Biotech Values

[DewDiligence]

MNTA 2008-2009 News Flow

[Updated for submission of response to FDA on Lovenox ANDA.]


1Q09: Expected FDA action on Lovenox ANDA.

2Q09: US launch of generic Lovenox (assuming FDA approval). The launch can occur when Amphastar’s 180-day first-filer exclusivity expires. (Now that there has been a final, non-appealable ruling invalidating SNY’s US Lovenox patent, the 180-day clock begins as soon as the ruling has formally been filed, which will occur in a few days.)

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

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

2H09: Start M118 phase-2b trial in ACS.

2008-2009: Announcements re follow-on biologics programs.

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, the FDA is allowed to take other actions during this period including tentative approval, non-approval, or a request for more information.