UCB S.A. ( UCBJF ) and its partner Dermira, Inc. announced that they have finished dosing the first set of patients in a phase III development program on Cimzia. The program, led by Dermira, is evaluating the safety and efficacy of Cimzia in patients suffering from moderate-to-severe chronic plaque psoriasis.
Cimzia is being developed as an alternative treatment option for moderate-to-severe psoriasis. The phase III program consists of three studies, of which two (CIMPASI-1 and CIMPASI-2) are multi-center, randomized, blinded, parallel-group, placebo-controlled studies evaluating the efficacy and safety of Cimzia in this indication.
The third (CIMPACT) is a randomized, parallel-group, placebo-controlled and blinded, active-controlled, multi-center study. The primary objective of this study is to compare the efficacy and safety of Cimzia to placebo for the same indication.
The study will also compare the efficacy and safety of Cimzia to Amgen's ( AMGN ) Enbrel. The program will enroll a total of about 1,000 patients (treatment-naïve as well as treatment-experienced with biologic products). Top-line data from these studies should be out in 2017.
According to the Jul 2014 agreement with Dermira, UCB is entitled to receive a milestone payment of $7.3 million from Dermira in the first quarter of 2015 owing to the dosing of the first patient in phase III program.
We note that Cimzia is already approved for the treatment of patients suffering from moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. The drug is also approved for reducing signs and symptoms of Crohn's disease and maintaining response in patients with moderately-to-severely active disease who responded inadequately to conventional therapy.
According to the International Federation of Psoriasis Associations, the signs and symptoms of psoriasis may vary from person to person, affecting 2%-3% of the global population, i.e., nearly 125 million people across the world. We note that Otezla and Stelara are already approved for the treatment of this disease among other indications. Meanwhile, Novartis' ( NVS ) secukinumab is under FDA review for the treatment of moderate-to-severe plaque psoriasis in patients.
We are encouraged by UCB's efforts to expand Cimzia's label. We expect investor focus to remain on further updates from the company.
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