UCB (UCBJY) recently reported positive data from a late-stage trial (RAPID-PsA) on Cimzia (certolizumab pegol), which is being studied 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 European Union (EU) and US in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults who have responded inadequately to disease-modifying antirheumatic drugs (DMARDs), including methotrexate.
Earlier this month, UCB entered into collaboration with the 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 of CImzia 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.
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