Diclofenac is marketed by Novartis as Cataflam/Voltaren and a topical diclofenac product is sold by SkyePharma under the brand name Solaraze. Formulations of topical diclofenac, a non-steroidal anti-inflammatory drug (NSAID), are also marketed in Europe, but no topical NSAID is currently available in the US.
Although terms of the licensing agreement were not disclosed, Cerimon said that it expects to initiate clinical trials in 2006 for the US market in mild to moderate chronic pain due to arthritis.
In a separate announcement, Cerimon also reported that it has raised $70 million in a series A financing, proceeds of which will be used to fund this development program, as well as to expand the company’s product pipeline through alliances and product acquisitions.
“With greatly increased concerns about the safety of orally administered pain medications, most notably, NSAIDs and COX-2 inhibitors, we believe there is a significant patient need for topical, non-systemic formulations that reduce the overall exposure to drug and therefore decrease the potential for adverse effects,” said Dr Gary Patou, executive vice president and chief medical officer of Cerimon.
“A head-to-head study of topical diclofenac with oral diclofenac conducted in Japan suggests that the topical product has a lower adverse event rate and retained efficacy. Based on these promising findings, we look forward to initiating our own clinical trials program here in the US.”