Biotech Values

[DewDiligence]

MNTA 2009-2010 Possible/Probable News Flow

[Retitled for the new calendar year—no substantive changes.]


1Q09: Expected FDA action on Lovenox ANDA.

2Q09: US launch of generic Lovenox. Assuming FDA approval, the launch can occur at any time after 4/1/09, the date when Amphastar’s 180-day first-filer exclusivity expires.

2Q09: Report M118 phase-2a data in PCI/stable angina.

Mid 2009 (any time after the reporting of the phase-2a data):
Ink partnership deal for M118.

2H09 (any time after inking partnership deal):
Start M118 phase-2b trial in ACS.

2009-2010: Possible announcements re FoB programs with partners other than NVS.

2009-2010: Possible 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.