Under the terms of the agreement, Forest will make a $50 million upfront payment to Replidyne as well as potential future milestone payments. In addition, Replidyne will receive royalty payments based on faropenem medoxomil sales.
Forest and Replidyne 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 faropenem medoxomil and Replidyne intends to market the product to infectious disease specialists and otolaryngologists.
Replidyne also has an option to market and promote the product to pediatricians upon FDA approval of a pediatric formulation.
Replidyne submitted a new drug application (NDA) to the FDA in December for faropenem medoxomil 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 NDA is based on the results of 11 phase III efficacy studies in these indications and a safety database of more than 5,000 patients treated with the product. Replidyne and Forest are coordinating additional studies including studies in support of pediatric indications.
Howard Solomon, chairman and CEO of Forest, said: “We are very pleased to have entered into this agreement with Replidyne for faropenem medoxomil. Antibiotics are a new and we believe important area for Forest to add to our CNS and cardiovascular franchises.”
Replidyne licensed exclusive rights to faropenem medoxomil in March 2004 from Daiichi Asubio Pharma Co for the US and Canada and an exclusive option to the rest of the world, except Japan. The product was known at that time as faropenem daloxate.