Healthcare Industry News: Savient Pharmaceuticals
News Release - December 29, 2006
Savient Pharmaceuticals Announces Launch of Authorized Generic of Oxandrin(R) with Watson PharmaceuticalsEAST BRUNSWICK, N.J.--(HSMN NewsFeed)--Savient Pharmaceuticals, Inc. (NASDAQ:SVNT ; "Savient" or "the Company") announced today that Watson Pharmaceuticals (NYSE:WPI ), 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 OxandrinŽ 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 OxandrinŽ brand and will contain the same active and inactive pharmaceutical ingredients. OxandrinŽ 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 OxandrinŽ 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 U.S. 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 (NYSE:NVS ), and Upsher-Smith Laboratories for infringement of Savient's methods of use patents for OxandrinŽ, in particular U.S. Patent Nos. 5,872,147 ("the '147' patent"); 6,090,799 ("the '799 patent"); 6,576,659 ("the '659 patent"); 6,670,351 ("the '351 patent"); and 6,828,313 ("the '313 patent").
"We are pleased to be launching our authorized generic of OxandrinŽ with Watson, a leading marketer of prescription brand equivalent products," said Christopher Clement, President and Chief Executive Officer, 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 OxandrinŽ 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 PuricaseŽ for treatment failure gout, and do not expect these unrelated activities to affect those programs," concluded Mr. Clement.
OxandrinŽ 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. OxandrinŽ is also indicated for patients who, without definite pathophysiologic reason, fail to gain or maintain normal weight. OxandrinŽ can also be used to offset the protein catabolism associated with prolonged corticosteroid use.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals is a biopharmaceutical company engaged in developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader markets. The Company's lead product development candidate, PuricaseŽ (PEG-uricase) for treatment failure gout, has reported positive Phase 1 and 2 clinical data; patient dosing in Phase 3 clinical studies began in May 2006. Savient's experienced management team is committed to advancing its pipeline and expanding its product portfolio by in-licensing late-stage compounds and exploring co-promotion and co-development opportunities that fit the Company's expertise in specialty pharmaceuticals and biopharmaceuticals with an initial focus in rheumatology. Savient also markets OxandrinŽ (oxandrolone tablets, USP) CIII in the U.S. PuricaseŽ is a registered trademark of Mountain View Pharmaceuticals, Inc. Further information on Savient can be accessed by visiting: http://www.savientpharma.com.
About Watson Pharmaceuticals, Inc.
Headquartered in Corona, California, Watson Pharmaceuticals is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
FORWARD LOOKING LANGUAGE
This news release contains forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond Savient's control.
Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections about Savient's business and the biopharmaceutical and specialty pharmaceutical industries in which Savient operates. Such risks and uncertainties include, but are not limited to, Savient's stock price and market conditions, delay or failure in developing Puricase (PEG-uricase) and other product candidates, difficulties of expanding Savient's product portfolio through in-licensing, introduction of generic competition for Oxandrin, fluctuations in buying patterns of wholesalers, potential future returns of Oxandrin or other products, Savient's continuing to incur substantial net losses for the foreseeable future, difficulties in obtaining financing, potential development of alternative technologies or more effective products by competitors, reliance on third-parties to manufacture, market and distribute many of Savient's products, economic, political and other risks associated with foreign operations, risks of maintaining protection for Savient's intellectual property, risks of an adverse determination in ongoing or future intellectual property litigation, and risks associated with stringent government regulation of the biopharmaceutical industry. Savient may not actually achieve the plans, intentions or expectations disclosed in Savient's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Savient makes. Stockholders should not place undue reliance on the forward-looking statements, which speak only as to the date of this press release. Savient's forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that Savient may make. Except as required by law, Savient does not assume any obligation to update any forward-looking statements.
Source: Savient Pharmaceuticals
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