In Light of Disappointing Trial Results, Acorda Terminates Epilepsy Drug Program
May 20, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Acorda Therapeutics , headquartered in Ardsley, New York, announced today that it is discontinuing development of its Plumiaz (diazepam) Nasal Spray for the treatment of epileptic seizures.
The company indicated that data from its ongoing clinical trial did not show bioequivalence to Diastat rectal gel, which would be needed to re-file the New Drug Application (NDA). Plumiaz actually showed “unexpectedly lower” absorption.
“We are very disappointed by this outcome, and for those in the epilepsy community who experience seizure clusters,” said Ron Cohen, Acorda’s president and chief executive officer, in a statement. “I want to thank the many clinicians, caregivers, people with epilepsy and their families involved with the Plumiaz clinical studies for their efforts to advance care for people with seizure clusters.”
Cohen added that the company plans to continuing developing other pipeline programs, including CVT-301 and tozadenant for Parkinson’s disease, and dalfampridine for post-stroke walking difficulty.
In 2012, Acorda acquired Neuronex, which was a strategic buy to expand beyond its multiple sclerosis drug Ampyra (dalfampridine).
Ben Fidler, writing for Xconomy, notes that, “Acorda’s decision to abandon the diazepam nasal spray ensures that most of the potential payouts to Neuronex’s equity holders in the 2012 buyout will never materialize—some $105 million in downstream payments were tied to future sales milestones. Neuronex was formed in 2010 and licensed the diazepam spray from Korea’s SK Biopharmaceuticals.”
Acorda didn’t take the news particularly well, although it’s been quite volatile the last year. Shares traded for $25.78 on Sept. 29, 2015, rose to $43.25 on Dec. 29, 2015, then dropped to $36 on March 4, 2016. Shares then plunged to $25.38 on March 28. Prices recovered a little bit on April 22 to $30.12, but are currently trading for $25.11.
According to The Post, on a scale from 1 to 5, with 5 being a Strong Buy, Acorda has an average rating of 3.75, based on four ratings. One analyst gave the company a “Moderate Buy” rating and another gave it a “Strong Buy” rating. The current Zacks Research consensus target price is $49, ranging from $31 to $65.
On April 20, the company published data in Movement Disorders on its Phase IIb clinical trial of CVT-301 in Parkinson’s disease patients. The data showed significant improvements in motor function in patients on the drug compared to those receiving placebo.