FDA turns down Teva Copaxone petition

Leader analyst Yoav Burgan: This is a very minor setback.

The US Food and Drug Administration (FDA) yesterday turned down a Citizen Petition by Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) regarding its multiple sclerosis treatment, Copaxone. The FDA said that reviewing a generic version of Copaxone "would be premature and inappropriate" at this time.

Copaxone had $1.38 billion in US sales in 2008.

A few months ago, Momenta Pharmaceuticals Inc. (Nasdaq: MNTA) and Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) generics unit Sandoz announced that the FDA had agreed to review their applications for generic Copaxone - M365, and Teva sued them in response for patent infringement. The patents are valid in the US through 2014 and in the EU through 2015. The lawsuit prevents the FDA from approving Momenta and Sandoz from marketing generic Copaxone for 30 months, or until a court rules in favor of the respondents, whichever happens first.

At the same time, Teva filed a Citizen Petition with the FDA, in which it argued that synthesizing generic Copaxone would be "extremely difficult, if not impossible". In addition, because the drug is rapidly absorbed, bioequivalence studies would be inadequate, and full-fledged clinical studies using clinical outcomes would be required.

Leader Capital Markets analyst Yoav Burgan said that the decision was a very minor setback for Teva. "The FDA did not throw Teva down the stairs. It merely said that it was not prepared to address the case at this time because that would be premature. In its petition, Teva argued that approval of a generic version of Copaxone would require clinical trials because of the complexity of the molecule. The FDA said that it was premature to discuss the matter, so long as there is no decision about a potential approval of a generic version of Copaxone," he said.

Published by Globes [online], Israel business news - www.globes-online.com - on March 26, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

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