Healthcare Industry News:  Valtrex 

Biopharmaceuticals Generics Litigation

 News Release - February 2, 2007

Valtrex (valacyclovir) - US Patent Litigation Update

PHILADELPHIA and LONDON, Feb. 2 (HSMN NewsFeed) -- GlaxoSmithKline (NYSE: GSK ) today issued an update on US patent litigation regarding Valtrex (valacyclovir), an antiviral drug used for the treatment and suppression of genital herpes, herpes zoster (shingles), and cold sores. In May 2003, GSK filed a patent infringement suit in the US District Court of New Jersey against Ranbaxy alleging that its generic product would infringe GSK's basic "composition of matter" patent (4957924) for Valtrex, which expires in June 2009 (excluding paediatric exclusivity). No trial date has yet been set for this litigation.

On February 1, 2007, Ranbaxy received FDA approval for its generic valacyclovir product, and notified GSK that it sought to market the product in the USA. GSK will apply to the court for a preliminary injunction prohibiting launch of this product pending completion of the lawsuit. Under the terms of an agreement between the companies, previously approved by the court, if GSK applies for such an injunction within 45 days, Ranbaxy will not launch its product until the court either rules on the preliminary injunction or decides the pending court case.

GSK remains confident in the strength of its intellectual property for Valtrex and the product's exclusivity, afforded by the basic "composition of matter" patent to June 2009. While several companies, including Ranbaxy Pharmaceuticals, have filed for US approval of generic valacyclovir, Ranbaxy is the only generic manufacturer to have made a direct challenge to this basic patent.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at http://www.gsk.com.


Source: GlaxoSmithKline

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