UCB and research partner Dermia have started its phase III trial programme for Cimzia in patients with moderate to severe plaque psoriasis patients.
Cimzia (certolizumab pegol) received FDA approval for its use in patients with psoriatic arthritis in late 2013, in addition to existing licences for rheumatoid arthritis and Crohn’s disease, but it is not currently approved for the treatment of psoriasis by any regulatory authority around the world.
In its existing indications, Cimzia reached net sales of €272m in the first half of 2013, making it UCB’s leading product.
Dr Iris Loew-Friendrich, chief medical officer and executive VP at UCB, commented: “Our collaboration with Dermira and the phase III psoriasis programme demonstrate our continued commitment to further investigate Cimzia in an effort to potentially broaden patient access and improve outcomes for people living with this chronic autoimmune disorder.”
The phase III programme consists of three studies that aim to enrol 1,000 patients, including people who have had and not had prior treatment experience with biologic products.
Two of the studies will assess Cimzia against placebo while the third will compare the drug to rival treatment Enbrel (etanercept), which is marketed by Pfizer and has revenues of around $9bn a year.
Tom Wiggins, CEO of Dermira, said: “We are excited to have advanced Cimzia into phase III trials in moderate to severe plaque psoriasis with the goal of extending product access to patients who live with this debilitating skin disease.
“Cimzia is approved as a treatment option for patients living with a range of inflammatory diseases and we are proud to be working with UCB with the goal of bringing this important therapeutic option to the millions of patients with moderate to severe psoriasis.”
In addition to Enbrel (etanercept), other potential competition in the psoriasis market includes Novartis’ Cosentyx (secukinumab) and Lilly’s ixekizumab.