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Re: DewDiligence post# 116686

Wednesday, 04/06/2011 8:22:37 PM

Wednesday, April 06, 2011 8:22:37 PM

Post# of 257253
MNTA 2011-2013 News Flow

[NVS reports 1Q11 results 4/19/11; Lovenox trial starts in Feb *2013*.]


Lovenox

19-Apr-2011 (1:15am ET): NVS reports 1Q11 Lovenox sales.

4-Feb-2013: Start of NVS/MNTA’s patent-infringement suit against Teva. (Please see #msg-61591240 for the relevance of this.)


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 FDA approval.

Timing uncertain: District Court ruling on Markman hearing. This may provide early feedback on the likely outcome of the Copaxone patent trial with respect to Teva’s Orange-Book and process patents; however, it is not assured that the Judge will rule on the Markman hearing prior to the trial.

7-Sep-2011: Start of trial on validity/enforceability of Teva’s Orange-Book and process patents.


Other programs

Mid 2011: 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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