Biotech Values

[DewDiligence]

MNTA 2012-2014 News Flow

[Removed obsolete entries and added
clarification re Lovenox patent trial.]


Lovenox

• 7-Jan-2013: Start of Lovenox patent-infringement trial against Amphastar/WPI. In the aftermath of the 8/3/12 ruling by the Appellate Court (#msg-78175269), there is some question as to whether the Lovenox patent trial will go forward; however, the Appellate Court did not order the District Court to abandon the trial.

• 4-Feb-2013: Start of Lovenox patent-infringement trial against Teva. (In the unlikely event that Teva were to get FDA approval for generic Lovenox before the patent trial against Amphastar/WPI begins, the Court would likely merge the two cases.)


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 late 2013/early 2014: Completion of the appeal of the District Court’s ruling in the Copaxone patent case. (If the Appellate Court were to reverse the District Court and find in favor of NVS/MNTA, a tentative FDA approval of NVS/MNTA’s Copaxone ANDA would be converted to a final approval.)


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 one or more of the first three FoB’s in MNTA’s partnership with BAX. (I’ve guessed they are Humira, Orencia, and Erbitux.)