Gilead Sciences sues Teva over generic AIDS drug

Teva also received approval for its joint venture with Lonza, and for a biliary cirrhosis treatment.

While Teva had a slew of generally positive announcements on Thursday, it was also sued by Gilead Sciences over patents related to AIDS treatments.

Gilead Sciences, Inc. (Nasdaq: GILD) filed a lawsuit in a US District Court in New York against Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Teva Pharmaceuticals USA charging patent infringement related to emtricitabine, a component of HIV drugs Atripla and Truvada.

The two patents involved are licensed exclusively to Gilead Sciences by Emory University. Teva has filed an abbreviated new drug application to manufacture and market a generic version of Atripla before the expiration of both emtricitabine patents

Atripla is indicated for use alone as a complete regimen or with other medicines to treat HIV-1 infection in adults. Truvada combines two anti-HIV-1 drugs, emtricitabine and tenofovir disoproxil fumarate, and is given in combination with other anti-HIV-1 drugs.

Separately, on Thursday, Teva reported that the US Court of Appeals for the Federal Circuit unanimously affirmed a September 2007 ruling, which denied a motion filed by Wyeth and Altana for a preliminary injunction related to Teva's generic version of Wyeth's Protonix DR Tablets.

Also on Thursday, Teva and Lonza Group Ltd. (SIX: LONN) announced that the European Commission granted antitrust approval to the joint venture between the two companies. The venture will develop, manufacture and market affordable, efficacious, and safe generic equivalents of a selected portfolio of biologic pharmaceuticals.

Teva also reported that the US Food and Drug Administration (FDA) has approved an abbreviated new drug application for Ursodiol Tablets USP, 250 mg and 500 mg. Teva’s Ursodiol tablets are the AB-rated generic equivalents of Axcan’s Urso 250 and Urso Forte, which are indicated for treatment of patients with primary biliary cirrhosis.

According to IMS figures, the brand product had annual sales of approximately $76 million in the United States for the twelve months that ended March 31.

Published by Globes [online], Israel business news - www.globes-online.com - on May 17, 2009

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

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