PBW November 2013

November 2013 

Vol.12



Issue 4



Mumbai



Price ` 150

www.pharmabioworld.com

Competitive Manufacturing IPC Special Pharma + BioTECH World Expo 2015 January 28-31, 2015, Mumbai, India

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PHARMA BIO WORLD R.N.I. No.: MAHENG/2002/8502 Chairman

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Editor: Ms Mittravinda Ranjan, 26, Maker Chamber VI, Nariman Point, Mumbai 400 021.

6 ď‚ƒ November 2013

Contents 6-8.indd 6

Pharma Bio World

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EXPERT’S TAKE 10

Access to Medicine - Part 5 – Jenik Radon, Maree Newson

INTERVIEW 18

From the Biggest Player in Diabetes Care…

– Melvin D’Souza

FEATURES

18

22

Automation Trends in Pharmaceutical Manufacturing – Govind Srinivasan

26

How Talent Management is Vital in Driving the Growth of Pharma – Vanita Sahgal

32

DMS: How it Helps Pharmaceutical Companies Reduce Time to Market and Improve Efficiency – Vatsal Makhija

40

The Impact of Competition Act, 2002 – Dr Gopakumar Nair

22

44

Easy on the Eye – Joachim Stoye, Marco Schweizer

47

Improving the Chemical Synthesis and Production of Duloxetine through Biocatalysis – Rose A Lance

NEWS FEATURE 51

Global Regulatory Challenges: Opportunity for Learning – Ananya Sen

55

India to Witness Growth in Retail Chain Pharmacy – Mahesh Kallayil

32

NEWS UPDATE 58 65

Pharma News Biotech News

CORPORATE AFFAIRS 69 72

Product Trends Events Diary

BACKYARD 44

73 74

Bookshelf AD Index Next Issue Focus: Pharma Packaging & Machinery

8  November 2013

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Pharma Bio World

23-11-2013 19:58:02

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expert's take

Access to Medicine: Moral

Imperative and a New Consciousness

Part 5

Jenik Radon

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

Maree Newson

Associate (NZ Qualified) Radon Law Offices New York

Alongside doctors, nurses, and other healthcare professionals, pharmaceutical companies are responsible for the wellbeing and the lives of millions of people around the world. But as pharmaceutical research has become more complex, abstract, and even separated from the medical profession, there is a risk that the industry is losing sight of its mission, helping people lead healthier lives.

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arlier in this series of articles, we explored the human right to health, the diseases that trigger that right, and the types of medicines that should be considered “essential”. In the previous issue, we discussed the practicalities of funding access to those essential medicines, and the pharmaceutical industry’s role in distributing those medicines. We raised the example of Gilead, a pharma company which has assured the availability of its HIV/ AIDS medication at low cost in countries where it is most needed.

Consciousness Raising, A Further Sine Qua Non Examples of access programs like Gilead’s are also useful because they change the way the industry is viewed and views itself, and, perhaps, the standard to which the industry holds itself. This consciousness raising is itself important.

Inherent in a moral imperative is a continuous search for an answer, namely how to live it, and with respect to access to medicine there are still no generally accepted answers, certainly none that transcend borders. Governments, pharma

The access to medicine discussion is clearly part of a larger ethical and pragmatic debate about provision of health care that has no easy or immediate answers, let alone an inexpensive answer.

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industry, the insurance companies and NGOs cannot agree on how to implement such access, certainly not internationally.

In order to advance access to medicine, the awareness that pharma touches people and impacts them intimately needs to be heightened for all those working in the pharma industry, whether scientists or accountants or distributors.

And the way forward is for all who work in this industry to be conscious that the industry is special, that in its essence is an extension of doctoring, and that it has a critical mission, namely satisfying health needs.

Jenik Radon, an author of this article, was Executor/Trustee of a German pharmaceutical company, Vetter Pharma Fertigung GmbH from 1999-2007 and continues to serve as independent legal counsel for the Vetter Group in Germany.

The Vetter company is a major producer of prefilled injectable systems for the pharma industry. To convey its health mission to its staff, Vetter, among other things, had pictures of patients hung on many walls in order to remind all of its employees that it was not simply producing every-day consumer goods but special goods. Rather, the Vetter company sought to underscore that its business was special – filling injectables with drugs for patients around the world – and this demanded a never ending focus and dedication to quality even in the performance of the most tedious, but vital, tasks such as visual product inspections.

Moreover, the Vetter mission statement was revised to note that its ultimate customers were its patients, and not just the next Pharma Bio World

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For thousands of years, doctors have recognised their unique duty, as enshrined in the ancient Hippocratic Oath, which is still today taken by newly admitted doctors.

buyer in the chain of commerce. These simple actions helped to give meaning to all aspects of the company’s and its employees’ work, whether analytical, production or administrative. The question is how such consciousness can be extended and expanded.

Similarly, consciousness can be raised in other ways. For example, the adoption of a Hippocratic Oath, a mission statement, for the pharma industry can serve as a similar reminder and incentive. Certain professions related to health have long acknowledged a special responsibility. For thousands of years, doctors have recognised their unique duty, as enshrined in the ancient Hippocratic Oath, which is still today taken by newly admitted doctors. At the time of Hippocrates, and until relatively recently, the role of a doctor also incorporated the preparation of medicinal remedies. The Oath recognised the unique position of trust, knowledge and power that doctors enjoyed in society. Yet, as economic, social and legal divisions have emerged between doctors, pharmacists, and pharmaceutical chemists, the obligations of the Oath have remained only with doctors. The Oath has never been sworn by people in the pharma business who make the medicines that doctors need to administer. A start, however, has been made in pharmacology schools in the United States, which have begun to have their graduates adopt a Code of Ethics. But pharmacologists are only a small minority of those working in the pharma industry.

use our products and services. In meeting their needs everything we do must be of high quality.” Following this, the Credo cites responsibilities to the corporation’s employees, the communities in which they live and work and to the world community as well. Then, the “final responsibility” is to the corporation’s stockholders: “When we operate according to these principles, the stockholders should realise a fair return”.

The Johnson & Johnson Credo of 1943 still needs universal application.

One of the authors argues that a Hippocratic Oath should also apply to the executives and management of, and all others working within, pharma companies. Such an Oath will raise everyday awareness of the industry’s mission and ensure that all within the industry become voices to be

heard on how this mission can be fulfilled and lived, which is important as long as the answer remains elusive. A start is that author’s adaptation for the pharma industry of the modernised Hippocratic Oath: • I swear to fulfill this covenant on my behalf and that of my fellow employees, to the best of my ability and capability, and I will have the pharmaceutical company in which I work dedicate itself to the fulfillment of this covenant.

• I recognise and respect the hard-won scientific gains of physicians, nurses, pharmacists, scientists and other medical workers in whose steps I also walk.

• I recognise that I work for a company whose products are special as they have the power to relieve pain or discomfort or heal sicknesses in human beings.

• I will remember that the medicines my company produces treat a sick

Yet pharma corporations have not been ignorant of their duties to society as a whole. In 1943, the chairman of Johnson & Johnson prepared the company’s “Credo”, a vision statement that begins: “We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who 12 November 2013

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Tab Ad Markem.indd 1

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The pharmacology schools in the US have begun to have their graduates adopt a Code of Ethics.

But pharmacologists are only a small minority of those working in the pharma industry. human being, who may well be my own mother, father, child, family member or friend, whose illness also affects a person’s family, economic stability and emotional health.

• I recognise that the end consumer and customer of my company’s medicines are sick human beings.

• I will remember that all persons are equal, wherever in the world, with an equal right to life and good health.

• I will work to have the medicines that my company produces made accessible to all so that they can cure illness and disease in all people wherever they may reside; • I will remember that I am a member of society, with special responsibility to all my fellow human beings, especially the sick, as my company’s medicines can improve and even restore their health.

• If I do not violate this oath, may I enjoy life, be respected while I live and remembered with affection thereafter.

May I always act so as to preserve the finest traditions of those who administer and provide medicine.

A pharma Oath might be one step toward the realisation of the human rights imperative embedded in Article 12 of the International Covenant on Economic, Social and Cultural Rights. The access to medicine discussion is clearly part of a larger ethical and pragmatic debate about provision of health care that has no easy or immediate answers, let alone an inexpensive answer. But raising the consciousness of all those involved in the pharma industry about their important, critical and special, if not unique, role will invigorate the way forward in finding 16 November 2013

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mutually acceptable societal solutions to the provision of international drug access to medicine to the poorer nations as well as all others who need it, even if they cannot afford it.

Conclusion Twelve years after the start of the PMA case, access to medicine is still an idea without clear parameters. While the PMA case highlighted the need for international access to medicine, especially with respect to life-threatening emergencies such as AIDS, the concept has not significantly advanced in practice since the settlement of that case. From a purely utilitarian perspective, as healthy nations are better and more stable economic and political partners, it may be in the self-interest of developed nations to improve access to medicine for chronic illnesses in the world’s poorer and developing nations, which has become another goal of the access to medicine “campaign.” From a utilitarian point of view, healthier nations have better consumers.

the industry can, for example, adopt a different business model and create sustainable profit through strategically tiered pricing. These companies may also develop access programs because they feel it is socially responsible and because they have come to recognise their unique responsibility as providers of health products to the end users of their products, the patients. Highlighting and living that responsibility will be critical in making access to medicine a reality and securing a social license to operate in the emerging market.

Recognising the moral imperative to deliver drugs to sick people and creating sustainable and pragmatic incentives to make that financially feasible are both essential parts of the effort to make the world healthier. A pharma Hippocratic Oath would be a welcome step to make the vision of a healthy world a reality!

Even if the goals of “access to medicine” are clearly defined, governments will nevertheless be unable to reach those goals without the involvement of private industry, if for no other reason than the fact that the industry is the motor of drug development. Pharmaceutical companies may well opt to provide broader access to medicine as they have come to realise that growth in the pharma industry depends on the emerging markets and its significant, albeit poorer, population, and that the pharma industry needs to address the societal and political concerns of that market in order to succeed.

The pharma industry needs a social license, social acceptance, in order to succeed in that market. Accordingly, Pharma Bio World

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interview

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M E LV I N D ’ S O U Z A

From the Biggest Player in Diabetes Care…

Tresiba will offer people with diabetes the flexibility in the timing of insulin administration on occasions when administration at the same time of day is not possible.

On the occasion of World Diabetes Day, Melvin D’Souza, Managing Director, Novo Nordisk India in an interview with Ananya Sen after the launch of Novo Nordisk’s Tresiba in India.

What is the size of the Indian Diabetes market as against the global Diabetes market?

Based on IMS SSA Audit July’13, Indian Diabetes market is valued at ` 4,700 cr. while insulin market is valued at ` 1,125 cr (contributes 24 per cent of diabetes market), OHA is valued at ` 3,500 cr & contributes to 75 per cent of diabetes market.

What is Novo Nordisk’s share in this market?

Novo Nordisk has been a clear market leader in the diabetes insulin market. Novo Nordisk currently holds 60% per cent of the ` 1,100 crore total insulin market in India. (Source: IMS) With 90 years of leadership position in diabetes care we have been continuously innovating and strengthening our portfolio to address the requirements of people with diabetes. To increase awareness amongst people we are engaging actively with key stakeholders including State and Central Government in various diabetes programmes to build awareness amongst people and clinicians about timely prevention, detection and control.

How has Novo Nordisk managed to stay as a global leader in Diabetes Care consistently?

Novo Nordisk has a long heritage in changing the diabetes landscape with 90 years of leadership position in diabetes care. We have focused our efforts in developing treatments that address key challenges faced by patients and clinicians. We have been constantly innovating and discovering new molecules that bring in significant clinical benefits to patients that would enable them to lead a healthy and productive life.

Novo Nordisk has focused on creating value through innovative and patient friendly diabetes care products.

We aspire to create value in the market by working closely with our key stakeholders including our end users. Be it through the services we offer or products which address real needs, we are continuously focused at creating value to help build credibility with our customers and end users. The commitment to continue with innovation and deliver quality products of international standards has helped us successfully maintain the leadership position in this space.

Do you think sustaining in the premier position is becoming tougher than ever before with the emergence of newer treatments by competitor companies?

Pharma Bio World

23-11-2013 20:08:47

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23-11-2013 21:40:29

How will your new product Tresiba prove to be more beneficial than any other existing insulin treatment?

Tresiba, a new basal insulin developed by Novo Nordisk for the treatment of type 1 and type 2, This is a once-daily basal insulin with a duration of action beyond 42 hours, allowing for flexibility in day-to-day dosing time when needed, without compromising efficacy or risk of hypoglycaemia.

It is the first insulin to offer people with diabetes the flexibility in the timing of insulin administration on occasions when administration at the same time of day is not possible. In current insulin treatments, people with diabetes are required to take their long-acting insulin at around the same time each day. However, the mode of action of insulin degludec ensures that, on occasions when this is not possible, people with diabetes can alter the time they take

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Innovation is the key to Novo Nordisk’s leadership position globally. Our vast pool of scientists and researchers across the globe are continuously engaged in creating innovative products that are cost effective and patient friendly in nature. We are committed in providing value to our endusers through newer and latest treatments in diabetes care. The case in point is the new basal insulin – Tresiba launched for the treatment of type 1 and type 2 diabetes in India.

We are involved in early stage research with leading academic centres to find a cure for type 1 diabetes.

their insulin without compromising their diabetes control or putting themselves at increased risk of hypoglycaemia.

When will it hit the Indian market?

Tresiba is already made available in India, we have ensured to bring this product line to India without much time lag. Physicians now have the option of prescribing the molecule degludec based on their patient’s requirement.

Which are the countries that have already approved Tresiba?

Tresiba has been successfully approved in 33 countries.

What will be your expectations from this product in India?

Tresiba is a new basal insulin that offers effective glycaemic control, a significantly lower rate of night-time hypoglycaemia, and the flexibility in day-to-day dosing time when needed. Novo Nordisk believes Tresiba will have significant impact on helping patients manage and control their diabetes effectively.

Could you please brief us on Novo Nordisk’s products pipeline?

In India Novo Nordisk has an entire range of Insulins - Human Insulins and Modern Insulins. We also have the GLP1 (Glucagon-Like Peptide-1) analogues.

Under Modern Insulin we have NovoMix, NovoRapid, Levemir and under Human Insulin we have Actrapid, Mixtard and Insulatard. In devices we have NovoPen 4 which is a durable insulin pen that allows patients to change their insulin cartridge whilst retaining the same pen.

In fact NovoPen was the first insulin pen ever produced. We also have the Next Generation FlexPen which is a prefilled insulin delivery device, eliminating the step of loading insulin into the delivery system.

We have some exciting new products in our pipeline which includes a once-weekly GLP1 analogue and a fixed-ratio combination of liraglutide and insulin degludec that is expected to get more patients to treatment target than GLP-1 analogue alone. We are also in the initiation of the phase 3 studies for semaglutide, a once-weekly G LP-1 analogue for th e tr e a tme n t o f type 2 diabetes. In addition, for both insulin and GLP-1, we have continued to explore oral formulations. These are currently in phase 1 studies. Finally, we are also involved in early stage research with leading academic centres to find a cure for type 1 diabetes.

Pharma Bio World

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Automation Trends in Pharmaceutical Manufacturing The pharmaceutical manufacturers have had to look at innovative ways to become more efficient and agile. This article explains how drug manufacturers can drive more competitive advantage into their operations by applying enhanced and improved automation technologies into drug manufacturing.

P

harmaceutical companies worldwide are facing challenging times due to a large number of patent expiry, high cost and long lead time to bring out new drugs, pricing regulations, global competition, regulatory norms, stringent quality protocols, etc. The regulatory authorities have become very stringent on deviations and are subjecting all manufacturers to strict quality norms.

Any product recall for an organisation is very expensive and also exposes the organisations to additional scrutiny by regulatory authorities.

Pharma companies are taking every effort to improve efficiencies in all steps of manufacturing, packing and distribution.

Automation and integrated systems are being planned to effectively address manual data entry and errors.

Key Challenges in Pharma Manufacturing

Govind Srinivasan

Senior Market Analyst Technology Services Group TAKE Solution 22 November 2013

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Most Pharma manufacturers have implemented manufacturing/packaging line management automations and backend ERP applications. The major area of weakness is integration such as manmachine integration, manual operation & its verification, automated data collection, and B2B to suppliers & distributors. Some key challenges typically faced by many pharma companies are: • Automating integration with suppliers for managing and controlling supplies & labeling of raw materials.

• Ensuring that all incoming materials have been sampled and tagged for usage.

• Dispensing of right ingredients to manufacturing lines.

• Dispensing right quantity of ingredients after considering the exact propensity of material.

• Ensuring compliance of all designed manufacturing process and control checks with appropriate escalations.

• Creating & maintaining batch manufacturing records electronically.

• Ensuring ePedigree Regulations compliance.

• Controlling final product labeling so that it matches with the packaged drug.

Pharma companies are employing a range of technologies and applications to address these challenges. Some of these technologies include: • Supplier integration portals.

• Barcode & RFID technologies.

• Enterprise Mobility for automated data collection and operation control.

• Automated data collection from the process control system.

• Upgrade manufacturing lines to include high speed printers and camera.

• Document management systems.

Automation Opportunities There are several opportunities for automation across pharma manufacturing processes as given below: Vendor Collaboration Portal: This portal enables seamless, efficient electronic business with your supplier partners, maximises control and compliance, and increases visibility into your business ecosystem – while adhering to XML and other messaging standards. Pharma companies can also enable and control all barcodes and labels printed on raw material which will make receiving of material at the manufacturing facilities easy.

Pre-Manufacturing Processes: These processes cover material receipts, sampling, warehousing & dispensing functions. ERP along with specialised applications like laboratory information management and quality management systems, address the requirements of these functions. Some pharma companies have also automated their operations by Pharma Bio World

23-11-2013 20:11:10

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using Enterprise mobility interfaces via handheld computers/scanners to capture data at the point of action and to post data to ERP for achieving real-time visibilities to the operations. These mobility applications help to extend the power of ERP to the hands of operational personnel for enhancing productivity and accuracy.

dispensed for a work order, data collection in each manufacturing step via direct machine interfaces and automation of in-process verification using barcodes and handheld computers. Electronic Batch Management Records (eBMR) will bring in a new dimension of analysing the historical data.

The mobility applications assist the warehousing and QA personnel to ensure all materials including samples to be barcoded and appropriately labelled. It also ensures storing of material in correct locations and dispensing of material based on FEFO (First Expiry First Out) method after considering any partially issued drums.

The ePedigree Regulations and the centralised Track and Trace repository require significant changes to the manufacturing lines to enable high speed printing of serialisation data and scanning to collect data to maintain the required parent-child relationship. The application software needs to generate the required serial numbers and maintain the events based on EPCIS standards.

There are also changes to packaging specifications to meet the requirements of anti-counterfeiting measures.

Manufacturing & Packaging Processes: Most of the Manufacturing & Packaging processes automation is based on Line Control Systems and the required record keeping is maintained manually. The manual operations are mostly performed with very limited automated verification.

There are significant opportunities to automate the manual operations starting from verification of input materials 24 ď‚ƒNovember 2013

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Distribution Processes: The Distribution Processes ensure that the manufactured drugs reach the warehouses and finally pharmacies/hospital for patient consumption. The Enterprise Mobility

applications have changed the landscape in this area to collect data at the point of action and post data to the back-end applications for real-time visibilities. The Track & Trace repository established in the previous step is also used to record packaging status during distribution and also facilitates serialisation verification by consumers and any intermediaries.

Conclusion There is significant progress in technology & software applications to ensure productivity and real-time visibilities to the operations. Many leading Pharma companies have enhanced robustness, reliability and safety to their products and operations by adopting these advanced technologies. Another important factor that needs attention is change management to business processes and people. The regulatory oversight and audit have also increased during recent times and it is critical to implement system so that organisations are always audit-ready.

Contact: poornima.naghendran@2020msl.com Pharma Bio World

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How Talent Management is Vital in Driving the Growth of a Pharma Company The author addresses the various issues related to h u m an r e s our ce management in a pharma organisation and how effectively it can be applied in promoting the growth of the company.

P

harma was once the only indestructible of industries; investments were high, revenues were never a glitch and recession did not matter. However, Indian pharma industry adapted well to the emerging business scenario in 90”s and developed India to be a hub centre of Generic pharma business, by quickly understanding the requirements of the regulatory markets. Today, India is the only country which has largest number of US FDA approved facilities outside of US. The new emerging scenarios are two fold, one for advantage and another of a challenge.

Indian generic market offers huge potential of 12 per cent growth both internal and external. The growth in the last 20 years was based on basic skill sets and technologies.

For it to sustain the same it would face a challenge of – New emerging technologies coming out of innovator laboratories , which would require high levels of skill sets to train and adopt to these technologies .

Most of the technologies would be in the old and new areas like; • • • •

New Drug delivery systems.

Bio pharmaceuticals.

Clinical studies.

Oncology (25 per cent of the current research pipe lines).

• Biotechnology and medical devices.

Vanita Sahgal

Head – Learning & Development Aurobindo Pharma

26 November 2013

Importance of Talent Management in Pharma.indd 26

Indian generic operators need to look into the Business strategies – from a service provider of cheap and low end offering CROs and CRAMS to Innovative, technology intensive organisations. This outlook is not only for the Indian and Chinese business organisations but the same is being looked at as enablers of growth by major global innovator companies.

A very recent global survey of 126 CEOs indicated that they would like to have

50 per cent of their focus on human resources development.

However today; - New patent laws allowing process reproduction, - Growth of emerging markets, - Thriving Asian manufactures, - Availability of many generic formulations, - Proliferation of competing drugs in the same therapeutic areas, - M&A mayhem, - Price wars, - Rising costs, - Affordable medicine, and - Aggressive and ever changing regulatory laws.

All of which has created havoc in the Pharma market scape. All the big pharma innovator companies have been undergoing tremendous stress on their revenues, due to the patent cliff, and now recognise emerging economies, as their growth engine. The 8-12 per cent increase in the E8 markets cannot be ignored by either Global players and or Indian domestic companies.

There are several global players increasing their stake in Indian companies , either through partnership, wholly owned set ups, or taking over the Indian companies which have a significant market share.

Easai India, Otsuka, Periggo are some examples of the wholly owned category and recent acquisition of Piramal generic business by Abbot stands for the last category.

Indian economic policies are quickly made friendly towards FII in pharma sector. With the large player’s trying to consolidate their positions to grab the growth in pharma sector and also to make best use of very economical operating costs in India, especially the high chemistry capabilities, good regulatory Pharma Bio World

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Keeping current scenarios, future expectations, linear versus organic growth, we came up with our own lean strategies to manage Talent and ensure HR developed into a Strategic Business partner rather than just any other functional department. We took care that we were two steps ahead of Business; we aligned the HR team Core Business wise & Capability wise.

awareness and very well trained manpower in India.

The challenges to the growth from the human resources front is coming from – areas like technology transfer for highly critical processes, training of HR , lack of academic institutions support (in the form of curriculum) for scaling up, ambiguity on regulatory frame work (a proper guideline

by Indian drug authorities on clinical trials is long pending requirement) and trained manpower on emerging areas like Clinical trials, regulatory requirements for Clinical, new process and packaging technologies, etc.

For the industry to grow at 8-12 per cent and to sustain the same the leadership teams are now focusing 50 per cent of their attention on resources to train and retention of quality talent. Its only obvious that no Knowledge based industry like Pharma can really sustain the growth without the required emphasis on HRD, with specific skill sets, for the emerging technologies.

If one looks at some random data, even though it’s emerging markets, the fact of the matter is that there is lack of focus on managing business strategy and its people.

Next, one of the greatest HR challenges companies face is retention. Only proving the fact that hiring quality talent, developing, maintaining culture of an organisation therefore retaining an engaged employee all are different sides of the same coin.

Booz and Company have looked at emerging markets versus HR challenges and found Retention is the most difficult of the sorts!

I have always been inspired by Bersin & Associates High Impact Talent Management model, taking a few cues from the model, developed & designed for the organisations I worked in; Contract Research and Pharma Manufacturing.

Based on a diversified strategy (portfolio), we relooked at the big-picture, reworked on Values, collaborated with internal customers, initiated project management to improve cycle times, worked on HR Cost to company, resolved to be anytime ready, and much more. Soon we had a roadmap and a Governance model in place. HR goals were: Goal 1 – Increase profitability by 20 per cent, Goal 2 – Increase revenue by 25 per cent.

We invited think tanks to iterate and formally draw up a final document of actionable items.

Talent management played a vital role in all aspects.

For attracting the best new hires, we initiated industry academia interface, where our Scientists (seniors from operations) helped academicians design programmes suitable for organisations so that transition from college to corporate was lowered.

We offered higher education after tying up with a few esteemed universities.

However it’s easier said than done…

- Quality of hires at affordable remuneration, - Settling down time, - Skill deficiencies, - Knowledge regulatory requirements and global best practices, - Leadership crisis, (dearth of leadership cap, - Attrition of quality talent, - Non-execution of big plans hindering progressive growth.

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Intellectual attraction was well taken care off.

We created a huge resource pool of Certified Internal Trainers to train existing employees in technical areas.

Various technical programmes like; cGMP norms, Safety aspects and anytimereadiness are today managed by them.

Identified the bridge between shop floor operators and managers, trained them to be effective Supervisors through a Young Leaders Programme. Out of which about 15 per cent grew to be successful managers managing larger roles. Second line leaders underwent a year-long MDP, owing to which 70 per cent of them moved vertically/laterally or simply increased their span of control in their current positions.

Action Learning projects, Coaching, Functional training, were part of the wide portfolio that help create availability of skills and ready-made talent to meet strategy demands.

We shaped enthusiastic employees to run an employee engagement forum organising cultural and sports events for the rest of the employees. Every year it grew in size to be managed professionally with the tiniest of budgets, offering challenge and excitement. Through many forums we got the CEO to speak to the Employee and share business plans.

Year on year measured HR performance through employee satisfaction surveys. We 30 November 2013

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organised three month long OD initiatives

by Collaborating Scientists & Functional Teams to get stronger on Internal Customer service, ended it with a Bamboo dance where all departments participated, ensuring employees were fully engaged.

As Business strategies became aggressive, M&A’s impacted our client surface; the Sales team was geared up in various ways. Management Trainees were set up as backbones for research, client calling.

Sales competencies were redefined, team was put through vigorous training & Sales Coaching, making certain right man for the right territory was recognised and appointed all based on hard data & psychometrics.

A CEO-controlled self managed team handled Key Accounts to increase depth of understanding Client requirements and ensuring value addition. As a conscious strategy we increased penetration in emerging markets and ROW by hiring local talent who understood local law & its procedures. Technology, processes and engagement all were put to work. Within a period of a few months, results started pouring in. Quality retention was well taken care of.

This is a Strategic competitive edge design generated through a Brainstorming session

by HR folks on Impact on Profitability.

Its initiatives giving very positive and simply positive outcomes were derived into actionable items and a road map;

as a result of HR commitment we accomplished 80 per cent of them.

What worked for us?

- Step 1 Perspective - Determined our Business Goals - Step 2 – Scan - Scanned the environment - Step 3 – Analyse - Conducted a gap analysis - Step 4 – Prioritise - Set HR priorities to help achieve business goals - Step 5 – Performance Metrics Measured, monitored and reported progress Ending with a note that we today need to be quick on our feet! Strategise & plan hard, but monitor harder!! There must be a total paradigm shift in the education curriculum, training methodologies and of course large investment in the facilities that should come up. Get people to dialogue with each other especially at the top, groom your finest the max; make commitments outcome based; don’t stop looking at improving processes, guaranteeing key differentiators affordability, reliability and sustainability. All of which help attract the best and retain the best of the best.

Contact: vanita.sahgal@aurobindo.com

Pharma Bio World

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DMS: How it Helps Pharmaceutical Companies Reduce Time to Market and Improve Efficiency Pharmaceutical companies face document control and management challenges from the preclinical phase through postmarket stage. This article aims to clarify the need for pharmaceutical DMS solutions and shows how it helps pharmaceutical industries accelerate time to market and increase productivity and profitability.

P

harmaceutical companies face mammoth doc umentation challenges at every step: research, development, production, marketing & sales. Several disparate teams, operating at different points of the process, many times at different locations, generate enormous quantities of documents.

Not only does a company need proper documentation for improving and streamlining all the major processes, but legal regulations for product registration and validation activities also make it imperative for large and mid-sized companies to modernise and digitize the documentation process.

Lack of proper documentation procedure can increase the costs, delay the launch of new products and lead to loss in revenue.

A document management system, on the other hand, can save countless man-hours, enhance communication between different team members and different departments, extend collaboration, improve the flow of information and engender savings at every stage through structured and simplified documentation processes.

What is a Document System (DMS)?

Management

At the core, the term ‘DMS’ refers to the use of computers, and other Internet-enabled devices like tablets or smartphones, to store, index, secure and manage documents for easy retrieval, audit and collaboration. EDMs (Electronic Document Management systems), deployed by major pharmaceutical companies in the 1990s, can be seen as precursors to the modern DMS. While an EDM could do little more than manage a limited number of proprietary files or file formats, the evolution of IT enabled developers to extend support for a wider range of electronic file formats, additionally providing auditing facilities and integration with collaboration tools.

This paved the way for the modern DMS. Along with documents that originate as electronic files, a DMS can also store and manage scanned paper documents, thereby simplifying and speeding up the process of retrieving, sharing, and

Vatsal Makhija

Senior Market Analyst Cygnet Infotech 32 ď‚ƒNovember 2013

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auditing every single document. While a business may choose to deploy a DMS independently, larger organisations integrate it with existing applications, CRM and the ERP system.

How a Document Management System Benefits Pharmaceutical Companies?

Right from the pre-clinical stage to the postmarket stage, pharmaceutical companies encounter several documentation challenges. A weak document management process can add extra weeks or months to submission review cycles, and debates regarding the right versions can cause widespread frustration and conflict in different departments.

International companies face a more severe challenge in form of several disparate teams working concurrently on the same project from different locations. The scope and variety of data further complicates the task of accessing and referencing documents.

Most drug company processes are information-sensitive, and an efficient DMS is critical, both from the viewpoint of organisational efficiency and regulatory demands. By introducing uniformity in document formats through usage tracking, by automating version control, and by establishing audit trails and restricting access to sensitive data, a DMS not only slashes the costs related to distribution and storage of documents, but also reduces the time and effort invested in managing documents.

Proper implementation of a DMS automates, restructures and rationalises most tasks associated with managing documents and data, thereby improving efficiency, cutting costs and accelerating time to market.

Let’s take a close look at how the different features and functionalities offered by a customised DMS help pharmaceutical companies.

Lower Cost & Effort for Storage Documentation processes dominated by paper are costly. Drug companies 36 ď‚ƒNovember 2013

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generate high volumes of data at every step: research, production, marketing, and sales. Thousands of documents created by different departments are the pieces that complete the puzzle. Members from different teams and departments may require to access any of the documents at any time. So, a lot of time and effort goes in managing and storing paper documents.

A DMS enables organisations to store all the paper data in legally admissible digital formats. While the initial step of digitising the paper data requires a moderate amount of investment, in the long run it significantly lowers most of the costs associated with storing and maintaining documents.

Automated Data Collection Integrating the DMS with existing ERP and CRM systems can help companies automate the process of data collection.

Deploying advanced DMS solutions, it is possible to capture information from fax, email, and other agencies and store it into a standard, easy-to-search format. This automates the collection and storage of all electronic data. DMS integration also enables pharmaceutical companies to access a wide range of documents and data via ERP or CRM systems.

Centralised Repository, Quick Retrieval Easy and instant access to documents is of paramount importance when several geographically-dispersed individuals or teams are working on the same project.

Using a DMS, it is possible to store various files in a well-structured, librarytype system. This enables easy retrieval of information through simple and straightforward search queries.

More complex needs can be satisfied by deploying a DMS with advanced features. Powerful systems can allow the administrator to rapidly set up a centralised repository for all the documents related to a specific project.

By customising a solution, companies

can create repositories and systems for data storage & access, mirroring their existing operational procedures. By restricting access to specific documents only to authorised users, data security is also consolidated.

Automated Version Control Any pharmaceutical company working on an ambitious project generates thousands of documents. As even the minutest changes are recorded and newer versions of documents with changes created, the chances of a team member accidentally using older or unapproved versions is very high. A small mistake of this type, if not detected early on, can lead to tremendous waste of time and energy at a later stage. Even if no mistakes are made, the employees involved in the task spend too much time and painstaking effort on ensuring that they are using the right versions.

An advanced DMS comes with built-in, automated revision control. This means that only approved and final versions of the documents are available to the end users, while older versions are archived and closed to revision. This feature negates the possibility of any errors arising out of usage of wrong versions. Also, a DMS can have features like electronic signoff that highlight the audits made to the previous versions of the documents, making it easy to trace the origin of changes and assign responsibility.

Improved Collaboration It is not always possible for members from different departments working on the same project to meet each other in person. Most document management systems are webbased, and enable groups of people to collaborate online. Using collaboration features, remote departments and external collaborators can view and edit documents on-screen, at the same time. It is also possible to customise existing systems to enable collaboration using standard browser tools. Needless to say, 24/7 access to digital documents means that employees do not have to risk carrying Pharma Bio World

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and transporting documents physically.

sensitive

paper

Securing Rare Data Owing to the increased use of computers in the industry, a good proportion of data originates electronically, and is backed up. But, several critical data originate as paper documents and are forever at risk of destruction of damage. For instance, most researchers stick to lab notebooks to record important data, and such notebooks are one-of-a-kind, unduplicated documents. Such data is mission-critical, and damage, destruction or theft can prove costly.

A custom DMS programme can help to secure all paper documents through highquality, secure imaging. Control access ensures that the data is available only to personnel with access rights. Also, creation of off-site copies or secure cloud storage can ensure that the loss or destruction of physical copies does not prove catastrophic.

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Customised DMS is the Future The above points underline how using a DMS can help pharmaceutical companies cut down costs and improve efficiency at the same time. While most companies operating in high-revenue markets like US, UK and EU and Japan are focusing on making their documentation paperless, the idea is just beginning to gain traction in organisations functioning in emerging markets like India, Brazil and China.

One of the biggest challenges standing in the way of paperless DMS implementation is that it is a complex and time-consuming process. It may be easier for large organisation with existing EDMs to shift to a DMS, but companies accustomed to working with paper need to invest a lot of time, energy and effort to successfully implement such systems.

companies handle documents in an idiosyncratic, individual manner. So, drug companies need a DMS customised to meet the specific requirements of their documentation and other work processes.

At the same time, companies need to standardise their documenting procedures to get the most out of DMS implementation.

To build and implement a DMS that actually helps to speed up work process and reduce cost of managing documents, a DMS implementer has to understand existing document management system, understand the data, appreciate the needs of different stakeholders, and recognise the context in which the data is used. The challenge is to find a solution provider who can work hand-in-hand with your company to build and implement a DMS tailored to your specific needs.

Contact: vrmakhija@cygnet-infotech.com

There are several high-caliber, offthe-shelf document management solutions out there, most pharmaceutical Pharma Bio World

23-11-2013 20:15:28

Who’s Who th 14 Edition

Who’s Who is an exhaustive listing & fact book on CHEMICAL PROCESS, PHARMA BIOTECH, HYDROCARBON INDUSTRY & INDUSTRIAL SAFETY

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The Impact of Competition Act, 2002

Dr Gopakumar G Nair CEO Gopakumar Nair Associates 40 November 2013

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T

he Competition Act, 2002, which was passed by the Parliament in 2002, was notified on May 20, 2009 with regard to the following provisions.

Sec.3 – Anticompetitive Agreement Sec.4 – Abuse of Dominant Position Sec.5 & 6 – Regulation of Combination Impact on Pharma Trade

Anti-competitive Agreements [Sec.3] and abuse of dominant position by AIOCD (All India Organisation of Chemists & Druggists) has been the first target of the Competition Commission constituted under the Act. On 2 nd May 2011, a suit (Case No.20/2011) was filed alleging abuse of dominant position by AIOCD. Various MOUs (Memorandum of Understandings) and Agreements caused to be signed between AIOCD and Associations of Drug/Pharma manufacturers such as IDMA (Indian Drug Manufacturers’ Association) and OPPI (Organisation Pharmaceutical Producers of India) were the subject matter of the complaint.

Evidence was made available regarding coercive, restrictive, abusive and anti-competitive practices of AIOCD. Restraining orders were passed against AIOCD as an interim measure. Fixing of Trade Margins (outside DPCO provisions), Boycott of Pharma Companies and other abusive practices of AIOCD were investigated by the Commission. The Competition Commission found AIOCD guilty of abuse of dominant position through its coercive agreements, NOC for appointment of stockists, fixation of trade

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margin, collection of PIS charges and Boycott of pharma products, as in violation of Sec.3 of the Competition Act, 2002.

The Associations of pharma industry were exonerated by the commission. Penalty amounting to average of 10 per cent of the income of AIOCD for 3 years preceding, amounting to nearly ` 50 Lakhs was imposed on AIOCD by the Commission.

AIOCD has challenged this order with the Competition Appellate Tribunal (COMPAT). This Appeal is in progress at COMPAT. Competition Law and Pharma Marketing through Medical Profession Irrational drug prescriptions motivated through extraordinary gifts, perks, paybacks and kickbacks to the prescribing doctors by the branded pharmaceutical manufacturing and marketing companies are likely target for enquiry by the Commission. The Medical Council of India and the Pharmaceutical Manufacturing Associations in India have already undertaken a “cleaning up” and “sanitisation” of abusive marketing and promotional activities. Code of Conduct for Good Marketing Practices has already been adopted by all leading pharma manufacturing associations.

Drug Pricing Under DPCO/NPPA It is rumored that the Competition Commission is looking in to exorbitant variations in pricing of branded generic medicines, often varying on a 1:10 ratio.

The Competition Commission of India appears to be evolving into a vigilant

“

The Indian Pharmaceutical Industry is subject to plethora of regulations. In its regulatory path, over and above the drug regulators there are Intellectual Property related regulations; in the commercial marketing, pharma industry has to extensively deal with the AIOCD (All India Organisation of Chemists & Druggists) and a very large number of State-wise, Districtwise Associations.

Further, the branded generics and new drugs are prescriptionbased, which brings the Medical Profession into the ambit.

The Medical Council of India and the Pharmaceutical Manufacturing Associations in India have already undertaken a “cleaning up” and “sanitisation” of abusive marketing and promotional activities.

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“

“

It will soon be be necessary for Indian generic pharma industry to approach the Competition Commission under the provisions of the Competition Act relating to “Abuse of Dominance.”

body, fully geared to take up anticompetitive, anti-public interest actions through abuse of dominant position. It is therefore, in the fitness of things, that the pharma industry adopts self-regulative measures in pricing.

the monopoly granted through patents.

It will soon be necessary for Indian generic pharma industry to approach the Competition Commission under the provisions of the Competition Act relating to “Abuse of Dominance”.

Competition Law and IP (Patents Act)

The excessive and protracted litigations challenging grant of Compulsory Licenses as well as grant of regulatory approvals by DCGI or State FDAs could be successfully resolved by seeking intervention of the Competition Commission, especially in view of the clear provisions or grant of Compulsory Licenses in Chapter XVI (Sec.84 to 103) and for regulatory approval under Sec.107(A)(a) of the Patents Act.

Avoidance of restrictive conditions in contracts and agreements are warranted as per Sec.140 of the Patents Act, 1970.

Sec.106 of the Patents Act, 1970 further provides relief in case of groundless threats of infringement proceedings. Other than this, the Patents Act is substantially silent on abuse of

The current trend of aggressive abusively protracted litigations could lead the generic pharma industry at the doors of the Competition Commission, sooner or later.

Mergers and Acquisitions This field being relatively dormant (we see a news report once in a while), there have not been much activity in this field. There was a recent newspaper report about a merged entity being asked to divest a couple of product ranges, however, this has apparently come from the US FTC (Federal Trade Commission) addressed to the US acquiring company. The Competition Commission looking into future mergers and acquisitions cannot be ruled out.

However, there are monetary limits under the Act, which may not impact small entities and mergers of relatively smaller companies.

Contact: gopanair@gnaipr.net

For Details Contact

Jasubhai Media Pvt. Ltd. Taj Building, 3rd Floor, 210 Dr D N Road Fort, Mumbai - 400 001 Tel: 022-4037 3636, Fax: 022-4037 3635 Email: industrialmags@jasubhai.com

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25-11-2013 11:57:07

Easy on the Eye A The overall concept of the FrymaKoruma vacuum processing units makes them ideal for sterile processes. These processing units find use in the manufacturing of ophthalmic products complying with the stringent Current Good Manufacturing Practices (cGMPs) requirements needed for the production of such sterile pharmaceuticals.

n American manufacturer of ophthalmic medicines has trusted in FrymaKoruma processing equipment for the last six years. The presentation of the CoBall annular gap bead mill, the first mill of this type to be used for the sterile production of ophthalmic medicines convinced one of the world’s biggest manufacturers of ophthalmic products.

Eight years ago, the packaging machinery supplier embarked on a tour of the USA designed to increase awareness of its process technologies. A mobile lab was set up on a truck especially for this purpose. In the course of the three-month round trip the FrymaKoruma crew took in 54 companies in 14 states.

More orders for several Dinex vacuum processing units followed in its wake. A

second Dinex 700 was installed in May last year and negotiations are currently taking place regarding the construction of further units.

Ophthalmic medicines are pharmaceutical products that are applied directly to the eyeball, conjunctiva or conjunctival sac. Strict compliance with the rigorous requirements of the cGMP (Current Good Manufacturing Practices) for sterile pharmaceuticals is therefore a must when these products are manufactured.

The regulations concern both the machine itself and the manufacturing process. The system is sterilised by passing hot steam through the machine and then drying it. All product-contacted surfaces, piping and filters have to be absolutely sterile.

Joachim Stoye

Product Manager Romaco FrymaKoruma

Marco Schweizer

Product Manager Romaco FrymaKoruma 44 ď‚ƒNovember 2013

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The product – in this case, the ophthalmic medicine – likewise has to be sterilised during the manufacturing process. All germs and microorganisms can be killed by selective heating. The normal values for in situ sterilisation are a constant 121°C over a period of at least twelve minutes. Temperatures of 124°C with a tolerance of plus/minus two degrees over a minimum of twenty minutes are explicitly stipulated for the ophthalmic products in question. End-to-end monitoring of the process is essential in order to meet this requirement. Six independent measuring systems continuously monitor and control the temperature in the vessel, cover, bypass and other piping as well as in the sterile filter of the vacuum processing unit. Homogeneous temperature control of the product mass is achieved in this way under sterile conditions.

Thorough mixing is vital here. The scraper agitator on the inner wall of the vessel and the centrally mounted counter-rotating agitator distribute the product quickly and homogeneously, leading to extremely effective heat exchange. The doublewalled pressure vessel ensures that the product is heated in line with sterility

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Precise Temperature Control of the Sterile Formulation

The CoBall mill is particularly suited for sterile applications involving wet grinding and is this mill type is the system of choice when it comes to producing sub-micron particle sizes.

requirements. The formulation must not be allowed to overheat, however, or the active ingredients will be destroyed. This narrow temperature window represents a daunting technological challenge, yet the FrymaKoruma vacuum processing units can be relied on to master it without fail. The scalability of the Dinex series guarantees highly reproducible processes regardless of their size.

Narrow Particle Size Range for Superior Product Quality The CoBall mill is particularly suited for sterile applications involving wet grinding. This mill type is the system of choice when it comes to producing submicron particle sizes. When ophthalmic medications are manufactured, very small particles have to be produced within a closely toleranced range. Variations in size must be avoided as far as possible because they impair the quality of the product and create a potential risk of eye injuries. Due to its very narrow milling gap, the annular gap bead mill provides extremely homogeneous results.

During this process the beads can be cleaned without being removed from the milling chamber, saving time, energy and money.

Energy Efficient Heat Exchange The interior of the mill has additionally been optimised to facilitate cooling. The powerful milling forces result in high temperatures throughout the wet grinding process and these temperatures have to be controlled. The annular gap bead mill offers a very large heat exchange surface in relation to the volume of the milling chamber. The product temperature is regulated continuously by means of cooling ducts in the rotor, stator and mill cover, so that the system makes particularly efficient use of energy.

The inlet temperature of the product can even be reduced during the milling process. Heat-sensitive ingredients can thus be processed gently and safely throughout.

Contact: susanne.silva@romaco.com

The milling chamber is filled with beads made from wear-resistant ceramic materials. They move in a controlled way within the gap between the rotor and stator and are swirled around the milling space by an internal recirculation system.

The product is milled by a combination of crushing, impact and cutting forces. The geometry of the process tool causes these milling forces to be input directly into the product. No additional aids such as pins, discs or other accelerating elements are required. The beads are separated from the product at the mill discharge by means of a dynamic sieve. Cleaning is fully automated in the form of CIP (cleaning in place) and SIP (sterilisation in place).

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Improving the Chemical Synthesis and Production of Duloxetine through Biocatalysis

W

ith new product innovation decreasing and several blockbuster drugs going or about to go off patent, the generic pharmaceutical market is becoming more and more prevalent. Pharmaceutical manufacturers that previously developed patent-protected therapies, known as innovators, increasingly have to compete with generics manufacturers. It is expected that generics will be adopted in almost all major markets around the world within the next three to five years, fuelled by the desire of many countries to reduce healthcare costs. Thanks to their ability to undertake cost effective API and pharmaceutical intermediate manufacturing, India and China are seen to be especially important in the generic and intermediates markets. Due to this increased level of competition over products whose patents have just or are just about to expire, cost reduction is at the forefront of manufacturer’s minds..

Cutting Costs Earlier Changes in manufacturing procedures are a major contributor in improving operating margins. By pursuing a new manufacturing process, the original innovator of a pharmaceutical can compete with generic manufacturers using a different, more effective manufacturing process. Traditionally, production cost reductions have taken place in the later stages of clinical development, as innovators have been reluctant to make process changes after a product has been launched.

Rose A Lance

Senior Marketing Manager Novozymes Biopharma

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“

However, pressures to reduce costs have increased alongside regulatory demands and generic competition. As a result, innovators have increasingly been pursuing cost reductions earlier in product development.

By investing in new technologies, productivity and efficiency of manufacturing processes for intermediates and active pharmaceutical ingredients (APIs) can be improved.

Biocatalysis is one recognised technique that can be employed to reduce costs, providing a sustainable process and improving the quality of the API. By pursuing this type of manufacture earlier, the pharmaceutical innovator can protect themselves much better against future generic manufacturers and remain aligned to the latest regulatory demands.

Implementation of Biocatalysis Biocatalysis involves the implementation of natural catalysts, such as enzymes, in place of chemical catalysts in synthetic processes. This change can enable new, more sustainable routes for the production of intermediates and APIs. One of the biggest advantages of enzymes in organic synthesis is their remarkable selective properties, which gives a number of commercial benefits including better production of single stereoisomers, fewer side reactions, less reprocessing or purification steps, easier product separation and less pollution.

The combination of all of these means lower costs. Biocatalysis has become an

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This article will discuss the benefits of utilising an enzymatic route rather than chemical synthesis route in the context of the manufacture of Duloxetine to outline the disadvantages of chemical synthesis and the benefits of using enzymes in the product manufacture in terms of cost savings, reduction in steps, improved quality of the final API, the technical advantage over chemical route and the sustainable process.

By pursuing a new manufacturing process, the original innovator of a pharmaceutical can compete with generic manufacturers using a different, more effective manufacturing process.

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increasingly important tool for medicinal chemists, process chemists and polymer chemists, allowing the development of efficient and highly attractive organic synthetic processes on an industrial scale.

The Changing Face of Duloxetine Duloxetine (sold under the brand names including Cymbalta, Ariclaim and Dulane) is a serotonin-norepinephrine re-uptake inhibitor. It is used in the treatment of a wide range of conditions, including major depressive disorder, general anxiety disorder, painful peripheral neuropathy, and chronic musculoskeletal pain associated with osteoarthritis and chronic lower back pain. The main brand name Duloxetine is sold under, Cymbalta, will go off patent this month. This has made its manufacture an ideal candidate for cost reductions through biocatalysis.

Using this example, this article will outline the specific disadvantages of chemical catalyst synthesis and the benefits of using biocatalysis enzymes during the manufacture of APIs and intermediates. It will go on to demonstrate how both cost savings and improved end products can be achieved through improved API quality, streamlined synthesis routes, process sustainability and technical advantages.

Chemical Synthesis of Duloxetine As demonstrated in Figure 1, Duloxetine is manufactured by chemical synthesis in eight or nine steps. Initially, racemic 3-(N,N-Dimethylamino)-1-(2-thienyl) propan-1-ol is formed, involving two steps. The racemic mixture then undergoes resolution to form (S)-N,NDimethyl-N-[3-hydroxy-3-(2-thienyl) propyl]ammonium (S)-Mandelate. Finally, this is converted in five steps to (S)Duloxetine Hydrochloride.

This is the traditional method for creating the product and comes with several disadvantages. For instance, numerous chemical steps are included within the process, increasing the overall cost of manufacture. Extra steps are also included for the recycling of the resolving agent and required isomer-recycling, which takes place by heating of the (R) isomer with hydrochloric acid. As well as adding stages to the process, this results in the formation of impurities which carry forward in to the API and impacts the quality of the end product.

As a further challenge, the final yield from this process is restricted to around 10-12 per cent of the acetyl thiophene starting material. A key area that results in such a high loss of yield is the chemical resolution of 3-(N,N-Dimethylamino)-1(2-thienyl)propan-1-ol and the removal of one or two methyl groups of the dimethyl amino side chain. This removal of an extra

Figure 1: Duloxetine chemical synthesis route

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Table 1: Enzymatic routes for production of Duloxetine

methyl group requires extra treatment of (S)-3-(N,N-Dimethylamino)-1-(2-thienyl) propan-1-ol with corrosive reagents, such as phenyl or ethyl chlorformate, and basic hydrolysis before condensation with1-Fluoronapthalene.

Importantly, the vital resolution step creates a low enantiomeric excess, meaning the final product is not as pure as often required. The chemical 49 ď‚ƒNovember 2013

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resolution of key intermediate formation also requires the use of costly (S)Mandelic acid in half molar quantities.

In order to create a more cost-efficient and sustainable manufacturing process, different techniques and methods need to be considered, including the use of biocatalysis enzymes.

Synthesis of Biocatalysis

Duloxetine

through

In contrast, the enzymatic routes for the synthesis of Duloxetine are shown in Table 1, where notable improvements on the chemical synthesis route are demonstrated.

Reducing Cost of Manufacture Costs of manufacture are reduced through various channels using this enzymatic method.

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“

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The biocatalysis enzymes themselves can be created from renewable sources and mostly operate in water, eliminating the need for organic solvents and thus replacing hazardous chemicals.

provides an opportunity for formulators and manufacturers to use enzymes to efficiently resolve an existing racemic mixture, creating new chiral centres or delivering a chirally pure compound through asymmetric reactions. This improves the production of single stereoisomers, creates fewer side reactions, allows easier separation of products and reduces waste. Due to the efficiency of the technique, the total cost of implementing biocatalysis in drug manufacture is relatively low.

in turn decreases the production of process waste and toxic chemical waste.

The biocatalysis enzymes themselves can be created from renewable sources and mostly operate in water, eliminating the need for organic solvents and thus replacing hazardous chemicals.

Overall, the entire manufacturing process becomes more sustainable and environmentally friendly.

The synthesis of Duloxetine through biocatalysis is vastly more cost-efficient due to the reduction in raw material input and raw material consumption. Raw materials no longer required include isopropyl alcohol, L-mandelic Acid, acetyl thiophene, formaldehyde, phenyl chloroformate/ethylchloroformate, diisopropylethylamine and 2-Methoxy2-methylpropane (MTBE). Therefore, the amount of components needed to be purchased and included into the formulation is reduced by as much as 10–15 per cent. There is also a notable reduction in overhead costs due to less process steps being involved - equipment costs, labour costs and energy savings can be reduced by up to 15%. The streamlined process, which has been dropped from nine steps to five or six, results in higher throughput and financial savings, with more batches being produced in the same timeframe. Combined, these factors have a positive effect on the cost of manufacture.

Alongside the financial impact, there are additional technological advantages to this new method. The enzymatic process for Duloxetine synthesis uses an immobilised enzyme providing enhanced stability under both storage and operational conditions (for example towards denaturation by heat, organic solvents or by autolysis) and allows for convenient handling of the enzyme.

Importantly, these have the added ability to be recycled and reused multiple times, decreasing the overall cost of use and improving efficiency. If required, the enzymatic synthesis route can also be converted into a continuous packed column/membrane based process.

A Sustainable Process

Using the biocatalysis method creates fewer opportunities for intermediates to be passed over to the final API, creating a purer product. In addition, the chiral resolution itself is very clean, so the risk of carry over from of chiral impurities

As previously mentioned, with high selectivity enzymes used in biocatalysis, the number of stages used during product synthesis can be reduced. This 50 November 2013

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Technological Advances for a Purer Product

will also be less. Finally, by reducing the use of solvents in the process, there is reduced chance of contamination from this source.

Conclusion Within API and intermediates manufacture, there is an increasing demand for opportunities to improve operating margins while still producing a high quality final product, and manufacturers are eager to incorporate these cost reduction measures earlier and earlier in the product lifecycle. As shown by the successful implementation of biocatalysis in the synthesis of Duloxtine, biocatalysis enzymes are efficient catalysts which can greatly benefit both final drug products and the manufacturing processes.

It has been shown that by providing an alternative manufacturing procedure, the entire process becomes more cost efficient and streamlined. These enzymes are capable of creating a unique route for manufacturers seeking to enhance sustainability, improve performance and reduce costs. By achieving these goals, companies are better placed to contend with generic or other generic manufacturers in this increasingly competitive marketplace.

Contact: syke@novozymes.com

These advances in technology go on to have an impact on the final product. It has been noted that biocatalysis creates more linear synthesis routes with fewer intermediates. In addition to improving productivity, this allows opportunity for a better quality of API or intermediate to be produced.

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news features

Global Regulatory Challenges: Opportunity for Learning Ananya Sen in a conversation with Dr Kavita Mehrotra, Global Strategic Head, UL Eduneering, andJibuMathew, Business development Head, UL- Health Sciences, (a global safety science organisation).that provide customised solutions to help companies achieve regulatory compliance and ensure safety of the products placed in the market.

T

he Pharma industry today is striving to cope up and live up to the standards of the regulatory agencies. But what could be the reason for this crisis?

To this Dr Kavita Mehrotra Global Strategic Head, UL Eduneering answers that we are not in a mode of crisis, but in a mode of opportunities. The regulatory scenario of the Indian Pharma industry is no different from that experienced globally. What we are witnessing right now, she says, is an increase in global demand, and its implications. With the increase in the number of exports from India, especially to the United States it is only natural for the US FDA to have increased their vigilance not only in India but across the world opines Jibu Mathew.

It is expected that the set standards of the US FDA be followed by the pharma industry.

On being asked if it is rather impossible to completely comply with the norms of the US regulatory agency, Mehrotra disagrees, saying that the standards are not unrealistic and compliance can be achieved if there is a common understanding of GMP guidelines universally. This, she believes, can be achieved by the right training to the

right people at the right time. Companies complying with the regulatory norms have proved the practicality of these regulations, she points out. When companies go wrong, she believes, it is most often due to lack of information, not intent, and access to the right training: which is where she asserts that UL can prove to be a significant learning partner.

Training: The Way Ahead UL Eduneering, Dr Mehrotra and Mathew explain, works with a mission of “working for a safer world.� In the regulatory education context, this is achieved through training in a robust quality system to minimise compliance risks and make companies audit-ready. UL EduNeering helps prepare companies validate their processes and demonstrate a superior compliance practice. This is done by providing a chiseled set of 700+ online learning modules, many authored by the US FDA including courses on GMP, CGMP,

Source: IPQ

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compliance, and more. UL is learning partner with the FDA for fifteen years now and have trained around thirty thousand FDA inspectors globally.

A benchmarking study conducted by UL in the end of 2012 reveals that the priority training topics in the regulatory and compliance world for 2013 are: Training Data as a Source for Business Metrics, followed by SOP Management and Training Effectiveness. This is also an area that differentiates UL Eduneering by a platter of offerings as a one stop shop: a validated Learning Management System, a GMP (Good Manufacturing Practices) and Compliance library comprising FDA authored courses, and advisory services to make the company audit-ready.

The significance of training cannot be overstated. Maintaining records of training is also a must. According to FDA “The use of metrics that span across the industry would enable FDA to better target which sites, and which products, processes and

systems at those sites, require agency attention, and decrease the inspection burden on sites that have robust quality systems.” Simply put, this means that companies with records of training will be less scrutinised.

But what about data fudging and when there are ethics related issues involved? Can these be corrected with training as well? A culture of Quality, believes Mehrotra, in an industry that is subject to global standards can be standardised and a global culture of quality can be inculcated amongst all.

Complying With the Standards When asked if FDA “gold standard” is unrealistic or too hard to attain, Dr Mehrotra replied that companies that demonstrated observance of good manufacturing practices, including documentation, records, and electronic signatures are an example of the fact that the standards are both applicable and feasible. In order to ensure the well-being of human health,

she says, enhancements of the latest compliance norms is a moral and legal obligation for all. To help employees of various organisations keep pace with the latest, UL has a multitude of courses designed for the Pharma and Medical Devices Industry in place, adds Mathew, sharing the formal announcement of their interest to partner with organisations in India.

In the end, says Dr Mehrotra, our hope as a company, as an industry, and as people, is reflected in our UL mission: “Working for a safer world”. Because ultimately, she says, “To be good examples of global citizenship and social responsibility is a commitment that transcends any geographical boundaries.”

- Ananya Sen

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NEXT ISSUE FOCUS In the forthcoming issue this December, Witness the latest trends in Pharma Manufacturing Machineries and Packaging.

With the high end technology available ready at hand, pharma formulation manufacturers can now span across myriad of latest manufacturing technologies to boost production and growth. Packaging as an industry especially in pharma has been expanding and promises for further progression with the introduction of stricter regulatory policies.

The state of Gujarat has shown a tremendous growth in both manufacturing as well as packaging technologies a lot of which will be covered in this issue.

news features

India to Witness Growth in Retail Chain Pharmacy This article reviews the emerging new trend of chain drug stores in Indian pharmaceutical sector.

“India, being a tropical country, is fertile ground for retail chain pharmacies. The vast population and exposure to tropical diseases will automatically lead to huge consumption of medicines,” explains R K Jatia, Managing Director, Emami Frank Ross Ltd. As per estimates, there are approximately 8,00,000 pharmacies in India today with about 60,000 distributors. Out of these 20 to 30 per cent is from all the organised retail companies and rest is dominated by traditional/local pharmacists.

There are plenty of opportunities for the organised players to grow in Indian retail pharmacy market.

F

or Indian pharmacy retail market, the last few years were packed with several significant developments.

The most prominent among these is the advent of retail chain pharmacies.

There are many factors contributing to the boom in this segment including increase in health care spending, change in consumer attitude, etc. Pharmacy retail market in India is one of the most unorganised and has the highest profit margins. It is a considerably big market and has tremendous scope to grow further. This has attracted many organised players in pharmacy retailing.

The organised retail pharmacies provide better consumer experience compared to the Mom and Pop retail medicine stores. They are bringing in international best practices into their operations by offering value added services like availing medicines in air-conditioned surroundings, 24x7 operations, door delivery, credit-card acceptance, insurance cover etc.

“The benefit of retail chain pharmacy is that the customers get genuine medicines and also entire requirement of their medicines,” says Jatia.

According to Jatia, the key challenge of pharmacy chain is availability qualified pharmacist. As per law, qualified pharmacists alone can sell drugs. The required labour strength is more and expensive at chain stores whereas the margin is fixed as per government drug price control order.

Adding to this, problems like rigid licensing norms and lack of effective regulatory mechanism, etc are some of the key constrains.

Retail chain pharmacy is considered as a sunrise industry in India. It is still in its nascent stage and has tremendous scope to grow in the future. At present in India, there are approximately 25 chains with total outlets aggregating to 2,000.

“Retail chain pharmacy has bright future since the customers can get all the required medicines at reasonable rates,” Jatia adds.

By easing FDI norms in muli-brand retail and opening up door to global chains such as Walmart and Tesco, India to see an exponential growth in retail chain pharmacy sector.

- Mahesh Kallayil

These new players include not just those with pharmaceutical or healthcare background, but also corporates from other sectors. Corporate tycoons like Reliance Industries and Aditya Birla Group have already forayed into pharmacy retail market. Even the central and state governments ventured into this segment with Jan Aushadi outlets and Karunya pharmacy etc. Moreover, government has paved the way for global medicine retail chains into the country by opening up multi-brand retail sector to FDI. 55 November 2013

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PBW Marketing Initiative

System for the Implementation of the New USP Chapters on Elemental Impurities Watson-Marlow Pumps Group, the leader in peristaltic pump technology, introduces DriveSure™ its new panel-mount OEM brushless DC gear motor with fully integrated speed controller. DriveSure is highly adaptable, offering 24V and 48V dc options, a 51:1 control ratio between 408-8 rpm, and directly accepts market-standard analogue control signals. With DriveSure, OEM engineers can bring products to market faster and with less engineering cost by eliminating the time, design uncertainty and risks associated with the separate specification of pump motor, gearbox and drive.

DriveSure helps OEMs to reduce their time-to-market significantly, so providing valuable competitive gain. Furthermore, the inherent risks of buying various system components from different manufacturers are eliminated, with the safety net of a single, comprehensive two year warranty.

Importantly, this includes a performance guarantee for the complete pump and full integration support.

Easy Set-up

and chromatography equipment, while in terms of analysers, process, toxicity and wet chemical analysis equipment is sure to benefit.

DriveSure technology enables the most competitively priced panel mount OEM pump range that Watson-Marlow has offered to date, giving customers the peace of mind of a fully integrated pump solution from the marker leader. This assurance of pump performance is back up by a comprehensive two year warranty, and direct support in over 50 countries.

CE marked and manufactured in conformance with IEC and EN 61010-1, the Watson-Marlow Pumps Group compact, lightweight and well-balanced The Driving Down Complexity design provides a ‘plug-in and forget’ comprises of: Building on Watson-Marlow’s extensive solution. The use of Watson-Marlow’s • Watson-Marlow Pumps: peristaltic tube pumps for pharmaceuticals and industry experience of providing peristaltic cased own gearbox provides the customer with pumps, DriveSure for the first time brings excellent torque and silent running. As • Watson-Marlow Tubing: precision tubing a range of panel-mount brushless DC motor a result, the solution is ideal for the life for pumping and other purposes, in a gearboxes and controllers as a package. science and Biopharm sectors where noise range of materials This innovative range offers market can be a major issue.

• Bredel Hose Pumps: heavy-duty leading speed control range and precision, hose pumps guaranteed torque and long service life ideal Typical life science applications might • Watson-Marlow Alitea: unique peristaltic dental, endoscopy, electrofor OEMs wishing to panel-mount Watson- include solutions for OEM customers Marlow’s proven pumpheads, including the medical and in-vitro diagnostics. The • Flexicon Liquid Filling: aseptic filling and 102R, 114, 313D, 501RL and 520R series comprehensive control and flow rate capping systems for a flow range from 0.1 to 6100 ml/min. capability also meets the requirements • M a s o S i n e P r o c e s s P u m p s : It also interfaces with the market-standard of biopharmaceutical equipment such as sinusoidal pumps bioreactors, bench-top cross-flow filtration analogue control signals.

Part of the Spirax-Sarco Engineering Group, Watson-Marlow Pumps Group is an international operation based in Falmouth, Cornwall, UK. Watson-Marlow Pumps has offices in Argentina, Australia, Belgium, Brazil, China, Denmark, France, Germany, India, Italy, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Russia, Singapore ,South Africa, Sweden, Switzerland and the USA. For more details, write to Watson Marlow India Pvt Ltd S .No 77/1 Opp Malan Farm Z.P.Road , Tathawade Pune -411 033 Tel No:- +91 20 6735 6200 Email:- info@wmpg.in Website:- www.wmpg.co.uk

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PBW Marketing Initiative

Watson-Marlow Pumps Aid the Recovery of Rare Industrial Mineral • •

21 Watson-Marlow pumps bring flotation process into 21st century Chemical reagents metered include methyl isobutyl carbinol, sodium isopropyl xanthate, sodium carbonate. Investment assisted the revival of UK’s only fluorite producer

In early 2013, Watson-Marlow Pumps Group supplied no less than 21 positive displacement pumps to British Fluorspar Ltd, the UK’s sole fluorspar producer. The pumps, which include 12 of the latest Qdos no-valve metering pumps, have all been set to work on vital flotation duties at the company’s Peak District facility. The mine reopened in May 2012 following closure 18 months beforehand. With the help of Watson-Marlow pump technology, the site is now responsible for producing 60,000 tonnes of fluorite every year.

Acid grade fluorspar (fluorite) is a relatively rare industrial mineral. The UK’s main reserves are now found solely within the Southern Pennine orefield in the Peak District National Park. Extraction can be by open cast methods, often to considerable depths, or by underground mining.

Following acquisition and investment by the Italian Fluorsid SpA group last year, British Fluorspar Ltd is now prospering with 45 people working across two shifts. The company today comprises an underground operation at Milldam Mine, open pit extraction at Tearsall Quarry, and processing operations at Cavendish Mill.

Time for Change When the site was re-opened last year, British Fluorspar was keen to source new pumps that represented 21st century technology: efficient, reliable, precise, low maintenance, clean and user-friendly.

The company called on the services of an external consultancy and the advice was simple: consider peristaltic.

“We knew about the peristaltic concept but in all honesty never had the financial

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backing to make the change,” says Mr Large. “However, with the new investment we were able to take a look at the market and soon realised that Watson-Marlow were the people to approach.”

Following consultation, Watson-Marlow was able to recommend: 12 Qdos 30 universal pumps offering flow rates from 0.1 to 500ml/min at 7 bar; eight 520UN/ REL process pumps providing flow rates up to 3550ml/min ; and a single 620UN/ RE with flow rate from 0.004 to 18 litre/min.

Regarding the latter, a probe is used to control the dosing in line with pH fluctuations.

All of this is far cry from the equipment used prior to the site’s reopening – where the system relied on a bucket and wheel feeder/proportioner which was both erratic and inaccurate.”

The emphasis on the Qdos 30 range reflects a design which is aimed specifically at chemical metering. These high performance pumps accurately dose chemicals without the need for any valves or ancillary equipment, keeping costs to an absolute minimum – in fact, the total cost of ownership is less than that of a typical solenoid or stepper-driven diaphragm pump.

Floating the Idea Today, all 21 Watson-Marlow pumps have been deployed successfully in the flotation process at British Fluorspar. Reagents are pumped up from mixing tanks into the head tank, from where they follow plastic pipes down into flotation.

Among the chemical reagents handled by the pumps include methyl isobutyl carbinol, sodium isopropyl xanthate, sodium carbonate, sodium sulphide, caustic soda pearl and sodium silicate. In total, British Fluorspar produces 60,000 tonnes of fluorite ore every year, which is extracted from 300,000 of crude product. As a byproduct, limestone is discharged from the mineral and sold.

“We first used the pumps in March 2013 and have been really pleased with their performance,” concludes Mr Large. “At last we have equipment befitting a business such as ours. I must also add that the back-up and response from WatsonMarlow has been excellent throughout the entire process.”

The Watson-Marlow Pumps Group comprises of: • Watson-Marlow Pumps: peristaltic tube pumps for pharmaceuticals and industry • Watson-Marlow Tubing: precision tubing for pumping and other purposes, in a range of materials • Bredel Hose Pumps: heavy-duty hose pumps • Watson-Marlow Alitea: unique peristaltic solutions for OEM customers • Flexicon Liquid Filling: aseptic filling and capping systems • MasoSine Process Pumps: sinusoidal pumps Part of the Spirax-Sarco Engineering Group, Watson-Marlow Pumps Group is an international operation based in Falmouth, Cornwall, UK. WatsonMarlow Pumps has offices in Argentina, Australia, Belgium, Brazil, China, Denmark, France, Germany, India, Italy, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Russia, Singapore,South Africa, Sweden, Switzerland and the USA. For more details, write to Watson Marlow India Pvt Ltd S .No 77/1 , Opp Malan Farm Z.P.Road , Tathawade Pune -411 033 Tel No:- +91 20 6735 6200 Email:- info@wmpg.in Website:- www.wmpg.co.uk

November 2013  57

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pharma news Ranbaxy Gets CDSCO Nod to Market HRS Unveils Innovative Energy-saving Synriam in India Technology at PharmaTech-‘13

Arun Sawhney, CEO & MD, Ranbaxy

Ranbaxy Laboratories Limited (Ranbaxy) has received approval from the Central Drugs Standard Control Organisation (CDSCO), Government of India, to manufacture and market Synriam (arterolane maleate and piperaquine phosphate tablet 150+750 mg) for the treatment of uncomplicated malaria in adults caused by the Plasmodium vivax parasite.

Phase III clinical trials for the drug conducted in India successfully demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine. Last year on World Malaria Day, April 25, Ranbaxy had launched India’s first new drug, Synriam, for the treatment of uncomplicated Plasmodium falciparum malaria in the country. Since its launch, Synriam has successfully treated around one million patients.The company has also received permission to conduct Phase III clinical trials for the pediatric formulation in pediatric patients of uncomplicated Plasmodium falciparum malaria.

Commenting on the approval, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “Synriam is a new-age cure for malaria and is fast emerging as the preferred option in the hands of doctors. This approval makes Synriam one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria. Ranbaxy remains committed in its fight against malaria and we are making all efforts to make this new therapy accessible to patients around the world.”

Ranbaxy is working to make this new treatment available in African, Asian and South American markets where Malaria is rampant. The company has filed New Drug Applications (NDAs) for marketing Synriam in some African countries and will be filing in more applications during the year. Once approved, the product will be launched in these markets.

Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95 per cent. It conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria.

As the dosage regimen for Synriam is simple, it leads to better compliance. A patient is required to take just one tablet per day, for three days, compared to other medicines where two to four tablets are required to be taken, twice daily, for three or more days.

The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost.

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HRS Process Systems Ltd (HRS PSL), part of HRS Group, UK participated in the second edition of PharmTech Expo 2013. The two-day exhibition was held in Indore from 6th to 8th October 2013 at Brilliant Convention Centre. With an aim to expanding reach across various industry sectors including Pharma, HRS showcased V Gokuldas, MD innovative and energy efficient technology HRS Process Systems Limited in the form of Ecoflux Corrugated Tube Heat Exchangers, HRS Funke Plate Heat Exchangers in gasketed and brazed variants, at this exhibition.

“The best way to gain a competitive edge in the Pharma industry is, energy efficiency vis-à-vis cost of the equipment and secondly reducing or eliminating down time for maintenance. Our foremost aim through this expo was to showcase our quality heat transfer solutions to ensure sustainability with a competitive edge,” said V Gokuldas, Managing Director, HRS Process Systems Ltd. HRS Funke Plate Heat Exchangers (PHE) offer versatile heat transfer solutions for various instant hot water applications required for the pharma industry. HRS also offers Corrugated Tube Heat Exchangers (CTHE) and PHE based hot water systems for AHU, HVAC, FFE, VTD, AFD, reactor heating and such other applications. Their expertise at manufacturing heat exchangers in stainless steel grade and exotic materials like C276, C22, titanium and various other materials, gives HRS us an edge in the industry.

Piramal Enterprises Buys CALADRYL in India Elores Piramal Enterprises Limited (formerly Piramal Healthcare Limited) today announced that it has acquired the Over-The-Counter (OTC) brand CALADRYL in India from Valeant Pharmaceuticals International, Inc. The brand CALADRYL in India was owned by Valeant Pharmaceuticals International, Inc. The rights to this brand were acquired by Valeant from Johnson & Johnson in the year 2012. CALADRYL is an antipruritic solution known for dermatosis application for minor skin irritations and itching.

This acquisition enables Piramal Enterprises (PEL) to widen its consumer products portfolio in the skin care segment. PEL’s current consumer products portfolio includes brands such as Lacto Calamine, Saridon, i-Pill, Itchmosol and Supractiv Complete, along with niche market brands like i-Pill, i-Can, Jungle Magic, Tetmosol and Triactiv. The division has one of India’s largest field forces in the industry covering more than 100,000 towns.

Pharma Bio World

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Antares Pharma Signs Marketing Deal with LEO Pharma Antares Pharma, Inc has announced an exclusive promotion and marketing agreement with LEO Pharma for detailing OTREXUP (methotrexate) to dermatologists for symptomatic control of severe recalcitrant psoriasis in adults.

Under the terms of the agreement, Antares may receive up to a total of USD 20 million in milestone payments including an upfront payment of USD 5 million. Antares Pharma will record all product revenue associated with future dermatology prescriptions and pay LEO Pharma a percentage of OTREXUP net sales generated in dermatology. LEO Pharma will be responsible for promotion and marketing activities in dermatology.

“We are very pleased to be working with LEO Pharma on the launch of OTREXUP,” said Paul Wotton, PhD, President and Chief Executive Officer of Antares Pharma.

“Collaborating with LEO on the launch creates a very strong partnership allowing Antares to team up with and benefit from a very successful commercial organisation while LEO expands their portfolio with a new product in their field of expertise.

With a dedicated US sales force of 75 representatives focused solely on the treatment of psoriasis, we believe LEO Pharma w i l l b e a b l e t o in t ro d u ce a n d e st a b lish OT REXUP as an important new treatment option with significant growth potential in dermatology while complementing our own dedicated sales representatives detailing OTREXUP for rheumatoid arthritis,” he added.

Granules India Acquires Auctus, Opens New R&D Facility Granules India, a fast growing pharmaceutical manufacturer, has announced the signing of a definite agreement for the acquisition of Auctus Pharma, a leading API manufacturer.

The acquisition process is expected to be completed in the next three to six months.

Auctus has two manufacturing facilities, an API facility in the Pharmacity in Vishakhapatnam and an Intermediate facility in Hyderabad. The API facility has approvals from leading regulatory agencies including the US FDA, EDQM, Health Canada, KFDA and WHO-GMP. Krishna Prasad, MD Granules India

Auctus’ product portfolio includes twelve APIs as well as key intermediates of those APIs. The portfolio includes APIs in several therapeutic categories such as Antihistaminic, Antihypertensive, Antithrombotic and Anticonvulsant as well as other therapeutic categories. Auctus currently sells its APIs and intermediates to Pharma Bio World

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customers in fifty countries. The team and assets from the acquisition will initially operate as a separate division with Granules.

Granules also announced the opening of a 10,000 sq foot R&D facility in Hyderabad. The new R&D will focus on full scale generic API development and will supplement the Company’s existing R&D facility in Pune which currently focuses on sustainable technology development.

“The acquisition of Auctus fits into our strategy of being a fully integrated manufacturer while diversifying our product portfolio by adding high-value products with significant market demand.

Auctus provides Granules with a meaningful API platform with a US FDA approved site to strengthen our Finished Dosage division.

Granules will offer tremendous value to customers since we can provide supply security all the way from key intermediates to finished dosages for these products. We will be a market leader by implementing our operational excellence philosophy while leveraging Auctus’ regulatory approvals. In order to accelerate growth with a sustainable development engine, we have established a new R&D facility to enable Finished Dosage filings for our new APIs” said Krishna Prasad, Managing Director of Granules India.

Eisai Begins Free Supply of DEC to WHO Eisai Pharmatechnology & Manufacturing Pvt Ltd has begun the free supply of Diethylcarbamazine Citrate (DEC) 100 mg tablets produced at its Visakhapatnam Plant in India to the World Health Organization (WHO). This is in line with Eisai’s commitment to help WHO in its global effort to eliminate lymphatic filariasis in targeted developing and emerging countries.

The Pacific island nations of Papua New Guinea, Kiribati, Tuvalu and Fiji have been confirmed as the first countries to receive the initial shipment. An estimated 6.25 million people1 living in at-risk communities will benefit from mass drug administration (MDA) programmes.

Eisai is an active partner and signatory to the London Declaration, a global public-private partnership that aims to eliminate ten Neglected Tropical Diseases (NTDs), including lymphatic filariasis, by 2020. As part of its commitment to this global initiative, Eisai has agreed to supply 2.2 billion DEC tablets to WHO for use in national MDA programmes, free of cost.

Lymphatic filariasis, commonly known as elephantiasis, is a parasitic disease that is transmitted to humans by the bite of a mosquito. Once transmitted, it can cause lymphatic dysfunction and lead to serious manifestations such as lymphoedema, causing painful and disfiguring manifestations of the disease.

C u r r e n t l y, a n e s t i m a t e d 1 2 0 m i l l i o n p e o p l e a r e a l r e a d y affected and more than 1.4 billion people are at risk of this disease, globally.

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23-11-2013 21:02:43

Agilent Technologies Opens CrossLab at Manesar Facility Agilent Technologies, a world leader in test and measurement launched, Agilent CrossLab Laboratory at its Manesar campus.

This initiate will further strengthen the company’s CrossLab Enterprise Services, a synchronised laboratory solution by Agilent Technologies, a service model for all instruments regardless of the brand.

CrossLab Laboratory is an Investment done by Agilent Technologies to further strengthen the CrossLab Services initiative started in India three years back for providing comprehensive Service support to analytical instrument’s from various manufacturers’ which is used in Pharma, Biotech, Food , Environmental industries across India. This Laboratory will help increasing the capability of Agilent Service Engineering Team with hands on training on Analytical instruments from various manufacturers and there by developing Services protocol to provide comprehensive solution to their customers.

Commenting on the inauguration of CrossLab Dr Siva Kumar Pasupathi, Country Head, Life Sciences and Chemical Analysis Unit, Agilent Technologies said “We are extremely proud of our CrossLab Laboratory which offers industry’s best facilities to our customers. We understand and recognize that laboratories are often equipped with instruments from a range of vendors.

Agilent CrossLab will enable simplification product selections and purchase for our customer. Apart from that, this initiative will also streamline their workday, and improve their overall productivity”.

USPTO Issues New Patent to Dyadic International

Mark Emalfarb President and CEO Dyadic

Dyadic International, Inc, a global biotechnology company focused on the d i s c o v e r y, d e v e l o p m e n t , m a n u f a c t u r e and sale of enzymes and other proteins for the bioenergy, bio-based chemical, biopharmaceutical and industrial enzyme industries, has been issued US Patent No. 8,551,751 B2 entitled, “BX11 Enzymes Having Xylosidase Activity” by the United States Patent and Trademark Office (USPTO).

The invention relates to methods of developing and producing novel enzymes, more specifically for the development of a variety of fungal enzymes. Also described in the patent is the encoding of nucleic acid molecules for such enzymes, compositions, recombinant, and genetically modified host cells, and methods of use.

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that degrade the lignocellulosic material and novel combinations of enzymes, including those that provide a synergistic release of sugars from plant biomass. Large amounts of carbohydrates in plant biomass provide a plentiful source of potential energy in the form of sugars that can be utilised to produce biofuels such as Cellulosic Ethanol and a variety of bio-based chemicals. Additionally, the patent addresses methods to use the novel enzymes and compositions of such enzymes in a variety of other processes, including washing of clothing, detergent processes, biorefining, deinking and biobleaching of paper and pulp, and treatment of waste streams.

Dyadic’s President and CEO, Mark Emalfarb, stated, “This latest patent builds upon our family of patents that address the conversion of lignocellulosic biomass into fermentable sugars for the production of renewable biofuels and bio-based chemicals using our proprietary C1 technology. This latest patent adds to our comprehensive IP portfolio further protecting our C1 protein expression system and the products derived therefrom, which continues to attract blue chip customers, partners, and collaborators.”

This patent is the thirteenth US patent issued to Dyadic adding to its portfolio of 41 international patents, 23 pending international and 11 pending US patent applications which cover various features of Dyadic’s proprietary technologies.

Novocure Announces FDA Approval of the NovoTAL System Novocure announced that the United States Food and Drug Administration (FDA) has approved the NovoTAL (Transducer Array Layout) System through a Premarket Approval (PMA) supplement.

The NovoTAL System allows certified physicians to use the individual MRI data of recurrent glioblastoma multiforme (GBM) patients to optimise the field distribution and intensity of Tumor Treating Fields (TTFields) therapy.

“With the NovoTAL System, certified physicians generate individualised transducer array plans for their recurrent GBM patients.

Physicians can now use clinical information and personalised patient characteristics in the transducer array planning process, which is essential for optimising treatment with NovoTTF Therapy,” said Dr Eilon D Kirson, Chief Science Officer and Head of Research and Development at Novocure.

“Not only can physicians optimise transducer array placement at the start of NovoTTF treatment, but can adjust array placement as tumor characteristics change over time,” added Kirson.

The NovoTAL System consists of a dedicated workstation and specialised, PMA supplement-approved software that enables physicians to determine optimal transducer array layouts based on morphological measurements of the head, tumor size and location, and the distribution of TTFields within the brain.

Pharma Bio World

23-11-2013 21:02:44

Immunocore Gets First GSK Milestone Immunocore Limited has announced the achievement of its first milestone in its major research and licensing agreement with GlaxoSmithKline (GSK) for multiple novel targets.

The achievement comes less than four months after the companies signed their James Noble, CEO agreement and triggers a first undisclosed Immunocore milestone payment to Immunocore following the identification of a first lead candidate ImmTAC against one of the targets.

Under the agreement announced in July, Immunocore will receive up to 142 million pound in pre-clinical milestone payments across the targets. In addition, for each product that reaches the market, up to 200 million pound is due to Immunocore in development and commercial milestone payments, as well as up to double digit royalties.

Immunocore is responsible for all pre-clinical development activity and for initial clinical trials in patients while GSK will handle the remaining development and commercialisation of the products.

Immuncore’s world-leading platform of bi-specific biological drugs, called ImmTACs (Immune mobilising mTCR Against Cancer), exploit the power of T Cell Receptors (TCRs) to recognise intracellular changes that occur during cancer or viral infection.

James Noble, Chief Executive Officer of Immunocore, commented: “We are delighted to have made rapid progress and achieved our first milestone within such a short timescale. We have established a very productive relationship with GSK during these initial months of working together and look forward to advancing this and other programmes towards the clinic.”

countries in Asia and Latin America for the treatment of macular edema following CRVO. “The number of patients suffering from diabetes on a worldwide basis continues to increase, and with it the need for new treatment options. DME affects many patients, including those under the age of 50. Whatever a person`s age, vision impairment impacts everyday tasks and has a detrimental effect on quality of life”, said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “With this filing, Bayer and Regeneron hope to make a significant contribution towards alleviating the impact of this disease in the future.”

The submission of EYLEA for DME is based on data from the positive Phase 3 VISTA-DME and VIVID-DME studies. One-year data from the VIVID-DME and VISTA-DME trials were already presented at medical congresses in the US and Europe. Both trials are planned to continue up to 148 weeks.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.

Ohr Pharmaceutical Receives Canadian Patent for Squalamine Ohr Pharmaceutical has announced the granting of Patent # CA 2606077, entitled “Polymorphic and Amorphous Salt Forms of Squalamine Dilactate” in Canada.

Bayer HealthCare has submitted an application for marketing authorisation of VEGF Trap-Eye (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME) to the European Medicines Agency (EMA).

Regeneron has submitted a supplemental BLA (‘Biologics License Application’) for VEGF Trap-Eye in this indication to the Food and Drug Administration.

“We continue to develop squalamine in the clinic, as well as strengthen its intellectual property protection,” said Dr Irach B Dr Irach B Taraporewala, PhD, Chief Executive Officer Taraporewala, CEO and President of Ohr Pharmaceutical. “We and President, Ohr Pharmaceutical are developing Squalamine eye drops for patients with neovascular age-related macular degeneration (wet AMD). Wet AMD is a common eye condition and a leading cause of vision loss among people 50 years of age and older.

Patients with wet AMD are seeking options that reduce or eliminate the need to receive direct injections into the eye. Our Phase 2 clinical trial of Squalamine eye drops is continuing as planned, and we currently expect interim data in the second quarter of 2014.”

VEGF Trap-Eye has been approved under the brand name EYLEA in Europe, the United States, Japan, Australia, and in many other countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD). EYLEA has also been approved in Europe for the treatment of visual impairment due to macular edema secondary to CRVO as well as in the US and in selected

The patent relates to the composition of matter for select squalamine salts, methods of their synthesis, their therapeutic use and their advantages related to manufacturing, product stability, and toxicity. More specifically, the patent is directed to various forms of the dilactate salt of squalamine and their utility in inhibiting neovascularisation and endothelial cell proliferation.

Bayer Seeks EMA Nod for VEGF Trap-Eye

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23-11-2013 21:02:44

Cadila, Helperby Sign Licensing Deal Cadila Pharmaceuticals Limited, one of India’s largest privately held pharmaceuticals company and UK based antibiotics discovery major Helperby Therapeutics have signed a joint agreement on Antibiotic Drug Resistance Research & Development.

Dr Rajiv I Modi Chairman and MD, Cadila Pharmaceuticals

Described as the most important innovation in the discovery of new antibiotics since Alexander Fleming’s original breakthrough more than 80 years ago, this announcement is a major breakthrough in the fight against resistance with the discovery of patented ‘resistance breaker’ compounds.

These new compounds are called Antibiotic Resistance Breakers.

When an Antibiotic Resistance Breaker is combined with an old obsolete antibiotic, it can rejuvenate it and make it active against highly resistant bacteria. Antibiotic Resistance Breakers can potentially rescue several different classes of antibiotics.

Furthermore, this approach requires the development of fewer novel compounds, is less risky and less costly than the traditional “one antibiotic” route.

On this occasion, Cadila Pharmaceutical’s Chairman and Managing Director Dr Rajiv I Modi said, “The Founder Chairman of our company, Shri IA Modi, believed in providing affordable medicines for the masses through innovative and cutting-edge research & development (R&D). This discovery will open new avenues against resistant organisms and is very timely in view of global concerns about rapidly growing bacterial resistance against current antibiotics. Cadila Pharmaceutical’s collaboration with Helperby can help the mankind win the battle against the microbes and hopefully save millions of lives in coming years.”

Helperby’s Chief Scientific Officer Professor Anthony Coates said, “The emergence and spread of drug-resistant pathogens has accelerated whilst the pipeline for new anti-microbial drugs has all but run dry - this exciting and timely partnership with Cadila Pharmaceuticals offers us all hope.”

Travelling with the UK’s Trade Delegation to India led by Prime Minister David Cameron, Helperby signed its first major licensing deal with Indian pharma giant Cadila Pharmaceuticals to take the compound through further clinical trials, approvals and into commercialisation. Helperby will supply Cadila Pharmaceuticals Ltd. with Antibiotic Resistance Breakers whilst Cadila Pharmaceuticals Ltd. will develop the combinations with old antibiotics. The deal value was undisclosed but could contribute to Helperby scaling up in the UK to a potential £500 million operation, creating employment for 500-1000 persons by 2019.

UK’s Prime Minister Cameron said, “The life sciences industry is the jewel in the crown for the UK economy, consistently growing and achieving new breakthroughs. “Today’s deal between Helperby 62  November 2013

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and Cadila Pharmaceuticals on antibiotic resistance research is another great example of UK-India collaboration helping both our countries to succeed in the global race. And it’s not just a step forward for medical research it also has the potential to create up to 1,000 highly skilled jobs in the UK by 2019.”

Columbia, Actavis End Exclusive Supply Agreement for Crinone Columbia Laboratories, Inc has entered into an agreement with Actavis, Inc for early termination of the companies’ current exclusive Supply Agreement for Crinone (progesterone gel). The exclusive Supply Agreement, which would have otherwise terminated in May 2015, provided for Columbia to receive a 10 per cent mark-up on its cost of goods of all product sold to Actavis. With the termination of the Supply Agreement, Actavis will manufacture Crinone in-house.

Under the terms of the agreement, Columbia will receive from Actavis a one-time fee of USD 300,000 to offset estimated lost production margin through the original term of the Supply Agreement. Actavis will purchase all remaining work-in-progress and finished CRINONE in Columbia’s inventory. Columbia will continue to receive a royalty of at least 10 per cent on Actavis’ US net sales of CRINONE under the terms of the companies’ 2010 Purchase and Collaboration Agreement.

“Actavis has made a significant long-term investment in the Crinone franchise including the scale up of new manufacturing capacity,” said Frank Condella, Columbia’s president and CEO. “Columbia will continue to benefit from these investments via royalties while simplifying our overall supply chain obligations.”

Defibrotide Gets Orphan Drug Status in Australia Gentium SpA and Link Healthcare announced that Defibrotide has been designated as an Orphan Drug for the Treatment of Hepatic Veno-Occlusive Disease (VOD). The sponsor of Defibrotide is Link Healthcare, Gentium’s exclusive distribution partner in Australia.

Veno-occlusive disease (VOD) is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). Stem cell transplantation is a frequently used treatment modality following high-dos e c hemotherapy and rad ia tio n th e r a p y for hematologic cancers and other conditions in both adults and children.

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FDA Grants PMA for NeuroPace Merck to Open New Pharmaceutical RNS System Manufacturing Facility in China NeuroPace, Inc announced that the US Food and Drug Administration has granted premarket approval for the NeuroPace RNS System, a treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs. The RNS System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to detect abnormal electrical activity in the brain and respond by delivering imperceptible levels of electrical stimulation to normalize brain activity before an individual experiences seizures.

“We believe the RNS System has the potential to provide substantial improvement in quality of life to hundreds of thousands of people diagnosed with epilepsy in the US who are unable to achieve seizure control with medications,” said Frank Fischer, NeuroPace CEO. “We anticipate that physicians will be able to make this breakthrough therapy available to eligible patients in the very near future.”

The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localised no more than two epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalised seizures).

The RNS System has demonstrated safety and effectiveness in patients who average three or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less frequent seizures. It is estimated that approximately 400,000 people in the US meet these criteria and may benefit from treatment with the RNS System.

“The Epilepsy Foundation celebrates PMA approval of the RNS System,” said Phil Gattone, CEO of the Epilepsy Foundation. “We badly need new, effective therapies for the hundreds of thousands of people in this country as well as the millions around the world who live with uncontrolled seizures,” added Warren Lammert, Chairman of the Epilepsy Foundation. “The RNS System from NeuroPace integrates the best of technology and neurology, and is an important new treatment option for these individuals and their families.”

The RNS System has been evaluated in three clinical trials, including a prospective, randomised, double-blinded, sham stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9 per cent reduction in seizure frequency in patients treated with responsive stimulation compared to a 17.3 per cent reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three month blinded period. The difference is statistically significant (p=0.012). For those subjects who reached two years post-implant, 55 per cent of the subjects experienced a 50 per cent or greater reduction in seizures.

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Merck Serono, the biopharmaceutical division of Merck, announced a EUR 80 million investment in a new pharmaceutical manufacturing facility, to be located in the Nantong Economical Technological Development Area (NETDA), in the Greater Shanghai region (Yangtze River Delta area).

Belén Garijo, President and Chief Executive Officer of Merck Serono

“This further investment in China reflects Merck’s long-term commitment to the country where our group has been present for 80 years,” said Belén Garijo, President and Chief Executive Officer of Merck Serono, the biopharmaceutical division of Merck.

“We are proud to be one of the first multinational companies investing in a local site focused on the manufacturing of medicines referenced in China’s essential drug list, and serve the country’s expanding healthcare needs in the areas of diabetes, cardiovascular diseases and thyroid disorders, by bringing high-quality medicines made in China to a broader population, in full alignment with the Chinese government’s goal to increase access to quality products,”adds Garijo The new facility will focus on the bulk production and packaging of Glucophage, Concor and Euthyrox, Merck’s leading brands for the treatment of diabetes, cardiovascular diseases and thyroid disorders respectively. Located in NETDA’s BioSpark, a high-tech industrial park designed to accommodate all aspects of the life science industry, the new facility will cover an area of 40,000 square meters, with a possible 20,000 square meters extension.

DoP Gets New Secretary V Somas undaran has b e e n a p p o in te d as the Secretary to the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals and Fertilisers.

He will fill the vacancy caused by the retirement of D S Kalha.

A Kerala cadre IAS officer of 1979 batch, soft-spoken Somasundaran has been holding the charge of finance and information technology in Kerala with the rank of Additional Chief Secretary. In his previous stint at the centre, he also served as the additional secretary, Department of Defence Production, before he was repatriated to his home state in September last year.

V Somasundaran, Secretary, DoP

Apart from his long experience in Kerala in different departments l i k e f i n a n c e a n d i n d u s t r y, h e a l s o s e r v e d i n t h e U n i o n Commerce Ministry.

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Pfizer Gets US FDA Nod to Expand New Facility Inauguration and R&D XELJANZ Labeling Launches from ACG’s Pam Glatt Pfizer Inc has announced that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate) to include additional Patient-Reported Outcomes (PRO) data in the label. These additional data show improvement in patients receiving XELJANZ based on health-related outcome measures reported by patients, including vitality, role emotional, physical function, bodily pain, social function, mental health, role physical and general health, which are the eight domains of the Medical Outcomes Study Short-Form (36-Item) Health Survey (SF-36). XELJANZ 5 mg twice-daily (BID) was approved by the FDA in November 2012 for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX), and is the first approved RA treatment in the US in a new class of medicines known as Janus kinase (JAK) inhibitors. In the US, XELJANZ may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). XELJANZ should not be used in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine.

“The patient-reported outcomes data show the impact that XELJANZ can have on the daily lives of patients with RA, based on physical, mental and emotional measures,” said Dr Steven Romano, senior vice president and the head of the Medicines Development Group for Pfizer Specialty Care. “Following the FDA approval of XELJANZ in November 2012, we are pleased with the agency’s decision to approve this sNDA and add to the growing body of knowledge about XELJANZ as an additional treatment option for patients with RA.”

US FDA Approves IGI Labs Econazole Nitrate Site Transfer IGI Laboratories Inc, a New Jersey based generic topical pharmaceutical company, has received formal approval from the US Food and Drug Administration (FDA) of its supplemental filing for the site transfer of econazole nitrate cream 1 per cent, to the company’s manufacturing facility in Buena, NJ. IGI had purchased econazole nitrate cream 1 per cent from Prasco, LLC in February of 2013.

Jason Grenfell-Gardner, President and CEO of the Company, commented, “This approval marks the first time the FDA has granted an approval to an IGI own-label project. In less than eight months, we successfully completed all the required steps to achieve approval from the FDA to manufacture our first proprietary IGI label product. This accomplishment is a testament to the dedication and efforts of our entire team. We are currently actively manufacturing, marketing and selling this product through our existing commercial infrastructure.”

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Pam Glatt Pharma Technologies, one of the group companies of ACG Worldwide recently inaugurated their brand new facility for the manufacturing of Fluid Bed Granulators and Tablet Coating machines.

The new facility has been opened up in Shirwal near Pune. This unit will have provisions for clients to try out these machines before buying them.

Pam Glatt also announced the launch of two new bench top models and two new table top models. Mini Quest F and Mini Quest T, the two bench top machines for granulation and tablet coating respectively will be made available to Pharmacy colleges within a reasonable price of ` 5 lakh that will help students gain hands-on experience before leaving college. The other two machines Quest FB and Quest TC have been designed for R&D in the industry.

Present in the inaugural function were Ajit Singh, Chairman, ACG Worldwide, Jasjit Singh, Managing Director, ACG Worldwide, and Dr Shirish Dhande, CEO, Pam GlattPharma Technologies among many others.

Sanofi Freezes Fedratinib Clinical Trial Sanofi has announced the decision to halt all clinical trials and cancel plans for regulatory filings with its investigational JAK2 inhibitor, fedratinib (SAR302503). Following a thorough risk-benefit analysis, including consultation with the US Food and Drug Administration (FDA), study investigators, independent expert neurologists and neuro-radiologists, Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib would bring to patients.

This decision follows recent reports of cases consistent with Wernicke’s encephalopathy in patients participating in fedratinib clinical trials. The FDA directed Sanofi to put all fedratinib trials on clinical hold while the company thoroughly investigated these cases to ensure the safety of fedratinib for patients. Sanofi took immediate action requesting that study investigators discontinue fedratinib treatment for patients in the trials. “We are deeply disappointed to have to discontinue development of fedratinib, especially given the needs of this difficult-to-treat patient population and the earlier promise shown for this therapy, but patient safety is our top priority and drove this decision,” said Tal Zaks, MD, PhD, VP, Head of Development and Interim Head of Sanofi Oncology.

Sanofi has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials. Patients currently in fedratinib trials should consult with their treating physician to determine the best alternative course of therapy for their myelofibrosis.

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biotech news Biocon Unveils Biocon Academy – A Centre of Excellence Biocon has announced the setting up of the Biocon Academy, a one-of-its-kind Centre of Excellence for Advanced Learning in Applied Bio-Sciences. Biocon Academy aims to train and develop industry-ready talent for India’s Biopharma sector and enable global competitiveness. The Academy will offer advanced learning in Kiran MazumdarBiosciences that will provide the required Shaw, Chairperson proficiency for enhanced career prospects and MD, Biocon in biotechnology for engineering and science graduates. It will connect the industry and academia to maximise the opportunities for aspiring biotechnologists and to address the skill deficit of the sector.

The Academy’s flagship programme in collaboration with Keck Graduate Institute, California, the ‘Biocon KGI Certificate Programme in Biosciences,’ is being opened for enrolments today, for the January 2014 session. The deadline for online application submission is December 6, 2013. KGI is a premier American graduate institution, devoted solely to bioscience education and discovery. Their training and education programmes have built a very strong capability in the US and it is through this partnership that we hope to emulate the success of KGI learning model in India.

Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon, said, “Biocon is pleased to partner with KGI in its new training initiative, the Biocon Academy, aimed at developing a new cadre of life sciences professionals. KGI is uniquely qualified, through its outstanding faculty and its state-of-the-art infrastructure that includes the Amgen Bioprocessing Center, to help us with this endeavor. Given the growing stature of India’s life sciences industry, both Biocon and the Indian life sciences sector as a whole will benefit greatly from this collaboration.”

Sinovac to Supply Healive in Jiangsu Province

Dr Weidong Yin Chairman, President and CEO, Sinovac

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Sinovac Biotech Ltd, a leading China-based vaccine manufacturer, has been selected by the Jiangsu Centers for Disease Control and Prevention (Jiangsu CDC) to supply the Company’s inactivated hepatitis A vaccine, Healive, under the Expanded Programme of Immunisation (EPI) in 2014 to the pediatric population in Jiangsu Province.

The total volume of the tender is up to 1.8 million doses. As one of the two selected suppliers, Sinovac will supply 900,000 doses of Healive to Jiangsu province.

Dr Weidong Yin, Chairman, President and CEO of Sinovac, commented, “We are pleased to be selected once again by the Jiangsu CDC as one of the two suppliers of inactivated hepatitis A vaccine pursuant to the tender for the 2014 EPI. We are advancing our strategy to collaborate with the government agencies to provide top-quality vaccines to prevent and control diseases in China and beyond.”

Healive is the first inactivated hepatitis A vaccine developed, produced and marketed by a China-based manufacturer. Healive was launched by Sinovac in 2002 in China and is currently available in adult and pediatric dosage forms. In February 2008, the Chinese government included hepatitis A vaccine in its national immunisation programme.

Genovate, ScinoPharm Co-Develop Hepatitis B Drug Genovate Biotechnology Co Ltd and ScinoPharm Taiwan Ltd have jointly developed the highly potent oral generic drug Livepro (Entecavir), representing a new generation of drugs for the treatment of Hepatitis B. It is expected to be commercially available by the end of the year in Taiwan, accounting for more than USD 70 million worth of market opportunity.

The new-generation oral Hepatitis B drug Livepro is a drug jointly developed by Genovate and ScinoPharm. Both companies combined their resources with ScinoPharm being responsible for the development and manufacturing of the active pharmaceutical ingredient for Livepro, “Entecavir”. Additionally, formulations were developed with the joint involvement of Genovate in order to enter the markets in Taiwan and China.

Jo Shen, President and CEO of ScinoPharm, stated, “This collaboration with Genovate signifies ScinoPharm’s strategic move into the formulation development field. Livepro is the first commercially available product produced through the company’s branching out into the field of formulation, specifically its “double A” strategy (API + ANDA) of combining Active Pharmaceutical Ingredient manufacturing with formulations required in Abbreviated New Drug Applications (ANDA). The company’s strategy is to respond to customers’ demand for high-quality drugs through its one-stop shop services. “ According to the clinical data collected over the past two years, the drug not only effectively reduces the amount of the Hepatitis B virus to undetectable levels, but also produces no drug resistance after intake by patients. The therapeutic effect appears to be better than any other commercially available drug.

The treatment of chronic hepatitis B has been one of the most important medical issues in the field of medicine in Chinese society. Three million hepatitis B carriers in Taiwan, which accounts for one-eighth of the population, is under health threats associated with hepatitis B. November 2013  65

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Dr Gerald Moeller Appopinted as VP of Genticel Supervisory Board Genticel, a biopharmaceutical company that develops innovative therapeutic vaccines for patients infected with the Human Papilloma Virus (HPV), has appointed a new vice-president to the supervisory board. Dr Gerald Moeller, PhD has over 35 years experience in the pharmaceutical and diagnostics industry. He has been Dr Gerald Moeller, an investment adviser at HBM Partners VP of Genticel in Switzerland since 2002 and chairs the supervisory boards of a number of health sector companies, including Sigma Ltd, Definiens AG, Invendo-Medical GmbH and MorphoSys AG. He is also a board member with FIND Foundation and Illumina Inc. “We are very pleased that Dr Moeller is joining our supervisory board,” says Benedikt Timmerman, founder and CEO of Genticel.

“His wealth of expertise in the pharmaceutical industry represents a considerable asset for Genticel, especially at a key moment in our development. We are launching the phase II clinical trial of our lead product, ProCervix, in Europe - so it is a priority for Genticel to forge close ties with major pharmaceutical industry players.

Gerry’s experience in this industry and his strategic advice will be invaluable in this.”

The supervisory board at Genticel is chaired by Professor Thierry Hercend. The membership comprises Ludovic de Meeus d’Argenteuil, co-founder of Genticel; Dr Rainer Strohmenger, General Partner at Wellington Partners; Alain Munoz, representing Kurma Life Sciences; Raphael Wisniewski, director of investment at Edmond de Rothschild Investment Partners (EdRIP); Olivier Martinez, director of investment, life sciences, BPI France; Alexandre Flageul, partner at Amundi Private Equity Funds, and Dr Didier Hoch, an independent industry member.

Txcell Appoints Damian Marron Chief Executive Officer TxCell SA, a biotechnology company developing innovative, personalised cellbased immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases, has announced the appointment of Damian Marron as Chief Executive Officer (CEO). In addition, François Meyer, Damian Marron previously CEO and Chairman of the Board CEO, Txcell of TxCell has been appointed Executive Chairman of the Board of Directors. One of the main initial tasks for Damian Marron as CEO will be to guide the development of Ovasave, TxCell’s lead autologous Ag-Treg cell-based 66  November 2013

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immunotherapy. Ovasave is currently in phase II development for the treatment of Crohn’s disease in patients who are refractory to current treatments. There are currently 160,000 such patients per year in Europe and in the US alone. TxCell’s strategy is to target niche and orphan indications for which there are few or no treatment options and a high unmet medical need. The company’s strong proprietary technology platform has so far demonstrated great promise in a number of chronic inflammatory and autoimmune conditions. Positive preliminary results for these indications have already been generated.

Damian Marron is a highly capable executive with 26 years strong experience in the orphan disease marketplace. Previously, he was CEO of Cytheris SA, a clinical stage biotechnology company focused on immunology through the development of IL-7 based therapeutics. Prior to Cytheris, Damian was CEO of Trophos SA from 2008 to 2012. Damian has also been Executive Vice President Corporate Development at NicOx SA. During that period, he was responsible for the establishment of major collaborations with Merck and Co. Inc. and Pfizer Inc. He also participated in financing rounds for NicOx, raising in excess of EUR 175 million.

Synageva BioPharma Reports Result from Sebelipase Alfa Study Synageva BioPharma Corp, a biopharmaceutical company developing therapeutic products for rare diseases, has reported 78week results from an ongoing extension study with sebelipase alfa in adults with Lysosomal Acid Lipase (LAL) Deficiency. Chester B. Whitley, PhD, MD, Professor, Director of the Gene Therapy Center, Advanced Therapies and PKU Clinic,Department of Pediatrics and Experimental and Clinical Pharmacology at the University of Minnesota, presented the results during an oral presentation at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) annual meeting held in Chicago, IL.With six of the eight patients enrolled in the Phase 1/2 extension study completing 18 months of treatment, the results show sustained improvements in biochemical markers of liver damage and in the dyslipidemia associated with LAL Deficiency.

Nine adults with LAL Deficiency with a median age of 29 years (range 19-45) enrolled in the Phase 1/2 trial. At 78 weeks of treatment with sebelipase alfa, patients continued to have sustained reductions in both ALT and AST, frequently into the normal range, from the pretreatment baseline. Sebelipase alfa was generally well tolerated through 78 weeks of the extension study. Most adverse events were mild and unrelated to sebelipase alfa. Infusion-related reactions were uncommon and the majority were mild and gastrointestinal in nature (diarrhea, abdominal cramping). No anti-drug antibodies have been detected in the patients tested to date in either the initial portion or extension portion of the Phase 1/2 study. Two serious adverse events (cholecystitis/cholelithiasis) considered unlikely related to sebelipase alfa occurred in one patient and this patient continues treatment with sebelipase alfa in the study. No drug-related serious adverse events have been reported in this study to date.

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Vexim Gets Biotech Future Award Vexim receives the Biotech Future Award (Prix Biotech d’Avenir) Technology Fast 50 – Southwest Region, from Deloitte In Extenso. This award recognises VEXIM’s growth and innovation.

Deloitte’s Technology Fast 50 was created

by Deloitte France in 2001 and covers all Vincent Gardès French regions. Each year, it promotes the CEO, Vexim development of high technology companies that combine growth and innovation. The Prix Biotech d’Avenir recognises a biotech company with more than three years of existence and having carried out the largest fundraising in its region during 2012.

It is worth noting that Vexim successfully raised EUR 11 million from its IPO in April 2012. This allowed the company to open two subsidiaries for direct marketing of SpineJack both in Germany and Italy – the two largest European markets, and to strengthen its management team by hiring managers with a strong experience in medical devices. Vexim was also granted the NYSE Alternext Award for best IPO of the year at the Stock Market second annual conference in December 2012.

“Vexim was granted the Prix Biotech d’Avenir by Technology Fast 50 – Southwest Region – for its innovative technology in minimallyinvasive back surgery, materialised by SpineJack, an implant that now allows restoration of the spine following accidental fractures related to osteoporosis, a disease that affects more and more people over 50 years old. It also rewards its successful IPO with its €11 million fundraising in a very difficult market context”, said Etienne Alibert, a Deloitte Partner in charge of Deloitte’s Technology Fast 50 awards for Southwest France.

“We are delighted to receive this award which recognises our dynamism and our efforts to become the European leader in minimally-invasive back surgery. I want to thank all our shareholders, especially Truffle Capital for its essential role in our IPO. We also thank Deloitte In Extenso for their support that reinforces SpineJack as the reference in the treatment of vertebral fractures. Today, we continue our growth strategy based on three pillars: efficient market deployment enhanced clinical programme and on-going innovation”, said Vincent Gardès, CEO at Vexim.

The year 2013 was also eventful for Vexim, which obtained an exclusive worldwide license for an innovative injection device in vertebroplasty, allowing the company to address the vast US market1 as of 2014. Vexim also created two new subsidiaries in Spain and the UK, expanding its SpineJack sales network in the 5 major European markets for the treatment of vertebral fractures.

Finally, Vexim has recently unveiled the preliminary results of an international clinical trial involving 103 patients, as well as the final results of a retrospective study regarding 77 patients that confirm the excellent performance of SpineJack in the treatment of vertebral fractures.

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USPTO Issues New Patent Covering Formulation for Navidea’s NAV5001 Navidea Biopharmaceuticals has announced that the US Patent and Trademark Office (USPTO) has issued a new patent covering the formulation of the Company’s radiolabeled dopamine transporter (receptor ligand, NAV5001, used with SPECT imaging for potential differential diagnosis of Parkinsonian Syndromes and Dementia with Lewy Bodies. The patent (8,574,545) is set to expire in 2031.

The new US patent, “Labeled Iodinated Tropane Formulation,” extends the scope and longevity of the NAV5001 intellectual property (IP) portfolio. The high concentration formulation protected by this patent may afford greater commercial flexibility and manufacturing efficiency to optimise distribution. Navidea anticipates commencing the NAV5001 Phase 3 clinical programme by year end. This new patent reinforces the Company’s NAV5001 platform alongside previously issued US Patent 8,084,018, “Methods for Imaging Dopamine Transporter Level,” which covers the acquisition of Dopamine Transporter SPECT images soon after injection of NAV5001, a unique feature and competitive advantage for NAV5001.

Keryx Announces Unaudited Data from Zerenex Safety Extension Study Keryx Biopharmaceuticals, Inc has announced preliminary, unaudited data from an ongoing 48-week safety extension study of Zerenex (ferric citrate coordination complex) the Company’s drug candidate for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.

Only patients who had participated in, and successfully completed the 58-week, long-term Phase 3 study were eligible for enrollment into this safety extension study. This 48-week, Open-Label Extension (OLE) study, which is not a regulatory requirement, is being conducted in 35 sites in the United States. The study commenced enrollment in August 2012 and is anticipated to be completed in the first half of 2014.

Patients in the OLE study are titrated to achieve and maintain normal serum phosphorus levels (3.5 to 5.5 mg/ dL) for a period of 48 weeks. This study, together with the 58-week, long-term Phase 3 safety and efficacy study, represents potential cumulative exposure to Zerenex of up to 2 years.

Enrollment in the OLE study included 168 patients, of which 166 patients were dosed with Zerenex, consisting of 114 and 52 patients from the Zerenex and Active Control arms of the completed long-term Phase 3 study, respectively.

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Covance, NeoGenomics Join Forces on CT Testing Services Covance and NeoGenomics entered a collaboration to provide comprehensive anatomic pathology and specialty laboratory testing services for global clinical trials. Through the deal, Covance’s clients will gain access to fully integrated Anatomic Pathology and Histology services, including immunohistochemistry, fluorescence in-situ hybridisation, and molecular testing. The company will establish a laboratory at NeoGenomics’ Fort Myers, FL facility and, together with NeoGenomics, will provide a range of APH, tissuebased biomarkers, and other specialty testing services. The firms will then expand joint capabilities at Covance’s central laboratory locations in Shanghai; Geneva and Singapore.

Additionally, Covance will have access to NeoGenomics’ extensive medical and scientific networks, which include more than 500 pathologists, according to the company. Covance’s market reach, established client relationships, and clinical trials experience will also be available to Neogenomics.

“The collaboration with NeoGenomics will offer our clients fully integrated anatomic pathology services from sample preparation, staining and imaging, to pathology interpretation by leading pathologists, in an end-to-end manner,” said Paul Kirchgraber, MD, vice president of laboratory operations and medical affairs, Covance Central Laboratory Services. “Providing these integrated services through the Covance laboratory co-located within NeoGenomics results in improved turnaround times critical to oncology clinical trials.”

WuXi PharmaTech Forms Alliance with Pharmacyclics WuXi PharmaTech, a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced that its wholly owned subsidiary Shanghai SynTheAll (STA) Pharmaceutical Co, Ltd, has entered into a supply arrangement with Pharmacyclics, Inc. This follows a successful multiple-year development and clinical manufacturing partnership that supported Pharmacyclics with the expedited New Drug Application submission and final approval by the US Food & Drug Administration (FDA).

After an expedited review by the FDA, IMBRUVICA received approval on November 13, 2013, for treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established. In the GMP pre-approval inspection of WuXi’s manufacturing facilities in August, no Form 483 observations were issued by the FDA. IMBRUVICA is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is a 68  November 2013

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key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells.

IMBRUVICA blocks signals that tell malignant B cells to grow and divide uncontrollably. IMBRUVICA has been granted three Breakthrough Therapy Designations by the FDA, a first for an oncology drug. These designations are intended to expedite the development and review of drugs for serious or life-threatening conditions. To date, nine Phase III clinical trials have been initiated with IMBRUVICA and 37 clinical trials are currently registered on www.clinicaltrials.gov.

“It is important that we work with a development partner with expertise in both clinical and commercial supply, as well as US and worldwide GMP regulations, to ensure reliable quality supply to patients,” commented Heow Tan, Chief of Technical Operations at Pharmacyclics. “STA’s extensive experience will help us meet the demands of clinical and commercial supply for IMBRUVICA.” “We are very pleased and honored that Pharmacyclics has selected STA, WuXi’s small-molecule development and manufacturing business unit, as a key partner for this supply,” said Dr Ge Li, Chairman and CEO of WuXi. “WuXi is determined to help our partners introduce innovative breakthrough drugs like IMBRUVICA to benefit patients around the world.”

Venus Remedies to Launch Elores in Latin America Venus Remedies Limited has made inroads into Latin America with its patent-protected novel antibiotic adjuvant entity, Elores, securing marketing authorisation from Guatemala, where the product will be launched in early 2014.

Hailing the development, Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies Limited, said, “This is the first marketing authorisation for Elores from a Latin American country. It will prove to be our ticket to Latin America by enabling us to expand our research product kitty there. Cashing in on this tremendous opportunity, we expect to generate a revenue of USD 5 million within three years of the launch. Keeping the rapid emergence of resistant microbes in mind, our product is the need of the hour in Latin American countries at this juncture.”

Aggarwal said that ever since Venus Remedies launched Elores in the Indian markets in January this year, the product had been receiving a tremendous response from the medical fraternity across the nation.

The prevalence of antibiotic resistance is among the highest in Latin America, a USD 50 billion pharmaceutical market, growing at the CAGR of approximately 15- 20 per cent. Resistance to Extended Spectrum Beta-Lactamase (ESBL), an enzyme released by resistant bacteria that deactivates antibiotics, is found to be as high as 40-60 per cent in Latin American countries.

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Chromatography Detector The recent addition of Viscotek SEC-MALS 20 to Malvern’s range of detectors puts the company in the unique position of being the sole provider of every commercially available light scattering technology for GPC/SEC. The popular white paper is just one of a suite of educational information and application notes provided by Malvern’s specialist team to help users select the right detector for their application.

Light scattering GPC/SEC detectors are used to determine absolute molecular weight, a key parameter in protein, polymer and macromolecular research. The new Viscotek SEC MALS 20 can be added to any existing GPC/SEC set-up and delivers market-leading, highly accurate MALS detector performance, even at the more challenging high molecular weights. Viscotek SEC-MALS 20 offers the greatest number of detectors of any commercially available MALS detector for GPC/SEC. For more information, please contact: Malvern Aimil Instruments Pvt Ltd Naimex House, BSEL Tech Park B Wing – 906 Sector 30A, Opp Vashi Railway Station, Vashi, Navi Mumbai 400 705 Tel: 022-39183596 \ Fax: 91-022-39183562 E-mail: Stuart.Wakefield@malvern.com

Sterile Liquid Filler The Macofar LF 200 ST aseptic liquid filler is capable of processing injection vials and infusion bottles with wide range of filling volumes from 0.5 to 500 millilitres. The max filling speed of 12,000 vials an hour is achieved with volumes up to 5 millilitres. The machine complies with the cGMP requirements for processing sterile, parenteral pharma liquids. The balcony structure of the Macofar LF 200 ST facilitates a strict separation between the white (cleanroom) and grey (technical) areas. The critical area passed through by the open vials is narrow and compact. The slim design of this area guarantees excellent sterility assurance levels. A vertical laminar flow prevents turbulent air movements in the vicinity of the open vials and stops particles and microorganisms from developing. The bottom-up filling process is intermittent and involves eight servo-driven rotary piston pumps. Once filled, the glass or plastic vials are sealed with a rubber stopper and aluminium cap. The Macofar closing system is also suitable for subsequent freeze drying.

For more information, please contact: Romaco Group Am Heegwald 11, 76227 Karlsruhe, Germany Tel. +49 (0) 721 4804 0 Fax: +49 (0) 721 4804 225 E-mail: susanne.silva@romaco.com

Sorption Microbalance Hiden Isochema offers XEMIS, a new sorption microbalance for precision weighing in extreme environments.

The XEMIS allows the analysis of gas and vapour sorption by materials at pressures as high as 200 bar and at temp between 77 K and 500°C. It can also handle aggressive species. This combination of conditions was not previously achievable with commercial gravimetric sorption analysers. Featuring Hiden Isochema’s new exosensing technology, the unique design of the XEMIS removes the sensing and control mechanisms from the microbalance chamber and so out of the wetted zone. This allows sorption analysis with hazardous and aggressive species without compromising measurement accuracy or resolution. Furthermore, unparalleled weight measurement stability is provided by the symmetric geometry beam balance design. The intrinsic long-term stability of the XEMIS, with no need to re-zero or re-calibrate the balance, thus ensures the capture of true sorption behaviour and provides the ability to record full kinetic data over extended timescales. It also allows microgram resolution weight measurement for milligram to gram sample sizes and can thus offer high accuracy sorption measurements on the range of sample sizes required by today’s researchers.

For more information, please contact: Hiden Isochema Ltd 422 Europa Boulevard Warrington WA5 7TS, U.K. Tel: +44 (0) 1925 244678; Fax: +44 (0) 1925 244664 E-mail: dbroom@hidenisochema.com / info@hidenisochema.com

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Single Use pressure Sensors Sensors measure static and dynamic process pressure and are perfect components for disposable systems requiring sterilisation but also minimal downtime. Sensors feature an integral flow sensor with no dead legs and no fluid path obstructions. All pressure sensors are manufactured in a FDA registered, ISO 13485 certified facility; in an ISO Class 8 (formerly Class 100,000) cleanroom.

Sensors are made from USP Class VI compliant polycarbonate or caustic resistant polysulfone. Both materials are gamma stable.

Sensors are 100 per cent tested for accuracy and leaks during the manufacturing process. Connect sensor to PressureMAT monitor with 3.6 m reusable cable. Sensors are designed for use up to a maximum pressure of 5.3 bar.

For more information, please contact: Cole-Parmer India Pvt Ltd 403-404, B-Wing, Delphi, Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67162222 Fax: 91-022-67162211 E-mail: info@coleparmer.in

Conveyorised Metal Detector Conveyorised metal detector metaltrap03 is an eddy current based digital metal detection system specially designed for food and pharma industry for detecting metal contamination in food products. It can also find application in other industries such as chemicals, cosmetics, garments, etc. The system meets the stringent requirement and hygienic standards of food and pharma industry.

Features digital technique; set parameter retention on loss of power; buzzer and LED indication on detection of metal contamination; LCD bar graph/numeric display to monitor noise and signal reject time stamping.

For more information, please contact: Technofour Electronics Pvt Ltd Gat No: 3 (PT), 5 (PT), 243 (PT), Kasurdi (Kheba) Khed Shivapur-Saswad Road, Post Khed Shivapur, Pune 412 205 Tel: 02113-305200; Fax: 91-02113-305250 E-mail: sales@tepl.co.in

Water Ring Vacuum Pump & Compressor Vacunair Engg Co Pvt Ltd offers water ring vacuum pump and compressor in non-pulsating vacuum and pressure. Energy saving pump design by operating at low periphery speed and offered for specific power of 60 to 65 m3/hr per kW. Pumps are available in wide selection for any requirement range from 20 to 15,000 m3/hr, vacuum up to 700 mm Hg and pressure up to 3.5 kg/cm2. The vacuum pump with air ejector is available in capacity from 50 to 2,000 m3/hr and vacuum up to 25 mm Hg abs.

No lubrication is required and can handle air/gas/air with water comfortably. Standard pumps are available with stuffing box type gland seal arrangement and can offer with mechanical seal. Easy to maintain the pump as axial clearance are in mm size. Impellers are duly dynamically balanced as per ISO 1940-1973 (E) Class G 6.3. Vacuum pumps are available in CIFG-260, gunmetal, phosphor bronze, aluminium bronze, SS304, SS-316 and other alloy steel material as per the requirements. It finds application in industries like chemical, pharma, fertilisers, paper, sugar, coal mines, power, steel, refinery, dairy, plastic, food processing, textile, etc.

For more information, please contact: Schneider Electric India Pvt Ltd Vacunair Engg Co Pvt Ltd Nr Gujarat Bottling, Rakhial, Ahmedabad, Gujarat 380 023 Tel: 079-22910771 Fax: 91-079-22910770 E-mail: info@vacunair.com 70 ď‚ƒ November 2013

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Thermic Fluid Heaters

Blister System Very good OEE values are a must for smaller batch sizes and frequent product changeovers.

Romaco’s Noack 960 blister system provides an optimal solution for pharma manufacturers and contract packagers. The blister system, which is offered with rotary or platen sealing, packs tablets, soft or hard gelatine capsules and caplets in a variety of shapes and sizes. The interchangeable QuickFeed unit is one of the Noack 960 Blister System’s technical highlights.

For the first time, parallel operating steps can now be realised instead of sequential if a second QuickFeed unit is installed. Product changes are completed in less than thirty minutes.

For more information, please contact: Romaco Group Am Heegwald 11, 76227 Karlsruhe, Germany Tel. +49 (0) 721 4804 0, Fax: +49 (0) 721 4804 225 E-mail: susanne.silva@romaco.com

Aero Therm offers thermic fluid heater/hot water generator in capacity range of 30,000 to 20,00,000 kcal/hr with max operating temp 300oC for thermic fluid and 130oC for hot water.

The concentric coil is made from MS seamless tube of ASTHMA 106 GR-B. The unit will be equipped with high efficiency oil/gas burner with air pre-heater arrangement gives high thermal efficiency 87 ±2% on NCV. The unit will be outside the purview of IBR. For more information, please contact: Aero Therm Systems Pvt Ltd Plot No: 1517, Phase III, GIDC Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-25890158, 25834987 E-mail: contact@aerothermsystems.com

Bottom Outlet Valve with Integrated PAT SensoTech developed in collaboration with valve manufacturer SchuF an innovative solution: MultiProbe. Featuring the bottom outlet valve with the SensoTech LiquiSonic sensor enables the process analysis even in low volume batches and without additional process adapters.

The LiquiSonic systems provide precise data about the concentration and density in liquids like solvents, nutrient solutions, emulsions or suspensions. Furthermore, LiquiSonic detects phase transitions to control exactly phase separation processes. Another focus is the reaction monitoring in crystallisation processes, eg, in cases of active substances or nutrient solutions. A LiquiSonic analyser consists of one or multiple sensors and one controller. The sensors are robust as well as corrosion-resistant and work maintenance-free. The controller works as evaluation unit visualising and recording the measuring results and transferring them to the process control system.

temperature sensors.

SchuF combines its usual bottom outlet valve with the LiquiSonic process analytical technology.

Therefore, the LiquiSonic sensor is incorporated into the bottom outlet valve. Through the built-in concept it is possible to measure directly in the reactor without any process adapters.

In addition to the concentration measurement the LiquiSonic analyser includes two Pt 1000

For more information, please contact: SensoTech GmbH Steinfeldstr 1 D-39179 Magdeburg-Barleben, Germany Tel: +49 39203 514100; Fax: +49 39203 514109 E-mail: info@sensotech.com

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events diary Clean India Pulire 2013

PHARMAceutical EXPO 2013

Dates: 5 - 7 December 2013 Venue: Bandra Kula Complex, Mumbai

Dates: 20 - 22 December 2013 Venue: Amity University, Noida, Delhi NCR

Setting new records, the international expo will showcase the latest in cleaning technology, hygiene solutions and maintenance for the all sectors. More than 40 new products will be launched from 13 countries; including from as far as Iceland besides Germany, Italy, Dubai, UK, USA, China, France, Malaysia, Spain, Switzerland, Hong Kong and India. Clean India Pulire 2013 is the single largest platform where cleaning professional, production heads of manufacturing industries; facility/ administration heads of hospitality, healthcare, retail, commercial and related segments from across the world will converge in extensive numbers to source maintenance solutions.

PHARMAceutical EXPO 2013 provides an opportunity to the participating companies to display their products and services to the business visitors from across the globe. The Delegates will include top Executives of the Pharmaceutical Industry, Officers from Regulatory Departments, Research & Development Personnel, Pharmaceutical Consultants, Hospital Administration, Top Officials of Centre & State Agencies, Academicians & Teachers from Medical and Pharmacy Colleges.

Contact: Harshala Nayak Media Manager Spin Communiqué, Mumbai Mobile: +91-9619700161 Email: harshalan@spincommunique.com

ICON-NANO 2013

Dates: 10 - 12 December 2013 Venue: Dharmsinh Desai University, Naidad, Gujarat The conference aims to impart knowledge on cutting edge research being carried out globally in the field of Nanotecnology.

This conference will boost the interest in nanotechnology and surface science related research in India and in the state of Gujarat that will impact the quality and direction of R&D in industry and academia in India. The Conference will create an opportunity for collaborative research on surface science and nanotechnology between Industry and Academia.

Contact: Shah-Schulman Center for Surface Science & Nanotechnology Faculty of Pharmacy College Road, Naidad- 387001, Gujarat Tel: +91-268-2520504/ 2900470 Email: deanpharmacy@ddu.ac.in, sscssn@ddu.ac.in 72 November 2013

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Contact: Kamal Bhardwaj Senior Assistant Director Federation of Indian Chambers of Commerce and Industry Federation House, Tansen Marg; New Delhi – 110001 Mob: 9899392930; Tel: +91 11 23357353, 23738760-70 Fax: +91 11 23359734 Email: kamal@ficci.com

P-MEC India

Dates: 3 – 5 December 2013 Venue: Bombay Convention and Exhibition Centre, Mumbai, India P-MEC India will give you an unprecedented insight into the future of pharmaceutical equipment and machinery. The event highlights latest knowledge and trends in the industry. It is the best place for you to source quality machinery and equipment at competitive prices.

Contact: Rahul Deshpande UBM India Pvt Ltd Times Square Unit No. 1 and 2, B Wing, 5 th Floor, Andheri Kurla Road, Marol Andheri (East) Mumbai - 400 059 Tel: +(91) 22 61727165 Fax: +(91) 22 61727273 Email: rahul.deshpande@ubm.com

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bookshelf Pharmaceutical Operations Management: Manufacturing for Competitive Advantage [Hardcover] Authors: Pankaj Mohan, Jarka Glassey, Gary Montague Price: USD 107.05 No of pages: 364 pages About the book: Pharmaceutical Operations Management focuses on policy execution, risk management, supply chain modeling, advance process control, and Six Sigma for the pharmaceutical industry; critical techniques that will offset cost, increase efficiency, and maximise profitability.

Taking an integrated approach to pharmaceutical product manufacturing lifecycle management, the book details the process design, including the value of scale-up and scale-down, understanding key elements of manufacturability, control strategy, and variability reduction, allowing your company to push its manufacturing to its fullest potential.

Project Management Industry [Hardcover]

for

the

Pharmaceutical

Authors: Laura Brown, Tony Grundy Price: USD 113.95 No of pages: 298 pages About the book: In this book, Laura Brown and Tony Grundy’s pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects.

Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships (Wiley Series on Technologies for the Pharmaceutical Industry) [Hardcover] Author: Rathnam Chaguturu (Editor), Ferid Murad (Foreword) Price: USD 101.16 No of pages: 592 pages About the book: This book provides insight into the potential synergy of basing R&D in academia while leaving drug companies to turn hits into marketable products. As Executive Director of the High Throughput Screening Laboratories at the University of Kansas, and one of the founding members of the Society for Biomolecular Sciences, Dr Chaguturu has assembled a panel of experts from around the world to weigh in on issues that affect the two driving forces in medical advancement.

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