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1. Company made the following comment on question on any speculation in potential settlement with Amphastar/lovenox or Teva/Copaxone. Made the distinction in settlement cases(and economic motives of the 2 parties) that typically happen in the marketplace and the lovenox case...most settlements are on patent infringement cases at the tail end of patent expiry period. Here it is different, MNTA's characterization patent is expiring in 2024 or something.So, the underlying implication, if legal case for MNTA is solid, the economic incentive has to be substantively better for MNTA to settle with Amphastar than typical infringement settlements. Here is my speculation: I think from a timing perspective, it is more likely for a potential settlement in Copaxone(patents run to 2014/2015 here) case...both parties know their legal cases(trial has run its course), and may want to de-risk from an unfavorable judgement. Could it be no generic launch until q1-2013?
2. Dr Venkatraman talked in general about characterization of Lovenox and how it compares with Copaxone.
3. Question went somewhat like this: Why are you doing interchangeable FOB instead of bio-similar like how large companies(Eg: Hospira,Teva,etc) are pursuing ?
a. Full characterization reduces clinical studies (Full Phase 1 & Full Phase 3 are required for biosimilar) and hence reduce duration of development & cost
b. MNTA believes Interchangeability is key to market share
4. Broad-based FOB partnership likely in 2012