Biotech Values

[DewDiligence]

MNTA 2012-2014 News Flow

[District Court ruled in favor of Teva in Copaxone patent case—new
entry for appeal; additional color re FDA approval of Copaxone ANDAs
from NVS/MNTA and from MYL. ]


Lovenox

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

• 19-Jul-2012: NVS reports 2Q12 Lovenox sales.

• 7-Jan-2013: Start of Lovenox patent-infringement trial against Amphastar/WPI in the District Court. (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 NVS/MNTA have decided not to launch “at risk,” FDA approval is still consequential for MNTA investors for the reasons mentioned in the penultimate paragraph of #msg-76905854.

• Timing uncertain: FDA action on Mylan’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.