of service, engineering, are already helping Indian biopharma Corning'sbreakthrough technologies and manufacturing facilities that provide companies develop and produce that significantly improve people'slives. quality products, market understanding, vaccines. The acquisition of the BD Today, Corning'sinvestments in India and reliable product supply to Indian (Becton Dickinson) Discovery Labware business in 2012 has expanded align well with emerging market trends customers. the Corning Life Sciences product in the region. From cover glass for consumer portfolio and enhanced its access to to microlithography an extensive dealer network to serve Corning'sOptical Communications electronics, business, offering optical fibre, cable solutions for the semiconductor customers in India. and connectivity solutions, has industry and many applications in played a key role in India'sgrowing between, Corning Specialty Materials Corning is also looking for new business telecommunications market. From develops customer-driven solutions for opportunities for other product lines, supporting India'sfirst optical fibre a wide variety of materials and optics including its Advanced-Flow TM reactors deployments in the 1980s, to currently challenges. Corning has been supplying and MASTERPIX TM. taking enterprise network solutions to high-quality eyewear lenses to the TM data centres, Corning continues to play Indian market for more than 25 years, Corning Advanced-Flow reactors are a strong role in connecting India'speople. with Corning'sophthalmic business specially designed for the seamless In 2012, with its investment of over serving as the company'slargest transition from lab feasibility to $100 million, Corning established a business in the region prior to the process development and industrialstate-of-art optical fibre manufacturing opening the Pune optical fibre plant. In scale production of chemicals for facility in Chakan, Pune which further May 2014, Corning introduced tough the pharmaceutical, specialty and confirms Corning'scommitment to and damage-resistant Gorilla ÂŽ Glass for fine chemical industries. Corning India'sconnected future. As the Indian mobile phone applications to the India established a laboratory for Corning Government invests in forward- market. Since then, Corning'sinnovative Advanced-Flow reactors in Pune in looking initiatives like Smart Cities and durable Gorilla Glass is being collaboration with Hikal Ltd. This Corning Incorporated (NYSE: GLW), founded in 1851, and headquartered in Corning, New York, USA is one of the world'sleading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people'slives.
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marketing initiative lab provides Indian customers with • continuous-flow demonstrations, • experimental trials, and technical supports for Corning AFR technology. • MASTERPIX TM prints photos onto thin, durable, optically clear Corning® Gorilla® Glass, which has been used as a cover glass on 4.5 billion electronic devices around the world. The same tough, damage-resistant glass that helps protect phones and tablets is now available to help preserve people'smost cherished moments. Across the company'sbusiness segments, Corning continues to bring life-changing innovations powered by specialty glass and ceramics to India'smarkets. As of today, Corning operations in India include:
business
•
Corning India office, Gurgaon
•
Corning Optical Communications Plant in Chakan, Pune
•
Corning Research Centre India in Chakan, Pune
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Corning Advanced Flow Reactor Lab, Pune
•
Corning Finolex Optical Fibre Private Limited - V in Chakan, Pune
Employees: Over 00 Products:
Corning'sproducts enable diverse industries such as consumer electronics, telecommunications, transportation, and life sciences. They include: •
Damage-resistant cover smartphones and tablets
•
Precision glass for advanced displays
•
Optical fibre, wireless technologies, and connectivity solutions for high-speed
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glass
for
communications networks Trusted products that accelerate drug discovery and manufacturing Emissions-control products for cars, trucks, and off-road vehicles
INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
Other product lines include image printing on glass; and advanced-flow reactors for chemical processing.
March 2012 l
Vol.10
l
Issue 8 l Price ` 150
www.pharmabioworld.com
` 150
BUDGET SPECIAL
• Corning Life Sciences offers a comprehensive range of innovative, high-quality labware products and solutions for life science research and bio production
• Corning Life Sciences uses its in depth understanding of the pharma sector to develop highquality lab ware products and solutions for life science research and bio production, transforming both, the industry and people's lives
• It specializes in providing the world's most comprehensive line of drug discovery tools to support Indian biotechnology researchers in their quest to minimize the time and cost being spent on the development of new medicines
• With
the growing Indian population, Corning's bioprocessing tools which facilitate mass production helps the Indian biopharma companies develop and produce vaccines to meet that demand
• The acquisition of the BD (Becton Dickinson) Discovery Labware business in 2012 has expanded the Corning Life Sciences product portfolio and enhanced its access to an extensive dealer network to serve customers in India.
PBW Spotlight © India Indian d an Pharma an and nd n d Bio B Biotech otech Industry o ustr ust stry ttrry ry Globalisation © Latest Developments in Pharma Innovation and Technologies © Future Trends of the Industry © Current Indian and International Corporate News © Novice & Updated R & D Strategies © In-Depth Market Research © New Product Launches © Event Alerts and Many More……
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Innovative Vacuum Solutions in Pharmaceutical Industry The Right Solution from Toshniwal Vacuum pumps and systems are common place across a tremendous range of industries. Once the essential principles are understood, the possibilities for application become apparent.
and condensables, then the choices will be limited. Therefore a right solution considering the load of condensable and ultimate vacuum should be struck. System Selection
In order to properly select a vacuum system, the principles of basic vacuum technology To select the best type of system for should be understood. Once the application a particular application, the following is clearly defined, a solution can be found list needs to be considered. Once it is by applying these methods. Since we determined which criteria is the most understand and can relate to atmospheric important from the list, then the vacuum pressure, it is chosen as a reference point. pump that best meets this can be selected. Vacuum is simply a pressure that exists • • Operating cost below atmospheric pressure. • • Solvent recovery • • Effect on process To create a vacuum in a vessel, a vacuum • • Materials of construction producing device needs to remove mass • • Operating range from it. The more mass that is removed, • • Reliability the lower the pressure that exists inside • • Waste generation the vessel. This is why it is important to • • Pollution abatement understand what vacuum is and how to • • Emission reduction select the right type of equipment. It is very • • Maintenance cost important to size vacuum piping correctly • • Ease of cleaning to minimize pressure loss. The greater • • Serviceability the pressure loss, the larger the vacuum • • Purchase price equipment needs to be. Pharmaceutical and Chemical Industry
The type, quantity of gas handled, and the operating pressure, normally defines The pharmaceutical and specialty chemical what vacuum pump can be used. If the industries use vacuum for distillation and gas consists of mainly non-condensable, drying. Various types of dryers are used then most types of pumps can be used. to purify products under vacuum. The If the gas consists of non-condensable chemicals are precisely mixed and then
heat is applied in the dryer to evaporate the excess chemicals. This is done under vacuum for purer end products; reduce the amount of heat energy required for drying, and also to recover any of the solvents evaporated off thereby not affecting thermally sensitive products. Pumps that are reliable and easy to service in the field are the most important for this industry. If an unreliable pump is tried and it fails in the middle of a drying cycle, then the product is not useable and profit is lost.
A typical setup used for this application is: • • Combining mechanical roots blower along with oil lubricated vacuum pump. This kind of setup is used to minimize utility costs, drying cycle time and contamination. A properly designed process condenser between your vacuum process and vacuum producing system will yield significant advantages. A process vacuum condenser can significantly reduce the size of the vacuum producing system, recover for reuse valuable product carried from your process with non-condensable gases, reduce amount of wastes produced by the vacuum system, and lower the operating cost of your process. Matching a vacuum condenser with the vacuum producing equipment is the best way to meet the objectives of your process. Toshniwal manufactures both the process condenser and the vacuum producing equipment. This single-source responsibility provides you with a unitized system matched to your process. For details Contact : Toshniwal Instruments(Madras) Pvt Ltd
267,Kilpauk Garden Road Chennai - 600010 Contact: +91 4426445626 / 8983 Email: sales@toshniwal.net Website : www.toshniwal.net 44 June 2017
Pharma Bio World
press release IIL to Expand its Protozoan Vaccine Portfolio Indian Immunologicals Limited (IIL) has signed MOU with INTA and Littoral Biologics of Argentina for transfer of technology for Bovine Parasitic vaccines in India. Introduction of vaccines against haemoprotozoan infections transmitted by ticks such as Babesiosis and Anaplasmosis will prevent loss in productivity in cattle and immensely benefit dairy farmers. Instituto Nacional de Tecnologia Agropecuaria (INTA), Argentina is Argentinian federal agency in charge of the generation, adaptation and diffusion of technologies. "Ec onomi c los ses due to Babesisosis alone in India are estimated to be about USD 57.2 million", said Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited. He added that "IIL is only vaccine manufacturer in India which is capable of producing effective parasitic vaccines for animals with vast experience in producing vaccine against haemoprotozoan Theileria annulata, since three decades. IIL recently introduced vaccine against Porcine Cysticercosis, a parasitic vaccine for Pigs. This agreement with the Argentinean collaborators will go a long way in uplifting productivity among dairy farmers in India". Dr Manual G Garcia, Director General of Littoral, Dr Nicora Amadeo, President INTA, Dr Cerioni Adolfo Luis, National Coordinator, INTA, Argentina signed the agreement with Indian Immunologicals to transfer technology to produce vaccine against Babesiosis and Anaplasmosis. IIL's Rakshavac-T (Vaccine against Theileria annulata) is the only vaccine against haemoprotozoan infections in India. IIL is set to address this unmet need to control haemoprotozoan diseases transmitted by ticks in India and prevent loss of productivity in cattle
Agilent and Agendia Ink Deal on Molecular Cancer Diagnostics Agilent Technologies Inc and Agendia, Inc jointly announced an agreement to expand their relationship to include the development of an RNASeq kit version of Agendia's currently marketed MammaPrint and BluePrint tests. Pharma Bio World
Agendia's MammaPrint test provides High-Risk or Low-Risk test results to assess the risk of distant metastasis within five years, in breast cancer patients with Stage I or Stage II disease. Agendia's BluePrint test builds on the foundational prognostic precision of MammaPrint, to classify the breast cancer into one of four molecular subtypes. These results help to predict clinical outcomes in women with early-stage breast cancer. Using Agilent's SureSelect target enrichment system, the new RNAseq kit will enable Agendia to develop and perform the MammaPrint and BluePrint tests, as next-generation sequencing assays. This capability will allow the tests to be run in decentralized settings that can utilize a larger footprint of next-generation sequencing instruments, thus affording patients global access to these revolutionary tests. The ability to perform these tests at locations closer to the patients, provides greater accessibility and the potential for more cancer patients to get better individualized treatment management. The initial phase of kit development is expected to be completed in 2017, providing early access to limited markets in Europe.
LifeCell and LifeCodexx to Launch Rapid and Affordable NIPT in India LifeCodexx AG, a pioneer in non-invasive prenatal DNA testing in Europe has announced its partnership with LifeCell - India's leading mother & baby preventive health care provider, to bring PrenaTesT qNIPT testing for the first time to India. The qNIPT technology that detects the presence of fetal trisomy 21 (Down Syndrome) from maternal blood, received CE marking (European Conformity) in December 2016 last year. This certification was obtained after a successful blinded clinical validation of around 1000 samples, demonstrating a 100 per cent credibility of test results obtained from PrenaTest. The novel qNIPT technology clearly demonstrates a significant cost-efficiency and rapid turnaround time compared to other NIPT techniques as it doesn't rely on costly and lengthy sequencing methodology. Down Syndrome (DS), also called Trisomy 21, is a condition where extra genetic material causes delays in a child development both mentally & physically and is one of the most common genetic birth disorders. Down Syndrome (DS) is associated with mild to moderate learning disabilities, growth milestone delays, typical facial features and low muscle tone in early infancy. Though Down syndrome can't be prevented, it can be detected before a child is born. June 2017 45
press release Hester Biosciences to Invest USD 3 Million in its African Subsidiary
DFO 4X Gel contributes about 12.5 per cent to the company's
Hester Biosciences Ltd one of India's leading animal health care companies is planning to invest USD 3 million in its wholly owned subsidiary in Africa. Company's board has approved the investment by way of equity in its wholly owned subsidiary company - Hester Biosciences Africa Limited, Tanzania, with an objective to manufacture animal vaccines and health products in Tanzania, to cater to the whole African continent.
With an efficacy rate of 31 per cent faster than normal gels, DFO 4X Gel is an effective and efficient advanced topical pain relief product containing 'high dose' - Diclofenac Diethylamine 4.64 per cent for 'Direct Acting' deep penetration of the epidermis (outer most layer of the skin), which translates into 'site-specific effect' and instant pain and inflammation relief.
The USD 3 million would be raised through internal a c c ru a l s o f H e s t e r I n d ia . Wh ile t h e p ro je ct siz e has y et to b e f i n a l i z e d , t h e b a la n ce a m o u n t f o r t h e p ro jec t would be ra i s e d t h ro u g h d e b t . More than 80 per cent of the required vaccines are imported in to Africa. Hester sees a very big potential in Africa for animal vaccines. Besides the common diseases, there are Africaspecific diseases, which currently remain unaddressed, thereby causing economical losses to poultry and livestock farmers. Hester has already started the exports of animal vaccines & health products to Africa. Hester's distribution network in Africa not only aims at servicing the organized poultry & livestock farmers, but also the backyard farmers which constitute a big percentage of the animal population in Africa.
overall business.
D.F.O. 4X Gel has superior efficacy without compromising safety in management of: osteoarthritis (oa) pain, acute musculoskeletal pain and inflammation, sprains and strains, sciatica pain, neck pain, back pain, epicondylitis (tennis elbow), carpal tunnel syndrome, knee pain and repetitive sports injury; this efficacy and safety profile makes D.F.O. 4X Gel the most preferred product.
Apollo Partners with RMS REGROW for Cell Therapy Treatment Apollo Hospitals, Asia's largest and most trusted healthcare group, has partnered with RMS REGROW, the first 'Make in India' Company in Cell Therapy Technology, to offer two new Regenerative Medicine Cell Therapy products- Ossron and Chondron for bone and cartilage problems, respectively. The two products will address unmet clinical needs in the orthopaedic market with respect to sports injuries, accidents
Ozone Pharma Introduces DFO 4X Gel Ozone Pharmaceuticals Ltd, one of India's premium Pharmaceutical companies brings its latest topical pain reliever product - DFO 4X Gel that aligns with the brand's
and alternate to hip replacements and knee replacements for a young arthritic knee. In an exclusive tie up between Apollo Hospitals and RMS Regrow, the treatment therapy will be made available across all Apollo Hospitals, Apollo Spectra Hospitals and Apollo clinics in India.
motto of "Pain Eradication" [Pain Elimination]. In sync with offering this new and innovative product, the brand launched a campaign in May, 2017; named, "Dard Baanton Nahi, Mitao", addressing the consumers' common pain points such as injuries, muscle pain, sprains etc. The aim was to create an emotional connect with consumers' agony and the brand. With an objective of 'eradicating' the word pain from consumers' life, the brand received an overwhelming response in the market, through this compelling campaign. Since the launch of this campaign, 70000 units of Ozone D.F.O. 4X Gel have been sold pan India - an incredible feat. It is noteworthy that, currently, 46 June 2017
Ossron and Chondron are the results of a dedicated research team at REGROW. The two products are innovative proprietary and patented technology which has been developed for both the products following the regulatory guidelines. Through several clinical trials and evaluation studies over 8 years, the company has achieved the market authorization for the two cell therapy products. As an exclusive offering, Apollo Hospitals will create a platform for orthopaedic doctors to practice Regenerative Medicine efficiently by conducting live surgical workshops, CME's for doctors and conferences (national and international). Pharma Bio World
press release Boston Scientific Brings the Next Generation Asthma Therapy to India Boston Scientific India announced the availability of Bronchial Thermoplasty (BT) Therapy indicated for the treatment of severe, persistent, drug-resistant asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. The first BT procedure was performed in Royal Care Hospital, Coimbatore. The Bronchial Thermoplasty therapy helps clear the bronchial airways by delivering thermal energy to the smooth muscle. This process decreases constriction in the patient's airways and enables easier breathing, reducing the frequency and severity of asthma attacks for patients with severe, persistent, drugresistant asthma. Bronchial Thermoplasty is performed under moderate sedation on an outpatient basis. The first BT patient is a middle aged woman, who is suffering from severe, persistent, drug-resistant asthma for the past 30 years. She had recurrent asthma attacks and frequent emergency room visits despite her medication regimes. "There are over 18 million estimated asthmatics in the country, for some of whom currently available medication has failed to provide any relief. Our Bronchial Thermoplasty Therapy holds great promise to help address this need gap. We have sufficient evidence that shows Bronchial Thermoplasty is an effective therapeutic option for patients with severe persistent, drugresistant asthma," said Prabal Chakraborty, vice president and managing director, Boston Scientific in India. Dr. Pattabi Raman, Head- Pulmonology Associates, Royal Care Super Specialty Hospital, who performed the first BT procedure said, "This is a ground-breaking solution which may provide a complementary treatment to severe, persistent, drug-resistant asthma patients in the country." This therapy is recognized globally and has been well received in around 20 markets.
Everest Names TCS as Leader and Star Performer in Life Sciences IT Tata Consultancy Services (TCS), a leading global IT services, consulting and business solutions organization, has been recognized as a Leader and Star Performer for Life Sciences IT Application Services by leading advisory and research firm, Everest Group, in its report, 'Life Sciences - IT Application Services Providers PEAK Matrix Assessment 2017.' Everest Group acknowledged TCS' strong foothold in the pharmaceutical Pharma Bio World
and medical devices sector, and a growing business presence with biotechnology firms. The report highlights TCS' strong focus on development of next-generation solutions, incorporating Artificial Intelligence, IoT and platform-driven approaches for areas such as drug development and patient engagement. Everest Group analyzed the capabilities of 22 service providers on the Everest Group PEAK Matrix in the Global Life Sciences sector. The PEAK Matrix is a composite framework that provides an objective, data driven and comparative assessment of Life Science IT Apps Service Providers, which are then divided into three categories based on market success and delivery capability. "Life Sciences firms are grappling with the reinvention of their business models, along with the need to unlock efficiency out of globally diversified operations. Technology is a key enabler to ensure this transition, and TCS continues to be a partner of choice for leading Life Sciences firms, based on its delivery excellence and ongoing market success," said Jimit Arora, Partner, Everest Group. "By taking a platform-driven approach to strategic value chain tenets, TCS is seeking to future-proof its portfolio and driving differentiation in a highly competitive market."
GNH Brings Malaria Relief to Yemen’s Conflict Zone India's global source for priority medicines, GNH India has successfully exported one of the largest orders for anti-malarial pharmaceuticals for a conflict zone in Yemen. The consignment contained 1, 20,000 Mefloquine tablets and Primaquine 45mg which were delivered in a record time of 3 weeks from receipt of order. The consignment was sent to a local aid agency operating in Oman; from there it was delivered to Yemen by road. Most established pharma companies fear to work in these zones due to the implication of US Sanctions, but GNH India has set an example by giving importance to humanity rather than business. Dr Piyush Gupta, Associate Director, GNH India commented, "It is an accomplishment for GNH India to export such a big order to Yemen in a time span of 3 weeks. Such consignments are a testimony to our belief that everyone in all parts of the world deserves access to proper medicines irrespective of their geographical boundaries or political affiliations. We ensured that despite the obstacles placed in our way, the conflict ridden citizens of Yemen would receive medicines that are in dire need in of these drugs." Mefloquine is commonly used to fight Malaria and used by travellers around the world to prevent malaria when visiting places where malaria is common. On the other hand, Primaquine is used with other medications to prevent and treat malaria. June 2017 47
Pharma News EC Approves Sandoz’s Rixathon Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) has approved Rixathon (biosimilar rituximab) for use in Europe. Rixathon is approved for use in all indications of the reference medicine, MabThera. Rixathon is approved for non-Hodgkin's lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. The EC approval was based on a comprehensive development program generating analytical, preclinical, and clinical - including pharmacokinetic/pharmacodynamic (PK/PD) - data. The program demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality. Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilar medicines. It is the pioneer and global leader in biosimilars, and now has four biosimilar medicines approved in Europe. Sandoz has a leading biosimilar pipeline, and plans to obtain approval for and launch four more biosimilars of major oncology and immunology biologics by 2020. A division of the Novartis Group, Sandoz is well positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing, and commercialization.
Merrimack Completes Enrollment in Phase 2 CARRIE Study of MM-141 Merrimack Pharmaceuticals, Inc., a biopharmaceutical company, has enrolled the last patient in the ongoing CARRIE study, a phase 2, double-blind, placebo-controlled, randomized trial, evaluating MM-141 (istiratumab) in combination with standard of care in previously untreated patients with metastatic pancreatic cancer. MM-141 is a bispecific antibody targeting both the Insulin Like Growth Factor 1 Receptor (IGF-1R) and the HER3 receptor, and is a potent inhibitor of the PI3K/AKT/mTOR signaling pathway. The CARRIE study is evaluating MM-141 in patients with high levels of the IGF-1 protein, which is known to play a role in tumor proliferation and metastasis. Patients with metastatic pancreatic cancer and high levels of free IGF-1 were randomized 1:1 to receive either MM-141 plus nab-paclitaxel/gemcitabine chemotherapy or placebo plus chemotherapy. 48 ď‚ƒJune 2017
The primary endpoint is progression-free survival, with objective response rate, disease control rate, duration of response and overall survival as secondary measures. Merrimack is a biopharmaceutical company based in Cambridge, Massachusetts that is outthinking cancer to ensure that patients and their families live fulfilling lives. Its mission is to transform cancer care through the smart design and development of targeted solutions based on the deep understanding of cancer pathways and biological markers.
Axovant Sciences Receives US FDA Fast Track Status for Nelotanserin Axovant Sciences has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug nelotanserin for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB). Dementia with Lewy bodies is the second-leading form of progressive dementia and affects over 1 million people in the United States. Currently, there are no approved therapies for the disease in the United States or in Europe. Nelotanserin is a novel 5HT2A inverse agonist being investigated in a Phase 2 double-blind, randomized, placebo-controlled crossover safety study involving more than 20 subjects diagnosed with Lewy body dementia who experience frequent visual hallucinations. In addition, nelotanserin is being investigated in a Phase 2 double-blind, randomized, placebo-controlled study involving up to 60 subjects diagnosed with Lewy body dementia who have REM sleep disorder. Fast Track designation is a process designed to facilitate the development, and expedite the review, of important new drugs to treat serious conditions which fill unmet medical needs in order to get them to patients earlier.
US FDA Marketing Nod for Zydus Eletriptan Hydrobromide Tablets Zydus Cadila has received the final approval from the US FDA to market eletriptan hydrobromide tablets, 20 mg (base) and 40 mg (base). The drug which is used in the treatment of migraine, will be produced at the group's formulations manufacturing facility at the Pharma SEZ in Ahmedabad. The group now has more than 120 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04. Pharma Bio World
Pharma News RASRx Gets US FDA Orphan Drug Status for RASRx1902 RASRx announced that the United States Food and Drug Administration has granted an Orphan Drug Designation (ODD) for its compound RASRx1902 for the treatment of Duchenne Muscular Dystrophy. RASRx1902 is an oral therapy that has shown positive effects on muscle function in animal models of Duchenne. In these models, the RASRx1902 has improved muscle strength and regeneration while decreasing muscle inflammation, degeneration, and necrosis. Through this ODD, RASRx is eligible for financial incentives that can stimulate investment in this program and expedite its regulatory timeline. In concert with CureDuchenne, the company is now transitioning to toxicology studies to advance RASRx1902 towards human clinical trials for the treatment of Duchenne. RASRx's founders worked with the USC Stevens Center for Innovation, the technology transfer office for the University of Southern California, to exclusively license RASRx1902. Funding by CureDuchenne Ventures and a collaborative US Department of Defense research grant with USC has accelerated the preclinical development of this program. Duchenne is a fatal genetic disease that causes muscles to degenerate. It impacts approximately 1 in 3,500 boys. Those with Duchenne are usually diagnosed by age 5, lose their ability to walk by 12 and most don't survive their mid-20s. There are limited approved treatments and no cure for Duchenne.
US FDA Approves Darzalex in Combo with Pomalidomide & Dexamethasone Janssen Biotech announced that the US Food and Drug Administration (FDA) has approved the immunotherapy Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (an immunomodulatory agent) and a proteasome inhibitor (PI). Clinical trial results showed an overall response rate (ORR) of 59.2 percent with Darzalex in combination with pomalidomide and dexamethasone in these patients. Darzalex is the first CD38-directed antibody approved anywhere in the world. It was first approved by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI Pharma Bio World
and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. It received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. To date, approximately 16,000 patients have been treated with Darzalex.
PharmaMar to Commercialize PM1183 with Trade Name of Zepsyre PharmaMar, a world-leading biopharmaceutical company, has announced that PM1183 (lurbinectedin), its third molecule of marine origin and analogue of Yondelis, will receive the trade name of Zepsyre. Zepsyre is currently undergoing development for the treatment of solid tumours. This promising agent is currently in final stage for platinum-resistant ovarian cancer and small cell lung cancer. Both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), as regulatory agencies, require the trade name to be unique and is part of the evaluation and approval process before marketing the product. After the positive results presented during the last ESMO and ASCO meetings about BRCA 2 -associated metastatic breast cancer and endometrial cancer, respectively, PharmaMar will initiate a pivotal phase III study in each indication.
ThromboGenics Appoints Thomas Clay as Chairman ThromboGenics NV, a biotechnology company developing novel treatments for diabetic eye disease, announces that the Board has appointed long-time non-executive director Thomas Clay as its next chairman. The appointment, effective 15 June 2017, coincides with the retirement of ThromboGenics' current Chairman of the Board, Staf Van Reet, PhD. Thomas Clay is Vice-President of East Hill Management, a USbased investment company. He also serves as the Chairman and CEO of Golden Queen Mining Co., Ltd., and is a director of the Clay Mathematics Institute. A graduate of Harvard College, Oxford University, and Harvard Business School, Thomas Clay has been a non-executive Director of ThromboGenics NV since 2011. In that year, he replaced his father, Landon T. Clay, who led the first external investment in ThromboGenics back in 2001 when the Company was private. June 2017 ď‚„ 49
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Pillow Pak
Euro head caps are closures for plastic infusion bottles made from blow-fillseal technology and stretch blow moulding with wash-fill-seal technology. The large size, 72 cavity moulds with hot runner technology, tailor-made injection moulding machine and ultra-high speed fully automated assembly machines ensures product quality without human interference. Moulding and assembly of the caps is done under clean room conditions. Hot runner technology and automated assembly machine ensures consistent quality and higher productivity. Their in-house laboratory facility ensures defect-free product including testing of pull load of pull ring and auto clave test. For more information, please contact: Medicap Inc E-73 GIDC Estate, Village Manjusar Tal: Savli, Vadodara, Gujarat 391 775 Tel: 02667-292771 Telefax: 91-02667-292993 E-mail: info@medicapinc.com
Sorbead India offer a complete line of pharma grade small desiccant paks called pillow paks which are manufactured using DuPont Tyvek and several custom substrates. Pillow pak can be used to absorb moisture vapour, odour or gas. DuPont Tyvek is made of spun bonded olefin and is intended for packaging of substances which are meant to remain stable and not getting mixed with other products. It has outstanding porous microbial barrier and is non-leaching and odourless. It finds application in packaging of variety of products like pharma, biological, medical devices, food, optical clothing, electronics and other consumer products. For more information, please contact:
Sorbead India 306-307 Prayosha Complex Next to Hyundai Motors, Chhani Jakat Naka Vadodara, Gujarat 390 024 Tel: 0756-7688877, 0265-2761041 E-mail: sale@sorbeadindia.com / sales@swambe.com
Conductivity Meter ILIUM Technology offers Model 2100 Conductivity Meter. The Model 2100 and its associated line of high-accuracy smart probes can measure liquid conductivities ranging from 10 -3 S/cm, typical of low concentration aqueous solutions, down to 10 -15 S/cm, typical of low concentration solutions in non-polar solvents. The Model 2100’s ability to follow conductivity changes over such a wide and low range with a single meter, and up to nine decades with a single factory-calibrated probe, has revolutionized the field by eliminating the need to correlate multiple meters and swap and calibrate multiple probes. For decades, measuring the electrical conductivity of liquids has been a workhorse technique in aqueous systems. The Model 2100‘s wide, low range makes it ideal for characterizing inks, paints, pharma and personal care formulations, resins, liquid toners, and other non-polar as well as polar fluid systems. For more information, please contact:
ILIUM Technology, Inc 242 E Border Road Medford, MA 02155-1106, U.S.A. Tel: 781-333-4000 E-mail: info@iliumtechnology.com / rich@iliuminc.com
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CORIOLIS Mass Flow Meter CORI-FLOWTM instrument can be used to control direct proportional valves, shut-off valves or pumps by using the integrated PID-controller. In CORIFLLLTM technology highly accurate filling applications are possible by using the integrated batch-counter. The maximum flow speed of the standard instrument is 600 kg/hr. This enables filling of 166.66 gram in 1 second or 10 kg/min. Features are direct mass flow measurement; independent of fluid properties; are integrated PID controller for control value or pump; fast response time; high accuracy, excellent repeatability; compact IP65 housing; optical: ATEX approval Cat 3, Zone 2, etc. For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448558, 26448983 Fax: 91-044-26441820 E-mail: sales@toshniwal.net
Hybrid - LRVP Toshniwal, leaders in vacuum engineering for over 70 years, now provide further solutions to your vacuum needs. The most advanced manufacturing technology in liquid ring vacuum pump has now created as improved Liquid ring pump that offer optimum performance and reliability .They offer minimal water consumption and an innovative impeller design that assure extremely quite operation and extending its life even under harsh condition. The most advanced manufacturing process is with the objective to reduce manufacturing times and shortening delivery times.
For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net
Standardized Chemical Pump with Magnetic Coupling KSB Pumps Ltd offers Magnochem pumps in India. These standardized chemical pumps with magnetic coupling are suitable for handling aggressive, toxic, explosive, valuable, flammable, malodorous or harmful fluids in the chemical, petrochemical and general industries. Magnochem - horizontal, seal-less volute casing pumps in back pull-out design with magnetic drive confirms to ISO 2858 / ISO 5199. Magnochem pumps are Atex compliant also. Its broad range of variants offers excellent flexibility. Pumps are optimally designed for excellent energyefficiency and offers maintenance-free long life. Magnochem pumps are available in 26 different sizes and are designed for 40 bar operating pressure and have capacity to pump liquid up to 300 cu meters per hour at head of 150 meters. To cater to wide range of applications; hydraulic components of Magnochem are available in different grades of SS and it can withstand fluid temperature between -90 and +300 o C.
For more information, please contact: KSB Pumps Ltd Mumbai-Pune Road, Pimpri Pune, Maharashtra 411 018 Tel: 020-27101241 E-mail: bipin.kode@ksb.com
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Warehouse Management System Warehouse management system is easy to use. It is user-friendly software with all required features to manage inventory in warehouse effectively. All warehouse owners always look for software which gives fast data entry and is easy report generation. Their WMS Inventory Software system is designed keeping your specific requirements for inventory management software in mind. It is complete online warehouse inventory control software with fast data entry facility.
Metal Detectors Metal detector detects metal in a filled bag when the bag passes through its electromagnetic field. When metal is detected in the bag passing through the metal detector, the same is rejected by the bag rejection system ahead of the metal detector. Such bags slide down the non-driven roller conveyor. Metal-free bags are transferred to the next system without any stoppage.
For more information, please contact: Sundaram Technologies F-339 Raghuleela Mega Mall Boraspada Road, Kandivli (W) Mumbai 400 067 Tel: 022-42661121 E-mail: info@makesure.org
For more information, please contact: Jasubhai Engg 64/a, GIDC Indl Estate, Phase 1 Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-49003636 Fax: 91-079-25831825 E-mail: mhd-sales@jasubhai.com
Temperature Controller Oven’s 5R6-900 temperature controller with ramp/soak capabilities is something that every laboratory should have. The 5R6-900 benchtop controller has many outstanding user-friendly benefits. Contained all in one enclosure, the device can be plugged into the wall as a self-contained temperature control system, which has its own power supply. This distinctive detail makes the device unique, as well as highly convenient for users. The temperature controller can also be used universally, which allows the user to use the device wherever they are located. As a solid state MOSFET bidirectional compact unit featuring an internal power supply, it is also capable of loading currents up to 10 A. The compact size, as well as the isolated communication port, makes using the 5R6-900 benchtop temperature controller a breeze. Great for usage in universities, science laboratories, PCR research and any businesses that specialize in temperature control. The controller features an easy-to-read digital display for controlling functions, including adjusting output voltage and setting the desired temperature. Complete with an auto output shutdown if the sensor is opened or shorted, the unit also includes high, low and no alarm settings. For more information, please contact:
OVEN Industries Inc 434 Railroad Avenue, Camp Hill, PA 17011, U.S.A. Tel: (717) 766-0721 Fax: (717) 766-4786 E-mail: r.wescott@ovenind.com / sales@ovenind.com / info@ovenind.com
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Octagonal Blender
Double Cone Blender Brilliant Process Machinery Pvt Ltd offers octagonal blender in 25 to 2,000 litre capacity. Contact parts are in SS-316. Baffles provided for ease of mixing/ blending.
Manhole with gasket is provided to fix baffles and for ease of cleaning the main pan. Charging and discharging is through a butterfly valve. A conical adaptor can be provided for fixing charging drum after butterfly valve. Unit can be provided with bin charging arrangement. All moving parts are enclosed in guards. A safety railing with a limit switch is provided for operator safety. Manual inching arrangement can be provided. Flame-proof motors with flame-proof pushbutton stations can be provided as an optional. For more information, please contact:
Brilliant Process Machinery Pvt Ltd Unit No: 1, 2, 14 Mordan Indl Estate Opp: Ipol, Waliv Phata, Vasai (E), Dist: Thane Maharashtra 401208 Tel: 0250-3293636 E-mail: brilliantprocess@rediffmail.com
GMP compliant, contact parts manufactured in SS. The double cone ensures good rolling and cross-mixing. A-shaped frames provide stability of structure. Main drive provided with variable frequency drive to control blender RPM. Start-stop arrangement ensures that the blender always stops in an upright position. Internal baffles ensure good blending and break lumps. Guard rails are provided with limit switch for safety. PLC/HMI-based control panel models available.
For more information, please contact: Kunal Machines 104 Kothari Indl Estate, Next to Asian Paints LBS Marg, Bhandup (W), Mumbai 400 078 Tel: 022-61271111, 67251949 E-mail: kunalmachines@gmail.com
Horizotnal Peeler Type Centrifuge Shiv Shakti Process Equipment Pvt Ltd offers horizontal peeler type centrifuge. Full opening housing gives complete access to the entire processing area, which allows for ease of maintenance, inspection, cleaning and validation. Clean room installation is possible with separation of the processing area from the mechanical components, which is achieved with a through the wall design. Inclined chute facilitate cake discharge, which is easily accessed for cleaning and validation. Feeding of the slurry across the entire length of the basket ensures uniform cake thickness. There are several possibilities for control systems from completely manual to fully automatic with a local operator interface and the possibility of plant networking. For more information, please contact: Shiv Shakti Process Equipment Pvt Ltd 407 Shivam Chambers, Next to Sahara, S V Road Goregaon (W), Mumbai 400 104 Tel: 022-26788480 Fax: 91-022-26798284 E-mail: sales@shivshaktiequipments.com
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Moisture Analyser Balances Citizen’s new MB Series moisture analyser with HALOGEN heating is mainly designed on the basis of time saving factor for universal use in chemical, pharma, oil and petroleum industries also in material testing and environmental laboratories, and in sewage treatment plants. MB Series is compact in shape and big in performance. It performs all the major functions of routing moisture analysis.
Double Cone Blender Leveraging on their years of experience and in-depth knowledge of this domain, Shefa Industries are offering a broad spectrum of quality assured double cone blender. These double cone blenders are widely used for mixing granules and dry powder homogeneously. Offered array of double cone blender is manufactured by using premium quality SS, which is procured from the reliable vendors of the market. These blenders are commonly used in the pharma, chemical, food and cosmetic industries.
For more information, please contact:
For more information, please contact:
Combo Deduster + Metal Detector
Gas Chromatographs
Citizen Scale (I) Pvt Ltd Citizen House, Unit No: E-2, Plot No: 11, WICEL Opp: SEEPZ Gate No: 1, Andheri (E), Mumbai 400 093 Tel: 022-42437700 Fax; 91-022-42437800 E-mail: sales@citizenscales.com
Combo Deduster + Metal Detector HS 30 consist of vertical deduster bottom and top integrated with digital metal detector. The deduster is provided with frequency and voltage (power) control insuring effective dedusting and deburring. The entire dedusting settings are controlled from the metal detector. The inlet can be rotated through 3,600 and hence the same can be used for right or left outlet of compression machine conveniently. The system is designed to ensure ease for cleaning and the entire deduster assembly can be dismantled and assembled within minutes without any tools. For more information, please contact:
Technofour Electronics Pvt Ltd Gat No: 3 (PT), 5 (PT), 243 (PT) Kasurdi (Kheba) Khed Shivapur-Saswad Road Post: Khed Shivapur, Tal: Bhor, Dist: Pune, Maharashtra 412 205 Tel: 02113-305200, 305246, Fax: 91-02113-305250 E-mail: pcssales@tepl.co.in / teplinbox@gmail.com
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Shefa Industries Gala No: 1, U K Quari Compound Gandhi Nagar, Vikhroli (W) Mumbai 400 083 Tel: 022-25942473 E-mail: shefaindustries@yahoo.co.in
Developed around key innovations driven by customer needs, including user-installable instant connect injectors and detectors, unique and patented solutions to conserve helium carrier gas while running analysis, and optimised and miniaturised electronic components, the compact Thermo Scientific TRACE 1300 Series GC is extremely fast, easy to use, and delivers high lab productivity at a much reduced cost of ownership. The new high-capacity TRACE 1310 auxiliary oven has multi-valve, multi-column capacity and enables the use of up to four conventional detectors simultaneously. For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494 Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com
Pharma Bio World
High Vacuum Pump (Oil Immersed)
Mini CORI-FLOW Coriolis Mass Flow Meter/Controller are used for accurate measurement and control of (very) low flow rates, whereas mini CORI-FLOW offers integrated PID control and close-coupled control valves or pumps, thus constituting very compact, cost- and space-saving, precise coriolis mass flow controllers for low flow liquid and gas regulation. Used in digital technology to allow fieldbus communication and offers user-configurable control characteristics. Features are high accuracy and excellent repeatability and also suitable for very low flow ranges
For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448558, 26448983 E-mail: sales@toshniwal.net
The compact and quiet in operation, highly reliable and sturdy in design GL Series pump is an oil sealed belt driven pump operating according to the rotary vane principle with gas ballast valve. Oil, which is injected into the pump chamber, is used for sealing lubrication and cooling purpose. It is easy to maintain and guaranteed ultimate vacuum. Double stage models from 180 m 3 /hr to 300 m 3 /hr are available to meet wide range of vacuum needs.
For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net
Single Quadrupole Mass Spectrometer and Specialized Columns Thermo Fisher Scientific Inc offers new technologies that are designed to allow analytical chemists to obtain high-resolution separations with outstanding sensitivity and reproducibility. The new Thermo Scientific ISQ EC Single Quadrupole mass spectrometer seamlessly integrates with an existing ion chromatography (IC) or high performance liquid chromatography (HPLC) system and provides excellent small molecule sensitivity and mass confirmation for users. The industryleading Chromeleon Chromatography Data Software (CDS) platform has embedded ISQ EC MS instrument control, which enables users to minimize time spent on new mass spectrometry (MS) user training. The instrument also provides exceptional robustness, enabling users to analyze a range of simple and complex sample matrices. Also, offers the new range of Thermo Scientific MAbPac RP 1-mm columns, which are designed to provide the resolution and ruggedness required for high-performance, reversed-phase chromatography characterization of monoclonal antibodies, fragments, variants, antibody drug conjugates and proteins. With a 1-mm inner dia, the new columns provide sensitive analyses of very small sample volumes at low flow rates for direct injection into the LC-MS, thus streamlining workflows and achieving high sensitivity. Featuring a polymeric resin with an optimized pore size and thermal and pH stability, the new columns allow consistent and efficient separations with low carry-over.
For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494, Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com
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events diary
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bookshelf The Fluorescent Protein Revolution (Hardcover) Authors: Richard N Day, Michael W Davidson (Editors) Price: USD 143 No of Pages: 347 Pages Advances in fluorescent proteins, live-cell imaging, and superresolution instrumentation have ushered in a new era of investigations in cell biology, medicine, and physiology. From the identification of the green fluorescent protein in the jellyfish Aequorea victoria to the engineering of novel fluorescent proteins, The Fluorescent Protein Revolution explores the history, properties, and applications of these important probes. The book first traces the history of fluorescent proteins and the revolution they enabled in cellular imaging. It then discusses fluorescent proteins with novel photophysical properties. The book also covers several cutting-edge imaging applications. These include superresolution microscopy of cellular fine structures, FRET microscopy to visualize protein interactions and cell-signaling activities inside living cells, photobleaching and photoactivation techniques to visualize protein behaviors, techniques that exploit plant and algal photoreceptors to enable light-regulated control of enzymatic activities, and the noninvasive imaging of tumor–host interactions in living animals.In color throughout, this book presents the fundamental principles and latest advances in the field, including the associated development of imaging techniques that exploit fluorescent proteins. It is accessible to a broad audience, from optical imaging experts to novices needing an introduction to the field.
Antiepileptic Drug Discovery: Novel Approaches (Hardcover) Authors: Alan Talevi, Luisa Rocha (Editors) Price: USD 99.51 No of Pages: 386 Pages This thorough volume delves into antiepileptic drug discovery with a comprehensive collection of innovative approaches for the development of antiepileptic therapies, focusing on novel molecular targets for antiepileptic drugs, computer-aided approaches for the identification of new drug candidates, and therapeutic strategies to overcome refractory epilepsy. The last section illustrates the potential benefits that network pharmacology and rational drug repurposing could bring to the antiepileptic drug discovery community. Written for the Methods in Pharmacology and Toxicology series, chapters include the kind of detailed description and implementation advice to ensure results in the laboratory. Authoritative and practical, Antiepileptic Drug Discovery: Novel Approaches aims to provide medicinal chemists, pharmacologists, and other researchers with the tools need to further explore the study of pharmacoresistant epilepsy and the discovery of new antiepileptic drugs.
Extremophilic Cyanobacteria For Novel Drug Development (Paperback) Authors: Sikha Mandal, Jnanendra Rath (Authors) Price: USD 36.81 No of Pages: 92 Pages This book presents recent developments in the novel drug development and potential of extremophilic cyanobacteria. It discusses how these tiny organism originated, produce oxygen that leads to evolution of life on the earth, how their survival strategies in extreme climatic conditions lead to diverse metabolic pathways, and the opportunity to use them to develop novel drugs. The book is comprised of five chapters, starting with the origin of cyanobacteria, their survival strategies under extreme conditions, and their capabilities to change metabolic activities.The second chapter explores the different metabolic pathways found in cyanobacteria and examines advances in this field and recent techniques like MALDI-TOF imaging and metagenomics tools as well as in silico techniques for rapid screening of secondary metabolites. Further chapters cover the glycomics of cyanobacteria, anticancer drug development, and some issues and challenges of using cyanobacteria to develop drugs. Extremophilic Cyanobacteria For Novel Drug Development provides insight into future perspectives in drug development and is a key resource for students, researchers and professionals in pharmacy, medicinal chemistry, pharmacognosy biotechnology, biology, and academics. Pharma Bio World
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