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Re: iwfal post# 121495

Sunday, 06/12/2011 9:20:00 AM

Sunday, June 12, 2011 9:20:00 AM

Post# of 252864
Hospira GS call

per the Hospira guy the major biosimilar players in US would be

Hospira
Teva
Sandoz
Mylan
Weird-No mention of MNTA

I am starting to think, MNTA is trying to negotiate with Sandoz a favorable FOB partnership (prolly much better share than the 45% contractual profit?) and it is not going anywhere. and hence the long, never ending negotiations? importance of strategic alignment... and the whole talk of "to succeed in this space, big pharma needs to think differently from legacy business....he used the words "blissfully unencumbered by legacy business"

I guess what prolly has happened is all these companies are way ahead in creating processes, cell culture, cloning, clinical trials, and some of em are selling biosimilars in europe etc...But MNTA is saying you have to start applying the sameness(if u have hopes of getting interchangeabality) from the beginning and many of your biosimilars that you already have no chances of qualifying for interchangeability based on MNTA IP for demonstrating sameness. So for example, if Sandoz has EPO biosimilar in the market(they have already done clinical trials) and MNTA wants to do parntership with Sandoz on EPO(presumably MNTA is getting their characterization expertise to the table and Sandoz their process expertise), Sandoz would probably not be interested or be prepared to do a deal which gives MNTA a fair share say 40%, unless they believe
1. the FDA pathway would be very stringent on sameness criteria
2. only with interchangability product u gain tangible market-share

Also, MNTA is prolly coming in and saying, hey BTW you have to maybe even throw that EPO product away(keep in mind they have made huge investment-could even be 50m), because it does not have the SAME starting material signature as RLD - Prolly that's where the strategic mis-alignment is coming in....the "legacy business"

I don't think MNTA partners would be Mylan or Teva. Mylan has parntership with India's Biocon. Teva also has a partnership

I know in the prior CC, wheeler did say Sandoz is more europe-centric, etc....but I am sure Sandoz would want to be a major player in US.

Also, in the call I heard Hospira is doing it's own generic enoxaparin, although it appears it is still early in the game in terms of it's ANDA...Does anyone here know about it ?
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