Teva nears generic Lovenox approval. An FDA letter requesting details implies that its review is almost complete.
Category: BioValleyThe day when Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) will be allowed to market its generic version of anticoagulant Lovenox is nearing. The company yesterday received a US Food and Drug Administration (FDA) Minor Deficiency letter, requesting its responses to questions from the review process. The letter indicates that the FDA has nearly completed its review of Teva's Abbreviated New Drug Application (ANDA).
Lovenox, made by Sanofi Aventis SA (NYSE: SNY; Euronext: SAN) has $4 billion in annual sales.
In June, the FDA unexpectedly allowed Momenta and Sandoz to market generic Lovenox, which is considered difficult to replicate. The announcement sent Teva's share price tumbling, because investors feared that the Lovenox approval implied that the FDA would expedite a similar approval for generic versions of Teva's multiple sclerosis treatment, Copaxone, which is also considered difficult to replicate. Momenta and Sandoz marked over $300 million in generic Lovenox sales between June and November.
Teva's announcement sent shares of Momenta Pharmaceuticals Inc. (Nasdaq: MNTA) down 21% yesterday to $12.50, giving a market cap of $568 million.
Teva's share price rose 3.6% on Nasdaq yesterday to $54.57, giving a market cap of $51.08 billion, and rose 1.4% in early trading on the TASE today to NIS 196.40.
© Copyright of Globes Publisher Itonut (1983) Ltd. 2011