Replies to post #107760 on Biotech Values

[DewDiligence]

MNTA 2011 News Flow

[Miscellaneous updates including court dates for oral arguments on
Teva-Mylan suit and the FDA’s response to complaint by Amphastar.]


Lovenox

• 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.

• Feb 2011 (exact date TBD): MNTA’s 4Q10 financial results and conference call, where investors will get a read on MNTA’s cash flow from Lovenox.


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. (Note: effective 1/11/11, the Hatch-Waxman 30-month stay on final FDA approval of NVS/MNTA’s Copaxone ANDA expires; starting on that date, the FDA can issue a final approval of the ANDA as it sees fit.)

• 12-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.)