Biotech Values

[DewDiligence]

MNTA 2012-2014 News Flow

[Miscellaneous updates.]


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. (Although highly unlikely, the Appellate Court could conceivably reinstate the injunction insofar as the Court’s prior ruling was merely a stay of the injunction pending the appeal.)

• Oct 2012: 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.)


Copaxone

• Timing uncertain—2Q12 likely: District Court ruling on the Copaxone patent trial. (Both Teva and MNTA have said that a ruling in 2Q12 is likely, but no one actually knows.)

• Timing uncertain: FDA action on NVS/MNTA’s Copaxone ANDA.

• Timing uncertain: FDA action on Mylan’s Copaxone ANDA.


Other programs

• 2012: IND filing for M402, MNTA’s proprietary heparin-based cancer drug, followed by the start of a phase-1 trial.

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