Acorda Chief Says if it Loses Patent Appeals, No Sales Layoffs
Published: Jun 07, 2018 By Mark Terry
In a recent interview, Ron Cohen, chief executive officer of Acorda Therapeutics, indicated that if the company lost its appeals over patent lawsuits for its Ampyra for multiple sclerosis, there would not be layoffs in its sales force. Instead, the company would shift all its sales reps to the company’s Inbrija, a treatment for Parkinson’s disease that is awaiting approval by the U.S. Food and Drug Administration (FDA).
In January, there were rumors that Acorda was considering a sale. It had been struggling, largely because of a number of deaths in its Phase III clinical trial of tozadenant for Parkinson’s disease, which forced the company to halt enrollment in the trial and eventually discontinue clinical development of the drug altogether.
Another big issue was affecting the company’s primary source of revenue, Ampyra. The drug’s patents expire in July. In March 2017, a district court judge invalidated four out of five patents that cover Ampyra, which is prescribed to patients with MS to improve walking ability. The company has been unsuccessful in getting the drug approved for other indications. The single remaining patent expires in the middle of this year.
If Acorda is able to recover the patents that were invalidated, it plans to expand its sales force “by roughly 35 percent or so, give or take,” Cohen said. “They would be detailing both products, and we would need to account for those places in the country where there was not a geographic overlap in certain prescribers.”
When the district judge invalidated four of the five patents, the company responded by laying off about 20 percent of its workforce, or 100 people. Cohen said in a recent interview, “That was very painful and traumatic for the organization.”
In February, the FDA accepted the company’s New Drug Application (NDA) for Inbrija. Inbrija is an inhaled formulation of levodopa to treat symptoms of OFF periods in Parkinson’s patients on a carbidopa/levodopa regimen. The PDUFA date for the drug is October 5, 2018.
At the time, Burkhard Blank, Acorda’s chief medical officer, said in a statement, “OFF periods greatly disrupt the lives of people living with Parkinson’s, and there is a significant need for new treatment in this community. We are excited about the potential to bring this highly innovative treatment option to people living with Parkinson’s, and look forward to working with the FDA throughout the review process.”
On May 29, the company announced that the European Medicines Agency (EMA) had completed formal validation of the company’s Marketing Authorization Application (MAA) for the drug. The MAA was submitted on March 23, 2018. The review by the EMA is expected within 210 days, which means by the end of December.
The company clearly expects approvals and is making plans for an Inbrija launch, utilizing the experience it gained from the launch of Ampyra. Cohen said, “It’s 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.” For example, both drugs are “intended to improve 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.”
On the other hand, they’re not the same disease and there are reimbursement differences. But in this case, after what has been a rough year or so, Acorda looks to be back on track and ready to get on with business.