Amid the doom and gloom headlines of debt laden countries and falling stock markets, economic trading conditions remain highly challenging midway through
2011, although FDA approvals offer a ray of hope.
A report given to the US House Energy and Commerce Health Subcommittee by Janet Woodcock, head of the FDA Drug Division, indicates that 20 new drugs have been approved by the FDA so far this year, a number almost equivalent to the 21 approvals for the whole of 2010.
For some time now, indications such as systemic lupus erythmatosus (SLE) and malignant melanoma have remained development graveyards for new products in development. It is therefore particularly gratifying to see that Human Genome Sciences’s Benlysta and Bristol-Myers Squibb’s Yervoy have now been approved for these respective indications. Other recent approvals include Zytiga, for prostate cancer, and Xarelto, for blood clot prevention, both from Johnson & Johnson, as well as Incivek from Vertex for hepatitis C. New products and approvals are analysed further in the article by John Ansell on page 24.
But the risk in development remains, with a commensurate negative impact on the deal when things do not go well. An increasing number of projects seem to be failing to reach successful clinical end points, often resulting in the discontinuation of a partnership if the candidate is an in-licensed product. Our article on crowdsourcing on page 12 takes a look at this perennial issue of risk in development and appropriate business models.
This issue of the journal coincides with the tenth International Pharma Licensing Symposium. Predating the now well established biopartnering events, the first IPLS was held on 22 September 1997, providing a unique opportunity for the national PLGs to network on an informal basis. Since then business development and licensing has become increasingly important as evidenced by the partnerships in place for the recently approved products noted above.
Sharon Finch
Editor, Business Development & Licensing Journal
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