Biotech Values

[DewDiligence]

MNTA 2009-2010 Possible/Probable News Flow

[Updated for release of M118 phase-2 data.]


2H09: FDA action on Lovenox ANDA. (ANDA’s do not have formal timelines, and hence an FDA decision could come at any time.) If approved, generic Lovenox can be launched immediately because all patent-related issues have been resolved.

2H09: Partnership deal for M118. (This partnership could not be consummated until MNTA reported the top-line M118 data from the phase-2 EMINENCE study, which occurred on 6/29/09.)

2H09 (following partnership deal): Start one or more phase-2b trials for M118.

2009-2010: IND filing for M402, MNTA’s proprietary heparin-based cancer drug.

2009-2010: Possible announcements of new FoB partnerships or progress on existing FoB partnership with NVS.

2010-2011: FDA action on Copaxone ANDA. Although the FDA is barred from granting final approval of the ANDA before the statutory 30-month stay expires in Feb 2011, the FDA is allowed to take other actions during this period including tentative approval, non-approval, or a request for more information.