Momenta Pharma $MNTA notes on 5/2/11 Deutsche Bank presentation

• 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