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No ‘weight’-ing: Celgene’s Otezla wins FDA nod on PDUFA date

By Randy Osborne, Staff Writer

Right on time, the FDA approved Celgene Corp.’s phosphodieasterase-4 inhibitor Otezla (apremilast) for adults with active psoriatic arthritis (PsA), a drug that could sell in the range of $1.5 billion to $2 billion by 2017, the company said.

A poll of 150 rheumatologists conducted by Celgene, of Summit, N.J., in the third quarter of 2013 showed that physicians plan to use Otezla as a pre-biologic to treat 66 percent of patients in PsA. (See BioWorld Today, Jan. 14, 2014.)

PsA, which afflicts some patients who have been diagnosed first with psoriasis, comes with joint pain, stiffness and swelling. Existing treatments include corticosteroids, tumor necrosis factor blockers and an interleukin-12/interleukin-23 inhibitor.

Clearing Otezla on its PDUFA date, the FDA said patients’ weight should be monitored for any unexplained or clinically significant weight loss, noted Wells Fargo analyst Brian Abrahams in a research report.  

“We do not believe safety data showing weight loss associated with Otezla had been previously reported, but based on our discussions with Celgene, we believe in the phase III studies [that] 10 percent of Otezla patients had 5-10 percent weight loss vs. 3 percent for placebo, with no clinical consequence,” Abrahams wrote.

“Importantly, this weight loss was not linked to the GI side effects and appeared to have a separable mechanism,” he added. “We wonder whether this ‘side effect’ might actually be attractive to some and help adoption.”

Celgene has set the wholesale acquisition cost at $22,500 per year for Otezla, “in line with our $20,000 per year net pricing assumption,” Abrahams wrote. The amount is far enough below the cost of biologics – which sell for $30,000 to $35,000 per year – to make Otezla successful, “given the drug's lesser efficacy, its positioning as an oral ahead of biologics, and the high price sensitivity we have sensed amongst rheumatologists we have spoken with in the past,” according to Abrahams.

The FDA also is requiring an exposure registry as a postmarketing requirement to assess the risks to pregnant women.

Celgene’s stock (NASDAQ:CELG) was trading mid-afternoon at $145.40, down $4.61.