Replies to post #115677 on Biotech Values

[go seek]

DD... You need to add this bullet under the Lovenox heading

Never: Teva's enoxaparin approved

[pollyvonwog]

Once the trial starts, What is the usual timeframe is for the ultimate ruling? TIA

[DewDiligence]

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.)