Replies to post #114330 on Biotech Values

[DewDiligence]

MNTA 2011 News Flow

[Updated with info from 4Q10 CC.]


Lovenox

• Timing uncertain: Update from the District Court on NVS/MNTA’s patent-infringement suit against Teva.

• Feb-Mar 2011: Redacted documents from Amphastar’s lawsuit against the FDA. The language that is not redacted may provide some insight regarding the deficiencies in the Teva and Amphastar ANDAs.


Copaxone

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

• Timing uncertain, probably 2H11: 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

• 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.)