Healthcare Industry News: Barr Laboratories
News Release - September 26, 2006
Savient Pharmaceuticals Files Patent Infringement Lawsuit Against Barr Laboratories Inc.
EAST BRUNSWICK, N.J.--(HSMN NewsFeed)--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 Barr Laboratories, Inc., a wholly-owned subsidiary of Barr Pharmaceuticals, Inc., (NYSE: BRL ) 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 an 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 in response to Barr's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to engage in the commercial manufacture, use or sale of 2.5 mg and 10 mg oxandrolone tablets prior to expiration of the '147 patent, the '799 patent, the '659 patent, the '351 patent and the '313 patent, all of which are listed in Approved Drug Products with Therapeutic Equivalence Evaluations ("the Orange Book") for Oxandrin®.
Christopher Clement, President and Chief Executive Officer of Savient Pharmaceuticals Inc., said, "We are determined to take the actions necessary to defend our patent rights relating to the use of Oxandrin®. We believe our patent position is strong and anticipate a favorable outcome."
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals is a specialty pharmaceutical company engaged in developing, manufacturing and marketing pharmaceutical products that address 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 June 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 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: 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 the 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 pharmaceutical industry.
These risks and uncertainties include risks related to Savient's businesses as well as the factors relating to the outcome of the lawsuit against Barr. 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
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
