What is going on with the Markman hearing of Copaxone? What do you think are the chances that Teva's patents will become invalid? If yes, when do you think this will happen? To the best of my understanding there is a process patent of Copaxone that will expire in the US only in September 2015 instead of May 2014. Do you know if Momenta has another process for making Copaxone than Teva's? Thanks
[Removed obsolete entries; added color to entry on NVS’ 3Q10 CC.]
Lovenox
17-Aug-2010: Hearing in US District Court on SNY’s ‘Hail Mary’ request for a preliminary injunction against NVS/MNTA’s generic Lovenox. The Court denied SNY’s request for a temporary restraining order on 7/26/10 (#msg-52672381).
21-Oct-2010: NVS’ 3Q10 financial results PR and conference call. On the CC, NVS executives will presumably comment on the first two months of generic-Lovenox sales and may update 2010 sales guidance for the parent company based on incremental sales by the Sandoz division from generic Lovenox. NVS’ updated sales guidance, in conjunction with other clues that have been discussed on iHub, may allow investors to make a more accurate projection of the run rate for NVS’ 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.
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