Hugin to lead PhRMA

by IainBate 23. April 2013 12:37

Hugin Celgene’s Chairman and CEO Robert Hugin (pictured) has been appointed chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA).

He succeeds Eli Lilly’s John Lechleiter and said his priorities for his 12-month term are to defend intellectual property and the incentives for new medicines.

John Castellani, PhRMA President and CEO, said the new chair will provide a “strong foundation for the millions of US jobs our industry creates and supports” through his policies.

Mr Hugin was appointed Celgene chair in 2011 having served as president since 2010 and chief operating officer since 2006.

“I look forward to working with our leadership team, the PhRMA staff, and our member companies to advocate for policies that support the advancement of medical innovation and that ensure access for patients to life-extending therapies,” Mr Hugin said. “Through our actions, we must ensure that continued medical innovation is part of the solution to healthcare costs and economic growth in the long term.”

Alongside Hugin’s appointment, the trade body also appointed Pfizer’s president and CEO Ian Read as the next chair and Merck and Co’s chief executive Kenneth Frazier as treasurer.

Access to medicines in developing world is improving

by JoelLane 29. November 2012 15:23

drug access Most of the leading pharmaceutical companies are improving access to their medicines in the developing world, a new report shows.

The Access to Medicine Index identifies GSK, J&J and Sanofi as the companies doing most to make their drugs available and affordable in poorer countries.

Better pricing deals and development of drugs for neglected diseases are among the areas of company activity praised by the report, but the management of drug trials in developing companies is criticised.

GSK, which topped the Index in 2010, remains in front though its overall rating is only slightly higher. J&J and Sanofi have significantly improved their ratings.

The major Japanese firms are bottom of the league, as well as being absent from such initiatives as the WHO campaign to fight neglected tropical diseases.

In its third year, the Netherlands-based Index notes that companies are showing better internal organisation in relation to drug access issues.

Of the 20 largest pharma companies, 17 have improved access to their drugs in the developing world since 2010: they are developing more relevant drugs and doing more to facilitate patient access to them.

In particular, more companies are using tiered pricing schemes to make products more affordable for certain countries or population groups – most notably Gilead, whose HIV drugs are used worldwide.

However, the Index states that companies could do more to support generic versions of their drugs and adapt drug packaging to local needs.

It also notes that the outsourcing of clinical trials to Contract Research Organisations lacks transparency and control, with only four companies (GSK, Sanofi, Eisai and Merck & Co.) saying they enforce ethical codes.

Wim Leereveld, CEO of the Index, said: “Access to medicine is a multi-faceted challenge and the pharmaceutical industry has a critical role. While it has made strides in many areas, companies that have sector-leading practices also show us there is more the industry can contribute.”

Merck could pay $1bn for cancer drug

by JoelLane 17. April 2012 11:45

Pf industry news Merck & Co. has paid $120m to license a cancer drug from US company Endocyte – and it could end up costing them as much as $1bn.

Vintafolide (or EC145) is in phase III trial as a treatment for ovarian cancer and has five other potential indications in cancer treatment.

Merck will pay $120m upfront for global rights to the drug, with an additional $880m depending on its reaching milestones across all six indications.

An example of personalised medicine, Vintafolide is being developed with a companion diagnostic to select patients who will benefit from the drug.

Vintafolide combines folate (vitamin B9) with a chemotherapy agent, and is designed to target fast-growing cancer cells in ovarian, lung, breast, colon and renal cancers that actively take up folate.

The drug is currently being evaluated in a phase III clinical trial for ovarian cancer and a phase II trial for non-small-cell lung cancer.

Endocyte will retain ownership of its companion diagnostic agent, etarfolatide (or EC20), which identifies tumours that over-express folate receptors.

The milestone payments depend on the regulatory and commercial success of vintafolide in six cancer indications. Endocyte will receive 50% of profit in the US and over 10% of sales royalties in the rest of the world.

Endocyte has rights to co-promote vintafolide with Merck in the US. Merck has exclusive promotion rights in the rest of the world. Endocyte will fund and complete the current phase III ovarian cancer trial, whereas Merck will be responsible for other development activities.

The EC granted orphan drug status to vintafolide in March 2012, and Endocyte had planned to apply for EU marketing approval in the third quarter of 2012.

Peter S. Kim, President of Merck Research Laboratories, described vintafolide as “a promising and innovative late-stage cancer drug candidate”.

The deal reflects industry confidence in personalised medicine and in the value of licensing deals with drug development specialists.

Shares soar at Amylin after BMS offer

by IainBate 29. March 2012 11:44

Pharma Industry News Shares in Amylin Pharmaceuticals doubled (54%) in price after it was revealed the company rejected a $3.5 billion takeover bid from BMS in February.

Two people with knowledge of the offer revealed that Amylin’s board rejected BMS’ $22 a share acquisition offer with analysts now predicting bids from other pharmaceutical suitors.

Robyn Karnauskas, an analyst with Deutsche Bank, says the San-Diego based company may be worth as much as $31 a share after it received regulatory approval for its diabetes drug Bydureon in January 2012.

Amylin saw its shares close at $23.77 in New York, the biggest single-day increase since August 1999.

Analysts now predict that Amylin could be set for further bids from the likes of AstraZeneca, Sanofi, Takeda and Merck.

“The question is who can extract the most value, because this is all a commercialisation story from here,” said Joshua Schimmer, an analyst from Leerink Swann.

It’s believed that BMS has not approached Amylin with a further offer since its initial bid letter, people familiar with the matter said.

Amylin is believed to be searching for a new marketing partner for its products outside the US and is in discussions with a number of interested parties, sources said, after its decade-long collaboration with Eli Lilly ended in November 2011.

It recorded $650.7 million in revenue last year, had nearly half-a-billion dollars ($496m) in long-term debts, a $924.3 million promissory note related to revenue sharing, and $204 million in cash, equivalents and short-term investments, according to a statement published around the same time as BMS’ offer.

Merck appoints new Chief Ethics and Compliance Officer

by JoelLane 29. March 2012 11:38

Pf industry news Merck & Co has appointed Michael J. Holston as its Chief Ethics and Compliance Officer as of June 25, 2012.

Holsten, an experienced business lawyer, will serve on Merck’s Executive Committee and be responsible for driving ethical standards and compliance for the company on a global basis.

He succeeds Richard S. Bowles, who is retiring after more than 35 years with Merck and the former Schering-Plough (which merged with Merck in 2009).

Holston joins from Hewlett-Packard, where as Executive VP and General Counsel he was responsible for overseeing compliance, government affairs, privacy, ethics operations and legal affairs.

Previously, he was a partner at law firm Morgan, Lewis & Bockius LLP, where he served as external counsel to Merck on product litigation and regulatory compliance.

Merck CEO Kenneth C. Frazier said: “We are delighted to welcome Mike as our new chief ethics and compliance officer. His extensive experience managing compliance with healthcare laws across international businesses and his background with Merck and our industry make Mike a terrific leader for our ethics and compliance organisation and a member of our Executive Committee.”

Frazier also praised Richard S. Bowles: “His strong leadership established the global compliance organisation for the combined new company following the merger with Schering-Plough.”

Hosten said he was “excited to be joining Merck at this important period of change for the company and the pharmaceutical industry” and looks forward to “helping to champion Merck’s high ethical and compliance standards so the company can focus on what it does best – discovering and developing innovative new medicines and vaccines.”

Merck is known as MSD outside the US and Canada.

Biopharma makes the running

by JoelLane 22. March 2012 13:06

Pf industry news Patent applications for biologics by leading pharmaceutical companies are surging further ahead of applications for small-molecule drugs, according to a new report.

Another report notes that the next few years will offer major opportunities for pharma companies to develop biosimilars.

Both of these findings reflect the increasing importance of biotechnology in drug development.

Research by patent law specialist Withers & Rogers shows that while the number of patent applications for biologics has exceeded that for small-molecule drugs for 15 years, the gap has widened rapidly since 2007.

The legal firm’s analysis of the top 10 global pharma companies reveals that the gap between the numbers of patents filed for biologics and for small molecules grew by 14.5% between 2007 and 2009.

By 2009, 60% of the drug patents filed by these companies were for biologics.

Novartis made the greatest number of patent applications for biologics in 2009, followed by Johnson & Johnson and Merck & Co.

Nicholas Jones, patent attorney at Withers & Rogers, said that despite the impact of “economic uncertainty and cost pressures facing big pharma as blockbuster drugs hit the patent cliff, R&D interest in biologics has remained strong.”

He noted although “it is considerably easier to develop and manufacture small-molecule drugs”, major drug companies may be “increasingly willing to compete with major generics producers for a share of the follow-on biologics market”.

Growth partnership company Frost & Sullivan (F&S) reached the same conclusion in a report on the growing opportunity for biosimilars in the European drug market, where numerous blockbuster biologics are nearing the patent cliff.

However, the report noted, the cost of developing and manufacturing biosimilars makes them financially a more high-risk option than conventional generics.

Srinivas Sashidhar, Research Analyst at F&S, said: “$100 billion worth biologics are expected to go off patent by 2020, as a result of which the market is likely to hold significant potential.”

Before this potential can be exploited, he commented, “Improvements concerning the manufacturing and the clinical development processes of biosimilars have to take place.”

The report predicted the European biosimilars market will grow from $172m in 2010 to $3,987 in 2017, at a CAGR of 56.7%.

To overcome the challenges in the way of access to the growing biosimilars market, Sashidhar said, “Collaborations among large pharmaceutical companies with financial capabilities and specialty biotech companies with technical expertise are expected. The strong integration of marketing and research and development skills is the key to success in the biosimilars market.”

F&S expects the growing biosimilars market to drive growth in such therapy areas as diabetes and oncology, where biologics are having the greatest impact.

New corporate development head at Mundipharma

by JoelLane 9. March 2012 12:32

Pf industry news European pharmaceutical group Mundipharma has appointed Paul Medeiros as Head of Corporate and Business Development.

Medeiros, who joins the group from AVI BioPharma, will join the executive leadership team and be responsible for extending and expanding areas for growth.

Based in the UK, Mundipharma is a network of companies across 32 European countries, including Napp in the UK.

Medeiros was previously Senior VP and Chief Business Officer at AVI BioPharma, a specialist in RNA-based drugs for rare diseases.

Over 19 years in the biopharmaceutical industry, Medeiros has also been VP of Global Licensing and Strategic Alliances for Schering-Plough and held several roles in sales and marketing at Merck & Co.

His experience includes licensing and strategic partnering initiatives in specialist therapy areas.

Antony Mattessich, Regional Director, Mundipharma Europe, said: “Paul’s deep experience and network in the pharma industry, combined with his entrepreneurial mind-set and nuanced understanding of the business, will be essential for Mundipharma’s continued growth.”

Alkermes gets new commercial chief

by IainBate 7. March 2012 12:20

Pharma Industry News Alkermes has appointed the experienced Mark Stejbach to the newly created position of Chief Commercial Officer, and as a member of the executive management team.

Mr Stejbach will be responsible for the biohpharma company’s commercial activities for products such as Vivitrol and the commercial strategies for its late-stage pipeline.

Richard Pops, Chief Executive Officer of Alkermes, says the company hopes the new recruit will “accelerate and expand” the Dublin-based company’s commercial activities.

The 46-year-old has more than 25 years’ experience in biotech and pharmaceutical marketing, sales, managed care and finance. He most recently served in a similar role at Tengion after working as the Vice President of Managed Care Marketing at Merck & Co between 2005 and 2008.

“I am thrilled to join Alkermes at this extremely exciting time for the company, and I see tremendous potential for Vivitrol as well as the robust pipeline of new product candidates,” commented Mark Stejbach. “I look forward to enhancing the company’s commercial capabilities to achieve its ultimate goal of bringing unique and compelling medicines to patients in need.”

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Pfizer tops social media chart

by IainBate 22. December 2011 13:28

Pharma Industry News Pfizer has been crowned the leading pharmaceutical company for their presence on Facebook and Twitter, a new study has found.

Cegedim Strategic Data (CSD) found the pharma-giant had the third-most ‘likes’ on Facebook and had more followers on Twitter than industry rivals. Novartis were ranked overall in second with Merck & Co in third position.

Christopher Wooden, Vice President, Promotion Audits for CSD, says the audit highlights how the industry is improving its social media footprint.

The study was conducted worldwide and focused on the top 100 pharmaceutical companies in terms of traditional sales force and marketing channel spending. CSD then identified the top 30 pharma companies for their presence and healthcare-focused activities on Twitter and Facebook.

Behind Pfizer, Novartis was ranked seventeenth for ‘likes’ on Facebook and overall fifth on Twitter for its number of followers. Merck – which came first for the number of pages on Facebook – ranked tenth for the number of ‘likes’ it has received, third for the number of ‘tweets’ it has made on Twitter and fifteenth for its followers.

CSD found that J&J is second for the number of ‘likes’ on Facebook with Roche occupying the same position for its number of followers on Twitter.

“The CSD social media audit shows clearly that most major life science companies are establishing a presence in social media – but coverage, methods and sophistication do vary significantly,” said Christopher Wooden.

“In broad terms we see an attempt by companies to reach out and create a positive, on-going message about their contribution to better health. The ability to target that message and encourage constructive dialogue through social media will bring value to companies developing this new channel.”

ABPI elects new President

by JoelLane 8. December 2011 10:19

Deepak Khanna web Deepak Khanna, UK Managing Director of Merck Sharpe & Dohme and Senior Vice President of its US-based parent company Merck & Co, has been elected President of the Association of the British Pharmaceutical Industry (ABPI).

Khanna will take over the role from Simon Jose of GSK after the ABPI’s next AGM in April 2012. He will serve initially for one year, with a possible re-election for a further 12 months.

Born in the UK, Khanna holds dual British and American nationality.

After starting his pharma career with Merck & Co in 1988, Khanna managed all aspects of the US Merck/Schering-Plough joint venture, including the US marketing and sales of the drugs launched by it.

He is currently Chair of the ABPI HTA Taskforce, a member of the ABPI Board of Management and Chair of the American Pharmaceutical Group.

Khanna commented: “The Government’s proposals for a new pricing system for branded medicines, the reforms of the NHS, and the recommendations of the Nicholson Review of Innovation mean it is vital for the industry to have a strong and united voice.

“I am looking forward to working with the Government, the NHS, patient groups and life science companies to ensure that the industry continues to make a significant contribution to the health and wealth of the UK.”

“With ongoing economic challenges, increased global competition, the largest ever patent cliff and NHS reforms, Deepak’s appointment comes at a crucial time for our industry,” commented Stephen Whitehead, CEO of the ABPI.

“We have had to evolve. Our industry has changed, and I expect it to continue to change. We are moving in the right direction, and I very much look forward to working together with Deepak to ensure this progress continues.”

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