Biotech Values

[DewDiligence]

MNTA – This is what Jeff George, CEO of Sandoz, said about Lovenox on NVS’ 4Q08 CC today:

April 1 is day 181—after Amphastar’s 180-day exclusivity expires. Every day that passes, frankly, is good news for Sandoz in that Amphastar has not launched since they don’t have US approval.

The two other factors associated with [Sandoz’s] launch are the Citizen Petition from Sanofi, and we’re still waiting from the FDA for a response on that, and the heparin supply from China. Two of the four heparin suppliers we use have been cleared and we’re still waiting for the compliance audits from the others.

We may presume that the FDA will respond to Sanofi’s CP concurrently with approval of the first ANDA(s).