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Promising PhIII apremilast data clear Celgene's path to the FDA

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Shares of Celgene ($CELG) surged yesterday as the company touted positive data from a pair of late-stage studies on apremilast, one of its top drug prospects now being prepped for FDA review.

The experimental drug cleared the bar with a statistically significant response among psoriatic arthritis patients of ACR20--a measure of success in reducing symptoms--at week 16, a key goalpost in the field. And the statistically significant response in symptoms was maintained through week 24. Patients will continue to receive treatment for a full year.

The data drop gives Celgene the numbers it needs to take to the FDA and the developer says it now plans to file its NDA in early 2013. The company plans to submit a combined application in Europe for both psoriatic arthritis as well as moderate-to-severe psoriasis in the middle of next year. An approval here would give Celgene a new product some analysts believe could earn about $500 million a year.  

Celgene has mounted an ambitious development program for this treatment. But it hasn't always been smooth sailing in the clinic. A mid-stage trial for rheumatoid arthritis recently failed to achieve its goal. Yesterday, though, the biotech said that apremilast had achieved success in a Phase II study of Behçet's disease, setting the stage for a possible label expansion down the road.

- here's the release
- read the AP report

Special Report: Celgene - The Biggest R&D Spenders in Biotech

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