Barr and Galen in agreement

Barr Pharmaceuticals and Galen Holdings have completed an agreement under which Barr Pharmaceuticals' subsidiary, Duramed Pharmaceuticals has acquired from Galen the exclusive rights in the US and Canada for Loestrin and Loestrin FE oral contraceptive products.

Under the terms of a second agreement, Barr Pharmaceuticals' subsidiary, Barr Laboratories, granted Galen an option to acquire an exclusive license for Barr's generic version of Galen's Ovcon 35 oral contraceptive. Barr Laboratories has a pending ANDA for the 0.4 mg norethindrone/0.035 mg ethinyl estradiol 21-day and 28-day generic Ovcon 35 products.

Barr Laboratories and Galen continue to negotiate a settlement of pending litigation between the companies regarding Galen's femhrt hormone therapy and Estrostep oral contraceptive products that, if completed, would allow Barr Laboratories to launch generic versions of those products under the terms of a non-exclusive license six months prior to patent expiry.

Loestrin product license agreement

Under the terms of the agreement, Duramed acquired from Galen the exclusive rights to manufacture and market Loestrin products in the United States and Canada for $45m.

Option agreement related to Ovcon 35 oral contraceptive

Under the terms of a second agreement, Barr Laboratories granted Galen an option to acquire an exclusive license under its ANDA for Ovcon 35, which is currently pending at the FDA. Within 45 days of FDA approval of Barr Laboratories" ANDA for Ovcon 35, Galen has the right to exercise its option. If Galen chooses to exercise the option, it would be granted a five-year exclusive license to sell the product under the ANDA. At the end of the five-year term, Galen can extend the license on a non-exclusive basis for an additional five-year period. Galen made a $1m payment to Barr Laboratories upon signing the option agreement and would pay Barr an additional $19m at the time of the exercise of the option.