Pullan’s Pieces
Business and Science for BD & others
#57, March 2011
Linda Pullan
www.PullanConsulting.com 805-558-0361
lpullan@msn.com
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Celebrating 5 years as a consultant!
Pullan Consulting has now reached its 5th birthday. I want to thank all the companies who have shared with me their exciting science and plans for great futures. It is great fun to be part of that promise. And I would also like to thank those who have been gracious in referrals and recommendations.
Now on to the next 5 years of helping with messages, strategy, outreach, valuations and negotiations!
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Phase III failures still mostly due to lack of efficacy
Thomson Reuters analyzed the 83 failures between 2007 and 2010 in Phase III or submission. Almost 90% of the failures were attributable to either lack of efficacy (66%) or safety issues (21%). 32% of the projects failed to demonstrate a statistically significant improvement versus placebo, 5% versus an active control, and 29% as an add-on to existing therapy. Nature Reviews Drug Discovery Feb 2011, p87.
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Cephalon and Merck join the list of companies with venture arms
Merck added a Global Health Innovation Fund with $125 million and five staffers who report into Merck's executive committee and chief strategy officer. The group's mandate is to invest beyond drugs: diagnostics, devices, information and health management tools, site-of-care services. The fund is run by Bill Taranto, who came to Merck from Johnson & Johnson, where he was most recently in charge of health care strategy and alliances. In Vivo Blog, March 4, 2011.
Cephalon also started a venture fund, headed by Peter Grebow who was EVP of technical operations. No details yet on its focus or size. In Vivo Blog, March 2, 2011.
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Bayh-Dole Act turns 30 but “March-In” Cases are Rare
The Bayh-Dole Act, passed 30 years ago, aimed to encourage commercialization of US government-funded academic research. To ensure that there was good use of the licensed inventions funded by the government, there was the right of the US Government to “March-In” and require the licensee to grant subsequent licenses. The march-in rights applied if there was a failure in the requirements, which included practical application of the funded inventions, benefit to the public health and safety, public use, or substantially manufacturing in the US. A recent article in the magazine of the Licensing Executive Society (William H. Pratt, Les Nouvelles, Dec 2010, pp. 195-200) reviewed the few cases where the NIH has been petitioned to march-in and force a subsequent license of the US government-funded inventions.
One case against Abbott was on the basis of unreasonable prices being charged for the protease inhibitor Norvir, but the NIH rejected the appeal and found that the drug had met the standards of practical application.
In the second case, CellPro petitioned when Baxter was stopped by injunction from selling a product found to infringe a Johns Hopkins patent, but the NIH decided that Baxter and Hopkins were going to work it out and that Baxter and Hopkins had modified the injunction to allow CellPro to continue to infringe until 3 months after FDA approval of the Baxter product.
The third and pending case is from 3 Fabry’s disease patients who want to force an alternative license because manufacturing problems are preventing Genzyme from making the drug Fabrazyme sufficiently available. The author notes that even if the NIH were to grant march-in rights, there might well be other necessary patents (not subject to the march-in) that would prevent an alternative manufacturer from making the drug. It would also seem that it might well be that an alternative would not likely get to the market sooner than would the supply from Genzyme solving of its manufacturing problems.
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Anti-infectives – a quick snapshot by the numbers
There are 582 anti-infectives listed in Phase 1 thru preregistration in Pharma Projects, compared to 1148 anti-cancer projects in development.
Chemical nature? 295 (51%) are some form of biological (peptide, protein, cells, viral particles). (versus 35% in anticancer drugs)
277 are chemically synthesized or partially chemically synthesized.
10 are classified as natural products.
New chemical entities? 30% or 196 of the 582 anti-infectives are New Chemical Entities. (compared to 43% of the anticancer drugs).
Target type? 137 target an enzyme
58 target a receptor (in anti-cancer drugs, 30% target a receptor)
4 target a cytokine or growth factor
4 target an ion channel
2 target a transporter
Route of administration? 169 are oral
116 are intramuscular
75 (13%) are iv (a big contrast to cancer, where 41% are iv)
63 are topical
46 are inhaled or transnasal
44 are subcutaneous.
Licensed Out? 174 (30%) are shown as licensed out (a bit less than the 35% for anti-cancer drugs)
Big companies? The top 10 pharma companies (by healthcare revenues) account for 35% of the anti-infectives (versus 25% of the anti-cancer drugs in development).
Glaxo has 41 anti-infectives in development, ahead of Novartis and Merck, each with 26.
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See you at the next meeting?
· BioEurope Spring, Milan, Italy, March 14-16th ,http://www.ebdgroup.com/bes/index.php
· BIO, Washington DC, June 27-30th.
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Linda Pullan
www.PullanConsulting.com <http://www.PullanConsulting.com>
4400 Paseo Santa Rosa, Newbury Park, CA 91320
1-(805)-558-0361 lpullan@msn.com <mailto:lpullan@msn.com>