Biotech Values

[DewDiligence]

MNTA 2010-2011 Possible/Probable News Flow

[Added entry for Copaxone Markman hearing;
reorganized entries for improved clarity.]


Lovenox

At any time: FDA decision on MNTA/NVS ANDA. ANDA’s do not have formal timelines, so no one outside the FDA knows when a decision is coming. What we do know is that the FDA has inspected the physical facilities MNTA in the supply chain and MNTA/NVS believe they have given the FDA everything the FDA needs to approve the ANDA. If approved, generic Lovenox can be launched immediately because all patent-related issues have been resolved.


Copaxone

20-Jan-2010: Markman pre-trial hearing in the Teva lawsuit against MNTA/NVS. This is the point in the litigation where the court irons out the meaning of the relevant patent claims.

Feb 2011: Expiration of 30-month stay on FDA approval of MNTA/NVS’ Copaxone ANDA. Unless there’s a final non-appealable judgment in the patent case before this date (possible but unlikely, IMO), this is the soonest that MNTA/NVS could launch their generic. Before Feb 2011, the FDA could take other actions including tentative approval, rejection, or a request for more information.


M118

1H10: Partnership deal followed by start of one or more phase-2b trials.


Other

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

Timing unknown: New FoB partnership(s) and/or progress on existing FoB partnership with NVS.