• Next month or so: NVS/MNTA request for US Supreme Court review of the Lovenox patent suit against Amphastar. (If accepted for review, the case will attract interest from the drug/biotech industry as a whole due to the Safe Harbor provision of the Hatch-Waxman act.)
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).
• 2Q13: Oral arguments in appeal of the District Court’s ruling in Copaxone patent case. The Court’s ruling on the appeal is expected in late 2013.
• 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.)
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.
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