EAST BRUNSWICK, N.J.–LAWFUEL – Law News, Patent Law –Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that the U.S. District Court for the District of New Jersey, after considering legal briefs and supporting affidavits from all parties, ordered late on Friday that the temporary restraints contained in the Temporary Restraining Order (“TRO”) previously issued by the Court enjoining all sales of generic oxandrolone tablets by Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company (NYSE: NVS), and Upsher-Smith Laboratories be lifted at 5:00pm on Tuesday, December 12, 2006. However, the Court has certified a legal issue for appeal by Savient, although the opinion underlying the Court’s Order has not yet been made available and thus the basis of such appeal is not yet known at this time. The TRO was granted in the lawsuit filed by Savient against 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.
“The basis of the Court’s Order on Friday is unclear to all parties at this time.” said Christopher Clement, President and Chief Executive Officer of Savient. “We look forward to receiving and studying the Court’s opinion in order to understand better what the Court has directed and to determine the next actions and steps that may be available to us in defending our patent rights related to the use of Oxandrin®. We continue to be committed to pursuing all actions necessary to enforce our patent positions, which we believe are strong, and anticipate ultimately a favorable outcome.”
Savient will provide a further update on this matter once the Court’s opinion has been received and analyzed.
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.