SVNTE Savient Pharmaceuticals (MM)

Court Stays Patent Litigation Proceedings to Allow Parties to Negotiate Definitive Agreement WOODCLIFF LAKE and EAST BRUNSWICK, N.J., Sept. 8 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. ("Barr") (NYSE:BRL), Organon USA Inc. and Organon (Ireland) Ltd. ("Organon"), business units of Akzo Nobel NV (NASDAQ:AKZOY), and Savient Pharmaceuticals, Inc. ("Savient") (NASDAQ:SVNTE) today confirmed that Barr Pharmaceuticals, Inc. and its subsidiaries have entered into a non- binding Letter of Intent to acquire the exclusive rights to Organon's Mircette(R) (Desogestrel/Ethinyl Estradiol) oral contraceptive product and to settle the pending patent litigation with Organon and Savient concerning Barr Laboratories, Inc.'s generic version of Mircette(R), which the Company markets under the trade name Kariva(R). The parties also confirmed that they have requested, and the District Court has agreed, to stay any further proceedings to allow the parties to negotiate definitive settlement agreements. The agreements are subject to several conditions, including negotiation of definitive agreements. Under the proposed transaction, which is subject to antitrust approval, Barr would pay Organon $142 million to purchase the New Drug Application ("NDA") for Mircette(R) and in settlement of the patent litigation and would pay Savient $13.75 million (which would yield Savient $10.75 million, net of pass-through royalties to Savient's licensor) in settlement of the patent litigation and as prepaid future royalties on sales of Mircette(R) and Kariva(R). Barr anticipates taking a charge of $62.3 million, or approximately $0.37 earnings per diluted share, in its financial statement for the quarter and year ended June 30, 2005, related to the transaction. Upon completion of the transaction, Barr's Duramed Pharmaceuticals subsidiary intends to promote Mircette(R) to female healthcare practitioners. "This acquisition ensures that there will continue to be both a brand and generic version of Mircette(R) in the marketplace, and removes the risk of a possible injunction against the continued sale of Kariva(R)" said Bruce L. Downey, Barr's Chairman and CEO. The patent litigation is currently before the U.S. District Court for the District of New Jersey. In April 2002, following a summary judgment ruling by the Court that Barr's Kariva(R) product did not infringe the patent at issue, Barr launched Kariva(R), a generic equivalent to Organon's Mircette(R) oral contraceptive. In April 2003, the U.S. Court of Appeals for the Federal Circuit reversed and remanded the case back to the U.S. District Court for the District of New Jersey for additional fact finding. Following the acquisition of Duramed in October 2001, Barr commenced manufacturing and marketing the Kariva(R) product, and was named as an additional defendant in the suit. On June 30, 2005, Barr and Organon filed the Letter of Intent with the Federal Trade Commission ("FTC") pursuant to the Hart Scott Rodino Antitrust Improvements Act. On August 1, 2005, the FTC issued a second request for information regarding the proposed transaction. Mircette(R) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Mircette(R) is available in a 28-tablet regimen that represents a combination of desogestrel/ethinyl estradiol and ethinyl estradiol. About Barr Barr Pharmaceuticals, Inc. is a holding company, whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals. A research-intensive pharmaceutical company, Barr currently manufactures and markets more than 100 different dosage forms and strengths of over 70 different generic pharmaceutical products, including 22 oral contraceptive products, representing the largest category of the Company's generic portfolio, and 13 proprietary pharmaceutical products, largely concentrated in the female healthcare arena. About Savient Based in East Brunswick, New Jersey, Savient Pharmaceuticals, Inc. is a specialty pharmaceutical company dedicated to developing, manufacturing and marketing novel therapeutic products that address unmet medical needs. The Company's lead product development candidate, Puricase(R), for the treatment of refractory gout has reported positive Phase 1 and 2 clinical data. 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. The Company's operations also include a wholly-owned U.K. subsidiary, Rosemont Pharmaceuticals Ltd., which develops, manufactures and markets liquid formulations of prescription pharmaceutical products. Rosemont's product portfolio includes over 90 liquid formulations primarily targeting the geriatric population. Further information on the Company can be accessed by visiting http://www.savientpharma.com/. Barr's Forward-Looking Statements Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004. The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law. Savient's Safe Harbor Statement This news release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included in this report regarding Savient's strategy, expected future financial position, discovery and development of products, strategic alliances, competitive position, plans and objectives of management are forward-looking statements. 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. In particular, the statements as to the possible outcome of Savient's request for continued listing on The Nasdaq Stock Market are forward-looking statements. 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, delisting of Savient's common stock from The Nasdaq Stock Market, delay or failure in developing Prosaptide, Puricase 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; our 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 on-going or future intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical and specialty pharmaceutical industries. Savient may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on 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. 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. Savient does not assume any obligation to update any forward-looking statements. DATASOURCE: Barr Pharmaceuticals, Inc. CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720, ; Jenene D. Thomas of Savient Pharmaceuticals, Inc., +1-732-565-4716, Web site: http://www.barrlabs.com/ http://www.savientpharma.com/ Company News On-Call: http://www.prnewswire.com/comp/089750.html

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