UCB (UCBJF) recently presented positive data on Cimzia (certolizumab pegol) from a late-stage trial (RAPID-PsA), conducted in patients suffering from psoriatic arthritis. The data was presented at the 2012 Congress of the European League Against Rheumatism (EULAR).
In the RAPID-PsA phase III study, 409 psoriatic arthritis patients were enrolled. It was observed that after 12 weeks of treatment with Cimzia, patients experienced a statistically significant improvement in the signs and symptoms of psoriatic arthritis as compared to placebo.
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 approved in the US for the treatment of moderate-to-severe rheumatoid arthritis patients above 18 years and for reducing the signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in moderate-to-severe CD patients above 18 years, who have failed prior therapy.
The drug is also approved in the European Union (EU) 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.
In February 2012, UCB entered into a collaboration with the Japanese pharmaceutical company Astellas Pharma Inc., to jointly develop and commercialize Cimzia for RA in Japan. UCB has 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.
Cimzia sales went up 41% from the year-ago quarter to €97 million during the first quarter of 2012. We note that sales of key drugs – Cimzia, Vimpat and Neupro – accounted for about 23% of the quarter’s revenues.
UCB anticipates 2012 results to be driven by the continued sales growth of Cimzia, Vimpat and Neupro. We expect that Cimzia’s growth will be further accelerated, if approved for psoriatic arthritis.
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