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Re: DewDiligence post# 112302

Sunday, 02/06/2011 3:45:51 PM

Sunday, February 06, 2011 3:45:51 PM

Post# of 257253
MNTA 2011 News Flow

[Miscellaneous updates.]


Lovenox

8-Feb-2011: Teva’s 4Q10 conference call, where investors may get some info on when Teva plans to respond to the FDA’s list of questions about Teva’s Lovenox ANDA.

9-Feb-2011: SNY’s 4Q10 financial results and conference call, where SNY will report US Lovenox sales and may provide some color on the state of the US Lovenox market.

10-Feb 2011: MNTA’s 4Q10 financial results and conference call, where investors will learn MNTA’s cash flow from Lovenox and get updates on MNTA’s drug-development programs.

Soon: 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.


Copaxone

Soon: District Court ruling on Markman hearing. This will provide early feedback on the probable outcome of the Copaxone patent trial.

Timing uncertain: Start of trial on validity/enforceability of Teva’s Copaxone patents.

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.


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: Announcements regarding MNTA’s 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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