Forest Laboratories, Replidyne form licensing agreement for antibiotic

By Angela McDaniels

Seattle, Feb. 13 - Forest Laboratories Holdings Ltd. and Replidyne Inc. said they have entered into an agreement for the commercialization, development and distribution of Replidyne's new oral antibiotic, faropenem medoxomil, in the United States.

Under the terms of the agreement, Forest will make a $50 million upfront payment to Replidyne and may make future milestone payments. Replidyne will also receive royalty payments.

Forest and Replidyne said they will jointly oversee the development and regulatory approval of faropenem medoxomil and share all expenses for current and future development programs. Forest will be primarily responsible for sales and marketing of the antibiotic.

Replidyne submitted a New Drug Application to the Food and Drug Administration for faropenem medoxomil on Dec. 20 for the treatment of acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections in adults.

The application is based on the results of 11 phase 3 efficacy studies in these indications and a safety database of more than 5,000 patients treated with the product, the companies said.

Replidyne and Forest are coordinating additional studies, including studies in support of pediatric indications.

Replidyne gained exclusive rights to faropenem medoxomil in March 2004 from Daiichi Asubio Pharma Co. Ltd. for the United States and Canada and an exclusive option to the rest of the world, except Japan. The antibiotic is protected by a U.S. composition of matter patent expiring in 2015.

Forest is a New York-based subsidiary of Forest Laboratories Inc. that identifies, develops and delivers pharmaceutical products for the treatment of illnesses such as depression, hypertension and Alzheimer's disease.

Replidyne is a privately held biopharmaceutical company based in Louisville, Colo., that develops and commercializes anti-infective products.

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