Barr Laboratories, Inc. and Galen Holdings PLC announced that they have received a letter from the Federal Trade Commission's (FTC) Bureau of Competition requesting certain information on Barr's proposed acquisition of the US and Canadian rights to Galen's Loestrin and Loestrin 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 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 stated that its letter should not be viewed as an accusation by the Commission 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.

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 and Loestrin FE oral contraceptive products. The proposed transaction also would include a settlement of pending patent litigation between Barr and Galen regarding Galen's femhrt hormone therapy and Estrostep 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 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 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.