Biotech Values

[DewDiligence]

MNTA 2010-2011 Possible/Probable News Flow

[Updated for Copaxone Markman hearing that took place today.]


Lovenox

At any time: FDA decision on the 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 the physical facilities in the supply chain and MNTA/NVS believe they have given the FDA everything the FDA needs to approve the ANDA. If approved, generic Lovenox can be launched immediately because all patent-related issues have been resolved.


Copaxone

Mar/Apr 2010: 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 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 this unless the feedback was tantamount to a rejection.)


M118

1H10: M118 partnership deal followed by start of one or more phase-2b trials. (Phase-2b trials in ACS are sufficiently large and expensive that I can’t see MNTA running one on its own dime: #msg-44370052.)


Other

Timing unknown: 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.)