FDA rejects Teva's petition to block generic Copaxone

A generic version of Teva's multiple sclerosis treatment could enter the market next year.

The US Food and Drug Administration has rejected a second civil petition by Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) to block approval of a generic version of its Copaxone treatment for multiple sclerosis. Teva submitted its petition last November after its first attempt had failed earlier in 2009.

The FDA denied the second petition for the same reason as the first attempt, because it would be "premature and inappropriate" to grant Teva's requests, but gave a detailed response that rejects many of the company's arguments against the generic approval.

Momenta Pharmaceuticals Inc. (NYSE: MNTA) and Mylan Inc. (NYSE: MYL) have both filed to produce generic versions of Copaxone, a process that is likely to span years. The drug, one of the world's best selling multiple sclerosis treatments and an important part of Teva's business.

Copaxone was approved in 2006. In 2009, sales of Copaxone rose 25% to $2.8 billion and overall sales since 2002 have totaled $11 billion. Copaxone recorded revenue of $796m for the first quarter of 2010, up 28% on the corresponding quarter of 2009.

Teva has sued both Momenta and Mylan, triggering an automatic 30-month stay on FDA approval, which is required by a generics-related law, meaning no generic version of Copaxone can enter the US market until early 2011.

Teva's share fell 0.95% in morning trading on Nasdaq to $58.11, giving a market cap of $51.94 billion.

Published by Globes [online], Israel business news - www.globes-online.com - on May 13, 2010

© Copyright of Globes Publisher Itonut (1983) Ltd. 2010

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