Acorda gets reprieve as Ampyra generic is delayed
- After a long patent fight, beleaguered Acorda Therapeutics is enjoying a bit of good news at last; a conditioned settlement agreement with Mylan that delays at least one of the Ampyra generic threats. Mylan's generic Ampyra launch will now be delayed until 2025, or potentially earlier "under certain circumstances."
- Documents filed with the Securities and Exchange Commission said that Acorda has also signed an interim agreement with Teva concerning Ampyra patent litigation covering the time until Aug. 31, 2018, and an agreement with Hikma covering the time until a Federal Circuit decision. All other terms of the interim and financial agreements remain confidential.
- Ampyra, a drug meant to improve walking in patients with multiple sclerosis, has long been Acorda's most valuable asset — making up nearly 95% of the biotech's revenues.
Acorda has had a rocky road with Ampyra (dalfampridine). It was approved by the Food and Drug Administration in January 2010 to improve walking in patients with multiple sclerosis, after facing a refuse-to-file letter in March 2009. The drug then failed a study in people with post-stroke walking difficulties in 2016 and this indication was discontinued.
In April 2017, the company cut its headcount by around a fifth when a court invalidated three of Ampyra's four patents. This legal move threatened Ampyra's sales, which at the time made up 95% of Acorda's revenue.
An activist investor, Scopia Capital Management, has been putting the management under pressure to sell the company, but Acorda has in place a "poison pill" to block individual investors from getting too much power.
But it's not just Ampyra that's been a challenge. Acorda has worked to diversify, bringing in a number of other drugs into its pipeline. However, it has faced a halt of enrollment into two long-term safety studies tozadenant, in development for Parkinson's disease, after signs of low white blood cell counts.
And Inbrija (levodopa inhalation powder), another Parkinson's treatment and Acorda's great hope, got a refuse-to-file letter from the FDA, following an FDA filing that was apparently "not sufficiently complete to permit a substantive review."
Perhaps surprisingly, CEO Ron Cohen, at the J.P. Morgan Healthcare Conference, described this move as a "blessing in disguise" for the company, allowing it to get a better idea of the FDA's thoughts.
Inbrija might still be the company's light at the end of the tunnel. The drug is under review with the FDA, with a user fee goal date of Oct. 5, 2018. The company predicts a market opportunity of more than $800 million, which could dwarf Ampyra's predicted $300 to $350 million this year, but there is still a way to go until a successful launch.
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