Announces Distribution Agreement with Watson Pharmaceuticals for Authorized Generic of Oxandrin®
EAST BRUNSWICK, N.J.–LAWFUEL – Law News, Law Jobs Network –Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against Sandoz Pharmaceuticals, a Novartis Pharmaceuticals company (NYSE: NVS), and Upsher-Smith Laboratories 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. 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.
The suit was brought following the U.S. Food and Drug Administration’s (FDA) decision late on Friday, December 1, 2006, to deny both Citizens Petitions filed by Savient, which had been pending since February 2004 and September 2005, and reliable information received by Savient indicating that Abbreviated New Drug Applications (ANDA) filed by both Sandoz and Upsher-Smith had also been approved by the FDA. Savient has also filed a Motion seeking a Temporary Restraining Order and Preliminary Injunction to restrain Sandoz and Upsher-Smith from marketing and selling their generic formulations of Oxandrin®.
Savient also announced that it is examining the impact of the FDA decisions and its agreement with Watson on its pending patent infringement lawsuit against Barr Laboratories, a wholly owned subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL).
In addition, Savient acknowledged that in anticipation of these developments it had previously entered into a supply and distribution agreement with Watson Pharmaceuticals, Inc. (NYSE: WPI) granting Watson exclusive U.S. distribution rights to Savient’s A-B rated authorized generic of oxandrolone tablets, USP (C-III), an Oxandrin® brand equivalent product, which will be manufactured and supplied to Watson through Savient. The authorized generic product, when launched into the market, will be distributed by Watson in both the 2.5 mg and 10 mg dosage strengths. The A-B rated authorized generic of oxandrolone tablets will continue to meet all quality control standards of the Oxandrin® brand, will contain the same active and inactive pharmaceutical ingredients and will contain in its labeling the geriatric dosing regime for which Savient has been granted exclusivity by the FDA. Savient will also continue to market and distribute the Oxandrin® brand product.
“We are very pleased to announce our partnership with Watson, a leading marketer of prescription brand equivalent products,” said Christopher Clement, President and Chief Executive Officer, of Savient. “Despite the actions of the FDA on Friday, we remain determined to take the steps necessary to defend our patent rights. Since we recognize that generic ‘equivalents’ of our drug may have an equivalency range from 80 – 125% of our branded and authorized generic tablets, we want to make certain that both the brand and it’s A-B rated authorized generic formulation would be available to the patients who depend on Oxandrin® to manage involuntary weight loss, which is a debilitating and sometimes life-threatening condition associated with diseases such as AIDS and chronic obstructive pulmonary disease.
“Over the last three years we have been awaiting action by the FDA with respect to our Citizens Petitions, and in advance of those determinations, have taken the steps necessary to ensure that if the decisions were ultimately not in our favor, that we, in collaboration with Watson, would be prepared. We remain resolute in that regard today and for the future,” continued Mr. Clement.
“We have a strong balance sheet with nearly $200 million in cash. We continue to make steady progress with our Phase 3 clinical trial of Puricase® for treatment failure gout, and do not expect these unrelated activities to affect those programs in any manner,” concluded Mr. Clement.
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(R) (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.
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.