Barr Laboratories Inc and Galen Holdings PLC have 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 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.
These transactions are subject to negotiation of definitive agreements, completion of due diligence and other conditions, including Hart-Scott-Rodino antitrust review and final approval by the Boards of Directors of both Barr and Galen. Barr and Galen expect to close the transaction by December 31, 2003.
"These agreements would add a significant new product to Barr's growing portfolio of oral contraceptive products," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "It also would allow both parties to resolve pending patent litigation in a way that will ensure Barr can bring alternative femhrt and Estrostep products to market prior to patent expiration, which will benefit our female healthcare products consumers."