MNTA tidbits from today’s DB webcast:
1. Craig Wheeler thinks the compromise on the exclusivity period for US FoB’s will shake out at 8-10 years. (This is less than the 14.5 years in the leading Senate bill, but much more than the zero years in Rep. Waxman’s bill in the House.)
2. Lovenox ANDA: MNTA and partner Sandoz continue to have regular discussions with the OGD group at FDA. Whatever happens, it’s certain that the apllication is not lying dormant on someone’s desk.
3. MNTA does not know anything definite about the Lovenox ANDA’s from Teva and Amphastar; however, Wheeler thinks the tealeaves suggest that Amphastar is not close to approval. If Amphastar were close, Wheeler thinks they would be more aggressive in their Washington-based lobbying because the 180-day exclusivity clock started ticking on October 2, 2008 and runs out on April 1, 2009. (The working hypothesis is that the exclusivity period is sufficiently valuable that Amphastar would not sit quietly by and let it run out if they thought they had any chance of near-term approval.)
4. There have been no recent updates to Sanofi’s Citizen Petition on generic Lovenox. Wheeler thinks Sanofi is simply out of aces.
5. MNTA’s internal research effort has largely switched over from sugars (e.g. Lovenox) and peptides (e.g. Copaxone) to glycoproteins. The emphasis is on reverse engineering the production process of biopharmaceuticals to enable MNTA to produce a fully substitutable biogenerics (as opposed to mere biosimilars). Wheeler thinks MNTA is the only company with the know-how to succeed in this endeavor.
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