UCB (UCBJY) recently announced the initiation of a late-stage study (C-EARLY), which will evaluate the efficacy and safety of Cimzia (certolizumab pegol) when dosed in combination with methotrexate (MTX). The study will focus on the effect of the drug on adults with early, progressive, active, and moderate to severe rheumatoid arthritis (RA), who have not been treated previously with disease-modifying antirheumatic drugs (DMARDs).
Under the study, patients will be randomized to receive either Cimzia plus MTX or placebo plus MTX for 52 weeks. Patients who achieve the primary endpoint of sustained remission with Cimzia at week 52 will be re-randomized to varying reduced doses of the drug or withdrawn from it for the next 52 weeks. UCB expects to report headline results from this study in 2016.
Earlier during the month, UCB reported positive data from a late-stage trial (RAPID-PsA) on Cimzia in patients suffering from psoriatic arthritis. The 48-week study demonstrated that after 12 weeks of treatment with Cimzia, patients experienced clinically relevant and statistically significant improvement in the signs and symptoms of psoriatic arthritis.
On the basis of these results, UCB plans to make regulatory filings by the end of 2012 for the approval of Cimzia as a treatment for psoriatic arthritis.
We note that Cimzia is currently marketed as a treatment for moderate-to-severe Crohn's disease (:CD) in the US. The drug is also approved in the European Union (EU) and the US in combination with MTX for the treatment of moderate to severe active RA in adults, who have responded inadequately to DMARDs, including MTX.
UCB has a collaboration with a Japanese pharmaceutical company Astellas Pharma Inc., to jointly develop and commercialize Cimzia for RA in Japan. UCB and Astellas have filed the drug with the Japanese regulatory authority. The companies are seeking approval for the treatment of RA in patients who have responded insufficiently to current therapies.
According to the agreement, UCB will manufacture and supply Cimzia to Astellas for commercialization. Astellas will exclusively distribute the drug and also book sales, while both Astellas and UCB will jointly develop and commercialize Cimzia in Japan. Under the agreement, UCB received an initial cash payment and is eligible to receive clinical, regulatory and commercial milestones payments.
We currently have a Zacks #2 Rank (short-term Buy rating) on UCB.
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