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Re: DewDiligence post# 115677

Sunday, 03/06/2011 3:18:51 PM

Sunday, March 06, 2011 3:18:51 PM

Post# of 257579
MNTA 2011-2012 News Flow

[Updates:
discovery in Lovenox patent-infringement suit runs until Nov 2012;
removed entry for Copaxone ‘Gad’ lawsuit because it is now moot.]



Lovenox

Nov 2012: End of pretrial discovery in NVS/MNTA’s patent-infringement suit against Teva. (The earliest possible trial is in 2013.)


Copaxone

Soon: 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.

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


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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