All of the recent problems have caused the company’s largest shareholder to push for a sale.
Acorda Therapeutics is rumored to be in talks for a sale, with potential acquirers Biogen, UCB and unidentified Asian pharmaceutical companies showing interest.
The company had a tough 2017. On Nov. 15, it ended enrollment in its Phase III clinical trial of tozadenant for Parkinson’s disease due to several patient deaths. Shortly afterward it discontinued clinical development of the drug completely. There were five fatalities out of seven patients with sepsis, all in the group receiving the drug. Four of the cases of sepsis were related to agranulocytosis, an absence of white blood cells, and two had no white blood cell counts at the time of the event. One patient had a high white blood cell count.
Acorda picked up the drug when it acquired Finland’s BioTie for $353 million in 2016.
The company has also been facing problems with its patents for Ampyra for multiple sclerosis to improve patients’ ability to walk. In March 2017, a district court judge invalidated four out of five patents for the drug. The single patent remaining expires in the middle of 2018.
Acorda cut 20 percent of its staff and shifted its resources to two Parkinson’s drugs, Inbrija, an inhalable version of levodopa, and tozadenant. Inbrija had some success in a late-stage trial in 2017, but in August the U.S. Food and Drug Administration hit the company with a “refusal to file” letter, indicating it wanted more data about the drug before it would consider approving it.
The company had addressed those issues and resubmitted the application in early December 2017.
At the J.P. Morgan Healthcare Conference, the company announced 2017 Ampyra net sales and gave 2018 financial guidance. Ampyra’s unaudited net sales for the fourth quarter were $166 million, and unaudited net sales for the full year were $542 million, which was an increase of 10 percent from the previous year.
“We are preparing for potential approval and launch of Inbrija, our investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking carbidopa/levodopa,” said Ron Cohen, the company’s president and chief executive officer, in a statement. “We look forward to working with the FDA during the NDA review process, and to bringing this new treatment option to the PD community to help address an important unmet need. Based on our continued market research we have increased our projection for Inbrija’s U.S. market opportunity to greater than $800 million.”
John Carroll, with Endpoints News, writes, “At JPMorgan, Cohen offered a best-case scenario for their late-stage drug, saying they had boosted the market potential for the therapy to $800 million. Touting prospective numbers like that during the annual confab—a parade of bullish talk—underscored the auction process that was underway.”
All of the recent problems have caused the company’s largest shareholder to push for a sale, which, Carroll writes, “Cohen and his team initially resisted by adopting a poisoned pill defense. Any sale of Acorda now would amount to a simple bolt-on for any acquirer. Cohen made it clear that he was getting rid of much of the rest of the pipeline when he announced cutbacks last year. And the remaining staff would face deep, deep cuts by any acquirer looking to justify the price.”
