Celgene ($CELG) says that its experimental drug apremilast aced the first of three late-stage studies, posting positive data for psoriatic arthritis. The top-line data sets the stage for an NDA at the FDA in the first half of 2013, with a subsequent app planned for Europe later in the year. But on a sour note, the same drug flunked a mid-stage study for rheumatoid arthritis.
Apremalist is one of the most important drugs in Celgene's pipeline. It's been touted by JP Morgan analysts as a potential $500 million drug. And analysts are watching investigators' progress closely as the inflammatory drug completes its ambitious slate of pivotal studies. Celgene shares were down slightly this morning.
The primary endpoint in the psoriatic arthritis study was a statistically significant improvement at ACR20. And there were also improvements seen in other endpoints while patients in the experimental drug arm also experienced improved physical function.
Celgene has a battery of studies underway for apremilast. Top-line data from two more Phase IIIs for psoriatic arthritis are due out in the third quarter while data is expected from two other Phase III trials involving patients with moderate-to-severe psoriasis by the end of this year.
The RA side of the apremilast equation, though, has run into a problem.
The drug failed to hit the ACR20 primary endpoint in Phase II. "Additional analyses from this combination therapy study are ongoing," Celgene reports, "including the potential dampening effect of methotrexate on apremilast efficacy. Data from a second phase II pilot RA study, using apremilast as monotherapy, are expected in the third quarter of 2012. Data from both of these studies will guide the registration study design by the end of this year."
- read the press release
- here's the Dow Jones story
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