Replies to post #114483 on Biotech Values

[jbog]

Dew,

I noticed that Sandoz was taking pre-orders for enoxaparin a full 6 months prior to approval. Were we aware of that or is that hush-hush normally?

[DewDiligence]

MNTA 2011 News Flow

[Miscellaneous updates pertaining to litigation.]


Lovenox

• 11-Mar-2011: Hearing in US District Court on NVS/MNTA’s request for expedited discovery in patent-infringement suit against Teva. A proposed pre-trial schedule is due from the parties by 3/4/11.


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.)