Replies to post #109489 on Biotech Values

[DewDiligence]

Craig Wheeler on MNTA’s 2Q10 CC (http://ir.momentapharma.com/eventdetail.cfm?eventid=83924 , about ¼ of the way through the webcast)*:

I will comment on the implications of the FDA's response to Sanofi-aventis’ Citizen Petition. As I said on our approval call [i.e. the CC on 7/23/10], we are very pleased with the high standards that the FDA has set for approving the generic version of Lovenox. They have outlined five criteria they used for the approval: first, equivalence of chemical properties; second, equivalence of heparin source material and the mode of depolymerization; third, equivalence in disaccharide building blocks, fragment mapping, and sequence of all disaccharide species; fourth, equivalence in biological and biochemical assays; and finally, equivalence of the in vivo pharmacodynamic profile.

…We have developed an extensive set of unique analytic tools that have allowed us to meet the FDA’s standards for assuring sameness, and we believe many of our insights were taken into consideration by the FDA as they established their equivalence standards.

While it is possible others could develop tools to meet these criteria, the technical depth required should not be underestimated.

*This is my own transcript from the conference call; the transcript from Seeking Alpha (http://seekingalpha.com/article/218116-momenta-pharmaceuticals-inc-q2-2010-earnings-call-transcript ) contains several errors.