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Pharmaceuticals Newsletter - November 12 to November 16, 2012

India Infoline News Service | Mumbai |

Ninety percent of women who suffer from migraines agree that with an increased understanding of the triggers, they can better manage their migraines, according to a survey conducted by Novartis Consumer Health, Inc., the makers of Excedrin Migraine.

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Dr. Reddy's, OctoPlus sign agreement for public offer


Dr. Reddy's (NYSE: RDY) and OctoPlus (Euronext Amsterdam: OCTO) jointly announced that they have reached conditional agreement in connection with an intended public offer by Dr. Reddy's, or a wholly owned subsidiary of Dr. Reddy's, for all issued and outstanding ordinary shares in the capital of OctoPlus at an offer price of € 0.52 (cum dividend) in cash (the "Offer Price") for each OctoPlus share (the "Offer").


Dr. Reddy's and OctoPlus hereby announce that preparations for the Offer, including preparations in respect of the offer memorandum for the Offer (the "Offer Memorandum") and obtaining approval from the Netherlands Authority for the Financial Markets (the "AFM") for the Offer Memorandum, are proceeding as planned.


Update indicative timetable


Dr. Reddy's intends to submit a draft of the Offer Memorandum for approval to the AFM as soon as reasonably practicable following this press release in the coming days. Once the Offer Memorandum is approved by the AFM, the Offer will be made by making the Offer Memorandum publicly available. It is currently expected that the Offer will be launched mid December 2012. If launched, the Offer period will run for at least eight weeks and no more than ten weeks, after which the Offer may, if the Offer conditions are fulfilled or waived, be declared unconditional or the Offer may be extended. Subject to the Offer conditions, if and when the Offer is declared unconditional, there may be a post-closing acceptance period of two weeks. Closing of the transaction is expected to occur in Ql 2013.


The extraordinary meeting of shareholde of OctoPlus pursuant to Section 18 Paragraph 1 of the Dutch Public Takeover Decree {Besluit openbare biedingen Wft) in which the Offer will be discussed and certain governance related resolutions will be proposed tojbe adopted will, depending on the exact date of launch of the Offer, take place around the end of January 2013. OctoPlus intends to combine the extraordinary general meeting of shareholders of OctoPlus pursuant to Section 2:108a of the Dutch Civil Code {Burgerlijk Wetboek) referred to in the joint press release of Dr. Reddy's and OctoPlus of 22 October 2012 with the aforementioned extraordinary general meeting of shareholders.Read more…


Biocon enters into agreement with Bristol-Myers Squibb


Biocon announced today that it has entered into an option agreement with Bristol-Myers Squibb Company (NYSE: BMY) for Biocon’s IN-105, a prandial oral insulin product candidate. Under the terms of the agreement, Bristol-Myers Squibb will have the right to exercise an option to obtain an exclusive worldwide license to the program.

Biocon will conduct clinical studies to further characterize IN-105’s clinical profile according to a pre-agreed development program up to the completion of Phase II.

If Bristol-Myers Squibb exercises its option to license IN-105 following the successful completion of the Phase II trial, Bristol-Myers Squibb will assume full responsibility for the development program, including all development and commercialization activities outside India. Biocon will receive a license fee in addition to potential regulatory and commercial milestone payments and royalties on commercial sales of IN-105 outside India. Biocon will retain exclusive rights to IN-105 in India.

Ms. Kiran Mazumdar-Shaw, MD and Chairman of Biocon, said: “This agreement is one huge step closer to realizing the dream of bringing oral insulin to market. We are excited to extend the excellent relationship we already enjoy with Bristol-Myers Squibb, and look forward to working closely with them to make this a reality.”

Diabetes is a chronic disease that affects about 350 million people worldwide. Long-term complications of diabetes include cardiovascular complications, peripheral vascular disease (leading to and including amputation), kidney failure, and other chronic diseases. It is estimated that the direct and indirect costs of diabetes to the overall healthcare system amount to over $650 billion worldwide.




IIFL Institutional Equities recommends 'Buy' on Sun Pharma

IIFL Institutional Equities, a part of the IIFL Group, one of the leading players in the Indian financial services space, recommends “Buy” Sun Pharma.

According to IIFL Institutional Equities report, Sun Pharma reported another strong quarter with revenue and Ebitda beating our estimates by 7% and 21% respectively. The upside came from continued strength from the Taro subsidiary in the US and strong growth in the emerging market businesses; domestic business growth came in below expectation.

Sun also announced acquisition of DUSA Pharma, a US-based innovative dermatology company, for US$230m. We expect Sun Pharma’s premium valuation to sustain although FY14 growth may suffer in comparison with the exceptionally high FY13 base. Maintain BUY, the brokerage added.

The report was published by IIFL’s Institutional Equities Research desk.

Domestic News


Orchid Pharma to exit its Chinese JV


Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals Ltd said that it was exiting its 50:50 manufacturing joint venture in China.


The 50% stake that Orchid holds in the Joint Venture (JV) company (NCPC-Orchid Pharmaceuticals) will be transferred to the partner company (NCPC) for a total cash consideration of USD 13.9 million (RMB 87.5 million).


Orchid had in 2002 entered into a 50:50 JV with North China Pharmaceutical Corporation (NCPC) to set up a Cephalosporin API manufacturing facility located in Shijiazhuang, China.


Commenting on the development, Orchid’s Chairman & Managing Director Mr K Raghavendra Rao said, “With the local Chinese players fast integrating, the operating conditions have grown quite competitive in China. Moreover, the products that the JV manufactures and markets in the local Chinese market have reached a mature stage resulting in flat growth prospects going forward. Hence, it was a prudent decision to relinquish our stake to the partner and exit the JV”.


Migraines suffered women want a better understanding of migraine triggers: Survey


Ninety percent of women who suffer from migraines agree that with an increased understanding of the triggers, they can better manage their migraines, according to a survey conducted by Novartis Consumer Health, Inc., the makers of Excedrin Migraine.


That is why today, the makers of Excedrin Migraine have joined with singer, actress and Broadway star, Jordin Sparks, and well-known Lenox Hill Hospital internist Keri Peterson, MD – both migraine sufferers – to launch, “Managing Migraines: Know Your Triggers. Know Your Treatment,” a new education campaign. It’s designed to raise awareness of the importance of tracking migraine triggers so sufferers can better manage their migraines.


While certain triggers may increase the risk of a migraine, triggers vary from person to person. According to the women surveyed, 83% said they would like better tools to help them track the triggers that lead to their migraines so that they can better manage attacks.


To help migraine sufferers, Excedrin Migraine has developed a convenient, new tracking tool, My Migraine Triggers App, with a neurologist. Available for free on iTunes, this app allows migraine sufferers to track the causes of their migraines and share them with their physician. Migraine sufferers can chart out a daily log of information into customizable reports to easily understand which activities, foods and beverages are associated with the onset of their headaches.


"As they say in my business … the show must go on. As someone who suffers from migraines, it is important for me to understand my migraine triggers so I can stop my migraines before they stop me,” says Sparks. “That’s why I’m thrilled to be teaming up with the makers of Excedrin Migraine to launch this education campaign and help migraine sufferers become better informed about their triggers and symptoms.”


“I encourage all my patients who suffer from migraines to download the My Migraine Triggers app,” says Lenox Hill Hospital internist and migraine sufferer Keri Peterson, MD. “I was shocked to learn that less than half (45%) of female migraine sufferers surveyed regularly share migraine trigger information with their physician. The new My Migraine Triggers app has a great feature which enables my patients to send me data about their migraines before they even walk into my office, allowing me to create a better treatment plan.”


New study finds alpha linolenic acid offer protective effects on cardiovascular diseases


A meta-analysis published in the recent issue of the American Journal of Clinical Nutrition evaluates how the plant-based omega-3 fatty acid alpha-linolenic acid (ALA) offers protective effects on cardiovascular diseases (CVD). The study found ALA to be associated with a lower risk of CVD, particularly coronary heart disease (CHD) death. 


These findings support the potential heart health benefits of ALA and suggest consumers should obtain adequate amounts of ALA in their diets. Walnuts  are a key source of ALA and the only nut that provides a meaningful amount  of the essential plant-based omega-3 fatty acid offering 2.5 grams of ALA in a mere handful. 


This systematic review incorporated 27 original studies and included 251,049 individuals and found that overall ALA exposure was associated with lower risk of CVD.  In fact, in the pooled dietary analysis, each 1 gram per day increment of ALA intake was associated with a 10% lower risk of CHD death. 


Previously, the majority of research funding of omega-3 fatty acids have been directed towards marine sources, however recently increased attention has been given to its plant-based counterpart ALA, and has been suggesting that ALA consumption also offer cardiovascular benefits. 


The researchers believe that there may be a direct or indirect antiarrythmic effect of ALA that could partially explain why ALA appeared protective against CHD.  Previous studies have found ALA consumption may lower cholesterol levels, positively effect thrombosis, improve endothelial function and decrease inflammation.Read more….


Precision medicine revolution is within our grasp: Report


Precision medicine, which combines established clinical parameters with molecular profiling to tailor treatment for individual patients, holds the promise of considerably better and cheaper healthcare but requires concerted multi stake holder action to fulfil its potential, a new report finds today.


Preparing for Precision Medicine, published by the Global Agenda Council on Precision Medicine, builds on the significant advances in personalized patient care that have been made in biomolecular medicine in the past 10 years by setting out key requirements for widespread adoption to be achieved.


Specifically, the report calls for the establishment of frameworks for regulating, compiling and manipulating the influx of information that can keep pace with rapid scientific discoveries by allowing:


More incentives for innovation

New disease classification systems that incorporate emerging molecular data

More streamlined clinical trial regulation frameworks

Effective data interpretation and clinical decision support (CDS)

Stimulation of consumer interest and active patient participation


“Such an approach will deliver significant benefits but also create new challenges. For one thing, preparing for precision medicine will require collaboration between all major healthcare stakeholders – clinicians, patients, government, industry and academic institutions – on a scale previously unseen. Ensuring the success of precision medicine will require that these challenges are acknowledged and effectively addressed early on,” said Lord Darzi, Hamlyn Chair of Surgery, Imperial College London and Chair of the 2011-12 Global Agenda Council on Precision Medicine.


The Co-Chairs of the Summit on the Global Agenda 2012 are Sultan Bin Saeed Al Mansoori, Minister of Economy of the United Arab Emirates and Sami Dhaen Al Qamzi, Director-General, Department of Economic Development of the Government of Dubai.


Pharma industry on cusp of golden era: PwC


Major scientific and technological advances, alongside socio-demographic changes and increasing demand for medicines, will revive pharma’s fortunes post 2020, according to a new report from PwC, Pharma 2020: From vision to decision.


However, in order to survive to 2020 and then to potentially thrive on the opportunities the next decade holds, important decisions need to be made - and the challenges of rising customers expectations, poor scientific productivity and cultural barriers need to be addressed. One of the major hurdles facing the pharma industry is the rising healthcare bill. Its expenditure as a percentage of GDP is climbing in countries in every income bracket and is increasing most steeply in the mature markets where the industry has historically made most of its money. At a time when all economies are feeling the tougher times, the industry is having to play its part. The bill payers are demanding better outcomes and introducing new mechanisms to measure these as a precondition for paying for new medicines.


As a result, PwC research suggests that the pharma industry must either offer more value without charging more or prove that it can remove costs from another part of the healthcare system to make room for the higher prices it’s charging. For example, the scope for helping healthcare payers save money in the mature markets is huge.


Currently, roughly more than 85% of the health budget goes on healthcare services and less than 15% on medicines – so if the industry can reduce spend on costly medical services and procedures, PwC estimates that its share of healthcare expenditure in these countries could rise to 20% by 2020.


Steve Arlington, global advisory pharmaceutical and life sciences leader, PwC, said:

“A healthy, vibrant and responsive pharma industry is vital to society for the development of new medicines. More needs to be done to support and encourage long-term investment in the discovery and development of medicines to treat serious disease. We need to all work together to improve the wellbeing of populations.”


The growth markets - which will account for 33% of the world’s GDP and where demand for medicines will more than double by 2020 - offer the pharma industry countless opportunities but the report highlights that for it to be profitable, it’s about being sensitive, strategic and targeting the right population with the right medicine and delivering value.


The report believes that the industry needs to rebalance its expenditure and invest more in the early part of the R&D process to deal with rising costs. More needs to be done to improve productivity and the returns on R&D investment. Most of the products that will be launched in the coming years are already in the pipeline, but they are not aligned with demand and rising expectations from healthcare payers, providers and patients. Marrying the pipeline with the market in the next decade is going to be the key.


Despite the big changes in the industry over the past few decades, the report also finds that the organizational culture at many pharma companies has changed very little, or if anything has become more stultifying. The industry has struggled to deal with change in the past, but the report says change must now be embraced in a rapidly changing world. A demanding commercial environment is set to continue and in order to succeed, the report suggests this must change and industry’s top figures need to foster a creative corporate culture that allows organisations to develop with the courage to explore and flexibility to thrive in different conditions.


Mike Swanick, global pharmaceutical and life sciences leader, PwC, said:


“The industry is at a crossroads. In established markets, budgets are constrained and all stakeholders want real solutions and cures. Pharma companies must now deliver ‘real’ value to payers and patients to prove their worth and to rebuild trust in the sector. In growth markets, companies must respond responsibly to a growing population’s needs, recognising demographic and cultural diversity.


“The industry has historically found change difficult to deal with but time is running short and decisions must now be taken. Those that do, face an optimistic future, while failure to respond now could lead to many regrets.”


South Asia’s largest pharmaceutical event in Mumbai


The much awaited 3-day CPhI/P-MEC/ICSE/ BioPh exhibition for the pharmaceutical industry is all set to open in Mumbai on November 21, 2012. The exhibition will have participation of over 920 companies from all over the world, making it South Asia’s largest pharmaceutical event. Visitor pre-registrations also show very encouraging numbers of attendees from over 90 countries interesting in visiting CPhI/P-MEC/ICSE/ BioPh.


According to the India Business Equity Foundation, the Indian pharmaceutical market is set to double its exports to reach US$500 billion by 2014, thereby attracting the attention of major global economies.


Growing at a pace of 15% annually, it is no secret that Generics are the major strength of the Indian pharmaceutical sector. With a strong domestic market potential and the low-cost manufacturing advantage working in its favour, India is set to become increasingly prominent on the global pharmaceutical landscape in the near future.


Rajeev Kher, Additional Secretary, Department of Commerce, Ministry of Commerce and Industry, will be the Guest of Honour at the inaugural session to be held on November 21, 2012. The platform will provide an opportunity for attendees and exhibitors to interact and network with the industry players from the various segments within the field of pharmaceutical ingredients, machinery, equipment & technology, contract services and solutions. Onsite seminars will address various technology issues and the latest industry trends.


The CPhI India Awards will recognise and appreciate the contribution and efforts of the Indian pharmaceutical industry. There are seven broad categories identified for the awards. The categories include innovation in quality, product development, cost, the environment, Health & Safety (EHS), packaging and the lifetime achievement and Pharma Personality of the Year awards.


The process advisors for the awards are Ernst & Young. Organised by UBM, the CPhI India Awards are supported by Pharmexcil and Brand India Pharma. The evaluation for the awards will be done by an independent panel of senior industry professionals. The award distribution event will be held on 21st November, 2012.


CPhI India Awards 2012 will be an elite gathering of industry leaders who will meet, network and also attend a panel discussion on “Developing the Capability, Credibility and Culture to penetrate deeper into the global value chain for the Indian Pharma Industry”.


Early check-up helps in better management of Diabetes: Kanchan Naikawadi


The World Diabetes Day (WDD) is celebrated every year across the world on November 14. The campaign celebrated in over 160 countries and over 200 member associations was first started in 1991 by the International Diabetes Federation (IDF) and the World Health Organisation (WHO) in response to the concerns about the growing threat posed by Diabetes, often called the silent killer. The United Nations made the World Diabetes Day official in 2007 with the passage of United Nations Resolution 61/255.


Objectives of WDD


World Diabetes Day is a campaign that features a new theme chosen by the International Diabetes Federation each year to address issues facing the global diabetes community. Every year the WDD draws the attention of the population globally to the paramount importance of this deficiency and the problems faced by the diabetic community, the need to be aware of the various complications related to heart, kidney, the eyes and other part of the body. While the themed campaigns last the whole year, the day itself is celebrated on November 14, to mark the birthday of Frederick Banting who, along with Charles Best, first conceived the idea which led to the discovery of insulin in 1922. The theme for the period 2009-2013 is Diabetes Education and Prevention. WDD is celebrated worldwide by all member states of the United Nations, as well as by other associations and organizations, companies, healthcare professionals and people living with diabetes and their families.


The global diabetes community including International Diabetes Federation member associations, diabetes organizations, NGOs, health departments, civil society, individuals and companies develop an extensive range of activities, tailored to a variety of groups. Activities organized each year include - Radio and Television programmes, Sports events, Free screenings for diabetes and its complications¸ Public information meetings, Poster and leaflet campaigns, Diabetes workshops and exhibitions, Events for children and adolescents, Walks, Runs, Cycle Race and Political Events. Read more…


Early marriage remains a challenge for many PPD countries: Ghulam Nabi Azad


Partners in Population and Development (PPD) is an intergovernmental initiative created specifically for the purpose of expanding and improving South-to-South collaboration in the fields of reproductive health, population, and development.


PPD was launched at the 1994 International Conference on Population and Development (ICPD), when ten developing countries from Asia, Africa and Latin America formed an intergovernmental alliance to help implement the Cairo Program of Action (POA).


PPD has presently 25 members countries committed to the implementation of the ICPD Programme of Action, willing to provide political, technical and financial support to South-South Cooperation. While there were only 10 developing countries at the time of formation of the Organization in 1994, over the years PPD’s membership has increased to 25 developing countries across Asia, Middle East and North Africa, Sub-Saharan Africa and Latin America covering more than 57% of total world population. The PPD member countries are: Bangladesh, China, India, Indonesia, Pakistan, Thailand, Viet Nam, Colombia, Mexico, Egypt, Morocco, Tunisia, Yemen, Jordan, Ethiopia, The Gambia, Ghana, Kenya, Mali, Uganda, Benin, Senegal, Zimbabwe, South Africa and Nigeria.


PPD is currently chaired by Shri Ghulam Nabi Azad, Minister of Health and Family Welfare, Government of India, who has been unanimously elected to the post in the 16th Annual Board Meeting of PPD held in Pretoria, South Africa in 2011. Read more…


158th Meeting of the E.S.I. Corporation helds in New Delhi


The 158th Meeting of the E.S.I. Corporation held under the Chairmanship of Union Labour & Employment Minister Mallikarjun Kharge here in New Delhi. The meeting was convened to approve the Annual Report and Annual Account – 2011-2012 of the Corporation before it is submitted to the Central Government for laying on the table of the both Houses of the Parliament.


Addressing the members Kharge expressed satisfaction on the well being of ESIC for increase of revenue from Rs. 8393.55 crores during the year 2011-12 in comparison to Rs. 6980.61 crores last year. Accordingly, the Corporation has spent Rs. 3374.67 crores in the year 2011-12 on Medical, Cash and other benefits, he added.


The minister also lauded the performance of ESIC and appreciated it for making a powerful presence at the world forum of ISSA by winning 3 Certificates of Merit in ISSA Good Practice Award, ASIA and Pacific Competition-2012. The Certificates of Merit in the categories of Extension of Social Security Coverage; Adequacy and Quality of Social Security Benefits and Services and Administrative and Operational Efficiency were awarded to the ESIC by the ISSA in the ISSA Regional Social Security Forum for Asia and Pacific held recently at Seoul, Republic of Korea.


He further expressed the hope that the performance of the ESI Scheme will further excel in coming years.


The Agenda Items discussed during the meeting were related to welfare of beneficiaries. This included - Enhancement of Confinement Expenses for confinement taking place outside ESI Dispensaries/Hospital from Rs. 2,500/- to Rs. 5,000/- ; Enhancement in the PDB and DB Benefit Rates to address the erosion in the real value due to inflation; Enhancement of the limit of daily rate of PDB for commutation; and setting-up of New ESI Hospital in Kanyakumari (TN).


Ghulam Nabi calls on Sheikh Hasina

Ghulam Nabi Azad, Minister of Health & Family Welfare, Government of India is currently on an official tour to Bangladesh capital Dhaka in connection with the International Conference on “Evidence for Action: South-South Collaboration for ICPD beyond 2014” organized jointly by Partners in Population and Development (PPD) and Bangladesh and also for attending PPD governance meetings.

Ghulam Nabi Azad called on Sheikh Hasina, Prime Minister of Bangladesh at her residence, Gonobhaban at Dhaka this morning i.e. 10th November, 2012.

At the outset, Ghulam Nabi Azad conveyed greetings of Prime Minister of India Shri Manmohan Singh and Chairperson, UPA, Smt. Sonia Gandhi and presented compliments to Her Excellency and to the Government and people of Bangladesh on his and India’s behalf.

Recalling the close and historical ties between the two countries, he stated that there are very few countries in the world whose destinies are so intrinsically interlinked as India and Bangladesh.

Azad said that the two countries shared common cultural, economic and political history. They also share the longest land borders with each other and have the same religious beliefs, language, customs and aspirations. These are factors which encourage cooperation in every possible area.

The recently concluded year-long joint celebrations of the 150th Birth Anniversary of Gurudev Rabindranath Tagore was cited as a testimony of shared cultural ethos and heritage between India and Bangladesh.

Ghulam Nabi Azad congratulated Prime Minister for her astute statesmanship and accomplishments in leading Bangladesh towards steady growth, continued progress and prosperity and appreciated her keen interest in Health.

Azad informed that he is visiting Dhaka to participate in the International Conference on “Evidence for Action: South-South Collaboration for ICPD beyond 2014”, organized jointly by Partners in Population and Development (PPD) and the Government of People’s Republic of Bangladesh.

The Indian Health and Family Welfare Minister thanked Bangladesh for graciously hosting the Executive Committee and the 17th Annual Board Meeting of the Partners in Population Development (PPD), of which he was the current Chairperson, having been re-elected for a second 3 year term.

The meeting lasted for more than 45 minutes during which several issues related to Health were discussed. Azad informed that India and Bangladesh are set to usher in an era of much closer cooperation in the field of health & medicine. Read more…



Wockhardt Q2 cons revenue up 29%


Wockhardt Limited, the Pharmaceutical and Biotechnology major, continues to be amongst the Top 3 in profitability in the Indian Pharmaceutical industry. It has reported a Profit After Tax in Q2FY13 of Rs.453 crores which is more than 250% growth over the corresponding quarter of Financial Year 2011-12. The PAT margin at 33% was the highest in the industry.

Wockhardt’s EBITDA for Q2FY13 stands at Rs. 517 crores, with EBITDA Margin at 38.4% for the quarter, one of the highest in the industry and has improved from 29.4% in the corresponding quarter of the previous year.

Wockhardt Ltd

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