FDA postpones ruling on generic Copaxone

Rivals will not be allowed to launch generic Copaxone until the FDA makes its decision on Teva's Citizens Petition.

The US Food and Drug Administration (FDA) has postponed a ruling on the Citizens Petition of Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) to prevent the launching of generic Copaxone. A company spokesman told "Globes" that the FDA decision has been put off to an unspecified date.

Teva was responding to a report on "Fly on the Wall" yesterday that the FDA had dismissed the company's petition regarding Copaxone, Teva's flagship multiple sclerosis treatment.

The report on the "Fly on the Wall" consisted of just one sentence and was based on anonymous sources. However, the report was picked up by "Yahoo Finance", which billed it as a rumor. Teva insists it received a different response from the FDA. The significance is that rivals cannot launch generic versions of Copaxone until the FDA makes a decision.

Teva is pulling out all the stops to protect Copaxone, which provides 25%-33% of the pharmaceutical company's profit. The Citizens Petition was filed with the FDA on December 12, 2010. In the petition, Teva insists that generic Copaxone cannot be launched without a full clinical trial. Should the petition be approved, Teva would receive a breathing space of at least two years before generic Copaxone would reach the market. But if the petition is dismissed, generic competition for Copaxone would start very soon.

In a survey published last night UBS analyst Marc Goodman said that he would not be surprised if the FDA waited until September before making a decision on the Citizens Petition.

Teva's share price closed at $49.56 on Nasdaq last night, giving a market cap of $44.26 billion.

Published by Globes, Israel business news - www.globes-online.com - on June 9, 2011

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

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