Biotech Values

[DewDiligence]

MNTA 2012-2014 News Flow

[Modified entry re FDA approval of Copaxone ANDA pursuant
to court order enjoining FDA from issuing a final approval.]


Lovenox

• 2-Aug-2012: MNTA reports 2Q12 results and holds quarterly CC, which will provide info on 2Q12 Lovenox royalties and anticipated cash usage in future quarters.

• Any day: Memorandum from Appellate Court on the reasons for staying the preliminary injunction on 1/24/12, which could have some bearing on handicapping of the Lovenox patent case per se.

• 7-Jan-2013: Start of Lovenox patent-infringement trial against Amphastar/WPI. (If Teva were to get FDA approval for generic Lovenox before Oct 2012, NVS/MNTA’s patent suit against Teva, which is scheduled to start in Feb 2013, might be consolidated by the District Court with NVS/MNTA’s suit against Amphastar/WPI.) The trial was originally scheduled to start in Oct 2012, but the date was pushed back to allow more time for discovery (#msg-76654547).


Copaxone

• Timing uncertain: FDA action on NVS/MNTA’s Copaxone ANDA. Although the FDA is now barred by court order from issuing a final approval of NVS/MNTA’s ANDA before May 2014 (unless there’s a settlement or reversal of the District Court ruling on appeal), the FDA can issue a so-called tentative approval, which will allow NVS/MNTA to launch their product upon the expiration of Teva’s patents. Inasmuch as NVS/MNTA had previously decided not to launch generic Copaxone “at risk,” an FDA tentative approval is just as consequential for MNTA investors as a final approval. A tentative approval will re-validate MNTA’s technical prowess in replicating complex drugs and guarantee that generic Copaxone can be launched at the expiration of Teva’s patents (or sooner in the event of a settlement or reversal of the District Court on appeal).

• Timing uncertain: FDA action on Mylan’s Copaxone ANDA. The same restrictions on a final FDA approval described in the above bullet item apply to MYL’s Copaxone ANDA. (Note: MYL’s Copaxone ANDA was accepted for FDA review about 14 months after NVS/MNTA’s ANDA.)

• Timing uncertain—probably 2H13: Completion of the appeal of the District Court’s ruling in the Copaxone patent case.


Other programs

• 1H13: M402 data (safety, tolerability, efficacy to determine dose(s) for further study) from first portion of phase-1/2 trial in pancreatic cancer. (M402 is MNTA’s proprietary heparin-based cancer drug.)

• Timing uncertain (probably late 2013 or 2014): Announcement of identities of the first two FoB’s in MNTA’s partnership with BAX.