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Re: DewDiligence post# 115006

Tuesday, 02/22/2011 5:35:48 PM

Tuesday, February 22, 2011 5:35:48 PM

Post# of 257253
MNTA 2011 News Flow

[MNTA’s motion for expedited discovery in Lovenox case has been denied;
in place of the hearing on this motion that would have occurred on 3/11/11,
a hearing will occur on 3/15/11 regarding pretrial scheduling.]



Lovenox

15-Mar-2011: Court hearing on pretrial scheduling in NVS/MNTA’s patent-infringement suit against Teva.


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.

Timing uncertain: District Court ruling on the ancillary lawsuit involving Teva’s “Gad” patents relating to measurement of molecular weight.

2H11/1H12: 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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