Battered Acorda pulls off delayed Parkinson’s approval for Inbrija

Acorda has proved wrong those doubting it could pull off a crucial approval for Parkinson’s drug Inbrija. But that doesn’t mean the company is out of the woods.

Last week, the New York drugmaker secured an FDA approval for the inhaled therapy, which treats so-called “off” episodes during which Parkinson’s symptoms return between doses of standard treatment carbidopa/levodopa. The label “looks clean with no major surprises,” Jefferies analyst Michael Yee wrote in a note to clients, and Acorda expects the new product to be available in the first quarter of 2019.

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The green light follows a three-month delay for the agency’s decision, which hit Acorda at a particularly bad time. The regulatory setback came in mid-September, the same week the company lost an appeal that could have held off generic copies of multiple sclerosis treatment Ampyra, its primary revenue generator.

And now, even with Inbrija arriving to help fill the sales gap, investors “may be more cautious than bullish on first year launch,” Yee said.

On the one hand, Wall Street’s $54 million in first-year sales “seems doable,” he wrote, adding that Jefferies models $50 million. Acorda also “previously did a fantastic job on the Ampyra launch years ago and handily beat consensus,” he wrote, though he noted that Ampyra was a “straight-forward pill, had pent-up demand and was already being used in compounding pharmacies.”

Still, the current biotech market “may not want to own the launch,” especially with competitor Sunovion, which bought Cynapsus, threatening to bring a rival drug to market; its FDA decision deadline is coming up at the end of January.

The “key question” is whether Acorda will find itself a prime takeout target given that it’s a “standalone company with full WW rights to this drug which could tuck-in to many neurology salesforces,” Yee said, pointing to NeuroDerm, maker of an implantable levodopa pump that last year secured the Israeli company a $1 billion sale to Mitsubishi Tanabe Pharma.

RELATED: CEO: Win or lose on Ampyra patents, Acorda reps are safe with Parkinson's prospect

For now, Acorda will plow ahead with its own sales force, which will transition away from Ampyra.

Inbrija is “a different product—it has its own specific details as any new product would. But what’s most impressive to me is actually how similar a lot of the process is,” Acorda CEO Ron Cohen said in a June interview of the Inbrija launch. Both drugs are “intended to provide relief for among the most severe and among the most bothersome symptoms that patients experience, so in that sense there’s a very close parallel,” he said.