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Celgene Up on Encouraging Long-Term Phase III Otezla Data

Zacks Equity Research

Celgene Corporation (CELG) was up 2.3% after the company announced results from long-term (104-week) efficacy and safety analyses from two phase III studies (PALACE 1 and PALACE 2) on its phosphodiesterase 4 (PDE4) inhibitor, Otezla, in patients with active psoriatic arthritis. The data was presented at the annual meeting of the American College of Rheumatology (:ACR)/Association of Rheumatology Health Professionals.

In PALACE 1, the ACR20 response rate was reached by 65.3% of patients in the Otezla 30 mg twice daily arm at week 104, while ACR50 and ACR70 response rates were 34% and 19.6% respectively. Approximately 84% of patients who received Otezla 30 mg twice daily for one year continued on the treatment at two years. It was found that improvements in efficacy measures, which were observed at 52 weeks, were sustained through 104 weeks of treatment.

In PALACE 4, out of all disease-modifying antirheumatic drug (DMAR)-naïve patients who completed one year of Otezla 30 mg twice daily monotherapy, 84% continued the treatment at two years. At week 104, the ACR20 response rate was reached by 61.4% of patients, while ACR50 and ACR70 response rates were 40.7% and 19.2% respectively.

We note that Otezla is already approved by the FDA for the treatment of adult patients with active psoriatic arthritis (Mar 2014) and for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy (Sep 2014). Celgene is seeking EU approval for Otezla in the combined psoriasis and psoriatic arthritis indication.

Celgene carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. (AMAG), Bristol-Myers Squibb Company (BMY) and Actavis (ACT). While AMAG Pharma carries a Zacks Rank #1 (Strong Buy), Bristol-Myers and Actavis carry the same rank as Celgene.

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