Barr's Duramed to Acquire Exclusive Rights to Prefest(R) WOODCLIFF LAKE, N.J. and BRISTOL, Tenn., Nov. 22 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE:BRL) and King Pharmaceuticals, Inc. (NYSE: KG) today announced that they have completed an agreement under which Barr Pharmaceuticals' subsidiary, Duramed Pharmaceuticals, Inc., has acquired from King the exclusive rights in the United States for Prefest(R) (estradiol/norgestimate) Tablets. Under the terms of the agreement, Duramed acquired from King the exclusive rights to manufacture and market Prefest(R) in the United States and King will assign to Duramed the regulatory approval in the United States. The acquisition price for the product is approximately $15 million. "This agreement allows Duramed to add another important female healthcare product to its portfolio of proprietary products that currently includes SEASONALE(R) extended-cycle oral contraceptive and Cenestin(R) (Synthetic Conjugated Estrogens, A)," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. Brian Markison, King's President and Chief Executive Officer, commented, "This transaction is part of our previously announced strategy to divest many, if not all, of our women's health products. Such divestitures should enable our company to focus more intently on in-licensing, development, acquisition, and promotion of branded prescription pharmaceutical products in other key therapeutic areas that we believe are more important to the future success and growth of our company." Prefest(R) is indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with the menopause, treatment of vulvar and vaginal atrophy and prevention of postmenopausal osteoporosis. Prefest(R) regimen consists of the daily administration of a single tablet containing 1 mg estradiol, a natural estrogen derived from plant sources, for three days followed by a single tablet of 1 mg estradiol combined with 0.09 mg norgestimate for three days. This regimen is repeated continuously without interruption. Barr and King are parties to pending patent litigation regarding the patents related to Prefest(R). Following Barr's acquisition of Prefest(R) from King, the Prefest(R) patent litigation will be voluntarily dismissed. Important Information About Estrogens/Progestins Estrogens/progestins combined should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast or uterus; known or suspected estrogen- dependent neoplasia; blood clots; stroke or myocardial infarction and known or suspected pregnancy. Prefest(R) should not be used in patients with known hypersensitivity to its ingredients. Estrogens and progestins should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. Other doses of conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. About Barr Pharmaceuticals Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals. About King Pharmaceuticals King Pharmaceuticals, Inc., headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management. 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. These forward-looking statements reflect managements' current views of future events and operations, including, but not limited to, statements pertaining to King's focus on in-licensing, development, and promotion of branded prescription pharmaceutical products. 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 business of Barr or King. 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 products of Barr or King; 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; Barr or King's ability to complete product development activities in the timeframes and for the costs they each expect; market and customer acceptance and demand for pharmaceutical products of Barr or King; dependence on revenues from significant customers by Barr or King; reimbursement policies of third party payors; Barr or King's dependence on revenues from significant products; the use of estimates in the preparation of financial statements by Barr or King; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes that Barr or King expect; the availability of raw materials; the availability of any product Barr purchases and sells as a distributor; the regulatory environment; Barr or King's exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; the timely and successful completion of strategic initiatives by Barr or King, including integrating companies and products Barr or King may acquire; implementing Barr's 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 each of the companies' filings with the Securities and Exchange Commission, including Barr's Form 10-K for the year ended June 30, 2004, and King's Form 10-K for the year ended December 31, 2003 and Form 10-Q for the second quarter ended June 30, 2004. The forward-looking statements contained in this press release speak only as of the date the statement was made. The companies do not undertake to publicly update or revise any of their forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law. DATASOURCE: Barr Pharmaceuticals, Inc. CONTACT: Carol A. Cox, Barr Pharmaceuticals, Inc., +1-201-930-3720, ; James E. Green, King Pharmaceuticals, Inc., +1-423-989-8125 Web site: http://www.barrlabs.com/ Company News On-Call: http://www.prnewswire.com/comp/089750.html

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