Replies to post #99136 on Biotech Values

[DewDiligence]

MNTA 2010-2011 Possible/Probable News Flow

[Updated for FDA approval of generic Lovenox.]


Lovenox

29-Jul-2010: SNY’s 2Q10 conference call, where executives may give an indication vis-à-vis the likelihood (or lack thereof) that SNY will launch an authorized generic.

5-Aug-2010: MNTA’s 2Q10 conference call, which may include information about the pricing of generic Lovenox and other details of the product launch.

21-Oct-2010: NVS’ 3Q10 conference call, where executives will presumably comment on the first two months of generic-Lovenox sales and update guidance for overall sales by the Sandoz division. (The latter will allow investors to make a rough forecast of generic-Lovenox sales even if NVS does not furnish such a forecast directly.)


Copaxone

• Any day: Claims-construction ruling by the US District Court pursuant to the Markman pre-trial hearing in Teva’s lawsuit against MNTA/NVS. This is the point in the litigation where the court irons out the meaning of the relevant patent claims prior to commencement of the actual trial. The Markman hearing occurred on 1/20/10 and it apparently went well for MNTA (#msg-45710295). There’s an outside chance the judge will issue a summary dismissal of Teva’s lawsuit, rendering the Copaxone patents in question unenforceable.

• Timing uncertain: FDA feedback on the 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.

• Feb 2011: Expiration of 30-month Hatch-Waxman stay pertaining to NVS/MNTA’s Copaxone ANDA. Unless there’s a non-appealable judgment in the patent case before this date, Feb 2011 is the soonest MNTA/NVS could obtain final FDA approval to market generic Copaxone.


M118

• Timing uncertain: M118 partnership followed by start of phase-2b trials. Phase-2b trials in ACS are sufficiently large and expensive that MNTA will not conduct such trials on its own prior to FDA approval of its Lovenox ANDA (#msg-44370052).


Other programs

• 1H11: IND filing for M402, MNTA’s proprietary heparin-based cancer drug, followed by the start of a phase-1 trial.

• Timing uncertain: Additional FoB partnership(s).