Healthcare Industry News: Sandoz
News Release - December 12, 2006
Savient Pharmaceuticals Announces Appellate Court Decision in Patent Infringement Lawsuit against Sandoz Pharmaceuticals and Upsher-Smith Laboratories
US Court of Appeals for the Federal Circuit Temporarily Enjoins Launch of Generic OxandroloneEAST BRUNSWICK, N.J.--(HSMN NewsFeed)--Savient Pharmaceuticals, Inc. (NASDAQ:SVNT ) announced today that the United States Court of Appeals for the Federal Circuit in Washington, D.C. (the "Federal Circuit") has issued late today an Order temporarily enjoining all sales of generic oxandrolone tablets by Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company (NYSE:NVS ), and Upsher-Smith Laboratories until the Federal Circuit has the opportunity to review this matter. This Order was issued by the Federal Circuit as a result of an appeal filed today by Savient of the Order late last Friday of the U.S. District Court for the District of New Jersey which would have lifted at 5:00 p.m. today a separate Temporary Restraining Order ("TRO") issued by that Court on December 4, 2006.
This appeal was filed in the pending lawsuit between Savient and Sandoz and Upsher-Smith for infringement of Savient's 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"). These patents relate to various methods of using Savient's product Oxandrin® (oxandrolone tablets, USP) CIII.
"We are gratified by the action taken today by the Court of Appeals in Washington," said Christopher Clement, President and Chief Executive Officer of Savient. "Upon receipt earlier this week of the District Court's opinion explaining the reasoning for their December 8th Order lifting the December 4th TRO, we believed that there were errors which warranted appeal of the decision. We have unwavering confidence in our underlying litigation and will continue to pursue all actions necessary to enforce our patent positions, which we believe are strong."
About Oxandrin®
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. Oxandrin® is also indicated for patients who, without definite pathophysiologic reason, fail to gain or maintain normal weight. Oxandrin® 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, Puricase® (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 Oxandrin® (oxandrolone tablets, USP) CIII in the U.S. Puricase® is a registered trademark of Mountain View Pharmaceuticals, Inc. Further information on Savient can be accessed by visiting: http://www.savientpharma.com.
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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