Barr and Galen Receive FTC Request for Information Related to Proposed Transactions WOODCLIFF LAKE, N.J. and CRAIGAVON, Northern Ireland, Dec. 23 /PRNewswire- FirstCall/ -- Barr Laboratories, Inc. (NYSE-BRL) ("Barr") and Galen Holdings PLC ("Galen") today announced that they have recently received a letter from the Federal Trade Commission's (FTC) Bureau of Competition requesting that they voluntarily provide certain information concerning Barr's proposed acquisition of the U.S. and Canadian rights to Galen's Loestrin(R) and Loestrin(R) FE oral contraceptive products and the proposed settlement of pending patent litigation between Barr and Galen. The letter also requests information concerning the proposed option for Galen to acquire an exclusive license to Barr's generic version of Galen's Ovcon(R) 35 oral contraceptive. The FTC's Bureau of Competition previously reviewed the proposed transactions under the Hart-Scott-Rodino Act. On October 24, 2003, the Hart-Scott-Rodino waiting period expired, permitting the parties to close the transactions. However, on December 16, 2003, Barr and Galen received letters from another group in the FTC's Bureau of Competition announcing that group's intention to review the proposed transactions. The FTC specifically stated that its letter should not be viewed as an accusation by the Commission or its staff of any wrongdoing. Barr and Galen believe that the proposed transactions are lawful and proper and intend to cooperate fully with the request. Barr and Galen are currently unable to determine the impact, if any, that the FTC's request would have on the closing of the proposed transactions, which is currently scheduled to occur by February 1, 2004. Background In September 2003, Barr and Galen announced that they had signed a letter of intent for Barr to acquire from Galen the exclusive rights in the United States and Canada for Loestrin(R) and Loestrin(R) FE oral contraceptive products. The proposed transaction also would include a settlement of pending patent litigation between Barr and Galen regarding Galen's femhrt(R) hormone therapy and Estrostep(R) oral contraceptive products that would allow Barr to launch generic versions of those products six months prior to patent expiry. Under the terms of a separate letter of intent, Barr would grant Galen an option to acquire an exclusive license for Barr's generic version of Galen's Ovcon(R) 35 oral contraceptive. Barr has a pending Abbreviated New Drug Application (ANDA) for the 0.4 mg norethindrone/35 mg ethinyl estradiol 21-day and 28-day generic Ovcon(R) products. Barr Laboratories, Inc. is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals. Galen is an international pharmaceutical company based in Craigavon, Northern Ireland and Rockaway, New Jersey, US. The Galen group of companies develops, acquires and manufactures branded prescription pharmaceutical products, which are promoted by the group's sales and marketing divisions in the UK, Ireland and the US. Forward-Looking Statements The following sections contain a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by their use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: 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 difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; 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; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products; 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 new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time to time in our filings with the Securities and Exchange Commission. DATASOURCE: Barr Laboratories, Inc.; Galen Holdings PLC CONTACT: Carol A. Cox of Barr Laboratories, Inc., +1-201-930-3720, ; David Kelly, Sr. Vice President, Finance and Planning, Galen Holdings PLC, +44-28-3833-4974, ext. 3634; Francetta Carr of Financial Dynamics, +44-207-831-3113 Web site: http://www.barrlabs.com/ http://www.galenplc.com/ Company News On-Call: http://www.prnewswire.com/comp/089750.html

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