Biotech Values

[DewDiligence]

MNTA 2009-2010 Possible/Probable News Flow

[Updated for disclosures on yesterday’s BIO-CEO webcast.]


2009: FDA action on Lovenox ANDA. (Neither NVS nor MNTA is willing to be more precise than “2009.” After FDA approval, generic Lovenox be launched at any time starting 4/1/09 when Amphastar’s 180-day first-filer exclusivity expires.)

2009: Progress (perhaps an IND filing) on proprietary heparin-based cancer program.

Mid 2009: Report M118 phase-2a data in PCI/stable angina.

2H09 (after reporting of the phase-2a data): Ink partnership deal for M118 and start phase-2b trial in ACS.

2010 (?): Possible announcements re FoB programs with partners other than NVS.

2010-2011: FDA action on Copaxone ANDA. There is no formal review schedule. Although the FDA is barred from granting final approval of the ANDA before the statutory 30-month stay expires in early 2011, the FDA is allowed to take other actions during this period including tentative approval, non-approval, or a request for more information.