Biotech Values

[DewDiligence]

MNTA 2010-2011 Possible/Probable News Flow

[Updated for today’s 4Q09 CC.]


Lovenox

At any time: FDA decision on Lovenox ANDA. ANDA’s do not have formal timelines, so no one outside the FDA knows when a decision is coming. What we do know is that the FDA has inspected and cleared all of the physical facilities in NVS/MNTA’s Lovenox supply chain and NVS is ready to launch immediately upon approval of the ANDA.


Copaxone

1H10: Claims construction ruling by the court pursuant to the Markman pre-trial hearing in Teva’s lawsuit against MNTA/NVS. This is the point in the litigation where the court irons out the meaning of the relevant patent claims prior to commencement of the actual trial. The Markman hearing occurred on 1/20/10 and it apparently went well for MNTA (#msg-45710295).

Feb 2011: Expiration of 30-month Hatch-Waxman stay on FDA approval of the Copaxone ANDA. Unless there’s a final non-appealable judgment in the patent case before this date (possible but unlikely, IMO), Feb 2011 is the soonest that MNTA/NVS could launch their generic. (Although the FDA could conceivably provide feedback on the Copaxone ANDA before Feb 2011, MNTA probably wouldn’t disclose such feedback unless it were tantamount to a rejection.)


M118

Timing unknown: M118 partnership deal followed by start of one or more phase-2b trials. (Phase-2b trials in ACS are sufficiently large and expensive that MNTA will not conduct such trials on its own prior to approval of the Lovenox ANDA—also see #msg-44370052.)


Other

1H11: IND filing for M402, MNTA’s proprietary heparin-based cancer drug.

Timing unknown: FoB partnership. (The likelihood and timing of this depend on what the US Congress does vis-à-vis FoB legislation.)