Biotech Values

[DewDiligence]

MNTA 2013-2014 News Flow

[Miscellaneous changes including more detail on events in the FoB program.]


Lovenox

• Timing uncertain: Possible US Supreme Court review of the Lovenox patent suit against Amphastar, perhaps in consolidation with the Classen case. (The CAFC denied MNTA’s request for an ‘en banc’ rehearing on 11/20/12.)


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.)

• 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.)


FoB Program

• Early 2014: Start of clinical trial for M923, the first compound in the BAX-MNTA FoB collaboration (which I think is Orencia). This will trigger two milestone payments from BAX (#msg-81498217). Note: MNTA has already established proof of concept on this compound.

• Early 2014 or thereabouts: BAX decision to formally license M511, the third compound in the BAX-MNTA collaboration (which I think is Erbitux). If BAX licenses M511, MNTA will receive an up-front license fee and be eligible for additional milestone payments on this compound (#msg-81498217).

• Timing uncertain: Progress on M834, the second compound in the BAX-MTA collaboration (which I think is Humira). BAX has already licensed this product for further development.

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


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: Progress on IVIG program based on the sialic switch technology.