August 29, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Ardsley, NJ – The U.S. Food and Drug Administration (FDA) turned down Acorda Therapeutics’ New Drug Application (NDA) for Inbrija today. Inbrija was being evaluated for OFF periods in Parkinson’s disease.
The FDA cited two reasons for its Refusal to File (RTF) letter. The first was related to the company’s stated date when its manufacturing facility would be ready for inspections. The second was related to the submission of the drug master production record. The FDA also requested more information at resubmission, although this was not part of the reason for the rejection.
Acorda plans to work with the FDA, including a Type A meeting, to respond to the issues. The company believes it can address the issues and proceed.
“We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application,” said Ron Cohen, Acorda’s president and chief executive officer, in a statement. “We remain confident in Inbrija’s data package and its promise as an important new therapy for people with Parkinson’s disease. We see tremendous long-term value in its solid clinical profile, significant commercial opportunity and strong IP, and we remain focused on working to bring patients this important new therapy.”
Earlier this month, New York-based hedge fund Scopia Capital Management urged Acorda to explore a sale. Scopia had a 17 percent stake in the company and filed with the U.S. Securities and Exchange Commission (SEC) requesting the formation of a special committee of independent directors to initiate “a review of all strategic alternatives to maximize value.” That included a sale of the company.
At that point, company shares had dropped 14.2 percent. They dropped 25.66 percent in premarket trading today after news of the FDA rejection broke. Shares are currently trading for $18.82.
The company has been tangled in patent lawsuits. In late March, the U.S. District Court for the District of Delaware overturned four of Accorda’s key patents for its lead drug Ampyra for multiple sclerosis (MS). That left the company with a single patent coverage for the drug, although it indicated it plans to appeal. The company otherwise will lose exclusivity for the drug after July 2018.
Ten companies filed with the FDA to market generic versions of Ampyra, including Mylan (MYL) and Roxane Laboratories. Acorda responded with a lawsuit. Seven of the generic companies, including Allergan (AGN) and Par Pharmaceuticals, settled with Acorda. Mylan, Roxane and Teva Pharmaceutical Industries (TEVA) refused to settle, and challenged the patents’ validity in court.
Scopia, in its letter to the SEC, suggested that the company’s plans to transition from Ampyra to Inbrija and Tozadenant was risky. A sales ramp-up of Inbrija would take time to replace lost revenue from Ampyra, and Tozadenant’s success in Phase III was not guaranteed.
In April, Acorda launched a restructuring campaign, laying off about 20 percent of its 597 staffers. At the time, the company stated, “Acorda believes that the cost savings from the restructuring and subsequent operating expense reductions will enable it to fund operations through the key milestones for its late-stage development programs, including the commercial launch of CVT-301, pending approval from the U.S Food and Drug Administration (FDA), and Phase III data for tozadenant. The Company plans to file a New Drug Application (NDA) for CVT-301 with the FDA in the second quarter of 2017.”
Scopia disagreed, which given today’s announcement, may have been correct, even though it also seems likely that Acorda will address the issues in a timely fashion.