Teva rival wins generic Lovenox approval

Teva still awaits FDA approval for its generic version of the anticoagulant.

The US Food and Drug Administration (FDA) yesterday approved Amphastar Pharmaceutical Inc's generic version of anticoagulant Lovenox, made by Sanofi Aventis SA (NYSE: SNY; Euronext: SAN). Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), headed by president and CEO Shlomo Yanai, is still waiting for FDA approval of its version of the drug. Amphastar and Teva both applied to market generic Lovenox in 2003. Lovenox is considered especially difficult to replicate.

Sanofi says that branded Lovenox's global revenue fell to $1.5 billion in the first half of 2011 from $4.28 billion in 2010.

In July 2010, the FDA previously approved a generic version of Lovenox made by Momenta Pharmaceuticals Inc. (Nasdaq: MNTA). Teva's share price fell 9% when the FDA approved Momenta's generic version of the drug, because investors feared that it signaled similar approval for generic Copaxone, Teva's branded multiple sclerosis treatment, which is also considered very difficult to produce. Copaxone is responsible for a third of Teva's profits.

Teva's share price fell 2.2% on Nasdaq yesterday to $37.73, giving a market cap of $35.4 billion, and fell 0.6% in early trading on the TASE today to NIS 139.40.

Published by Globes [online], Israel business news - www.globes-online.com - on September 20, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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