June 6, 2017
By Alex Keown, BioSpace.com Breaking News Staff
ARDSLEY, N.Y. –Shares of Acorda Therapeutics are up more than 8.5 percent this morning as the company moves closer to securing regulatory approval for its inhaled Parkinson’s disease treatment, CVT-301.
In February, the company announced top line Phase III data that showed the drug was successful in treating patients with Parkinson’s disease experiencing OFF periods. Data from the trial showed patients taking CVT-301 saw a statistically significant improvement in motor function. CVT-301 is an inhaled formula of levodopa (L-dopa). The inhaled formula is designed to reach the brain faster by bypassing the digestive system. The Phase III trial compared patients on a 12-week regimen of CVT-301 versus placebo in 339 patients. Participants self-administered treatment up to five times daily for 12 weeks, the company said. Patients received a high or low dose of CVT-301 or placebo. Patients with the high dose showed a 9.83 score on the Unified Parkinson’s Disease Rating Scale-Part 3 versus a 3.91 score for placebo.
Now Acorda is looking to file a New Drug Application with the U.S. Food and Drug Administration by the end of the second quarter of 2017. The company is also looking to seek marketing authorization in Europe by the end of the year.
On Monday, the company presented its Phase III findings at the International Congress of Parkinson’s Disease and Movement Disorders in Vancouver, Canada. Investors reacted positively, sending the stock up. Industry analysts also showed their favor. Leerink’s Paul Matteis said the company has about a 90 percent chance of securing approval from the FDA, Endpoints News reported this morning.
“Within the full data we are encouraged with what looks to be an acceptable safety profile as well as a low, placebo-like dropout rate. Secondary endpoints also mostly trend or are clearly in favor of drug–including the patient global impression of change–though the lack of difference (p-value of 0.98) on total OFF time may emerge as a subject of discussion as investors debate the size of the commercial opportunity,” Matteis said, according to Endpoints.
People diagnosed with Parkinson’s often deal with times classified as “ON” and “OFF.” OFF periods are characterized by the reemergence of Parkinson’s symptoms. In OFF times, which CVT-301 addresses, patients experience periods of decreased mobility. Over the course of the disease, patients OFF periods in patients can increase in frequency and severity. The “ON” time refers to when patients are responding to medication and symptoms are decreased.
Acorda acquired CVT-301 in a 2014 acquisition of Civitas Therapeutics. The company anticipates CVT-301 could generate $500 million in annual revenue. That is good news for the company as it scrambles to find revenue streams after the courts overturned four of the company’s key patents for its lead drug Ampyra for multiple sclerosis (MS). Acorda will lose patent protection for its MS drug after July 2018, which means it will be looking for new revenue as it will face increased competition. Currently there are about 10 companies that are looking to develop a generic of Ampyra, including Mylan and Roxane Laboratories. Ampyra accounted for the vast majority of Acorda’s revenue stream last year. The drug was responsible for $493 million of Acorda’s total revenue of $520 million.
