MNTA - Summary of Deutsche Bank presentation on 5/2/11
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 discussions.
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 critical.
Need partner to move m118 forward, out actively looking
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