• 27-Jan-2011: NVS’ 4Q10 financial results and conference call, where NVS will report 4Q10 sales of generic Lovenox.
• Early 2011: Teva’s written response to MNTA’s patent-infringement suit.
• 2-Feb-2011: FDA’s written response to legal complaint by Amphastar. This may provide insights as to how far removed from approval the Lovenox ANDAs from Teva and Amphastar are.
• 8-Feb-2011: Teva’s 4Q10 conference call, where investors may hear an update on the status of Teva’s Lovenox ANDA. (See #msg-58660381 for related survey.)
• 9-Feb 2011: MNTA’s 4Q10 financial results and conference call, where investors will learn MNTA’s cash flow from Lovenox and get development updates on the other programs.
• 9-Feb-2011: SNY’s 4Q10 financial results and conference call, where SNY may comment on the Lovenox market and the status of its lawsuit vs the FDA.
Copaxone
• Timing uncertain: FDA feedback on Copaxone ANDA. MNTA would presumably disclose these details only if they were deemed to have a material affect on the probability or timing of eventual FDA approval.
• 19-Jan-2011: US District Court hears oral arguments for Teva’s patent suit against Mylan (which has been consolidated with Teva’s suit against NVS/MNTA).
• Timing uncertain (before start of Copaxone trial): District Court ruling on Markman (claims construction) hearing. This will provide early feedback on the probable outcome of the Copaxone patent trial.
• Probably 1H11: Start of trial on validity/enforceability of Teva’s Copaxone patents.
Other programs
• 1H11: IND filing for M402, MNTA’s proprietary heparin-based cancer drug, followed by the start of a phase-1 trial.
• Timing uncertain: Announcement(s) regarding MNTA’s progress on its FoB programs.
• Timing and occurrence uncertain: M118 partnership. (Phase-2b/3 trials in ACS are sufficiently large and expensive that MNTA will not conduct such trials without a partner.)
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