Biotech Values

[DewDiligence]

MNTA – Generic Lovenox in the EU:

While perusing SNY’s Form 20-F filing (similar to a 10-K), I found the expiration dates in the various EU countries for the composition-of-matter patents on Lovenox:

• Germany, UK, Italy, and all EU countries not listed here: Jun 2011;

• France: Jun 2010;

• Spain, Portugal, Finland, Norway, Greece, Eastern European countries: already expired.

Annualized Lovenox sales in Europe during 4Q08 were approximately $1.2B (#msg-35570519).

The generic-Lovenox program in the EU falls under the 2006 collaboration between NVS and MNTA (#msg-12222305), which is separate from the companies’ 2003 collaboration to develop generic Lovenox in the US.

NVS and MNTA have not disclosed when they plan to file an application for generic Lovenox in the EU. Inasmuch as Lovenox’s period of EU data exclusivity (which is separate from EU patent protection) has long since expired, an application for generic Lovenox may be filed at any time. In all likelihood, a patent challenge will not be needed because the Lovenox composition-of-matter patent in all EU countries will have expired by the time the necessary clinical studies can be completed for the EMEA to render a decision.