Cerimon Pharmaceuticals has acquired exclusive rights to develop and commercialise diclofenac sodium patch in Europe, including most countries in the the EU, Turkey, Switzerland, Norway, the Balkan countries and Iceland. Terms of the agreement were not disclosed.
Cerimon initially acquired the US rights to develop and commercialise the patch formulation of diclofenac in 2005. Cerimon also stated that it recently received notification from the USPTO allowing patent claims covering diclofenac patch.
Cerimon has also completed enrollment of its Phase 3 program evaluating the diclofenac patch for the treatment of acute pain. Cerimon’s Phase 3 program consists of three, multi-center, randomised, double-blind, placebo-controlled studies.
The studies include 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. These are designed to assess the safety and efficacy of Cerimon’s diclofenac patch compared to placebo.
James Shannon, chief executive officer of Cerimon Pharmaceuticals, said: “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.
“Based on our current timelines, we expect to report top-line data from our Phase 3 program by the end of 2009. The company is currently exploring a number of partnership opportunities that would allow for the commercialisation of Cerimon’s diclofenac patch in the US and Europe.”