UCB is teaming up with dermatology company Dermira to develop and commercialize the arthritis drug Cimzia® (certolizumab pegol), with the aim of making it available to patients with psoriasis. While Cimzia is approved in the U.S. to treat several different types of arthritis in adults as well as to reduce the signs and symptoms of Crohn's disease, UCB says the drug is not currently approved for the treatment of psoriasis by any regulatory authority.
UCB is giving Dermira an exclusive license to develop certolizumab pegol in psoriasis in the U.S., Canada, and the EU. Dermira will be in charge of Phase III development costs and could get up to $49.5 million upon achieving specific milestones; it also will receive an exclusive commercial license to market Cimzia to dermatologists in the U.S. and Canada should the drug receive regulatory approval for psoriasis. UCB will record the sales and Dermira will receive tiered royalty payments on those product sales and up to $40 million upon reaching tiered commercial milestones. UCB has made a $5 million equity investment in Dermira plans to invest up to $15 million more in future Dermira equity financings to support the deal.
Iris Loew-Friedrich, M.D., Ph.D., UCB's CMO and evp, said in a statement that the exploratory Phase II trials of the drug in patients with plaque psoriasis have shown promising results that merit further development. “In addition, the improvement in psoriasis skin symptoms observed in patients with significant skin involvement in the pivotal RAPID™-Psoriatic Arthritis study were consistent with those seen in our Phase II study in patients with plaque psoriasis,” she added.
“If successfully developed and approved, Cimzia would bring a new therapy option to adult patients with moderate to severe psoriasis,” Tom Wiggins, Dermira's chairman and CEO, commented. “Cimzia for psoriasis is our most advanced program and an important addition to our existing pipeline of dermatology products.”