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News : Innovation Last Updated: Dec 10, 2010 - 3:24 AM

US Food and Drug Administration approved as many drugs in 1950 as it did in 2008; Pfizer's CEO announces retirement
By Finfacts Team
Dec 6, 2010 - 6:16 AM

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The Minister for Enterprise, Trade and Innovation, Batt O'Keeffe TD, announced in July 2010 that US pharmaceutical firm, Eli Lilly, is to establish a European Financial Services Centre and create 100 finance jobs in Cork City. O'Keeffe is pictured in Cork with Kay Flynn, Senior Finance Director, European Shared Services, Eli Lilly, and Denis Molumby, Executive Director, IDA Ireland.

Roughly the same number of drugs was approved by the US Food and Drug Administration (FDA) in 2008 as were approved in 1950. At the same time, the cost of funding a breakthrough drug is rising by 13.4% annually. Meanwhile, Pfizer, the world's biggest drugs firm on Sunday abruptly announced that its CEO and chairman, Jeffrey B. Kindler (55) was retiring after 4½ years to "recharge." Kindler, a lawyer by profession, who had objected to the creation of a role of chief operating officer, gets a $16.5m final settlement and forfeits nearly 2m in stock options but receives a pension worth $6.9m and retains health insurance for 12 months.

 As new drugs become more expensive to produce, research dollars have been shifted to research that holds the most potential for blockbuster market returns. Many argue that this has resulted in replicative and risk-averse research, rather than bold innovation. Venture capital, which has driven success in funding medical innovation, has fallen in recent years. In 2009, the amount of venture capital devoted to bioscience was less than in 2005. With the drying up of the capital markets, venture capital has been intolerant of investment risk.

A white paper published in the United States last week looks at how the medical innovation process can be improved.

Finfacts reported last June that the pharmaceutical industry continues to rely heavily on sales from an ageing portfolio of drugs, whilst the proportion of total sales from newer drugs has dropped, according to data from the 2010 Pharmaceutical R&D Factbook complied by CMR International, a Thomson Reuters business. In 2009, over $65bn was spent in the US on R&D and 200,000 jobs will be cut in the industry in the US, Europe and Japan in the period 2009-2015.

Eli Lilly halted two late-stage clinical trials of an experimental Alzheimer’s treatment last August. At the early stage, the drug was jointly developed by Lilly and Elan, the Irish drugs firm, and the latter had retained marketing rights and was also expected to enjoy royalties from sales. Alzheimer’s disease affects an estimated 5.3m Americans.

Lilly is losing patent protection in the next seven years on drugs that accounted for 74% of its sales in 2009, a decline considered to be the worst patent cliff facing major companies in the industry.

The New York Times says Lilly, which has an Irish plant in Dunderrow, near Kinsale, has introduced only one product in the last five years, the blood thinner Effient, to sluggish early sales. It has virtually no new products to market until 2013, when it hopes to start rolling out two a year.

Meanwhile, five leaders in the medical innovation field released the white paper titledThe New Role of Academia in Drug Discovery and Development:  New Thinking, New Competencies, New Results.  This white paper reflects key recommendations from a July 2010 town hall meeting in Kansas City hosted by Friends of Cancer Research, Kansas Bioscience Authority, The University of Kansas Cancer Center, Ewing Marion Kauffman Foundation, which is a leading promoter of entrepreneurship and innovation, and the Council for American Medical Innovation.

Art Koch, senior vice president at Impax Laboratories and Saulius Jurgelenas, CEO of Sanitas joined CNBC to discuss the future of the pharmaceutical industry as pricing pressure and healthcare reforms weigh:

The paper says that while some 7,000 diseases affect the human family, only 600 have treatments. Fewer than 3% of rare diseases have an FDA approved treatment, yet one in ten Americans is affected by a rare disease.

Bernard Munos, a strategist at Eli Lilly, has noted that, since the early 1980s, large pharmaceutical and biotechnology companies share of FDA approved drugs has declined from about 75% to 35% of approved drugs. At the same time, small companies' share has increased from about 23% to nearly 70%. Munos noted the growth of venture capital funding as a significant factor. He also suggested that small firms have the ability to fill research needs that large companies - - with pressure to find and fund blockbuster drugs - - overlook, including rare and neglected diseases.

The period between early stage research and clinical trials is colloquially referred "Valley of Death" because it is here that many potential breakthroughs languish. A number of factors converge to contribute to this growing problem: prohibitive costs, unclear market potential, lack of capital, regulatory unpredictability, and lack of training in how to bring a discovery from the lab through the early process of commercialization.

New models should be collaborative, with government, academia, nonprofits, advocacy groups, the venture capital community, and private industry all making commercialization of patient treatments their highest priority. Collaboration will require new platforms for data sharing and an end to the "pervasive proprietary mindset." The FDA will need an enhanced scientific foundation to ensure predictable, efficient, and appropriate review of new compounds and treatments developed by innovators. Higher education institutions, which host the bulk of early stage science research, will have to become better equipped to move advances toward commercialization.

The paper outlines how government, nonprofit organizations and academic institutions can define new models of working with the private sector to enhance drug development efforts and bring safer, more effective drugs to the market more efficiently.  Recommendations for this new model are based on a series of expert panel discussions held during the town hall meeting.

"This call to action is the result of an extraordinary meeting of key policy makers, academics, industry leaders and the non-profit community, who understand the urgency for new collaborations in cancer research and drug development," said Roy A. Jensen, M.D., director of The University of Kansas Cancer Center.  "As universities increasingly seek to commercialize their research, we need a new paradigm for drug discovery. The University of Kansas Cancer Center is proud to partner with these organizations to lead the way." 

“Together, we can knock down barriers to scientific innovation, and, as we do that, we will accelerate our progress in the fight against diseases such as cancer,” said Tom Thornton, president and CEO of the Kansas Bioscience Authority.

“We hope our nation’s healthcare leaders and policymakers will study the insights and adopt the recommendations in this report.  We can make groundbreaking progress in how scientific discoveries translate to patient healthcare if they do,” said Lesa Mitchell, vice president of advancing innovations at the Kauffman Foundation, which promotes entrepreneurship and innovation.

"This white paper outlines critical steps toward much-needed increased interagency collaboration,” said Dr. Ellen Sigal, Chair, Friends of Cancer Research.  “The proposals discussed within this document aim to accelerate the process to help get scientific breakthroughs to patients.  The message is clear; without collaboration among all agencies and academic centers, the full potential of biomedical research may be stifled."

"The Council for American Medical Innovation is pleased to have supported this ground breaking event examining the new role of academia in drug development," said Debra Lappin, President of the Council for American Medical Innovation. "The white paper reflects a rare dialogue among leaders across sectors and paves the way forward for the next generation of research, discovery and medical advances."

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