Savient Pharmaceuticals, Inc. has announced that Watson Pharmaceuticals, under the terms of its previous supply and distribution agreement with Savient, has launched an A-B rated authorized generic of oxandrolone tablets, USP (C-III), an Oxandrin brand equivalent product manufactured and supplied through Savient.

The authorized generic product will be launched immediately and distributed by Watson in both the 2.5 mg and 10 mg dosages. The A-B rated authorized generic of oxandrolone tablets will continue to meet all quality control standards of the Oxandrin brand and will contain the same active and inactive pharmaceutical ingredients. Oxandrin is Savient's oral anabolic agent for the treatment of involuntary weight loss, a frequent and sometimes life-threatening condition associated with numerous disease states. Savient will continue to market and distribute the Oxandrin brand product.

This action by Savient follows the denial by the court of appeals for the Federal Circuit on December 28, 2006, of the company's motion for a preliminary injunction pending its appeal of the action of US district court for the district of New Jersey on December 12, 2006 lifting of the Temporary Restraining Order ("TRO") it had previously granted on December 4, 2006.

Savient has been seeking these restraints under its pending lawsuit against Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company, and Upsher-Smith Laboratories for infringement of Savient's methods of use patents for Oxandrin, in particular US Patent Nos. 5,872,147 ; 6,090,799 ; 6,576,659 ; 6,670,351 ; and 6,828,313.

"We are pleased to be launching our authorized generic of Oxandrin with Watson, a leading marketer of prescription brand equivalent products," said Christopher Clement, president and CEO, of Savient. "Over the last three years we have been anticipating potential generic competition, and, as previously announced, made sure that we, in collaboration with Watson, would be prepared to make certain that both the brand and its A-B rated authorized generic formulation would be available to the patients who depend on Oxandrin to manage involuntary weight loss, a debilitating and sometimes life-threatening condition associated with diseases such as AIDS, cancer, and chronic obstructive pulmonary disease. We remain resolute in that regard today and for the future.

"We have a strong balance sheet with nearly $200 million in cash and continue to make progress with our phase 3 clinical trial of Puricase for treatment failure gout, and do not expect these unrelated activities to affect those programs," concluded Clement.

Oxandrin is Savient's oral anabolic agent indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infection, or severe trauma.

Savient Pharmaceuticals is a biopharmaceutical company engaged in developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader markets.