Biotech Business Development Consulting

www.pullanconsulting.com and www.lindapullan.com

email:  lpullan@msn.com  805-558-0361

Issue #39, September 2009

Pullan's Pieces

Commentary on Science & Business of Drug Development

Part of a fun panel at Foley’s 2009 Life Science Conference (La Jolla, CA, Sept 30th)

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Look out for deal analysis in Foley Life Science Newsletter

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David Charapp and Rick Kaufman of Foley & Lardner LLP and I have analyzed the Daiichi Arqule c-met inhibitor licensing deal.  We hope that deal analyses will be a periodic feature of the Foley Life Science newsletter.  To sign up, go to http://www.foley.com/publications/newsletters.aspx.  Click on “newsletter sign up” and select the Life Science letter. 

For some sense of what is to come, check out my older analysis of the Immunomedics Nycomed deal in Pullan’s Pieces #35 on www.pullanconsulting.com. 

Market exclusivity for the leader in a new class of drugs is shorter than ever

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The Tufts Center for the Study of Drug Development has long provided real data on how our industry has performed (often published under DiMasi et al).  Now they report that in the 2000-2003 period, the first drug of a new mechanistic class had an average of only 2.5 years of marketing exclusivity before the 2nd drug entered the market, down from 10.2 years in the early 1970’s.  And the 3rd drug of the same class came only 1.1 years later. 

The 2nd and 3rd drugs were not intentionally developed to be “me-toos”.  Drug development is a competitive race to market built upon common early research publications. Work on what turn out to be follow-on drugs begins before there is clinical validation by the leader.  Indeed, about half of what turn out to be follow-on drugs actually had patent filing dates before the first to launch in the class.   http://www.marketwire.com/press-release/Tufts-Center-For-The-Study-Of-Drug-Development-1041820.html

Personalized medicine shocker:  Failure to test for Her2 in breast cancer

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When we talk about biomarkers and companion diagnostics, we all mention Herceptin as one of the first demonstrations of the potential power of personalized medicine.  The Genentech (now Roche) breast cancer antibody Herceptin (approved in the US in 1998) is recommended for patients who are positive for overexpression or gene amplification of the HER2 gene that makes the target of the antibody.  Without the diagnostic for overexpression or gene amplification of the target to enable selection of the appropriate patients, the efficacy of the drug would likely not have been enough to get approved.   The small molecule kinase inhibitor Tykerb is also recommended for HER2 positive breast cancer. 

Now we learn from the Sept 14th New York Times reporting on an article from Cancer (http://www3.interscience.wiley.com/journal/122596162/abstract ), that up to two-thirds of women with invasive breast cancer had no documentation of having undergone testing for abnormalities on the HER2 gene. Also reported was that about 1 in 5 tests for HER2 done by local laboratories are inaccurate when compared with larger laboratory results on the same tissue. About 20% of women with breast cancer have gene amplification and overexpression of HER2 and have a more aggressive and difficult to treat form of breast cancer. Without the test, presumably women who would benefit are being denied an efficacious drug, and others who won’t likely benefit are being exposed to the drug’s toxicity. 

I would guess there would be greater use a companion diagnostic for a drug in cancer than for other diseases given the severity of cancer and the constant experimentation of oncology treatments.  Is the use of other diagnostics even worse? 

How much delay is there for launch of new drugs in Japan?

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Frequently, we model the value of deals and include milestones for approval in Japan.  Recently, I examined what gap we should use between the US launch and a Japanese launch.  Taking the PharmaProjects list of the 26 products launched in Japan in 2008 and 2009, the average launch in Japan was 6 years behind that of the US, with the range being from 1 to 16.  The shortest lag was for Merck's HIV drug, launched in 2007 in the US, and 2008 in Japan.  Pfizer had a cancer kinase inhibitor and Chantix for smoking cessation with launches in 2006 in the US and 2008 in Japan.  GSK and Nippon Shinyaku had a 2 year difference for a kinase inhibitor in cancer launched in Japan in 2009.  The 15 and 16 year lags were both from Sanofi and were a thrombin product and an infection vaccine.  Presumably, my analysis is slightly biased because I did not take any examples launched in the US and still not launched in Japan, but clearly, it is still very challenging to launch a new drug in Japan “simultaneously” with the US. 

Client News:  A Deal for ImmmunoCellular Therapeutics and Roche

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I’m delighted to have a client signing another deal, this time for a preclinical antibody from Immunocellular Therapeutics is now licensed to Roche.    Check out the news release at http://imuc.com/press/Sept0909-ImmunoCellular-Therapeutics-Enters-into-Research-and-License-Option-Agreement-with-Roche-Group.html .  It was fun to help make this one happen. 

Special offer on useful book: Biopreneurs: The Molecular Millionaires

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Dr.  Ryan Baidya and Miyuki Shitratani have written a useful, accessible guide to biobusiness, and they are offering readers of Pullan’s Pieces a special 10% off.  

Biopreneurs: The Molecular Millionaires is a how-to guide to starting biotech businesses.  If you want an overview of pharmaceutical drug development from preclinical studies to the basics of the regulatory process, this is a good place to start.  If you want an introduction on funding, from business plan to the roles and expectations of angels and VCS, that is here too. A useful light discussion of PR is included.  There are many good figures and tables (e.g., listings of typical studies for drugs in preclinical, the percentage of drug failures for efficacy and safety, who provides various stages of funding).  I would have liked links or citations to original resources; there is an overall statement that much came from Wikipedia.  But very clear examples, such as the calculation of the investor’s return and its relationship to pre and post-money valuation, are to be commended.  I learned some things from this easy read and think you probably would, too.  

If you would like to get a copy, use the code 78510 on the website www.ctuniv.org/affiliate.htm  for your 10% discount.   You will be termed an Affiliate and you can enter the code after you enter your credit card information to get your discount.   

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How can I help you?  

I offer help with all the aspects of partnering for therapeutics, from shaping a message or a presentation, to making contacts, to evaluation and valuation of product candidates, to negotiations. I can represent you at partnering meetings.  I can help with searches of pipeline databases for competition, sizes of clinical trials, or potential partners.  I can help you find deal comparables and help estimate or model deal values.  I have a great list of business development contacts.  You do not need to pay a minimum or a retainer, just use what you need when you need it.  Let’s chat and see if there is a fit.

Pullan Consulting

Linda M. Pullan, Ph.D.

Biotech Business Development

www.pullanconsulting.com and www.lindapullan.com

e-mail: lpullan@msn.com

805-558-0361

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