Days after a court decision torpedoed four patents protecting Acorda Therapeutics Inc.'s Ampyra (dalfampridine) – clearing the way for generic versions of the only drug approved in the U.S. for improving walking in people with multiple sclerosis – the company learned that the FDA has extended the PDUFA date for its NDA related to Inbrija (levodopa inhalation powder) to treat off-period symptoms in people with Parkinson's disease (PD) on a carbidopa/levodopa regimen.
The PDUFA date was pushed out from Oct. 5 to Jan. 5, 2019. Regulators, having accepted the Inbrija NDA in February 2018, said they need more time to sort through the updated approval bid with regard to chemistry, manufacturing and controls (CMC). Ardsley, N.Y.-based Acorda at the agency's request had submitted additional CMC information.
Jefferies analyst Michael Yee called the news "mixed," noting that the holdup "adds more uncertainty around CMC and [the] drug-device combo, pushing out timelines. While some investors could construe this to be a positive (e.g. no outright rejection/conclusion, so a higher chance of approval, since FDA is willing to take time to review things)," he wrote in a report, "the key questions specifically around human factors still linger, such as showing that patients can put the [levodopa] capsule into the device."
Such human factors and the making of the device "are common reasons for delays, particularly for a new facility and a device that have never been approved by the FDA. We find it interesting that the FDA has delayed the PDUFA despite still having weeks to the original October approval date," he wrote, conceding that the agency's neurological division often insists on extensions.
A precedential opinion handed down Monday had the Federal Circuit split 2-1 affirming a lower court decision that cut the legs off Acorda's patents and sent its stock into a 24 percent tailspin. The Inbrija hitch brought less severe consequences, and shares (NASDAQ:ACOR) closed Thursday at $18.05, down 45 cents. (See BioWorld, Sept. 10, 2018.)
During the company's conference call on earnings in early August, CEO Ron Cohen was asked how the patent case might affect pre-launch plans for Inbrija. "It's not affecting [the preparations] at all," he said. "The sales force is highly motivated. They're doing a great job as you can see from the quarter with Ampyra. They are still out there, working to bring Ampyra to any patient who might benefit from it, and we are in the process of transitioning them to training [in PD] and what they're going to need to know to transition into an Inbrija launch, so none of that changes regardless of the [outcome of the patent] case. If we lose the case, and we have generic entry, then it will be a straight shift from the existing sales force. We'll just move right into Inbrija." The team is "right-sized, as of right now, to be selling Inbrija out there," he said. "We would not expand, but we also would not contract."
Geographic preference, he added, will depend on "where the patients are and where the treating physicians are, and we have mapped out the country with respect to those issues, both in terms of the movement disorder specialists all the way through the general neurologists, and even into certain primary care [doctors] who have robust PD practices. That's dictated not by our preferences but really by the data."
Jefferies' Yee asked how assured the company might be about an on-time approval for Inbrija, and Cohen said during the earnings call that he could not speculate on what the FDA might do, but Acorda was "confident that we submitted a robust package."
Cowen analyst Phil Nadeau predicted in a report last month that Inbrija will launch next year and sell $375 million in 2022. "In a survey conducted in conjunction with our March health care conference, 92 percent of polled physicians estimated that Inbrija will be used by at least 10 percent of their patients experiencing 'off' episodes within three years, with half of physicians anticipating use in 20-30 percent or more of patients with motor fluctuations," he wrote. "This is consistent with Acorda's own survey results outlined [during the earnings call], in which 89 percent of physicians polled by Acorda would include Inbrija as part of a treatment regimen for their patients."