Pharma Bio World February 2014

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Pharma Bio World6 February 2014

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EXPERT’S TAKEThe Evolution of the Indian Patent Regime and its Effect on Indian Generic Players and MNCs in the Pharma Sector– Jay Parikh, Verus Advocates

FEATURESGenotoxicity in Pharmaceuticals– Chris Bouton, Thomson Reuters Life Sciences

Gearing Up For a Pharmacovigilance Audit Using a Risk Based Approach– Dr J Vijay Venkatraman, Oviya MedSafe Pvt Ltd

Worth Every Rupee: Why Investing in Original Components Pays Off– Udo Benndorf-Giese, Bosch Packaging Services

The Task of Managing Big Data in the 21st Century - Chris Bouton, Thomson Reuters Life Sciences

MARKET RESEARCH

Pharma Q3 Result Highlights for Financial Year 2013-2014

NEWS FEATURETrials and Tribulations– Mahesh Kallayil

Endorsing “Quality”– Ananya Sen

NEWS UPDATE

Pharma News

Biotech News

CORPORATE AFFAIRS Product Trends

Events

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expert's take

The Evolution of the Indian Patent Regime and its Effect on Indian Pharma Sector

I ndian patent regime and the pharma industry Patents confer on the inventor (the patentee) the right to prevent others

from using their invention. However, such exclusive rights cannot ever be unbridled and some qualifications are necessary to check the scope and operation of such rights. It is this inherent paradox that has been at the centre of recent debates around the development of the Indian patent regime, especially those governing pharmaceutical sector.

Brief History

In India, the concept of patent protection, which originated in 1856, finds its eventual place in the Indian Patent Act, 1970 (Act). Up until 2005, the Act only provided process patents for certain sectors such as food, pharmaceuticals and chemicals; and abolished product patents in these fields entirely. However, in 2005, India amended the Act to (re)introduce the product patent regime so as to meet its obligations under the Agreement for Trade Related Aspects of Intellectual Property Rights (TRIPS). India, along with many of the developing countries, attempted to incorporate TRIPS flexibilities in their domestic law.

Pre-TRIPS and Post-TRIPS: Over the years, the public health spend in India has fallen short of expectations and consequently access to affordable healthcare has only remained a dream for millions of low income Indians. In addition,

This article gives an overview of the Indian patent regime’s evolution, analyses recent legal developments in the pharma sector and sets out the effects that these have had on both Indian generic players and multi-national corporations (MNCs).

Jay ParikhPartnerVerus Advocates

the country’s healthcare landscape has also been characterised by the co-existence of communicable diseases in addition to the emerging epidemic of non-communicable diseases. These factors have only fuelled the growing need for affordable medicines.

As a result, there was a dire need for India to develop an effective domestic pharma industry that could deliver cost-effective solutions. This was made possible thanks to the absence of product patents, which enabled domestic companies to easily develop generic drugs that were far cheaper than the expensive alternatives marketed by the pharma MNCs in India. In the ten years it took between the signing of the TRIPS and the introduction of product patents in India, the generic drug players in India had already built themselves a reputation for being global leaders in manufacturing affordable medicines. Moreover, the regulatory environment enhanced competition amongst the generic producers as no single company enjoyed a monopolistic right over a pharma product.

However, progress was set to be interrupted with the introduction of the new patent regime to comply with India’s obligations as a signatory to the TRIPS. Indian companies were legally prevented from introducing generic versions of the patented medicines. These medicines

A direct result of the Natco decision will be the voluntary decrease in prices of patented drugs in order to avoid applications for compulsory license and increase price-competitiveness of products.

Expert_s_Take_.indd 12 21-02-2014 17:47:30

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Pharma Bio World February 2014 14

expert's takewill be made. This will prompt pharma companies to voluntarily grant licenses which will, in turn, increase efficiencies and decrease the gestation period in discovery of essential but affordable drugs. As a fall-out of the Novartis case, the industry may see a reduction in over-lapping patent applications, which are filed in order to pre-empt patent infringements and to make a strong entry-barrier.

2. Lowering of drug prices: A direct result of the Natco decision will be the voluntary decrease in prices of patented drugs in order to avoid applications for compulsory license and increase price-competitiveness of products.

3. Decrease in Foreign Direct Investment (FDI) and investments in new drug R&D: As a result of the above-mentioned recent developments, it will not be surprising to witness a decline in FDI in the pharma sector directly impacting in flow of capital into new drug R&D.

On one hand, the socio-political objectives of the Indian government in protecting domestic generic players and providing affordable drugs to India’s poor proved to be a thorn in the side of pharma MNCs. They have cited the high R&D costs incurred when developing new drugs, but on the other hand pharma MNCs have been accused of maximising profits by not lowering drug prices and failing to invest in R&D in India or transferring technology.

Managing these conflicting interests in an increasingly globalised environment is proving to be a challenge for the Indian government. However, recent developments do point towards a protectionist trend that may not be conducive to India’s ever-increasing need for foreign capital and technology in the pharma sector.

Contact: [email protected]

could now only be accessed through a compulsory licence or a government use authorisation. This led to a situation wherein generic companies could only produce off-patented medicines, thereby resulting in the denial of new medicines that were earlier available at affordable prices. In the meantime, pharma MNCs have aggressively marketed newly patented and expensive drugs whilst expanding their presence considerably in the generics segment through M&As and strategic alliances with domestic players.

Recent Developments

The seemingly good run that the pharma MNCs were having, or at least were expecting to have, has recently been marred by two landmark judicial pronouncements outlined below.

The Natco v. Bayer case - Compulsory licensing: The Act provides for an option of compulsory licensing and governmental use, which essentially implies that any interested person may make an application for compulsory licensing on the grounds that the reasonable requirements of the public have not been satisfied, that the patented article is not available at an affordable price to the public or that the patented invention is not worked in the territory of India.

Bayer (the patentee) owned patent no.215758 over a compound ‘sorafenib tosylate’, which it marketed under the brand name ‘NEXAVAR’ and used for the treatment of advanced stages of kidney and liver cancers. Natco Pharma (the applicant) had developed the process for manufacturing the drug and filed the instant application for compulsory license.

The Controller of Patents held that all three grounds available for an application for compulsory licence under S.84(1) of the Act, as above, had been satisfied given that (a) the drug was not easily available and was in fact under-supplied, (b) the price of the drug at ` 280,428 pm did not satisfy affordability parameters,

and (c) the patentee did not ‘work’ the product ie, either manufactured on its own or through a third-party, in India. Consequently, the Controller of Patents granted a compulsory license to Natco for manufacturing and selling the said drug for the remaining term of the patent at royalty of 6 per cent of net sales to be paid to the patentee.

This decision is the first instance of grant of a compulsory license under the Act. It is significant in more ways than one and particularly stands out because of a marked socio-political approach adopted by the regulator to suit India’s healthcare needs as a developing country, protect the domestic generic drugs industry and its position as the pre-eminent exporter of affordable medicines in the global pharma market.

The Novartis case - Patentability criteria: The Act has sought to put restrictions on the grant of product patents by limiting the scope of patentability. This has been done by firstly providing a patentability criterion and secondly by excluding certain kinds of products as inventions.

However, the Supreme Court interpreted the 2002 amendments to S.3(d) of the Act as setting up “a second-tier of qualifying standards for chemical substances, pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds” to reject the patent application of Novartis and hold that the beta crystalline form of Imatinib Mesylate does not qualify the test of S.3(d) of the Act.

Implications on the Industry

The above-mentioned developments could have the following short to mid-term implications on the pharma sector as a whole:1. Increase in efficiencies: A natural

result of the Natco decision is that more compulsory license applications

Expert_s_Take_.indd 14 21-02-2014 15:38:54


Genotoxicty in Pharmaceuticals

In genet ics, genotoxic i ty descr ibes a deleterious action on a cell ’s genetic mater ia l a f fec t ing i ts in tegr i ty. Th is

includes both, certain chemical compounds and certain types of radiat ion. Typical geno tox ins l i ke a romat i c amines a re believed to cause mutations because they are nucleophilic and form strong covalent bonds with DNA resulting with the formation of Aromatic Amine- DNA adducts, preventing accurate replication. Genotoxins affecting sperm and eggs can pass genetic changes down to descendants who have never been exposed to the genotoxin.

What are Genotoxic Impurities?

Genotoxic substances in pharmaceuticals, known as Genotoxic Impurities (GTIs), have gained more attention in the recent years. These are substances that add risk without any benefit to pharmaceuticals. During the synthesis of Active Pharmaceutical Ingredients (APIs) and the manufacturing of pharmaceutical products in general, reactive intermediates, catalysts, acids or bases are used.

These compounds can potentially be present at trace levels in final drug products. Due to their chemical structures and reactivity, some of these solutes are recognized as genotoxic or potentially genotoxic. Recently, the possible presence of these GTIs or Potential Genotoxic Impurities (PGIs) in APIs received increased attent ion and official guidelines are issued. European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has published guidelines regarding limits of genotoxic impurities.

Recently, in 2008 US FDA has also come up with the draft guidelines on genotoxic and carcinogenic impurities in drug substances and products. A threshold of toxicological concern value (TTC) was proposed as an acceptable risk. Based on the daily intake of the drug (dose), this translates into target limits of detection for the determination of these potential impurities in the drug

substances below 1 ppm (<1μg/g API). This is about 500 times lower than for classical impurity analysis in pharmaceutical quality control (1PP versus 0.05 per cent).

The Concern with GTIs

T h e s e c o m p o u n d s h a v e b e e n demonstrated to induce, genetic mutations, chromosomal breaks, and/ or chromosomal rearrangements, are considered genotoxic and have the potential to cause cancerin humans. Exposure to even low levels of these impur i t ies may be of s igni f icant concern. GTIs are those that interact with DNA either direct ly or indirect ly. Since any exposure to these agents can convey some level of carcinogenic risk, and since complete elimination of genotoxic impurities from drug substances is often unachievable, the presence of a concerning impuri ty requires the implementation of a concept of an acceptable risk level.

Classification of Impurities (Müller et al. 2006)

Class 1: Impurities known to be genotoxic (mutagenic) and carcinogenicC l a s s 2 : I m p u r i t i e s k n o w n t o b e genotoxic (mutagenic), but with unknown carcinogenic potentialClass 3: Alerting structure, unrelated to parent structure and of unknown genotoxic (mutagenic) potentialClass 4: Alerting structure, related to this parent APIClass 5: No alerting structure or indication of genotoxic potential

E x a m p l e s o f G T I s o r P G I s i n Pharmaceuticals

a) Impurity E in Terbinafineb) Alkyl methane sulfonates have been

highlighted as PGIs. <ethyl methane sulfonates, ethyl methane sulfonate etc in Emtricitabine.

c) Ary lamines and aminopyr id ines are building blocks of APIs and these PGIs can potent ia l ly be present at t race

Genotoxic substances are those substances that add risk to the pharmaceutical products without any benefit to pharmaceuticals. Regulations concerning genotoxic impurities are relatively new in the history of modern drug regulation. This article provides an overview of genotoxicity and the ways to identify and control them

Dr Padmaja PrabhuApplication SpecialistPerkinElmer (India) Pvt Ltd

list of functional.indd 16 21-02-2014 15:42:16


levels in Bupivacaine hydrochlor ide (purity minimum 99 per cent) Lidocaine hydrochloride (Purity minimum 99 per cent) and Chlorhexidine diacetate (Purity min imum 97.5 per cent) Dic lofenac sodium salt (purity minimum 98 per cent).

d) Isopropyl chloride, 1-(3-chloro-propane-1 - s u l f o n y l ) - 4 - m e t h y l - p i p e r a z i n e , 2-chloro-1-butene, 4-chloro-1-butanol, Formaldehyde, Sulfolane, N-(2-Iodo-Ethyl) methanesulfonamide in APIs.

e) Nitro compounds in APIsf) Hydrazine in isoniazid

ICH Guidelines

ICH provides guidelines for impurities (Q3A, B and C), but does not specifically provide acceptable levels for those genotoxic in nature. It does address the need of lowered levels for unusually potent impurities, such as those that are genotoxic. The occurrence of these impurities in pharmaceuticals must be avoided as far as possible, by altering synthesis route, and or reagents used, introduct ion of a genotoxic reagent as early as possible in the synthetic scheme to allow elimination of this substance during subsequent reaction and purification steps

including additional purification steps to the synthetic route to drive off the impurities. I f a l l these precaut ions fai l to remove the impurity, then appropriate analytical methodologies need to be identif ied to measure and moni tor these genotoxic impurities.

Their analysis at the sub-ppm level in APIs is challenging and requires state-of-the-art instrumentation providing the necessary sensitivity to detect trace concentrations of the PGI, and the selectivity to reduce matrix interference.

Source of Impurities

Potential sources of GI or PGIs may be the materials used in the synthetic pathway or degradants. Raw materials, intermediates, reagents, solvents and impurities from side reactions may contribute to the occurrence o f GI . A lso the degradat ion produc ts originating from drug substances, drug products or microbiological activity may result in such toxic impurities.

Over reduction, or over oxidation, catalysts, solvents, functional isomers, posit ional

isomers, stereo isomer and geometrical isomers may also lead to impurities.

Strategies for Identification and Control

Step 1: Identify and classify structural alerts in parent compound and impuritiesStep 2: Establish a qualification strategyStep 3: Establish acceptable limits

Several computer packages have been developed to study Structure-Act iv i ty-Relat ionships (SAR) in toxicology. The approaches fo l lowed by these toxic i ty production packages fall into two categories: 1) Rule based expert systems that rely on a set of chemical structure alerts and 2) Correlative structure activity relationship methods based on stat ist ical analysis. DEREK (Deductive Estimate of Risk from Existing Knowledge) is such rules based system which indicated whether a specific toxic response may occur and TOPKAT (Toxicity Prediction by Kompter Assisted Technology) is based on SAR.

A posit ive sil ico result from a chemical st ructure infers potent ia l genotoxic i ty, which is further investigated by bacterial reverse mutation test such as the AMES test by which DNA reactive genotxins can be identified. The AMES test is a biological assay to assess the mutagenic potential of chemical compounds.

How can they be Analysed?

Determination of these impurities at ppm levels requires highly sensitive analytical methodologies, which poses tremendous chal lenges on analy t ica l communi t ies i n pha rmaceu t i ca l R&D. App rop r i a te instrumentation like HPLC, LC-MS, GC-MS and NMR etc are both sensitive and specific to determine trace levels and should be used for the qualification of these impurities.

(This article has been reprinted from Pharma Bio World May 2012.)


A list of functional groups identified by Ashby & Tennant (1988, 1991) and Tennant et al. (1990) as structural alerts for DNA reactivity

(From WHO Food Additive Series 40)

•Alkyl Esters of Phosphoric or Sulfonic Acids•Aromatic Nitro-Groups•Aromatic Azo-Groups (Reduction to Amin)•Aromatic Ring N-Oxides•Aromatic Mono- and Di-Alkyl Amino Groups•Alkyl Hydrazines•Alkyl Aldehydes•N-Methylol Derivatives•Mono haloalkanes•N and S Mustards, Beta-Haloethyl-•N-Chloramines

•Propiolactones and Propiosulfones•Aromatic and Aliphatic Aziridinyl Derivatives•Aromatic and Aliphatic Substituted Primary Alkyl Halides•Urethane Derivatives (Carbamates)•Alkyl N-Nitrosamines•Aromatic Amines and N-Hydroxy Derivatives•Aliphatic Epoxides and Aromatic Oxides•Centre of Michael Reactivity•Halogenated Methanes: C(X)4 •Aliphatic Nitro Groups

list of functional.indd 18 21-02-2014 15:43:48


Gearing up for a Pharmacovigilance Audit Using a Risk Based Approach

I n recen t years , Pharmacov ig i lance r e g u l a t i o n s a c r o s s t h e g l o b e a r e becoming more stringent, placing various

regulatory obligations on the Marketing Authorisation Holders (MAH) – a term that includes pharmaceutical companies as well as external agencies that hold the right of marketing any given medicinal product in a specified market. One of such stern obligations warrants the MAH to conduct a regular audit of its Pharmacovigilance system. As a result, the MAH is expected to assess their own Pharmacovigilance system us ing per iod ic r isk-based and independent audi ts, and communicate any safety r isks to the regulators and healthcare professionals.

E v e r y M A H m u s t e s t a b l i s h a n d maintain a system for performing their Pharmacovigilance activities, monitoring the safety of authorised medicinal products and detecting any change in their r isk-benefit balance. Likewise, the MAH must establish and use the quality systems that are adequate and effective to measure the outcomes relevant to Pharmacovigilance.

Being a component of the Pharmacovigilance system, a qual i ty system has i ts own s t ruc tures and processes which must e n v e l o p o r g a n i s a t i o n a l s t r u c t u r e , responsibi l i t ies, procedures, processes and resources of the Pharmacovigilance system. It should help in ensuring adequate compl iance and record management . Regulatory authorities emphasize a process or measure to invest igate or evaluate the performance and effectiveness of a Pharmacovigilance system and the quality system by the MAH themselves which is commonly referred to as audit.

In general, an audit is defined as an organised and unbiased assessment of activities to determine whether the evaluated activities were performed according to the defined requirements (audit criteria, regulations, procedures). From the pharmacovigilance perspect ive, an audi t is def ined as a “systematic, disciplined, independent and documented process for obtaining evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulf i l led, contributing to the improvement of risk management, control and governance processes” (European Medicines Agency). In other words, an audit can simply be defined as the process of assessing the appropr iateness and effectiveness of the implementation and operation of the pharmacovigilance system through the evaluation and examination of objective evidence.

Risk based auditing is defined as an audit process that explains how the concept of risk are integrated into the strategies and approaches used for management. It emerged as a methodology that l inks internal auditing to an organisation's overall risk management framework (Institute of Internal Auditors, IIA). The risk based audit uses certain techniques to determine the areas of risk, where risk is defined as the probability of an event occurring that will have an impact on the achievement of objectives, taking in to account, the severity of its outcome and/or likelihood of its non-detection by other methods.

So, why is there a regulatory requirement to adopt the risk based approach to conduct PV audits? The recent switch to the risk based approach is because it helps to identify

This article details the needs, significance and advantages of adopting a risk based approach for conducting Pharmacovigilance audits.

Dr J Vijay VenkatramanManaging Director & CEOOviya MedSafe Pvt Ltd

The risk based approach helps to authenticate the effective operation and implementation of Pharmacovigilance system and to ensure that the company is operating in congruence with the established policies

Oviya.indd 20 21-02-2014 15:51:06


the areas of highest risk to the organisation’s Pharmacovigilance system, including its quality system for Pharmacovigilance activities. Moreover, it acknowledges the internal audit to provide assurance to the authorities that the risk management processes are managing risks effectively, in relation to the risk appetite (the amount of risk organisations are prepared to accept in order to pursue their objectives). In other words, the risk based approach helps to authenticate the effective operation and implementation of Pharmacovigilance system and to ensure that the company is operating in congruence with the established policies and that it complies with the regulatory requirements for the Pharmacovigilance/quality system.

Furthermore, a risk based audit empowers a MAH to evaluate the operations of the Pharmacovigilance system and provides numerous benefits to it such as:• It helps to prevent under or over auditing;• It provides results that are rational, unbiased,

valid and reliable;• It reduces the investigator bias;• It helps to strengthen accountability for

achieving objectives;• It improves understanding and communication

of risk and mitigation options;• It details the complete risk management

processes including their design and effectiveness;

• It enables complete, accurate and appropriate reporting and classification of risks.

While trying to explore the basic differences between the traditional audit and the risk based audit, it is identified that the previous auditing standards just focused on the deficiencies in internal controls, and cases of non-compliance with policies, procedures and the country’s regulatory requirements which might not be present over time. In contrast, the modern risk based auditing spotlights the present and the organisation's level of preparedness to deal with

the future. As a matter of fact, the concept of risk based auditing is not limited to identifying the risks that have a significant impact on the organisation’s Pharmacovigilance system but also to ensure whether the organisation has the ability to achieve or surpass its objectives.

Using this approach, the risk is assessed at the three different stages. The first stage includes the strategic level audit planning that gives rise to a long term audit strategy that usually lasts for a period of 2-5 years. The goal at this stage is to portray the areas highlighted for audit and must include the governance, risk management and internal controls of all parts of the Pharmacovigilance system.

Meanwhile, the risk can be assessed using the second stage, the tactical level audit planning. This strategy results in an audit programme planned for a specific timeframe, normally for a year. The main focus at this stage is on the critical Pharmacovigilance processes and the key control systems relied upon for Pharmacovigilance activities. The final stage of risk assessment is done via operational level audit planning resulting in an actual audit plan which comprises of risk prioritisation, sampling and design, grading, and results and reporting of audit findings.

The audit findings should be in line with their relative risk level and the grading should be documented in an audit report and then communicated to the management in a timely manner. Communications that involve critical findings requiring immediate action must be expedited to the superior management. The organisation must ensure that necessary action such as CAPA (Corrective Action, Preventive Action) is taken to address the audit findings.To conclude, we are aware that every organisation is different, with a different attitude to risk, different structure, different processes

and different quality systems. The European Medicines Agency (EMA) as well as the United Stated Food & Drug Administration (US FDA) and other regulatory agencies are now robustly conducting regulatory inspections based on the risk based approach. Considering the benefits of modern risk based audits and to comply with the global regulatory obligations, it is time for the pharmaceutical companies in all parts of the world to gear up for a Pharmacovigilance audit using a risk based approach. (The author would like to thank Gayathri Subramani, Pharmacovigilance Associate and Ganesan Ramakrishnan, Drug Safety Manager from Oviya MedSafe for their valuable contribution in preparing this article.)

References:

1) Guideline on good Pharmacovigilance practices (GVP), module I Pharmacovigilance systems and their quality systemshttp://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129132.pdf2) Guideline on good Pharmacovigilance practices (GVP), module IV – Pharmacovigilance Auditshttp://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/12/WC500136233.pdf3) Chartered Institute of Internal auditors, UKhttp://www.iia.org.uk/resources/risk-management/risk-based-internal-auditing/4) Information Systems Audit and Control Association (ISACA), http://www.isaca.org/education/upcoming-events/documents/2012-nacacs-presentations/121-nac2012.pdf5) Institute of chartered accountants Australia (ICCA),h t tp : / /www.cha r te redaccoun tan ts . com.au /News-Media/Charter /Charter-ar t ic les/Audi t -and-assurance/2011-07-The-Risk-Based-Audit-Approach.aspx6) Thomas M, The seven step process to risk based auditing, Institute of Internal Auditors, 2003, 3 (4). http://www.theiia.org/FSAarchive/index.cfm?iid=2237) Spadaccini D, Difference between Traditional and Risk Based Auditing, 2010, http://www.spe.org/atce/2010/pages/schedule/tech_program/documents/spe1357341.pdf


The basic differences between the traditional audit and the risk based audit, is that the previous auditing standards just focused on the deficiencies in internal controls, and cases of non-compliance with policies, procedures and the country’s regulatory requirements which might not be present over time.

Oviya.indd 22 21-02-2014 15:57:10

Ad Template 01.indd 27 25-11-2013 11:12:31


Worth Every Rupee: Why Investing in Original Components Pays Off

Because o f t he s t rong economic growth as wel l as the expansion o f r e g i o n a l i n f r a s t r u c t u r e a n d

industry, the requirements and expenditure for pharmaceut ical products are r is ing signif icant ly. Typical ly, the demand for reliable and productive machinery increases wherever industry expands, but even the most durable machine will require single components to be exchanged during its life cycle. This is where counterfeiters sense a lucrat ive business. The International Chamber of Commerce est imates that counterfeiting accounts for between five and seven percent of world trade . Historically, the problematic nature of imitation spare parts has been known pr imari ly in the automotive and electronics industries .

Fits Like a Glove

For manufacturers of pharmaceut icals w o r l d w i d e , t h e g r o w i n g n u m b e r o f counterfeit machine components constitutes an add i t iona l r i sk . There fore work ing with reliable partners is becoming more and more important to them. With each regional market being characterised by its own very special requirements, machine suppliers must possess profound market knowledge. What’s more, the spare parts for their machines must be available on a regional basis. As production companies in any market will know: original equipment suppliers not only provide best quality, they also offer reliable and durable components that make the investment in their spare parts pay for themselves in the long run.

The development, construction and design of a machine are based around the optimum

interaction of different components within a complex system. Even the s l ightest variation of part specifications can result i n se r ious damage to o the r mach ine e lemen ts . Fo r an op t imum command o f a conveyo r be l t , f o r i ns tance , a l l angles must be adjusted correctly and all parts must interlock exactly; counterfeit parts of inferior quality can rarely meet these constructive requirements. Once a machine no longer delivers the accustomed packaging speed, effectiveness or quality, the d i fferences between or ig inals and fakes become obvious. The r isk of an unplanned machine s top is increased many times over.

Safety for Man and Machine

Complying with strict safety and quality cr i ter ia is especial ly important when i t comes to the production and packaging of pharmaceuticals. It is essential for the producer’s market success and contributes to the sa fe ty o f pa t ien ts , consumers and pe r sonne l . Coun te r f e i t mach ine par ts do no t fu l f i l l t hese h igh sa fe ty requ i rements ; the i r assemb ly en ta i l s considerable risks that producers should not underestimate.

If, for instance, a substandard electronic component causes a short circuit, this can have devastating consequences for the entire production line and the employees. Highest safety levels can only be ensured by using qual i ty-tested components. I f required, the original manufacturer wil l supply detailed installation instructions as well as additional parts or special tools.

Producers increasingly address the challenge of meeting the growing demand with high-performance production machinery. Pharmaceutical manufacturers fully depend on these machines and all of their components. Companies who rely on equipment and spares from original manufacturers are sure to be on the safe side. Only originals guarantee permanent safety, reliability and profitability – and are worth every rupee.

Udo Benndorf-GieseProject Manager Strategic Spare Parts Bosch Packaging Services

The answer to the Big Data question requires a trusted, respected and effective mechanism to make content manageable at its most important research, discovery and developmental level.

Bosch.indd 24 21-02-2014 16:01:55

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The Danger of Superficial Knowledge

High-quality original parts pass through add i t i ona l hea t t r ea tmen t o r coa t i ng processes to ra ise the i r l i fespan and safety. Counterfeiters can only surmise these p rocesses bu t do no t possess the necessary engineering expertise to match that of the original manufacturer. If the defective component is already a couple of years old, pirates face an almost insoluble problem: They only see the part they want to copy in its worn-out form. They cannot know whether the original manufacturer has undertaken adaptions in the meantime, such as improving the machine’s performance or safety.

At first sight, replicated components often appear identical to the originals. In many cases, only the installation reveals that not all elements fit perfectly into the original machine. Gearwheels, for example, must interlock down to the tenth of a millimeter; otherwise they jeopardise the trouble-free production flow and can cause damages to the entire machine. Some counterfeiters have an astonishing amount of expert knowledge at their disposal, yet they are rarely able to bring this expertise in line with the special requirements of a certain industry’s or an individual product’s line concepts. As the demands of the industry fo r d imens ions , to le rances and o ther compatibi l i ty criteria change over t ime, repl icated parts cannot be assumed to conform to the state of the art.

False Economies

Machine components and spare par ts from original manufactures comply with the high in-house standards regarding mater ia l , p rocess ing and sa fe ty, and are cert i f ied and l icensed accordingly.

The user receives a qual i ty guarantee and is entit led to warranty. Businesses that instal l counterfeit parts and safety c o m p o n e n t s i n t o o r i g i n a l e q u i p m e n t w i l l l ose th is c la im. The GMP (Good M a n u f a c t u r i n g P r a c t i c e s ) o r I S O certi f icates required for product l iabil i ty c laims also lose their val idi ty, as only the or ig inal par ts can be ver i f ied and have been produced in compliance with these regulations.

The l i fe expectancy of copied parts is signif icantly lower than that of cert i f ied components from original manufacturers. If a component with a 40 per cent lower purchase pr ice has to be exchanged three t imes more often, the purchasers h a v e n o t a c h i e v e d a n y s a v i n g s . O n the con t ra ry : They mus t acqu i re and exchange replicas far more often, which in turn leads to more machine downtime and additional costs. Whilst original spare parts init ial ly lead to higher purchasing costs, they result in longer l i fe cycles for machines and ult imately in a lower total cost of ownership.

Invented for Life

Apart from manufacturing and delivering single parts, renowned original parts manufacturers offer their customers a broad after-sales service portfolio once the machine has been installed. This portfolio also includes maintenance and consulting services. On the basis of identification of components that are exposed to most wear and tear and the frequency of their replacement, customised maintenance plans can be defined and the spare parts management at the manufacturer’s site can be optimised. Owing to machine operations, components which are in direct contact with the spare part that is to be replaced will also wear out. The replacement of individual elements may not always be realistic given production demands. In such cases, replacement with tailor-made parts or complete assembly groups can be considered to help minimise machine maintenance downtime.

In cases where a customer has unknowingly purchased counterfeit components from a third party, these parts need to be removed and exchanged for originals. The experts can then conduct the required repair work, so that the machine is restored into its original state. In contrast to unlicensed parts producers, original producers manufacture components based on original drawings, which are archived regardless of the machine’s age.


At first sight, replicated components often appear identical to the originals. In many cases, only the installation reveals that not all elements fit perfectly into the original machine.

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The Task of Managing Big Data in the 21st Century

Al t h o u g h w e ’ v e b e e n h e a r i n g increased talk about Big Data, it’s not a new phenomenon. Big Data

has created challenges since the patent boom of the midcentury, when mammoth amounts of pharma patents challenged scientists’ abilit ies to keep up with new findings in their fields. By 1960, a pharma scientist would have had to read more than 1,000 patents just to stay current. And that’s not even considering the languages that scientist would have to be able to read: English, German, Japanese, and French.

Then back in the 1970s we witnessed the emergence of computer databases that had the ability to store, search and display chemical structures. Suddenly companies were able to build internal registry databases and online transactional services emerged. Bibliometrics was born. Data was now in a computable form and filters were available to sift through the volume of scientific and scholarly journals—whose numbers kept growing and growing.

Public sequence databanks came along in the early 1980s, which allowed available biological sequences to be identified by nascent sequencing technologies and in the 1990s, we witnessed the emergence of microarray technology that was able to simultaneously measure the expression levels of large numbers of genes, providing experimental data on an unprecedented sca le . Th i s gene ra ted ex t r ao rd i na ry excitement within the scientific community, but it wasn’t without its challenges.

Next generation sequencing in the 2000s built on previous breakthrough technologies and—as is typically the case—created its own host of new challenges. So, as far back as mid-century, Big Data had become an elephant that was difficult to manage. Interestingly, however, the elephant has only become bigger and more ornery as science, scholarship, and technology has advanced. It has reached an exhausting climax that companies seek to address.

The fact is humans can’t work with this Big Data directly. The answer is to reduce this seemingly insurmountable mountain of data to human proportions that we’re able to comprehend, use and appreciate.

Even if the unspecific, unscaled term “Big Data” fades away, the challenges of data integration and analytics will remain. Big Data is real, not a buzzword. It defines the challenges we face every day to effectively use and gain insight from all the available information out there. Being able to connect disparate data sets is just as important as having the data in the first place.

According to some estimates, the Big Data market could be worth more than $50 billion by 2017, and organizations are actively searching for solutions.

“Making Big Data Look Like Little Data.”

Many c l i en ts approach the B ig Da ta challenge by shrinking it into Little Data through customized in-silico experiments

The overwhelming abundance of opportunity presented by Big Data is enough to make a scientific head spin. When we consider the vast amount of value and analytics that exist in our scholarly and scientific universe, we understand that there’s a growing swath of causal, actionable data that could lead us and our clients toward more effective and efficient research and development.

Chris BoutonGeneral Manager Thomson Reuters Life Sciences

Big Data is real, not a buzzword. It defines the challenges we face every day to effectively use and gain insight from all the available information out there.

Big Data.indd 28 21-02-2014 16:06:27


that require building up data sets from incongruent sources. Little Data is reliable, ev idence-backed fac ts that sc ient is ts can use in models, v isual izat ions and analysis—it’s data that we’re equipped to handle in a practical way. Little Data i s v i t a l b e c a u s e i t ’ s a c t i o n a b l e a n d c a n h e l p c o m p a n i e s d e t e r m i n e h o w to make co re bus iness deve lopmen t d e c i s i o n s . T h i s s h r i n k i n g , h o w e v e r, r equ i res c ross - f unc t i ona l t eams and proves to be a signif icant challenge in data harmonization. It’s a grandiose task to filter the outputs of collected data so the correlations you need stand out among those you don’t. Example challenges faced by Big Data include:• C o n n e c t i n g i n t e r n a l c o n t e n t w i t h

external sources• Discovering unexpected associations• Scanning for novel information• Connecting document repositories with

structured sources• Achieving a competitive advantage• Catalyzing greater insights• Driving revenue growth

Thomson Reuters surveys have shown that the volume and variety of data behind the firewall of a typical pharma company is fast approaching a point where it exceeds the content from the outside. More than 45 percent of respondents said access to external content was their top challenge. O u r s u r v e y s a l s o s h o w e d a s t r o n g interest in NoSQL databases, linked data/semant ic web technologies and visual analytics as necessary tools to solve Big Data challenges.

Many organizations purchase high-quality content externally and generate significant data internally. All of this data—most of which is textually challenging—needs to work together, and organizations need to

be able to unlock its value. As if this isn’t daunting enough, the task usually needs to be done sooner rather than later.

Over the years, information professional have become skilled at extracting relevant content from the most valuable resources and reformulating and presenting those results to users; however, this process is unsustainable over the long-term and lends itself to an organizational bottleneck.

We have more data that we know what to do with—so much that we don’t know the things we know. We need to get the da ta in to a pa t te rn tha t has tang ib le meaning and then we have to translate that meaning into knowledge. Without an information provider to do that for you, you’re essentially lost. It’s like traversing through a forest of endless resources without a compass—you’re surrounded by the things you need, but have no direction to get where you’re going.

The answer to the B ig Data quest ion r e q u i r e s a t r u s t e d , r e s p e c t e d a n d effect ive mechanism to make content manageable at its most important research, discovery and developmental level. As organizations tap into the complicated and potentially lucrative aspect of Big Data management, it will be crucial for solutions to include reliable, linked data technology frameworks that allow content to be shared across appl icat ions and enterpr ise or community boundaries. This framework must then connect users with data from internal proprietary systems, as well as third-party resources.

T h e r e a l i z a t i o n o f u n e x p e c t e d associat ions—a cri t ical part of the Big Da ta managemen t p rocess—enab les c l ien ts to make new d iscover ies and pioneer new paths in their f ields. This is perhaps one of the most far-reaching c h a r a c t e r i s t i c s o f s o l u t i o n - b a s e d analytics. T h e a b i l i t y t o w h i t t l e B i g D a t a i n t o L i t t le Data in an effect ive, product ive and resourceful way is how information providers can best serve their c l ients. Litt le Data has the ontologies that can meld content from multiple sources, f i l ter the noise of large-scale analyses, provide context that enables users to fol low a train of thought, and power the analytics that turn content into insight. It isn’t just about the technology—it’s about knowing, understanding and appreciating the data env i ronment in a way that a l lows the information to f low in a relevant manner, which requires breaking down the walls between internal , external , publ ic and commercial content and putting the tools into the right hands.

T h e r e m a y n o t b e a s i n g l e c o r r e c t answer, but there are several right paths. Information providers have a history of building and maintaining Litt le Data so the elephant doesn’t run rampant across the scholarly scientif ic landscape. This is an opportunity for companies to build the nex t genera t ion o f so lu t ions tha t wi l l enable new d iscover ies, which is why we ’ re a l l in th is bus iness in the f irst place.


Over the years, information professional have become skilled at extracting relevant content from the most valuable resources and reformulating and presenting those results to users; however, this process is unsustainable over the long-term and lends itself to an organizational bottleneck.

Big Data.indd 29 21-02-2014 16:06:58


market research

Pharma Bio World reviews the results declared by selected Indian Pharma giants this quarter.

PHARMA Q3 RESULT HIGHLIGHTS FOR FINANCIAL YEAR 2013-2014

Tightening of regulatory vigilance and introduction of the new drug pricing policy have been few of

the key challenges this quarter. Ranbaxy faced with yet another ban now on its API manufacturing plant at Taonsa assured to take necessary actions to address all concerns of the USFDA in order to resolve them as early as possible. Nilesh Gupta, Managing Director, Lupin declared a robust quarter with record profits, driven in particular by strong business growth in the US. Glenmark stated its emerging markets business being their key growth driver. Biocon announced Q3 FY14 as a very eventful quarter with several research milestones across their novel molecules and biosimilars portfolio. The key highlight being the DCGI approval for CANMAb.

Ranbaxy Laboratories

Ranbaxy Laboratories reported consolidated sales of ` 28.6 billion in the quarter that ended in December 2013 and declared their earnings (before Interest, Tax, Depreciation & Amortisation) to be at ` 2.7 billion. In the domestic market, sales for the quarter were ` 5.8 billion. The Toansa facility was issued a US FDA Form 483 containing certain observations in Jan 2014. Subsequent to issuance of Form 483, the Company had voluntarily suspended shipments of API to the USA market from the facility out of abundant caution. Impact of the above mentioned development was ` 2.6 billion on account of stock write-offs in addition to other related costs.

Ranbaxy and EPIRUS announced signing of licensing agreement for BOW015, a

biosimilar version of Infliximab used in the treatment of rheumatoid arthritis. The product will be introduced in India and other Emerging Markets. Ranbaxy received Central Drugs Standard Control Organisation (CDSCO) approval to manufacture and market Synriam in India for the treatment of malaria. During the Quarter, 3 ANDAs were filed for the USA market by Ranbaxy.

Lupin Ltd.

Lupin showed net sales growth by 21 per cent to ` 29.83 billion during Q3, FY 2013-14, up from ` 24.66 billion in Q3, FY 2012-13. Net profit grew by 42 per cent to ` 4.76 billion during this quarter. Revenue expenditure on R&D stood at 9.1 per cent of net sales at ` 2.71 billion. The Indian formulations business contributed 22 per cent of the company’s overall revenues for the quarter which grew by 14 per cent, recording revenues of ` 6.5 billion.

Lupin filed 5 ANDAs and received 5 ANDA approvals in the quarter and received 5 approvals from European regulatory authorities.

Dr Reddy’s Laboratories

Dr Reddy’s declared consolidated revenues of ` 35.3 billion. R&D expenses were reported to be at ` 3 billion. Revenues from Global Generics segment for Q3 FY14 was ` 29.4 billion, YoY growth of

41 per cent primarily driven by North America and other Emerging Market territories while revenues from India for Q3 FY14 was reported to be ` 3.9 billion.

The weakened growth this quarter was impacted by the revised prices under new pharma pricing policy declared the company. During the quarter, 2 ANDAs were filed with the USFDA.

Sun Pharmaceuticals

Sun Pharma declared their net sales from operations to be at ` 42.87 billion, a growth of 50 per cent over the same quarter last year. Their sales from branded generics in India were at ` 9.47 billion, up by 20 per cent over Q3 last year. Their overall international revenues accounted for more than 75 per cent of total revenues for the quarter.

Sun Pharma generated a net profit at ` 15.31 billion compared to ` 8.81 billionfor Q3 last year, up 74 per cent over Q3 last year; resulting margin of 36 per cent.

Sale of branded prescription formulations in India was ` 9.47 billion, up by 20 per cent from Q3 last year. Consolidated R&D expense for Q3 FY14 was ` 3.06 billion, or 7.1 per cent of sales.

In the third quarter, ANDA for 5 products were filed. ANDAs for 4 products received approvals in the third quarter. ANDAs for 131 products now await USFDA approval, including 14 tentative approvals.

The weakened growth this quarter was impacted by the revised prices under new pharma pricing policy declared Dr Reddy’s.

MARKET RESEARCH.indd 30 21-02-2014 18:22:49


market research

Glenmark Pharmaceuticals

For the third quarter ended Dec 31, 2013, Glenmark’s consolidated revenue stood at ` 16 billion an increase of 15.92 per cent as against the previous corresponding quarter while their net profit for the third quarter was ` 2.1 billion.

Sales for the Formulation Business in India for the third quarter ended, was at ` 3.81 billion recording a growth of15.27 per cent. Glenmark Generics Inc, USA registered revenue from sale of finished

dosage formulations was ` 5.21 billion (USD 85.00Mn) for this quarter. Bicon Limited

Biocon declared their consolidated revenue at ` 7.19 billion with biopharmaceuticals generating a revenue of ` 5.17 billion. The branded formulations vertical grew at 15 per cent YoY in Q3 FY14 closing the period with 99 Crs in sales. Biocon’s R&D expenses this quarter stood at ` 0.2 billion.

The company announced the launch of CANMAb™, biosimilar Trastuzumab

Organisations

Consolidated Revenues Q3 FY 2013-14 (In Rs Billion)

Profit Q3 FY 2013-14(In Rs Billion)

Ranbaxy Laboratories 28.6 2.7*Lupin Limited 29.83 4.76

Dr Reddy’s Laboratories 35.3 6.2Sun Pharmaceuticals 42.87 15.31

Glenmark Pharmaceuticals 16.012 2.16Biocon Limited 7.19 1.05

*EBITDA

in India. Biocon entered into strategic collaboration with two organisations; namely Quark Pharmaceuticals, to develop a range of siRNA based novel therapeutics and Advaxis Inc for novel cancer immunotherapy. Biocon declared their plans to initiate a global Phase III trial for the generic Insulin Glargine with their partner Mylan.

MARKET RESEARCH.indd 31 21-02-2014 18:24:18


marketing initiative

as well as an aluminum single-beam crane system. The vacuum is generated by a dry-running pump with a suction capacity of 40 m³/h that provides a vacuum of -600 mbar.

Vacuum tube lifter with replaceable suction pads provides maximum versatility

While cardboard boxes are pi led directly on a palette, sacks must be packed in an addit ional cardboard box before palletizing. In order to meet both handling tasks, the vacuum tube l i f ter is attached to an easily moving aluminum single-beam crane system with a large working area 11 meters long and 5.5 meters wide. The compact design of the crane system ensures that i t can be used together with the vacuum tube l i f ter despite low room height without impairing the tube l i f ter’s l i f t ing capacity of 1,600 mm.

The JumboFlex is easily operated with its ergonomic handle for one-finger

V acuum tube l i f ter with replaceable suction pad facil i tates ergonomic and economical picking of sacks

and cardboard boxes in pharma logistics

Handling goods in the pharmaceutical industry is subject to a large number of requirements. The industry is characterized by national and international regulations result ing in high standards in the areas of quality as well as process and product safety. These do not only affect the entire production process but are also employed in pharma logistics. This means that for storage and transport processes, companies do not only have to observe various environment requirements, as in the case of production under clean room condit ions or handling of hazardous goods, but also labor law regulations. The fol lowing example shows how companies can meet such requirements in practice. Looking for a complete solution for sacks and cardboard boxes

For picking packaged goods, the company Lil ly Deutschland GmbH, based in Giessen (Germany) and a subsidiary of the international pharmaceuticals manufacturer Eli Li l ly and Company, rel ies on a material f low solution that also meets the work regulations of the American parent company. During implementation, technical as well as health-related and economical aspects were taken into account. Given that the use of l i f t ing aids for handling goods heavier than 10 kg is mandatory according to American labor law, the goods were f irst divided into weight classes of up to 10 kg and over 10 kg. The group also prescribes this for Li l ly, the German subsidiary. In Li l ly’s logistics center, sacks and cardboard

boxes f i l led with animal medicine or feed addit ives that weigh signif icantly more than 10 kg are picked every day. While cardboard boxes weigh 14 kg at most, sacks can be as heavy as 25 kg. Therefore, the responsible managers looked for a material f low solution that would cover the handling of both types of workpiece. At the same time, they wanted to deal with growing cost pressure in the industry.

After a detailed analysis of the company’s needs, J Schmalz GmbH was successful, prevail ing over several competitors. The vacuum special ist succeeded in combining the necessary f lexibi l i ty with the desired eff iciency in one handling system. The material f low solution for Li l ly consists of a JumboFlex 35 vacuum tube l i f ter designed for loads of up to 35 kg. The standard version of the tube l i f ter is already equipped with a quick-change adapter for taking up different suction pads. The system is completed by a suction pad for handling sacks and one for cardboard boxes,

Flexible Handling of Cardboard Boxes and Sacks

JumboFlex 35 vacuum tube lifter during cardboard box handling, attached to an aluminum single-beam crane system

Marketing initiative.indd 32 21-02-2014 16:17:32



The integrated quick-change adapter facilitates the use of a sack gripper for picking sacks

control and enables the user to control the up and down movement as well as the l i f t ing and lowering speed at al l working heights. In addit ion to that, you can use the handle to adjust the suspension height of the Jumbo Flex, so that the tube l i f ter can be adapted to the user’s individual requirements. This ensures a precise handling of cardboard boxes and sacks at Li l ly’s. The change from the sack gripper to the double suction pad for taking up the cardboard boxes and vice versa takes just a few seconds and no tools, which reduces unproductive changeover t imes to a minimum. The sack gripper is 255 mm long and 175 mm wide and equipped with a f lexible seal. The material used offers high elasticity and a good thermic and chemical resistance. The double suction pad for the cardboard boxes consists of two f lat suction pads of the size 140 x 70 mm, which are mounted on a 250-mm beam. Both suction pads can be swivelled by 90° and rotated without l imits, which al lows picking up from the side and f lexible posit ioning in large containers or on palettes.

At Li l ly’s, this individual material f low solution made up of standard components met with great satisfaction.

Regardless of the comparatively small investment, the requirements in terms of productivity and f lexibi l i ty were ful ly met. The system runs for one shift and is operated by one person. The ergonomic design of the workplace now makes the picking of packaged goods signif icantly more comfortable. Moreover, the present arrangement prevents fatigue and physical overstrain. This makes the vacuum tube l i f ter a valuable investment, also from the employees’ perspective.

The company

Schmalz India Pvt Ltd, Pune is the 100 per cent subsidiary of J Schmalz GmbH, headquartered in Glatten in the

Black Forest, Germany, is one of the leading suppliers of vacuum technology worldwide. Its portfol io includes high-quality products and services in the area of automation, handling and clamping technology. Founded in 1910, the company with a proud tradit ion, offers innovative and eff icient vacuum solutions to customers from many different industries. The company has a total of 600 employees at i ts headquarters in Glatten (in the Black Forest region of Germany) and at i ts 16 overseas branch off ices.

Contact for questions:Schmalz India Pvt. Limited, EL 38, J Block, MIDC, Bhosari,Pune 411 026. Tel: 020 40725500Email: [email protected]: www.schmalz.com

Double suction pad for handlingcardboard boxes

Sack gripper for handling plastic sacks

Marketing initiative.indd 33 21-02-2014 16:17:40



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The Panel PC 900 takes full advantage of the state-of-the-art projected capacitive touch screen also used in the Automation Panel widescreen display series. With an edge-to-edge, anti-glare glass surface and high-resolution monitors, maximum functionality and an advanced design have been integrated into a single operator panel. Displays ranging from 15.6” to 24” with Full HD resolution ensure that every possible requirement is covered.

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These multi-touch displays allow new and innovative user interactions, such as zooming with two fingers or quickly paging forward with swipe gestures. In addition, two-hand gestures for critical or potentially dangerous operations provide an effective way of preventing unintentional operator errors.

Compatible

Systems in the Panel PC 900 series are available as widescreen displays in addition to the traditional 4:3 format. Equipped with an analog resistive touch screen and display sizes ranging from 12.1” to 19”, Panel PC 900 single-touch systems provide full compatibility with the previous device generation with respect to screen resolution and dimensions.

Fanless

Many Panel PC 900 variants can be operated without fans. Used together with SSD drives and/or CFast cards, these systems completely eliminate rotating components, making maintenance work such as regularly replacing the air filter a thing of the past.

About B&R

B&R is a privately owned 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 process 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

Fast, Fanless and Flexible

The Panel PC 900 is available in a wide range of sizes and configurations.

BuR_PR13170_Panel PC 900.indd 34 21-02-2014 16:19:06


news features

Trials and Tribulations

Clinical trial in India is always in the shade of controversy. Recent news about unethical trials and trial related death have made laymen more sceptical about clinical trials. This article tries to shed light on the controversies and taboo related to clinical trials.

Over recent years, Indian clinical research landscape has undergone a sea change. India emerged as one

of the preferred locations for clinical trials by the multinational pharma companies. It all started when restrictions on drug trials were relaxed by Indian government in 2005 to bolster its clinical research sector. Beside the favorable laws and regulation, several factors like low cost of conducting trials and availability of highly skilled professionals with English speaking skills, strengths in science and technology, access to a large patient population with diverse race and ethnicity and good patient recruitment, retention and compliance rates lured western companies to shift their clinical trial destination to India. In less than no time, India began to be referred as ‘Global hub of clinical trial outsourcing’.

As every coin has two sides, the new status also brought so many controversies. The main allegation is that patients are coerced into clinical trials without their consent. There is an argument that illiterate patients are lured into trials by offers of free medication and financial inducements. They are often unaware of risk in participating trials.

“It is an erroneous allegation,” Objects Dr Suresh Menon, Executive Committee Member & Chair – Regulatory Council, Indian Society for Clinical Research.

“The conduct of clinical research is governed by international and local guidelines which include the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines. These guidelines include the Informed Consent process which

clearly stipulates what a study patient must understand before participating in a clinical trial. The informed consent process involves the investigator informing the patient and their family, where necessary, of all the details of the study prior to his/her participation in a study. This is done in local language and is supplemented with written material again in local language. If the patient is unable to read/write, an impartial witness needs to be present during the entire informed consent discussion and must sign the Informed Consent Form. The Informed Consent Form must be signed by the patient or impartial witness and the doctor prior to the subject’s participation in a study, and a copy of the signed form must be handed over to the patient to keep. The Informed Consent Form and all other supporting material are reviewed and approved by the Ethics Committee of the hospital where the study is being done."

"Therefore, there are already very strict guidelines and procedures in place to ensure that a patient understand all aspects of the trial he or she is participating in and has consented to participate in the study of his or her own free well. A patient also has the right to refuse to be part of a clinical trial at any point in time once he/she is enrolled and can leave at any time and for any reason,” explains Suresh Menon.

Another major accusation on clinical trials is related to death in clinical trials. Recently, in a written reply in the Lok Sabah, Health Minister Ghulam Nabi Azad stated that total number of deaths related to clinical trials during three years from 2010 were 54 while the casualties and injuries during the year of 2013 were still to be assessed. Source: The Daily Telegraph

Trials and tribulations.indd 35 21-02-2014 16:22:23


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While critics says these figures may be merely passed on by the government from the private conductors of the trials and often the doctors overseeing the trial and the drug companies themselves determine the causes of fatality, government argues most of the patients enrolled in the trials only to have died during the course of the trials and not as a result of the trials. Even though a drug is passed to the human trial only after it successfully completes in-vitro testing and animal testing, the side-effects of a new drug are always unknown, and may cause serious injury or even death. In such cases, the trial conductors are obliged to make compensation to the trail subject. As compared to the foreign countries, in India, the trial conductors need to pay only a pittance as compensation to the victims. But, there are cases where compensation denied to trail-victims.

“Sponsors of clinical research are not against compensation and in fact have been paying compensation for a few years now where causality has been established. The industry concerns all this while has not been whether compensation should be paid or not as much as in ensuring a standardised compensation formula that is transparent, objective and all encompassing. However, a compensation formula on its own will be ineffective until such time as we have more clarity on the compensation guidelines that were introduced in January, 2013. Stakeholders across the spectrum have raised concerns with some of the rules within the guidelines as some of these are against the basic tenets of research and act as a disincentive to do research in the country."

"While there are indications from the regulatory authorities that these concerns will be addressed and Minutes of the DTAB Meeting addressing them have

been made public, we are still waiting for the changes to be effected. Only once these changes are in place will we have more clarity on the real impact of the compensation-related developments and whether it balances the interests of all stakeholders,” says Suresh Menon.

Also, it is the responsibility of concerned regulatory body to make sure that new drugs tested in India will actually benefit patients locally, and then be made available to them at reasonable prices.

As controversies surrounding the conduct of clinical trials are growing in India, the government has made some progress to ensure a tighter regulatory framework that assure safer and more secure environment for the conduct of clinical trials.

“Over and above existing guidelines, there have been several regulations and guidelines introduced this year with a view to enhancing the safety of patients in a clinical trial and ensuring better governance of clinical trials in the country,” elaborates Suresh Menon.

“The regulators now need to ensure that industry concerns on some of the pending issues like compensation guidelines are addressed on priority, the backlog of clinical trial applications are addressed and that there is sufficient machinery and resources to manage the roll out and implementation of the recent guidelines and notifications. Currently there is a lack of confidence of stakeholders in doing clinical research in India due to the uncertainty and unpredictability of regulatory developments. If we do not address this on priority, India will lose out in the quest to discover and develop new medicines and in ensuring that patients have access to these medicines. It is a battle of confidence that regulators need

Currently there is a lack of confidence of stakeholders in doing clinical research in India due to the uncertainty and unpredictability of regulatory developments.

to win in ensuring the progress of the industry,” adds Suresh Menon.

As India is working to tighten the regulatory framework, it also raises a question. Weather the strict regulation will prompt MNCs to shift their clinical research operations elsewhere? Indian clinical research landscape is still in nascent stage as compared to rest of the world. India has 16 per cent of the world’s population and 20 per cent of the global disease burden and yet, less than 2 per cent of global trials take place in India. So, implementing more rigid regulations may adversely affect Indian clinical research landscape.

Suresh Menon says it is a baseless fear. “A stricter regulatory environment is not a deterrent for clinical research as stakeholders want a more robust and regulated environment. What has been a deterrent is the uncertainty and instability in the Indian regulatory environment coupled with activism. Although the regulatory authorities have been taking several steps to create a more robust regulatory framework in 2013, there is still lack of clarity on many issues. This has eroded the confidence of Indian and global biopharma companies, research and teaching institutions and not for profit organisations in doing clinical research in India and we have seen a decline in the number of clinical trials done in India in the last nine months and trials being moved to other countries,” concludes Suresh Menon.

A central tenet of clinical research is that it should benefit wider society. There are lots of misconceptions about clinical trials. As in every profession and industry, there are players who operate at both ends of the spectrum and there may be a couple of instances where guidelines are not followed. But, if we have to find better and more cost effective cures for these diseases in a population that is multi-racial and heterogeneous, it is necessary to conduct more clinical research in India.

- Mahesh Kallayil

Trials and tribulations.indd 36 21-02-2014 16:22:39


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Endorsing “Quality”

Here is an account of US FDA Commissioner, Dr Margaret A Hamburg’s recent 9 day visit to India presented by Ananya Sen

The US FDA Commissioner was recently in India for a 9 day visit that ended on 19th of February. During

her visit she constantly emphasised on ‘Quality’ that Indian drug manufacturers need to build to ensure compliance and therefore safety of patients.

While a lot has been talked about and discussed on the FDA’s heightened inspections especially during Hamburg’s stay, Yusuf K. Hamied, Chairman, Cipla Limited, in an interview to a leading Indian Business Daily commenting on US FDA’s regulatory vigilance in India said,"Let them (US) not buy from us, then (if they are not satisfied). Today, fifty per cent of the drugs sold in the US comes from India but they can’t manufacture”. He further added, “It is very important for the US government and the FDA there to notify and update us as and when they change rules.”

Anand Sharma, Indian Minister of Commerce and Industry after meeting Hamburg said,“We are going to give a non-paper (to the US) overall on some of our concerns, when it comes to duration for the registration process for the filing". During the meeting concerns over unnecessarily stringent penalties and FDA inspections were discussed. “Most of the time, audit inspections were not followed by a discussion with the companies and if clarifications were sought (by USFDA) in some cases, harsh decisions were taken even before clarifications were given”, Sharma brought up during the meeting.

Ghulam Nabi Azad, Health Minister responded FDA Commissioner saying, that affordable drugs should not mean they are cheap and spurious. During this meeting between Azad and Hamburg, a Statement of Intent on Cooperation in the Field of Medical Products, was signed between India and US which seeks sharing of information between the two nations primarily to establish a better regulatory understanding.

In a meeting of CEOs of leading Indian pharmaceutical companies with Hamburg, Arun Sawhney, Managing Director, Ranbaxy Laboratories expressed the company’s disappointment over US FDA’s strict decision on Ranbaxy. He appealed to the FDA Chief to allow them to export from their banned facilities to compensate for the expenses that will be incurred in taking remedial measures. However, Dr Hamburg turned down the request.

During her stay in India, Hamburg on the FDA blog wrote, "Unfortunately, the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms". She also wrote about FDA’s plan to collectively work together with India to ensure the export of safe and high quality products from Indian drug makers. She spoke about the participation of the Indian drug and food regulators in FDA-hosted workshops.

Yusuf K. Hamied, Chairman, Cipla Limited, in an interview to a leading Indian Business Daily commenting on US FDA’s regulatory vigilance in India said,” Let them (US) not buy from us, then if they are not satisfied.”US FDA Commissioner, Margaret Hamburg with

Indian officials

Endorsing “Quality”.indd 39 21-02-2014 16:35:31


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"We think this is a critical moment in time, when we have to think and act in new ways, and that requires real commitment as national regulators to work as a coalition of global regulators," FDA Commissioner Margaret Hamburg told reporters.

"Around 40% of the drugs in the US are imported. Around 80% of the active ingredients are imported mainly from China and India. And that is why it is so important that the Indian regulator really

"Around 40% of the drugs in the US are imported. Around 80% of the active ingredients are imported mainly from China and India. And that is why it is so important that the Indian regulator really joins us at the table, because they are so important in the global marketplace for medical products,"

joins us at the table, because they are so important in the global marketplace for medical products," stated Hamburg expressing her concern over the shortage of drug supply in the United States. FDA also announced their decision of increasing manpower in the office here in India.

All through her visit she didn’t for once move away from her core focus on ‘Quality’. She emphasised on the same thought even during her visit to the Taj

Mahal appreciating the diligence that was involved in building it and that involved in maintaining the same. Over and over again the one thing that came up from her meetings and discussions was that the American regulatory Agency is up for no compromise at the cost of their consumers. Nevertheless an attempt to understand and address challenges faced by both countries is certainly commendable.

References

The Economic TimesBusiness StandardFDA Voice: http://blogs.fda.gov/

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Endorsing “Quality”.indd 40 21-02-2014 16:38:03


pharma news

DCGI Nod for SPARC Breast Cancer DrugThe Drug Controller General of India (DCGI) has given approval for Paclitaxel Injection Concentrate for Nanodispersion (PICN), breast cancer treatment medicine from Sun Pharma Advanced Research Company (SPARC).

The company noted that PICN was found to be equally effective and safe when compared to Abraxane in a cl inical study in metastatic breast cancer patients. The medicine is approved in India for both the 260 mg/m2 and 95 mg/m2 doses to be administered every 3 weeks. It offers the convenience of a quick and easy one-step dilution and infusion preparation for heal thcare profess ionals . PICN can be admin is tered in a short 30 minute infusion and unl ike conventional pacl i taxel formulations it does not require pre-medication and does not lead to any significant hypersensitivity reaction. SPARC has licensed Sun Pharmaceutical Industries (SPIL) or its assignee to manufacture, promote and distribute PICN in the Indian market. As a part of the arrangement, SPARC is eligible for milestone and royalty income.

Aurobindo Gets FDA Approval for Repaglinide Tablets

AstraZeneca to Shut Down Avishkar

Aurobindo Pharma Limited has received the final approval from the US Food & Drug Administration to manufacture and market Repaglinide Tablets USP 0.5 mg, 1 mg and 2 mg. The product is ready for launch.

Repaglinide Tablets USP 0.5 mg, 1 mg and 2 mg are the generic equivalent of Novo Nordisk Inc’s Prandin Tablets USP 0.5 mg, 1 mg and 2 mg and indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The market size of the product is estimated to be USD 274 million for the twelve months ending November 2013 according to IMS. Aurobindo now has a total of 189 ANDA approvals (164 Final approvals including 7 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

As a part its ongoing global restructuring exercise, AstraZeneca has decided to close down Avishkar Research and Development Centre in Bengaluru later this year. This will have an impact on 168 full-time employees who work on pharmaceutical development and drug discovery research into neglected tropical disease, tuberculosis and malaria.

The Existing projects in Avishkar site will either be transferred to the company’s Macclesfield site in the UK or possibly be carried out by external providers. Employees affected by the changes will start leaving the company by the end of April.

Zydus Cadila to Market Arthritis Drug in US

BCPL Gets New MD

Mylan Launches Generic Trastuzumab in India

Ahmedabad-based Cadila Healthcare (Zydus Cadila) has received final approval from the US drugs regulator US Food and Drug Administration (USFDA) to market Etodolac Extended-release Tablets USP, 400 mg, 500 mg, and 600 mg. The drug is used to treat juvenile arthritis, rheumatoid arthritis and osteoarthritis.

The group now has 88 approvals and has so far filed 216 ANDAs since the commencement of filing process in FY 2003-04.

The Ministry of Chemicals & Fert i l isers has appointed E A Subrahmanian, CEO of HLL Biotech, as the Managing Director of Bengal Chemicals and Pharmaceuticals Limited (BCPL). Subrahmanian, a chemical engineering graduate from Kerala, is in charge of the project implementation of the ` 600 crore integrated vaccine complex being set up near Chennai. He is also heading the revival projects of the three government vaccine manufacturing units, BCG VL Chennai, CRI Kasauli and PII Coonoor. BCPL Kolkata was established in 1901 by the eminent scientist P C Roy. It is the first drug manufacturing company in the public sector in the country.

Mylan Inc announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched the world’s f i rst trastuzumab biosimilar in India. The product, which wil l be marketed by Mylan under the brand name Hertraz, is a biosimilar to Roche’s Herceptin. Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths, 440 mg and 150 mg.

Hertraz was approved by the Drug Controller General of India. In support of this approval, Mylan conducted an extensive series of physicochemical and functional assays to demonstrate similarity to the reference brand Herceptin. These analytical methodologies confirmed the high degree of molecular similarity as well as biological activity of Hertraz. In addition, Mylan conducted a multi-centre clinical trial to demonstrate comparable safety and efficacy to the reference product.

Trastuzumab is one of the f ive bio logic products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercial isat ion r ights for biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries and co-exclusive commercialisation rights with Biocon for product in India.

Final Pharma News.indd 41 21-02-2014 16:40:27


pharma news

Syngene, India’s leading contract research organisation and Baxter International Inc, a leading global pharmaceutical company, have collaborated to establish the Baxter Global Research Centre at Syngene, in Bengaluru.

The Centre was inaugurated by Ghulam Nabi Azad, the Honorable Minister of Health and Family Welfare, Govt of India, in the presence of U T Khader, Minister of Health & Family Welfare, Govt of Karnataka, S R Patil, Minister of IT, BT & ST, Govt of Karnataka, Keshav Desiraju, Secretary, Dept of Health & Family Welfare, Govt of India and Srivatsa Krishna, Secretary, Dept. of IT, BT & ST, Govt. of Karnataka. The Baxter Global Research Centre (BGRC) at Syngene, is a part of Baxter’s global strategy of building R&D collaborations with strategic partners.

According to reports, at a closed-door meeting with US Food and Drug Administration (US FDA) Commissioner Margaret Hamburg, Ranbaxy Managing Director Arun Sawhney had requested to to lift the ban on its manufacturing facilities as the company was taking remedial measures to rectify the issues flagged.

Last month, the US Food and Drug Administration (USFDA) had prohibited the company from producing and distributing drugs for the American market from its Toansa plant. The import alert on Toansa plant was in addition to the alerts already in place on its Dewas, Paonta Sahib, and Mohali facilities.

In her polite but detailed response, Hamburg has turned down Ranbaxy Laboratories’ plea.

GenVec, Inc has achieved the third milestone in its collaboration with Novartis for the development of treatments for hearing and balance disorders. In January 2014, Novartis filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) for the clinical development of CGF166, the lead product candidate under the collaboration. The IND was deemed effective on February 7, 2014 and this triggered a USD 2 million milestone payment to GenVec under the terms of the collaboration.

SCHOTT to Track Pharmaceutical TubingSCHOTT is supporting the pharmaceutical industry in its efforts to track the tubing used to produce pharmaceutical packaging made of glass. The company issued its 1 millionth certificate for its FIOLAX glass tubing just recently. These certificates help to identify the products shipped as tubing that are subsequently processed into pharmaceutical packaging, vials or syringes, for example. These documents contain more detailed information on the dimensional quality and the quality of the glass. This enables pharmaceutical companies to track their packaging all the way back to the raw material “glass tubing,” if necessary.

Traceability is currently one of the most pressing issues for the pharmaceutical industry. It is closely related to more stringent requirements for quality and safety in manufacturing, shipping and administering medicines. SCHOTT became the first company in the industry to allow for all of the pharmaceutical tubing it manufactures to be identified back in 1999. The certificates are applied to the pallet in a clearly visible position and enable customers to inspect incoming shipments more easily because they contain plenty of detailed information.

Ghulam Nabi Azad Inaugurates Baxter Global Research Centre at Syngene

US FDA Turns Down Ranbaxy’s Plea to Lift Ban

GenVec Achieves 3rd Milestone in Novartis Collaboration

UL EduNeering, a leading provider of compliance and knowledge management solutions, and the US Food and Drug Administration (FDA), have extended their Cooperative Research and Development Agreement (CRADA) for f ive additional years, extending the agreement to 2019. FDA’s CRADA with UL is the only learning technology agreement of its kind between FDA and a private-sector company. This new agreement will expand the learning resources of the Office of Regulatory Affairs’ virtual university, UL EduNeering and FDA originally collaborated and co-developed the ORA-U infrastructure in 1999, to train the agency’s food, drug and medical device investigators.

Global production of FDA-regulated products has quadrupled over the last decade and continues to grow. Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. 40 per cent of finished drugs come from overseas, and 80 per cent of active ingredients manufacturers are located outside the US. Further, half of all medical devices are imported.

US FDA, UL EduNeering Extend Partnership

“Hearing loss and balance disorders negatively impact the lives of millions of people worldwide, and CGF166 represents a novel approach to bringing relief to this population,” said Douglas E Brough, PhD, GenVec’s Chief Scientific Officer. “We look forward to studying this product candidate in the clinic and finding out more about its potential.”

“We are very excited that our novel regenerative approach to addressing the leading cause of hearing loss will soon be in clinical testing,” said Douglas J Swirsky, GenVec’s President and CEO. “The next milestone payment available to GenVec under our Novartis collaboration will be triggered by the first patient visit in the planned Phase 1 clinical trial of CGF166.”



pharma news

inVentiv Health has extended its partnership with NeuroVive Pharmaceutical AB, a publ ic ly-traded Swedish biotech f i rm spec ia l is ing in drugs that t reat acute card iovascu lar and neurological conditions.

inVentiv Health works with pharmaceutical and biotechnology firms to help define innovative alternatives to traditional development and commercialisation models. inVentiv offers mid-size pharmaceutical and biopharmaceutical companies an expansive set of services that run from early-stage cl inical development to ful l global commercialisation. The breadth of inVentiv Health’s services is unique in the industry and includes comprehensive drug development, risk management, market access and reimbursement, launch, marketing communications, payer relations and patient outcomes.

NeuroVive, with a promising portfolio of mitochondrial drugs in development to treat acute cardiovascular and neurological conditions, has been evaluating various collaborations with large pharmaceutical companies and contract research organisations to reduce risk and increase cost efficiencies. They are currently in the planning stage for commercialisation of their lead product, CicloMulsion, now in a phase III study to determine the drug’s effectiveness in reducing cardiac damage following stenting in heart attack patients.

Endo Health Solutions has confirmed that the United States District Court for the District of Delaware ruled that United States Patent No. 5,464,864, Endo’s patent covering Frovatriptan, the active ingredient in Frova (Frovatriptan succinate) tablets, is valid and infringed.

The Court’s decision prevents Mylan from marketing its generic version of Frova in the US before Endo’s patent expires November 8, 2015, pending possible appeal by Mylan.

Endo Health Solutions Inc is a US-based specialty healthcare company with four distinct business segments that are focused on branded and generic pharmaceuticals, devices and services and provide quality products to its customers while improving the lives of patients.

In another development, Endo announced that its Qualitest subsidiary has completed the acquisition of privately held Boca Pharmacal, a specialty pharmaceutical company, for approximately USD 225 million in cash. Boca Pharmacal is a specialty generics company that focuses on niche areas, commercialising and developing products in categories that include: controlled substances, semisolids, and solutions. Boca Pharmacal’s commercial footprint and R&D pipeline is expected to be a strong complement to Qualitest.

Avanir Submits NDA for AVP-825 Avanir Pharmaceuticals, Inc has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of AVP-825, its innovative Breath Powered investigational drug-device combination product for the acute treatment of migraine.

The company’s 505(b) (2) NDA for AVP-825 includes data from one pivotal phase III clinical trial for the acute treatment of migraine. The NDA is also supported by data from a phase II placebo-controlled clinical trial for acute treatment of migraine, and two pharmacokinetic studies. Overall, the submission includes safety data from 222 subjects who received AVP-825 in clinical trials, and references data from the extensive clinical use of sumatriptan over the past 20 years.

AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilising a novel Breath Powered delivery technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.

The Breath Powered delivery technology is activated by user ’s breath to propel medications deep into the nasal cavity where absorption is more efficient and consistent than through most other routes. A user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity completely.

Sanofi Files Eli Lilly for Patent Infrigement Sanofi f i led a patent infr ingement suit against El i Li l ly and Company on January 30, 2014 in the United States District Court for the District of Delaware. In its suit Sanofi alleges infringement of four patents.

The sui t was t r iggered by not i f icat ions received f rom Li l ly beginning in mid-December, in which Lilly stated that it had filed a NDA (505(b)(2) New Drug Application) with FDA for an insulin glargine drug product. Lilly also stated that its NDA included a paragraph IV certification challenging six of the seven Sanofi patents listed in the FDA Orange Book for Sanofi’s Lantus and Lantus SoloStar products.

Lilly has also stated that it will not launch its product before the expiry of Sanofi’s patent on the active ingredient in Lantus, which is in force through February 12, 2015.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris and in New York.

inVentiv, NeuroVive Extends Partnership

US Court Rules Endo’s Frova Valid



pharma news

AMAG Pharmaceuticals, Inc has announced that the United States Patent and Trademark Office (USPTO) has issued a new US patent to AMAG for ferumoxytol, US Patent No. 8,591,864, Polyol and Polyether Iron Oxide Complexes as Pharmacological and/or MRI Contrast Agents, expiring in March 2020. This patent is directed to compositions that include the chemical structure and to 500 mg to 600 mg unit doses of ferumoxytol. This patent is l isted in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the United States Food and Drug Administration.

“We are pleased to announce this new patent for ferumoxytol that is especially important for the long-term value of a product that generated 28 per cent revenue growth last year in the United States,” commented Frank Thomas, chief operat ing officer of AMAG.

AMAG now has five Orange Book-listed patents for ferumoxytol, with patent protection through March 2020, without patent term extension. AMAG has applied for a patent term extension for an Orange Book-listed ferumoxytol patent, which would lengthen that patent term through June 2023.

Ace l la Pharmaceut ica ls , LLC, a spec ia l ty pharmaceut ica l company, has announced the approval and launch of Loutrex Topical Cream following a successful 510(k)1 notification with the Food and Drug Administration (FDA), which determined that Acella’s 510(k) submission was equivalent to another legally US-marketed device and at least as safe and effect ive as the predicate.

The approved 510(k) (Loutrex) is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatit is such as itching, erythema, scaling and pain. The product helps relieve dry, waxy skin by maintaining a moist wound and sk in env i ronment , wh ich i s bene f i c ia l to the healing process.

“ I would l ike to thank Acel la ’s Research and Development Team and Akesis, LLC (Lake Wylie, SC) for their work with the FDA to help get Loutrex to our customers,” stated Allen Fields, Vice President, Head of Research and Development for Acella Pharmaceuticals.

Algorithme Pharma has announced that their clinical facility located in Montréal, Québec, has recently been expanded to become a 7-unit clinic with 265 beds for increased trial capacity. The modern design enhances the participant experience with 3 independent lounges, soundproof dormitories and facility-wide complimentary WiFi. With the open concept processing and nursing areas, the company now have an increased flexibility in conducting complex study designs for our sponsors.

Vanda’s HETLIOZ Gets FDA NodVanda Pharmaceuticals Inc announced that the US Food and Drug Administration (FDA) has approved HETLIOZ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ is the first FDA approved medication for Non-24.

Non-24 was first described more than 60 years ago, and is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder.

The approval of HETLIOZ was based on two key efficacy studies and the safety has been evaluated in over 1,300 individuals.

The most common adverse reactions in the clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection. After taking HETLIOZ, patients should limit their activity to preparing for going to bed because HETLIOZ can impair the performance of activities requiring complete mental alertness.

Vanda anticipates making HETLIOZ commercially available in the second quarter of 2014.

USPTO Issues New Patent to AMAG’s Ferumoxytol

Acella Pharma Introduces Loutrex Topical Cream

Algorithme Pharma Expands Montreal Clinical Facility

Pharmaceutical major Lupin Limited announced the acquisition of Nanomi BV in the Netherlands. With this acquisition, Lupin has made i ts foray in to the technology intensive complex injectables space.

Nanomi has patented technology platforms to develop complex injectable products. Nanomi has a rich talent pool of scientists who would be backed by Lupin’s global R&D and manufacturing teams.

Commenting on the acquisition, Vinita Gupta, Chief Executive Officer, Lupin Limited said “We are very pleased with the acquisit ion of Nanomi. With the use of Nanomi’s proprietary technology platform, Lupin would be able to make significant in-roads into the niche area of complex injectables.”

Lupin Acquires Nanomi BV



pharma news

Valeant to Buy Precision Dermatology

Valeant Pharmaceuticals International, Inc has entered into a definitive agreement under which Valeant will acquire PreCision Dermatology, Inc for USD 475 million in cash, plus an additional USD 25 million payable upon the achievement of a sales-based milestone. PreCision develops and markets high quality dermatology products with leading products such as Locoid, Hylatopic, Clindagel, and BenzEFoam. PreCision expects to have approximately USD 130 million in revenue in 2014. The transaction is expected to close in the first half of 2014 and Valeant expects the transaction, once completed, to be immediately accretive to Valeant’s cash earnings per share.

PreCision operates in two key segments: Onset Dermatologics, which focuses on prescription therapies, and PrecisionMD, which focuses on physician dispensed products. The Company is based in Cumberland, Rhode Island and has approximately 175 employees.

JP Morgan Securities LLC acted as exclusive financial advisor to PreCision, and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP acted as legal advisor to PreCision. Sullivan & Cromwell LLP acted as legal advisor to Valeant.

DSP, Edison Amend Licensing Pact

Ab l y n x , Me rc k S i g n Resea r ch Collaboration & Licensing Deal

Dainippon Sumitomo Pharma Co, Ltd (DSP) has entered into an agreement with Edison Pharmaceuticals, Inc that amends the license agreement between the two companies relating to EPI-743 and EPI-589, therapeutic agents under development for mitochondrial disease. As of the same date, in addition, a joint research agreement for discovery of novel candidate pharmaceutical compounds targeting cellular energy metabolism and a stock purchase agreement for DSP’s purchase of an equity in Edison have been concluded.

Through the joint research with Edison which has a very strong position in the development of EPI-589 in North America and the research and development of therapeutic agents for Mitochondrial disease and related diseases, DSP aims to become an established leading company in this domain and offer innovative therapeutic agents to as many patients as possible. It should be added that implementation of the three Agreements mentioned above is subject to fulfillment of the conditions of and completion of statutory procedures based on the US Antitrust Law.

Ablynx has entered into a second research collaboration and licensing agreement with a subsidiary of Merck & Co, known outside the US and Canada as MSD.

Valeant Pharmaceuticals International, Inc has entered into a definitive agreement under which Valeant will acquire PreCision Dermatology, Inc for USD 475 million in cash, plus an additional USD 25 million payable upon the achievement of a sales-based milestone. PreCision develops and markets high quality dermatology products with leading products such as Locoid, Hylatopic, Clindagel, and BenzEFoam. PreCision expects to have approximately USD 130 million in revenue in 2014. The transaction is expected to close in the first half of 2014 and Valeant expects the transaction, once completed, to be immediately accretive to Valeant’s cash earnings per share.

PreCision operates in two key segments: Onset Dermatologics, which focuses on prescription therapies, and PrecisionMD, which focuses on physician dispensed products. The Company is based in Cumberland, Rhode Island and has approximately 175 employees. JP Morgan Securities LLC acted as exclusive financial advisor to PreCision, and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP acted as legal advisor to PreCision. Sullivan & Cromwell LLP acted as legal advisor to Valeant.

Rexam PLC, a leading global beverage can maker, announces the proposed sale of the Pharmaceutical Devices and Prescription Retail Packaging divisions of its Healthcare business for USD 805 m in cash.The Healthcare business has three divisions: Pharmaceutical Devices, Prescription Retail Packaging and Closures & Containers. Rexam is in discussions regarding the sale of Closures & Containers and will provide an update in due course.

Montagu Pr ivate Equi ty has made a b ind ing offer for the Pharmaceutical Devices and Prescription Retail Packaging divisions for a total of USD 805m in cash.

Valeant to Buy PreCision Dermatology

Rexam to Sell Healthcare Business to Montagu Private Equity

This new exclusive collaboration and licensing agreement is focused on the discovery and development of several predefined Nanobody candidates (including bi- and tri-specifics) directed toward so called “immune checkpoint modulators,” proteins believed to provide potential targets for the development of cancer immunotherapies, a rapidly emerging approach to the treatment of a wide range of cancer types.

Under the terms of the agreement, Ablynx will receive an upfront payment of EUR 20 million and up to EUR 10.7 million in research funding during the initial three year research term of the collaboration. In addition, Ablynx is eligible to receive development, regulatory and commercial milestone payments on achieved sales thresholds for a number of products with ultimate potential to accrue as much as EUR 1.7 billion plus tiered royalties. Merck will be responsible for the development, manufacturing and commercialisation of any products resulting from the collaboration.



pharma news

Venus Remedies Gets US Patent for Achnil

EffRx Pharmaceuticals SA has signed exclusive distr ibution agreements with three leading local pharmaceutical companies in Italy, Spain and Portugal for Binosto - EffRx’s innovative osteoporosis medication. Under the terms of the agreement, EffRx grants exclusive marketing authorisation and distribution rights to Abiogen Pharma SpA for Italy, Lacer SA for Spain, andLaboratorios Atral SA for Portugal. Binosto is the first and only buffered solution for the treatment of osteoporosis, delivering fracture-risk reduction at the hip & spine. Binosto is administered as an effervescent tablet for oral solution and offers convenience for the patient. Binosto is currently marketed in the United States, and approved in Europe and Australia; approvals in other territories are pending. Binosto was originally developed by EffRx through an agreement with Merck & Co, Inc granting EffRx worldwide rights to all Merck effervescent and related patents protecting alendronate.

Teva Pharmaceutical Industries Ltd has announced that the US Food and Drug Administration (FDA) granted full approval of SYNRIBO (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA. SYNRIBO is indicated for adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).

“With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of SYNRIBO, we believe healthcare providers can be even more confident in the clinical profile of this important medicine,” said Rob Koremans, MD, President and CEO, Global Specialty Medicines.

Actavis plc has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Bendamustine Hydrochloride for Injection, 25 mg/vial and 100 mg/vial. Actavis’ ANDA product is a generic version of Cephalon’s Treanda, a treatment for chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.

Cephalon, Inc filed suit against Actavis on January 31, 2014, in the US District Court for the District of Delaware seeking to prevent Actavis from commercialising its ANDA product prior to the expiration certain of US patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Genzyme, a Sanofi company, announced that Mexico’s national regu la tory author i ty, COFEPRIS, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting

EffRx to Market Binosto in Italy, Spain and Portugal

Teva’s Leukemia Drug Gets FDA Nod

Actavis vs Cephalon

Mexico Okays Genzyme’s Lemtrada

Venus Remedies Ltd, a research-oriented global pharmaceutical company, has bagged a patent from the United States Patent Office for Achnil, a once-a-day painkiller injection developed by the Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies. The patent will remain in force till 2032.

“The formulation will be commercialised in the US market through technology transfer/outlicensing of exclusive marketing rights

route and we are open for such deals,” said Venus Remedies Chief Financial Officer Dheeraj Aggarwal.

Containing aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), Achnil is a pioneering product developed by the VMRC in its efforts to develop a controlled release formulation based on the novel drug delivery system. While the US represents the largest market for pain management worldwide, NSAIDs account for 28 per cent of the global painkiller market, the size of which was USD 10.22 billion in 2013. The share of injectables in this market is 15 per cent, making it a market worth USD 1.5 billion. Expected to grow at a compound annual growth rate (CAGR) of 3.1 per cent, this potential market for Achnil will be worth USD 1.75 billion by 2018.

Dheeraj Aggarwal Chief Financial Officer, Venus Remedies

forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations. Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up. Approval in Mexico follows the recent approvals of Lemtrada in Canada, Australia and the European Union. Lemtrada is currently not approved in the United States. In December, Genzyme received a complete response letter from the FDA on its application for US approval of Lemtrada. Genzyme plans to appeal the agency’s decision. Marketing applications for Lemtrada are also under review in other countries. More than 2.3 million people worldwide have been diagnosed with MS, including approximately 15,000 people in Mexico. Lemtrada has been granted orphan drug designation in Mexico. Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.



pharma news

Ma l l i n c k r o d t t o Bu y Cadence PharmaceuticalsMall inckrodt plc, a leading global specialty pharmaceuticals company, and Cadence Pharmaceuticals, Inc have entered into a definitive agreement under which a subsidiary of Mallinckrodt plc will commence a tender offer to acquire all outstanding shares of Cadence Pharmaceuticals, Inc. for USD 14.00 per share in cash or approximately USD 1.3 billion on a fully diluted basis, which represents a 32 per cent premium to the trailing 30-trading-day volume weighted average price (VWAP) of USD 10.62 per share for Cadence Pharmaceuticals, Inc.

Subject to customary terms and conditions, the parties expect the transaction to close in mid- to late-March. Mallinckrodt expects the acquisition will be immediately accretive to its fiscal year 2014 adjusted diluted earnings per share, and significantly accretive to its fiscal year 2015 adjusted diluted earnings per share.

Oramed Seeks FDA Nod to Initiate ORMD 0801 Phase 2a Trial

Gilead Submits NDA for Genotype 1 HCV Drug

Oramed Pharmaceuticals Inc, a clinical-stage pharmaceutical company focused on the development of oral drug del ivery systems, has submitted a protocol to the US Food and Drug Administration (FDA) to initiate a Phase 2a trial of its orally ingestible insulin capsule, ORMD 0801, for type 1 diabetes.

The protocol was submit ted under Oramed’s ex is t ing IND for ORMD-0801 to include both type 1 and type 2 diabetes indications. The double-blind, randomised, placebo controlled, seven-day study design will be carried out at an inpatient setting on twenty-four type 1 diabetic patients. This US- based study is expected to start later this quarter. Oramed proposes to introduce ORMD-0801 to reduce the mealtime insulin doses, introducing a treatment regimen which would allow for fewer daily injections. Moreover, oral administration offers the benefit of reduced systemic exposure and may enable tighter regulation of b lood sugar levels by di rect ly affect ing glucose control in the liver.

Gilead Sciences, Inc has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. The data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (HCV) infection, with treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Approximately 75 percent of

Aegerion Pharmaceuticals, Inc has announced that Health Canada has granted a Notice of Compliance (NOC) approving Juxtapid as an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH). HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.

Based on the risk of liver toxicity, Juxtapid is subject to a risk management plan in Canada. Due to its benefit-risk profile, the prescribing of Juxtapid should be limited to physicians experienced in the diagnosis and treatment of familial hypercholesterolemia. The safety and effectiveness of Juxtapid have not been established in patients with hypercholesterolemia who do not have HoFH, or in pediatric patients.

Mast Therapeutics, Inc has entered into a definitive agreement to acquire Aires Pharmaceuticals, Inc, a privately-held, clinical stage pharmaceutical company developing therapies to treat pulmonary vascular disorders such as pulmonary arterial hypertension and pulmonary hypertension due to heart failure. Aires’ lead product, AIR001, is an intermittently nebulised formulation of nitrite and has orphan drug status with the US Food and Drug Administration and the European Medicines Agency for the treatment of pulmonary arterial hypertension.

Under the terms of the all-stock transaction, Aires would become a wholly-owned subsidiary of Mast Therapeutics, Inc in exchange for shares of Mast common stock representing approximately 6 per cent of Mast’s outstanding common stock, 80 per cent of which would be subject to a six-month holdback for certain indemnification claims of Mast. There are no milestone obligations payable to Aires.

Health Canada Okays Aegerion’s Juxtapid

Mast Therapeut i cs to Acqu i re Aires Pharma

people infected with HCV in the United States have the genotype 1 strain of the virus.The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomised to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis.



pharma news

Jazz Pharmaceuticals Introduces Versacloz in USJazz Pharmaceuticals plc announced US commercial availability of Versacloz (clozapine, USP) oral suspension, the first and only oral suspension clozapine for severely ill treatment-resistant schizophrenia patients or those at risk of recurrent suicidal behavior with schizophrenia or schizoaffective disorder.

Versacloz is an atypical antipsychotic indicated for the treatment of people with schizophrenia who have failed to respond adequately to other therapies. Versacloz is also approved to reduce the risk of recurrent suicidal behavior in people with schizophrenia or schizoaffective disorder who are at chronic risk for re-experiencing suicidal behavior. Versacloz has a unique, tasteless formulation and can be administered in an outpatient setting or under the supervision of a healthcare professional through an oral suspension. This formulation helps eliminate the mixing and matching of pill dosage strengths. In institutional settings, the formulation may help with confirmation of administration, and may reduce the possibility of “cheeking,” hiding, or sharing the medication.

Because of the risk of agranulocytosis with clozapine therapy, Versacloz will be available only through a restricted program called the Versacloz Patient Registry, which ensures appropriate monitoring of white blood cell and absolute neutrophil count prior to delivery of the next refill of medication. As part of its ongoing commitment to the psychiatry community, Jazz Pharmaceuticals, through the Versacloz Patient Registry and experienced Clinical Compliance Liaisons, will provide blood monitoring and reporting support services not typically offered by generic clozapine manufacturers.

Truven Health Analytics has announced the global availability of its new Micromedex Pharmaceutical Knowledge solution, specifically designed to meet the needs of professionals in the pharmaceutical and associated business sectors.

Forty-four of the top 50 pharmaceutical companies around the world rely on Micromedex Solutions for trusted, global drug evidence. The new Micromedex Pharmaceutical Knowledge solution offers a unique, role-based interface for advanced searching across multiple databases, drug results customisation and data export, to better support research efficiencies in the pharmaceutical (non-hospital) business setting.

“By partnering closely with our customers at every stage in the development of this solution, we’re confident our goal of creating a tailored, more productive pharmaceutical user experience has been achieved,” said Thomas Hegelund, Senior Vice President and General Manager with Truven Health Analytics. “The new Pharmaceutical Knowledge solution brings together the trusted evidence and global guidance of Micromedex clinical content with specific functionality our pharmaceutical customers’ business demands.”

Truven Health Analytics is providing dedicated trainers with pharmaceutical sector experience, tailored promotional support and user engagement programs to help raise organisational adoption and ensure customers receive the most value from the solution experience.

Cardiome Pharma Corp’s subsid iary, Correv io GmbH, has entered into an agreement with Tamro AB, headquartered in Gothenburg, Sweden, to distr ibute BRINAVESS (vernakalant IV) to customers in the Swedish market.

“We are delighted to have entered into this distribution agreement with Tamro, a leader in pharmaceutical distribution in Sweden,” said Karim Lalj i , Cardiome’s Chief Commercial Off icer. “Our agreement will allow orders for BRINAVESS to be rapidly fulfilled and shipped to hospital customers. Coupled with the posit ive real-world effectiveness data from Skåne University Hospital in Malmö, Sweden that demonstrated conversion to normal sinus rhythm in approximately 70 per cent of patients treated with BRINAVESS who were experiencing atrial fibrillation of less than 48 hours duration, we expect Sweden wil l be a key market for BRINAVESS growth.

Financial detai ls of the agreement have not been disclosed.

BioMarin Pharmaceutical Inc announced that the US Food and Drug Administration (FDA) has approved VIMIZIM (elosulfase alfa) for patients with Mucopolysaccharidosis type IVA.

VIMIZIM is an enzyme replacement treatment for Morquio A syndrome, which affects an estimated 3,000 patients in the developed world. The disease occurs as a result of a deficiency of activity in an enzyme involved in glycosaminoglycan (GAG) metabolism. The pervasive and progressive accumulation of GAGs leads to significant morbidities and multisystemic clinical impairments resulting in diminished functional capacity, impaired quality of life, and early mortality. The most common features of the disease are progressive skeletal dysplasia, the need for frequent surgical procedures related primarily to musculoskeletal or respiratory dysfunction, and significant limitations in mobility, endurance, and breathing.

Shipments of VIMIZIM to the distribution channels will commence immediately, and BioMarin will begin promotion of VIMIZIM in the US immediately.

Tr u v e n L a u n c h e s M i c r o m e d e x Pharmaceutical Knowledge Solution

Tamro to Market Cardiome’s Brinavess in Sweden

US FDA Approves BioMarin’s VIMIZIM



biotech news

Dyad ic Completes Expans ion o f Netherlands Research Centre

Domain, XOMA Ink Drug Discovery Collaboration

AVEO, Astellas Halt BATON Breast Cancer TrialAVEO Oncology and Astellas Pharma Inc have jointly decided to discontinue the BATON (Biomarker Assessment of Tivozanib in ONcology) breast cancer clinical trial, a Phase 2 study in patients with locally recurrent or metastatic triple negative breast cancer, due to insufficient enrollment. AVEO previously announced that enrollment in this study had been slower than anticipated, and enrollment rates did not improve substantially following additional patient recruitment efforts. The BATON-BC study initiated patient enrollment in December 2012 in a randomised, double-blind, multicenter Phase 2 clinical trial, evaluating the efficacy of tivozanib in combination with paclitaxel compared to placebo in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer who have received no more than one systemic therapy for advanced or metastatic breast cancer.

Separately, as announced in December 2013, data from a planned interim analysis of the Phase 2 study of tivozanib in patients with colorectal cancer indicate that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.

Domain Therapeutics, a biopharmaceutical company specialising in the research and development of new drug candidates targeting G protein-coupled receptors (GPCRs), has entered into a multi-step collaboration with XOMA Corporation (XOMA), a leader in the discovery and development of therapeutic antibodies.

Domain Therapeutics and XOMA will jointly evaluate the robustness of DTect-All to identify allosteric modulator antibodies of a first target. If successful, the partners may elect to further collaborate on other GPCRs from a set of preselected targets for which, under the terms of the agreement, Domain Therapeutics will be eligible for an upfront payment and certain undisclosed milestones per target, as well as undisclosed royalties.

Domain will have the right to offer its DTect-All platform to discover antibody-based drugs to other companies outside the scope of the set of GPCRs selected by XOMA.

Allosteric modulator antibodies are expected to display superior selectivity and safety over classic GPCR drugs. Domain’s technology has the potential to overcome the limitations of other technologies to discover this class of antibodies with novel mode of action. The majority of ongoing GPCR antibody discovery and development programmes are dedicated to the identification of antagonist entities, which induce an inhibition of the GPCR signalling.

Dyadic International, a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes, and other proteins for the bioenergy, bio-based chemical, biopharmaceutical and industrial enzyme industries, has announced that the expansion of its research laboratory in The Netherlands is now complete.

Danai Brooks, Chief Operating Officer, Dyadic, stated that commercial interest in

Dyadic’s C1 expression technology has increased with new end markets, such as biopharmaceuticals, and new customers, such as BASF. By investing in our R&D capabilities, we are able to expand our new product development pipeline, take on additional projects with our strategic partners, and invest in strengthening the technology platform. We are extremely excited about several new projects commencing in 2014 and we expect to provide additional details about these projects in the coming weeks. Floor space at Dyadic Netherlands has significantly increased, allowing for the installation of a wide range of state-of-the-art research equipment including a new fermentation lab. In addition, the expansion will facilitate the housing of new scientists who were recently hired for the new C1-technology projects. Dyadic increased its scientific staff by 40 per cent in 2013 and plans to continue hiring molecular biologists, enzymologists and fermentation specialists through 2014.

Danai BrooksChief Operating Officer, Dyadic

AbbVie to Start Manufacturing Unit in SingaporeAbbVie Inc has announced a USD 320 million investment to establish operations in Singapore for small molecule and biologics active drug substance manufacturing. The completed facility will provide manufacturing capacity for emerging compounds within AbbVie’s oncology and immunology pipeline to serve markets globally.

The investment will establish the first manufacturing presence in Asia by AbbVie. Other AbbVie operations in Asia include research and development (R&D) functions in Tokyo, Japan and Shanghai, China, as well as commercial operations throughout the region. AbbVie’s existing presence in Singapore includes 120 personnel, supporting commercial operations, global R&D and general operations.

The investment is expected to result in additional headcount of more than 250 new employees. AbbVie anticipates the new facility will be fully operational by 2019.

Biotech News_Final.indd 49 21-02-2014 16:41:47


biotech news

ArQule’s Partner Kyowa Hakko Kirin Commences Tivantinib Phase 3 Trial

Targacept Closes Recruitment in Phase 2b Trial of TC-5214

BioMarin Selects BMN 250 for the Treatment of MPS II IB

ArQule, Inc has reported the announcement by its partner, Kyowa Hakko Kirin Co Ltd of the initiation of a Phase 3 clinical trial evaluating tivantinib (ARQ 197) in Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma treated with one prior sorafenib therapy.

The trial is a randomised, double-blind placebo-controlled study to compare progression-free survival (PFS) in patients treated with tivantinib with those treated with placebo. Kyowa Hakko Kirin plans to enroll approximately 160 patients in this study.

“With the commencement of this study, two Phase 3 trials are now ongoing worldwide to evaluate the impact of tivantinib therapy in second line HCC,” said Brian Schwartz, Managing Director, Chief Medical Officer, ArQule. “We are also enrolling patients in the ongoing pivotal, randomised, double-blind METIV-HCC trial, being conducted in the West by ArQule and our partner, Daiichi Sankyo Co, Ltd, under a Special Protocol Assessment (SPA) agreement.”

Targacept, Inc, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, has completed recruitment of patients in its Phase 2b clinical study of TC-5214 as a treatment for overactive bladder (OAB). The company expects to report top-line results from the study in mid-2014. TC-5214 acts potently on alpha3beta4 and other neuronal nicotinic receptors (NNRs) located in or around the bladder that are believed to play a key role in bladder contraction and signaling of the urge to urinate.

The ongoing Phase 2b study is a double blind, placebo controlled, randomised, parallel group study being conducted at sites in the United States. The study’s co-primary endpoints are change in micturition frequency per 24 hours and change in urinary incontinence episodes per 24 hours, in each case from baseline to 12 weeks. The study is designed to randomise approximately 750 patients and includes a 3- or 5-week screening period followed by a 12-week treatment period during which patients receive either one of three doses of TC-5214 (0.5mg, 1mg or 2mg) or placebo twice daily, randomised in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a 2-week follow-up period.

BioMarin Pharmaceutical has selected a new drug development candidate, BMN 250, a novel fusion of alpha-N-acetyglucosaminidase (NAGLU) with a peptide derived from insulin-like growth factor 2 (IGF2), for the treatment of Sanfilippo B syndrome or Mucopolysaccharidosis type IIIB (MPS IIIB). BioMarin has initiated IND-enabling studies and expects to initiate clinical studies with BMN 250 in mid-2015.

Discovered by BioMarin, BMN 250 is an enzyme replacement therapy using recombinant human NAGLU with an IGF2, or Glycosylation Independent Lysosomal Targeting (GILT) tag. BMRN 250 is delivered directly to the brain using BioMarin’s patented technology.

BioMarin has issued patents which broadly cover delivery of lysosomal enzymes directly into the cerebrospinal fluid to treat lysosomal storage diseases.

“We are pleased to add an exciting new candidate to our pipeline that could be a potentially first-in-class therapy for Sanfilippo B patients who currently have no drug treatment options available,” said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin.

Jean-Jacques Bienaimé, Chief Executive Officer BioMarin

US FDA Accepts Regado ’s IND Application for REG2Regado Biosciences, Inc, a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, has announced that the United States Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose Phase 1 clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future.

REG2 is comprised of a subcutaneous depot formulation of Regado’s aptamer-based anticoagulant pegnivacogin designed for a slower onset of activity and a durable antithrombotic effect. Like REG1, it is paired with an intravenous (IV) bolus formulation of anivamersen intended to be used as an active control agent, if needed.

REG2 is an early clinical-stage programme evaluating an extended release formulation of pegnivacogin, the same Factor IXa inhibiting anticoagulant used in REG1. REG2 is formulated for subcutaneous depot injection and is intended to provide a controllable level of anticoagulation for up to two weeks for sub-acute uses, especially in cases where a patient may be unable to swallow an oral anticoagulant. Regado is developing REG2 for potential uses in a variety of acute and sub-acute care cardiovascular indications.



biotech news

Hong Kong Patent for Biondvax’s Universal Flu Vaccine

Advax is , SynCo B io S ign Drug Manufacturing Deal

BiondVax, a developer of a universal flu vaccine, has received approval from Hong Kong’s patent office to register its patent concerning Multimeric Multiepitopes for its universal flu vaccine, as well as an approval from the US patent office for the completion of the testing process for patent registration. As part of the US registration process, the patent was found eligible and currently is pending fees.

The patent addresses the vaccine structure and composition as well as the manufacturing methods and the usages of the universal flu vaccine, while providing scope for possible changes in the structure of the protein that is the basis for the universal vaccine. The patent extends and secures the coverage provided by existing patents that protect BiondVax’s intellectual property.

These approvals in Hong Kong and the US build on patent approvals already received in Australia, China, Russia and Mexico. In parallel, the Company is in the process of registering the patent in other locations worldwide such as Europe and Israel.

Advaxis, Inc, a biotechnology company developing the next generation of cancer immunotherapies, and SynCo Bio Partners BV (SynCo), have signed an agreement for SynCo to manufacture Advaxis’ novel drug candidate, ADXS-HPV. Under the agreement, SynCo will assist Advaxis in developing scale-up and commercial manufacturing processes for ADXS-HPV bulk drug substance and drug product. Advaxis plans to initiate registrational trials this year with ADXS-HPV for the treatment of cervical cancer.

“SynCo’s ability to manufacture both drug substance and drug product for ADXS-HPV will offer us increased flexibility as we expand our manufacturing process in preparation for commercial-scale production,” commented Daniel J. O’Connor, Chief Executive Officer of Advaxis. “To have the support of a world class manufacturer, such as SynCo, is pivotal to our ability to make ADXS-HPV available to patients on a global scale, upon approval.”

ADXS-HPV has demonstrated improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV. ADXS-HPV is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and neck cancer, and a Phase 1/2 in anal cancer.

Avaxia Biologics Gets US Patent for IBD Treatment

Avaxia Biologics, Inc, a clinical-stage biopharmaceutical company developing gut-targeted therapeutics, was awarded US Patent No 8,647,626, entitled “Compositions Comprising TNF-specific Antibodies for Oral Delivery.”

The patent covers milk-derived anti-TNF antibodies that are orally administered within a broad dose range for the treatment of Inflammatory Bowel Disease (IBD). The

claims also cover use of these antibodies for the treatment of IBD. Importantly, the patent broadly covers Avaxia’s lead product, AVX-470, which recently completed a Phase 1b clinical trial in ulcerative colitis.

Barbara S Fox, PhD, Chief Executive Officer of Avaxia, said, “This patent award is an important milestone for our company. This is the first in a series of patents that Avaxia expects to receive on the composition of our lead clinical-stage candidate, AVX-470. Avaxia will continue to build on its strong intellectual property portfolio in the gut-targeted antibody therapeutics field.”

Barbara S Fox, PhD, Chief Executive Officer, Avaxia

Agenus Acquires 4-Antibody Agenus Inc, a biopharmaceutical company developing novel immunotherapeutics, including a portfolio of checkpoint modulators (CPMs), anti-cancer vaccines and adjuvants, completed the previously announced acquisition of 4-Antibody AG, a private European-based biopharmaceutical company.

The acquisition includes the Retrocyte Display technology platform which enables rapid discovery and optimisation of fully human antibodies against a wide array of molecular targets.

For the past three years, 4-Antibody has been applying Retrocyte Display to create therapeutic antibodies to six key checkpoint targets that regulate immune response to cancers and other diseases. The company has multiple preclinical immune CPM programmes in development.

In this transaction, Agenus acquired all outstanding stock of 4-Antibody for approximately 3.3 million shares of Agenus common stock, plus additional contingent payments, payable in cash or Agenus common stock, that may exceed USD 40 million based on the combined company achieving certain milestones. Agenus intends to continue 4-Antibody’s operations in Basel, Switzerland and Jena, Germany, and to retain the 4-Antibody management team as part of the combined company.

In addition, Shahzad Malik, MD, General Partner at Advent Venture Partners, 4-Antibody’s largest investor, has been appointed to Agenus’ Board of Directors upon the closing.



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Check weigher Model CW 600HSA uses the state-of-the-art technology weigh cell (EMFC) to achieve greater accuracy in dynamic weighing at high speed. The system provides 100 per cent online weighing, ensuring compliance with International Standards of pharma, food, chemical and cosmetic industries.

Check weigher Model CW 600HSA also improves production line profitability through significant reduction in product giveaway. The entire system made from SS, designed for easy removal for cleaning purpose.

Features 100 product memory; height adjustment for ease of integration with exiting line; variable conveyor speed control to match the inlet speed; facility for dynamic weight compensation; display of net weight; statistical data of total accept, total reject, standard deviation; percentage of rejection, range value, etc, on graphic LCD display.

Check Weigher

For more information, please contact:Fluidyme Process Flow TechnologiesE-2/4, Popular Prestige Off Highway BridgeWarje, Pune, Maharashtra 411 058E-mail: [email protected]

Agitators

Principle of the system is to recover any substance from the main product for further process. The system is built in fabricated structure incorporated with vacuum pump, motor, automatic valves, pipings, switches and control panel. The capacity of the vessel for collection of the substances is

approximately 200 litres. The vessel is manufactured in food grade SS-316. The liquid ring vacuum pump develops vacuum in the vessel. The suction nozzles are bypassed through the storage vessel for its connecting point. The suction nozzle functions with vacuum sensor, which is connected to foot operated switch on both sides of the unit for dual operation.

The company provides hydro/pneumatic circuit for automatic disposal of the substance to other subsequent processes as may be feasible and the needs of customers.This system is used mainly in seafood processes, pharma industries, chemical applications, distillation and recovery processes in any industries.

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Fluid bed technology offers several advantages such as the product lump formation/caking, no particle overheating/cooling, a well-defined product residence time, uniform product quality, better energy economy due to lower specific heat requirements, etc. In fluid-bed, the material is suspended in an upward moving hot air and the mass behaves like a boiling fluid after fluidization.

The fluid-bed dryers are most suitable for drying granular, crystalline, coarse or similar material. It is also from the bottom of the container, which has got perforations of SS fine wire mesh. Hot air passes through the product container, turbulence in the product is obtained, and hence the product moves up and down in the product container.

Due to this the heat transfer is quick and the product is dried fast without appreciable loss of heat. The fluid-bed dryers are not suitable for drying liquids of pasty materials. The fluid bed dryer will be complete with 2,800 RPM, TEFC motor blower, control panel with timer, two temperature gauge, filter bag, SS-316 quality container with trolley and heater or steam radiator.

For more information, please contact:Bombay Pharma Equipments Pvt LtdGala No: 2, P V K Compound, Laxminarayan Mandir MargKherani Road, Saki Naka, Mumbai 400 072Tel: 022-28594877, 28521608, Fax: 91-022-28521608E-mail: [email protected]

Tray Dryer

For more information, please contact:Amkette Analytics Ltd ANM House,Plot No: A-141, Road No: 23, Wagle Indl Area, Thane (W), Maharashtra 400 604Tel: 022-66141500, Fax: 91-022-66681600E-mail: [email protected]

Matec Applied Sciences offers easy to use particle size and Zeta potential analyser, the patented Zeta-APS.

APS sample analysis is quick and easy without requiring sample dilution. Simply pour or continuously pump your sample into the APS sample cell and the

APS’ intuitive software does the rest in minutes.

APS acoustic attenuation measurements can be made on high concentration and/or opaque samples. Particle setting is not a problem since samples can be stirred or pumped during measurement. APS analysis is independent of the sample’s Zeta potential level. The APS readily analyses particles of zero, as well as high electric charge. It analysis opaque and/or highly viscous samples.

The APS uses software patented by Lucent Technologies to calculate detailed PSD data without the need for assumptions regarding the PSD shape.

Particle Size Analysers with Zeta Potential

For more information, please contact:Brilliant Pharma MachineryUnit No: 1, 2 & 14, Modern Indl Estate, Next to Paras Indl Estate, Opp: IPOLWaliv Phata, Vasai (E), Dist: Thane, Maharashtra 401 208Tel: 0250-3293636, 2454015, Fax: 91-0250-2454015E-mail: [email protected]

Fluid Bed Dryers

Bombay Pharma Equipments Pvt Ltd offers electrical/steam/oil heating mode tray dryer designed for uniform circulation of hot air in the drying chamber.

In small dryers the material is placed on trays, which slide into the drying

cabinet, while in large installations the interior may be designed for the wheeling in of trolleys containing the trays. The simplest form of heating places the sources of heat, eg, a steam coil or electrical coil, at floor level and relies on natural convection. Fans provide a forced circulation of air across the trays. Air flows in axle direction over each shelf in turn. The wet material spread directly on the shallow trays resting on the shelves. Electrical elements (heater) or steam-heated pipes are positioned so that air is periodically reheated after it has cooled by passage over the wet material on one shelf before it passes over the material on the next shelf. Tray dryer is a type of fixed bed dryers, ie, the bed of the material to be dried is stationary.



PTWS 310, PTWS 610, PTWS 1210 and PTWS D610 constitute the PTWS Series of tablet dissolution testing instruments. All instruments are equipped with a central, automated pollar lift and integrated protocol printer.

The PTWS310 combines compact design with state-of-the-art features and a comprehensive supply scope, which includes a synchronous TM tablet drop magazine. It is fully compliant to the valid USP <711/724> and EP <2.9.3/4> pharmacopoeia. The PTWS 310 is secure in its handling and features the

Monoshaft stirrer tool design for all USP/EP stirring tools. The vessels are arranged in two rows (4+4) and are easily removable after driving up the instrument head. The Plexiglass water bath is equipped with a water diffuser for an even temperature distribution. The standard supply includes 1 litre vessel but smaller 250 ml mini vessels and mini paddles can be used as well. Furthermore, the PTWS 310-2 instrument variant is equipped to handle 2-litre vessels.

Cole-Parmer offers lightweight portable temperature freezer, developed to bring ultra-low -86°C temperature storage to places conventional compressor freezers cannot go or won’t work. It weighs less than 19 kg, making it ideal for benchtop or fi eld applications. It offers secure mobile transport

of biological specimens. Ideal for use within biorepositories and other applications associated with pharma distribution.

Operating on a stirling engine, the freezer requires no compressors, dry ice, or LN2, and draws the same amount of energy as a conventional light bulb, making it environmentally friendly and cost effective. The Humm free-piston stirling engine contains two moving parts that fl oat on helium gas bearings to eliminate contact wear. The linear driver modulates engine power to deliver cooling on demand for straight line control without On/Off cycling. Freezing is performed by the thermosiphon evaporator. A microcharge of environmentally friendly cooling medium creates a uniform ultra-low temperature by a continuous process of evaporation and condensation within the sealed tube.

For more information, please contact:Cole-Parmer India403-404, Delphi-B, Hiranandani Business Park, Powai,Mumbai 400 076Tel: 022-67162253, 6716222, 67162209, Fax: 91-022-67162211E-mail: [email protected] / [email protected]

For more information, please contact:Agilent TechnologiesUnit Nos: 105-116, 1st Floor, Splendor ForumPlot No: 3, Jasda Vihar, New Delhi 110 025Tel: 011-46237100E-mail: [email protected]

Agilent Technologies Inc offers the third version of its Intelligent System Emulation Technology for the 1290 Infinity Binary LC and 1290 Infinity Quaternary LC systems. The new ISET version allows emulation of the Waters Acquity UPLC and Acquity H-class systems and the Shimadzu Prominence HPLC system.

ISET provides a seamless transfer of methods between varying LC technologies, delivering unchanged retention time and peak resolution. The 1290 Infinity LC is now the world’s most adaptive LC system, as it can execute other HPLC and UHPLC methods and deliver the same chromatographic results without any instrument or method changes.

The 1290 Infinity LC together with ISET allows users to emulate other (U)HPLC instruments with a simple mouse click; run existing (U)HPLC methods without modifying method or system; deliver same retention times and peak resolution for -enhanced method transfer.

Emulation Technology for Liquid Chromatography Systems

For more information, please contact:Pharma Test Instruments India Pvt LtdNo: 2, 2nd Floor, Sree Datri Niwas, Nagwara CircleOuter Ring Road, Opp: Manyata Softech ParkBengaluru, Karnataka 560 045E-mail: [email protected]

8-Station Dissolution Testing Instruments

Portable Ultra-Low Temperature Freezer



STEER displays a versatile 40 mm Mega Special Plus extruder with new technology to utilize full motor power of 160 kW at screw speeds of 625, 750, 1,000 and 1,200 rpm. The Mega Special Plus shares the general purpose Do/Di of 1.55 with earlier MEGA models, with the added features of a continua shaft for improved safety and reliability apart from the availability of STEER proprietary line of conveying and mixing elements.

In addition STEER offers OMICRON 12. This machine will process RESOMER (PLGA Polymer), an EVONIK brand product. OMICRON 12 PHARMA co-rotating twin-screw laboratory extruder is specially designed for pharma industry. The ability of this hot melt extrusion system is to generate

outstanding dispersive and distributive mixing. It can produce material at an extremely low output rate, which helps in lowering the cost of development of new products.

STEER’s Alpha and OMEGA line of extruders features a process section with a Do/Di of 1.49 and 1.71 respectively. Both extruders have the tightest and most optimized screw to screw gaps in the industry. The result is a lower shear signature during processing and enhanced product quality due to narrowed residence time distribution.

For more information, please contact:Cole-Parmer India403-404, Delphi-B, Hiranandani Business Park Powai, Mumbai 400 076Tel: 022-67162253, 6716222, 67162209, Fax: 91-022-67162211E-mail: [email protected] / [email protected]

The Cole-Parmer rotational viscometer series offers greater chemical resistance, enabling the instruments to handle chemically corrosive materials. Each is designed with SS-316 spindles, a sealed keypad and over/under range alarms.

You can determine the dynamic viscosity of samples in applications such as food, adhesives, petroleum products, biofuels, paints, pharma, chemicals, etc. Over/under range alarm sounds when your sample is too high/low for the spindle selected. All models feature 10 language options, pushbutton control with easy-to-use menu system, motor self-test, user enabled calibration to a known standard and universal power supply.Select from basic, intermediate, and advanced models.

Rotational Viscometer Series

For more information, please contact:E14 Technologies Pvt Ltd141-A Great Western BldgMedows Street Ext, Fort, Mumbai 400 001Fax: 91-022-2222831652E-mail: [email protected]

E14 Technologies & Techno-Sciences of United States of America, offers NOVAView, a ful ly integrated, economical , high-speed bl ister packing inspect ion system to help meet the str ict requirements of pharmaceut ical packaging l ines.

Features easy to instal l on most exist ing machines; supports PVC and ALU-ALU; no f i l l detect ions, breakage and size var iat ions; intui t ive 7” touch screen wizard based UI; real t ime textual and image logs; and 21 CFR Part 11 compl iant.

Blister Packing Inspection System

For more information, please contact:STEER Engg Pvt Ltd290, 4th Main, 4th Phase, Peenya Indl AreaBengaluru, Karnataka 560 058Tel: 080-23723309, Fax: 91-080-23723307E-mail: [email protected]

Extruders



events diary

4th Annual Vaccine World Summit 2014 Dates: 4-6th March 2014Venue: Hyderabad

The Vaccine World Summit is the most sought after vaccine conference for India and rest of the developing country manufacturers. The Summit will be the definitive meeting place for vaccine industry players to come together to establish and renew partnerships to help develop new products, acquire new technologies, and establish new relationships.

Contact:Chamindika KonaraTel: +65 6493 2097Email: [email protected]

2nd Edition Healthcare & Pharma Expansion SummitDate: 7th March 2014Venue: Mumbai

The demand for Healthcare services in India is poised to grow exponentially to cater to a growing old age population, with rising incidence of lifestyles diseases, rising incomes and affordability, and increased penetration of health insurance. Another key segment of the Healthcare Industry is the Pharmaceutical Industry that contributes a significant portion of the overall revenues in the Indian Healthcare Industry.

The 2nd Edition Healthcare & Pharma Expansion Summit 2014, Mumbai sources and presents leading global case studies from top Healthcare & Pharma Sector & Service providers across India. The summit is packed full of issues & challenges faced as well the opportunities that lies within for the year 2014.

Contact:Ashfan KarkalExito Media Concepts Pvt. Ltd.#677, 2nd Floor, 13th Cross, 27th MainSector - I, HSR LayoutBengaluru - 560102 (India)Tel: (080) 42015540 / 6570 5295Fax: (080) 42012720Email: [email protected]/[email protected]

The 7th Annual Pharma Resource Planning and Portfolio Management Conference Dates : 12-13th March 2014Venue : Philadelphia, USA

The 7th Annual Pharma Resource Planning and Portfol io Management Conference wil l take the delegation beyond the tradit ional approaches to programme forecasting and budgetary al locations and put them in touch with cutt ing edge strategies and methodologies that wil l prepare them to achieve a comprehensive and balanced portfol io.

Achieving a balanced portfol io in terms of new product development, l i fecycle management and business development and l icensing is key to reducing risk and growing franchise sales. With patent expiry of key blockbuster drugs, approaching l i fecycle management is very popular but over rel iance on this approach can damage long-term prospects.

Contact:Michelle Thomas Tel: 312-540-3000 ext 6491Email: [email protected]

Conference on Pharmacovigilance & Drug Safety - ‘A New Era’Dates: 21-22th March 2014Venue: Scitech Center, Jogeshwari, Mumbai

Safety management of Medical Devices; Medical information & Safety integration; Cosmetic Vigilance; PV Harmonization in Asia; Cardiac, Hepatic & Renal Safety Issues; Drug and Vaccine Safety in public health; Tete a tete with EU QPPVs; Career opportunities potential in PV; Challenges in PV outsourcing.

Contact:Manoj K TrivediDia India, 303, Wellington Business Park - 1Andheri (East), Mumbai - 400059Tel: (022) 67417625Mob: 9820746323Email: [email protected]

Events.indd 56 21-02-2014 16:45:00


bookshelf

Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance [Hardcover]Author: Shayne C Gad Price: USD 133.89No of Pages: 213 pages

About the Book: Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard—particularly in individuals with compromised or limited organ system functions.

This book covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author ’s more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan.

Manual of Drug Safety and Pharmacovigilance [Paperback]Author: Barton CobertPrice: USD 74.44No of Pages: 292 pages

About the Book: This book teaches the ins and outs of drug safety in the industry, a hospital, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done in the industry and FDA when confronted with a drug safety problem. Manual of Drug Safety and Pharmacovigilance is a how-to manual for newcomers to the field of drug safety, clinical research, regulatory affairs, law and other domains touching on pharmacology who wish to learn the theory and the practicalities of drug safety (pharmacovigilance) and side effects, this comprehensive and practical guide provides essential information on drug safety and regulations, including recognising, monitoring, reporting, and cataloging serious adverse drug reactions.

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk [Paperback]Authors: Michael J Klepper, Barton CobertPrice: USD 85.98No of Pages: 316 pages

About the Book: This book provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarise and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr Klepper and Dr Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, this book is the definitive guide to drug safety data analysis and reporting.

Bookshelf.indd 57 21-02-2014 14:44:58


ad index

Sr No Client’s Name Page No

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R.N.I. No.: MAHENG/2002/08502. Date of Publication: 1’st of every month. Postal Registration No: MH/MR/SOUTH-284/2014-16Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 60

Pharma Bio World February 2014

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Transcript of Pharma Bio World February 2014