Biotech Values

[DewDiligence]

MRK FoB organizational change signals downgrading of program—maybe:

http://invivoblog.blogspot.com/2012/04/merck-says-goodbye-to-independent.html

Merck BioVentures, the biosimilars endeavor set up by Merck & Co. in late 2008 [#msg-34365756] is being subsumed into the biologics and vaccines division of Merck Research Laboratories. Mike Kamarck, who has led BioVentures since 2010, has left the company.

Kamarck's departure is either a blow for the company's biosimilar ambitions or a reflection of reduced expectations and investment for the business. Kamarck has been for the past few years probably the most visible Big Pharma executive on the biosimilars front, and Merck has been -- at least among large, brand-focused pharma companies -- the most bullish on biosimilars' regulatory and commercial prospects.

There have been several bumps in the road. The company's first big biosimilar hopeful was a version of Amgen's Aranesp. That project was discontinued in early 2010. The company also had big plans for its biosimilar version of Enbrel, which it licensed in Phase III from Korea's Hanwha in June 2011 [#msg-64164954]. Only a few months later Amgen laid waste to those plans, announcing a 'stealth patent' that could keep Enbrel biosimilars off the market for another 15 years [#msg-69265200].

MRK’s merging its FoB program into its general biologics program may make perfect sense, however, insofar as MRK plans to bring its FoB’s to market via the conventional BLA pathway rather than the 351(k) pathway—something that was noted when the FoB program was originally announced in 2008 (#msg-34365756). Thus, I’m not convinced that the organizational change described here is as relevant as the author of the above blog thinks it is.