Biotech Values

[DewDiligence]

MNTA 2011 News Flow

[Copaxone trial starts 7-Sep-2011.]


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.

• 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.)