Biotech Values

[DewDiligence]

MNTA 2013-2014 News Flow

[5/7/13 start date of Copaxone patent appeal; M402 data release
delayed due to redesign of phase-1/2 trial to include Abraxane.]


Lovenox

• Sometime after 5/2/13: US Supreme Court decision whether to accept MNTA’s Lovenox case for review of the Appellate Court’s decision based on the Hatch-Waxman Safe Harbor. (Amphastar, the defendant in this action, has until 5/2/13 to submit a brief to the USSC.)


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 the 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. An FDA tentative approval is highly consequential for MNTA investors because it will: i) re-validate MNTA’s technical prowess in replicating complex drugs; and ii) 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).

• 7-May-2013: Oral arguments in appeal of the District Court’s ruling in Copaxone patent case. The Appellate Court’s ruling on the appeal is expected in late 2013. (See #msg-85870008 for musings on why a reversal by the Appellate Court is more likely than some investors probably think.)

• Timing uncertain: FDA action on Mylan’s Copaxone ANDA. The same restrictions on a final FDA approval described in the bullet item above apply to MYL’s Copaxone ANDA. (Note: MYL’s Copaxone ANDA was accepted for FDA review about 14 months after NVS/MNTA’s ANDA.)


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

1H14: M402 data (safety, tolerability, efficacy to determine dose(s) for further study) from first portion of phase-1/2 trial in pancreatic cancer. The timing of this data report has been pushed back due to a redesign of the trial to include Abraxane. (M402 is MNTA’s proprietary heparin-based cancer drug.)

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