) 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 (
). The study will focus on the effect of the drug on adults with
early, progressive, active, and moderate to severe rheumatoid
), 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or withdrawn from it for the next 52 weeks.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 (
) 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
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