- See Upcoming Events page for link to webcast
- NVS/MNTA generic lovenox currently has 45-50% market share...largest injectable generic launch ever...continue to tweak supply chain but that is still the limiting factor in their enoxaparin market share
- Expect continued $800m-$1b annual run rate as long as sole generic
- Generic lovenox has been widely accepted all settings, hospital and retail
- "not happy" w/ copaxone review timeline...avg genric timeline was 15 months when lovenox was filed, 22 months when copaxone was filed, 26 months now
- At first we worried about delays, but now have positive view of court case consolidation w/ mylan
- Expect Teva's 3rd CP to be rejected just like the first two - expect response by FDA this summer (supposed to respond w/in 6 months)
- Question about Copaxone settlement with Teva: Wheeler said there was an opportunity for settlement, just like any large dollar value generic case. But no comment on if they have held any dicussions
- Question about "secret russian Copaxone trials": Wheeler said that MNTA would only disclose trials if outside standard generic pathway (ie, efficacy rather than healthy volunteer/bioequivalence studies)
- Believe there are assays that can give indication of Copaxone biological activity
- Needs from Follow On Biologics (FOBs) partner- large scale manuf and commercial infrastructure. But most importantly, must be aligned in all aspects--scientific, legal (offense and defense), regulatory, clinical (confirmatory vs evidence), belief that core issue is analytics of the biologic and can go after substitutible
- MNTA is confident in their ability to fully characterize any biologic, the process development side is the harder part
- Which FOB to try for first? Need to pick one that is hard enough to show differentiation of MNTA technology w/o causing too much data and political risk in approval process. plus of course consider patent expiration timelines.
- hope for FOB deal 2011 but not crititcal
- need partner to move m118 forward, out actively looking
I agree with Wheeler that the Copaxone timeline is getting ridiculous. The whole ANDA system is a mess and a waste of time. They should be charging fees for generic reviews.
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