Healthcare Industry News:  epileptic seizure 

Biopharmaceuticals Generics Litigation

 News Release - July 2, 2007

Valeant Pharmaceuticals Settles Suit with Kali Laboratories on Diastat Generic Challenge

ALISO VIEJO, Calif.--(HSMN NewsFeed)--Valeant Pharmaceuticals International (NYSE: VRX ) today announced that it has settled its lawsuit with Kali Laboratories, Inc. for patent infringement on Diastat®, the only FDA-approved at-home acute treatment for break-through epileptic seizures. Under the terms of the settlement, the companies reached an agreement in principle that would allow Kali to introduce a generic version of Diastat and Diastat® AcuDial(TM) no earlier than September 2010. Other terms of the settlement were not disclosed.

In March 2004, Kali submitted an Abbreviated New Drug Application with the Food and Drug Administration seeking approval for a generic version of Diastat (a diazepam rectal gel). In July 2004, Xcel Pharmaceuticals, Inc., which was acquired by Valeant in March 2005, filed a complaint against Kali for patent infringement. The settlement, which was reached at a conference held last week in the U.S. District Court of New Jersey, requires the companies to finalize the agreement within 60 days.

About Valeant

Valeant Pharmaceuticals International (NYSE: VRX ) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at

Diastat and Diastat AcuDial are trademarks or registered trademarks of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or registered trademarks of their respective owners.

Source: Valeant Pharmaceuticals

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