Replidyne Inc., a privately held biopharmaceutical company and Forest Laboratories Holdings Ltd., a wholly owned subsidiary of Forest Laboratories Inc. have entered into an agreement for the commercialisation, 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 as well as potential future milestone payments. In addition, Replidyne will receive royalty payments based on faropenem medoxomil sales, states the company release.
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 paediatricians upon FDA approval of a paediatric formulation.
On December 20, 2005, Replidyne submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) 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 paediatric indications.
"Forest has a proven track record of launching branded products in the primary care market, and they will be an ideal partner. Forest has consistently demonstrated the commitment and knowledge necessary for a successful product launch. The Replidyne team looks forward to working with Forest on co-promotion and continued development of faropenem medoxomil to maximise its significant market potential," said Kenneth Collins, president and chief executive officer of Replidyne.
"Upon FDA approval, faropenem medoxomil will be the first orally available penem in the US Faropenem medoxomil also has other desirable features which we expect will enable it to achieve a significant position in the armamentarium of antibiotics prescribed by physicians. We are also especially delighted to be entering into this partnership with Replidyne, whose principals have expertise in the development and marketing of antibiotics, which will be immensely useful in establishing faropenem medoxomil," said Howard Solomon, chairman and chief executive officer of Forest.
Faropenem medoxomil is an ester prodrug derivative of the beta-lactam antibiotic faropenem. The prodrug form of faropenem offers dramatically improved oral bioavailability and leads to higher systemic concentrations of the drug. Faropenem medoxomil is a broad-spectrum antibiotic that is highly resistant to beta-lactamase degradation.
Replidyne licensed exclusive rights to faropenem medoxomil in March 2004 from Daiichi Asubio Pharma Co. Ltd. for the US and Canada and an exclusive option to the rest of the world, except Japan.