• Timing uncertain: 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 supply chain and NVS is ready to launch immediately upon FDA approval.
Copaxone
• Any day: 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). There’s an outside chance that the judge will issue a summary dismissal of Teva’s lawsuit, rendering the Copaxone patents in question unenforceable.
• Timing uncertain: FDA feedback on the Copaxone ANDA. MNTA would presumably disclose the details of the FDA feedback only if it were deemed to have a material affect on the probability of eventual approval.
• Feb 2011: Expiration of 30-month Hatch-Waxman stay on FDA approval of NVS/MNTA’s Copaxone ANDA. Unless there’s a final non-appealable judgment in the patent case before this date, Feb 2011 is the soonest MNTA/NVS could obtain final FDA approval for Copaxone generic.
M118
• Timing uncertain: 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 FDA approval of its Lovenox ANDA (#msg-44370052).
Other programs
• 1H11: IND filing for M402, MNTA’s proprietary heparin-based cancer drug, followed by the start of a phase-1 trial.
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