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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 annual scientific meeting of the American College of Rheumatology (ACR).
In the RAPID-PsA phase III study, 409 psoriatic arthritis patients were enrolled. It was observed that after 12 weeks of treatment with Cimzia, adult patients with or without prior anti-TNF (tumor necrosis factor) exposure 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.
Currently used products for psoriatic arthritis include Abbott’s ( ABT - Analyst Report ) Humira and Johnson & Johnson’s ( JNJ - Analyst Report ) Simponi.
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 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.
Cimzia sales went up 41% from the year-ago period to €334 million during the first nine months of 2012.
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.
We currently have a Zacks #3 Rank (short-term Hold rating) on the stock.
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