Biotech Values

[DewDiligence]

MNTA 2012-2014 News Flow

[Request for en banc rehearing in Lovenox case has been filed.]


Lovenox

• Soon: Decision by Appellate Court on whether to grant an en banc rehearing with respect to the Jan 2012 Order to lift the preliminary injunction against Amphastar/WPI. (MNTA confirmed on the recent Stifel webcast that it has formally requested the en banc rehearing. Review by the US Supreme Court is also possible due to the wide applicability of the Hatch-Waxman “safe harbor” issue at the heart of the case.)


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 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 as consequential for MNTA investors as a final approval; it 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.)

• Timing uncertain: Selection of the fourth, fifth, or sixth FoB compound to be developed in the BAX-MNTA collaboration.