Replies to post #107358 on Biotech Values

[DewDiligence]

Well, the cat is out of the bag. The product Teva is trying to pass off to the FDA as a generic copy of Lovenox was developed by ItalFarmaco and is manufactured by ItalFarmaco. It’s the same product Lupin sells in India under the brand name, Lupenox (#msg-56014815). Teva’s contribution is limited to FDA regulatory submissions and prospective US distribution.

As presented in #msg-55885444 and #msg-55952595, Lupenox is demonstrably different from Lovenox. The two drugs do not even have the same average molecular weight in their mixtures, which would seem to rule out the possibility that Teva’s product could satisfy the FDA requirements for sameness set forth in #msg-52582225 and in the FDA’s response to Sanofi’s Citizen Petition (http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM220083.pdf ).

Teva’s CC next Tuesday ought to be worth a listen :- )