Biotech Values

[DewDiligence]

MNTA 2008-2009 News Flow

[Added clarification and elaboration.]


3Q08: Resubmit Lovenox ANDA with immunogenicity info requested by FDA.

2H08: Present M118 phase-2a data in stable angina at a medical conference (probably ASH in Dec 2008).

2H08: Start M118 phase-2b trial in PCI.

Late 2008/early 2009: Probable FDA action on Lovenox ANDA (assuming resubmission of ANDA in 3Q08).

Late 2008/early 2009: Partnership deal for M118.

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

2009-2010: Possible FDA action on Copaxone ANDA. There is no formal review schedule and the first action taken by the FDA could be a request for more information (as was the case with the Lovenox ANDA). Although the FDA is barred from granting final approval of the ANDA before the statutory 30-month stay expires in June 2010, the FDA is allowed to take other actions during this period including tentative approval, rejection, or a request for more information. (The 30-month stay could be overridden if MNTA/Sandoz prevailed against Teva in a patent trial.)