Cerimon Pharmaceuticals, Inc, has acquired exclusive rights to develop and commercialize its once-daily topical diclofenac sodium patch in Europe, including most countries in the European Union, Turkey, Switzerland, Norway, the Balkan countries and Iceland. Terms of the agreement were not disclosed.
Cerimon initially acquired the US rights to develop and commercialize the patch formulation of diclofenac in 2005. Cerimon also announced that it recently received notification from the United States Patent and Trademark Office allowing patent claims covering its diclofenac patch.
“There is a growing physician and patient interest in prescription therapies that can deliver safe, effective and convenient site-specific pain management. We believe our patch will be able to address this interest, and by acquiring the European rights to our diclofenac patch, we hope to bring safe and effective pain relief to a greater patient population,” stated James S Shannon, chief executive officer of Cerimon Pharmaceuticals.
Cerimon also announced today that it completed enrollment of its phase-3 programme evaluating the company’s diclofenac patch for the treatment of acute pain. Cerimon’s phase-3 programme consists of three, multi-center, randomized, double-blind, placebo-controlled studies of over 800 patients with acute pain caused by mild-to-moderate ankle sprains, wrist injuries and soft tissue injuries of the upper and lower extremities, respectively. The studies are designed to assess the safety and efficacy of Cerimon’s diclofenac patch compared to placebo.
Dr. Shannon added, “Based on our current timelines, we expect to report top-line data from our phase-3 programme by the end of 2009. The company is currently exploring a number of partnership opportunities that would allow for the commercialization of Cerimon’s diclofenac patch in the US and Europe.”
Pain represents a large and dynamic market in the United States. While currently marketed products, such as non-steroidal anti-inflammatory drugs (NSAIDs), are very effective at controlling the signs and symptoms of acute pain, adverse side effects can arise due to the oral delivery and systemic distribution of these drugs, thereby limiting their dosage and use in certain patient populations. Treating pain topically through over-the-counter balms, ointments, gels, lotions, creams and patches, represents a treatment method that has been readily accepted by patients for several decades. While topical treatments have had a strong position in the over-the-counter market, prescription-strength topical NSAIDs have only been available in the US since early 2008. Patients are demonstrating a willingness to pay out-of-pocket for the unique benefits offered by a prescription-strength topical pain treatment, particularly in the acute injury and sports medicine markets. With relatively few topical NSAIDs currently in development, there remains significant market opportunity for new products with improved efficacy, safety and ease of use.
Cerimon Pharma is a biopharmaceutical company dedicated to developing and commercializing therapeutic products for pain and inflammation.