New York-based Acorda Therapeutics announced yesterday it is acquiring Civitas Therapeutics, obtaining the worldwide rights to the CVT-301 compound currently in Phase III trials for OFF episodes of Parkinson’s disease.
Speaking in a call yesterday, CEO Ron Cohen told investors the firm is looking to file an NDA as early as the end of 2016 and expected US sales of the drug could exceed $500m. The deal brings with it rights to Civitas' proprietary Arcus technology used in CVT-301 which, he said, may also have application for other therapies.
The platform is “potentially applicable wherever you have drugs with similar quantities that are required, and which for whatever reason are not optimal when delivered through on oral route," he said, though was unable to offer up specific therapy areas for now.
“One of the beauties of this technology - which originally came out of Bob Langer's lab at MIT - is that you can load far more drug substance into it for delivery than you can with other inhalable technologies, so that's really where we're looking.”
Tech Protection
The Arcus platform is an aerosol delivery system which allows precise delivery of large quantities of drug per inhalation administered using the firm’s breath-actuated inhaler and, unlike other pulmonary systems, does not require carrier particles or supplemental energy to disperse.
“The technology itself is complex, involving a combination of active ingredient and device that is engineered to deliver significant amounts of drug and distribute them consistently through the lungs,” Cohen explained.
Furthermore, he told stakeholders the tech is protected through both an extensive patent portfolio and the US Food and Drug Administration’s (FDA) requirements for pulmonary device drug combinations, which were updated last year.
“It's an extremely technical, difficult, and challenging type of technology that has been perfected at Civitas but which would be very difficult for someone else to copy.”
GMP facility and Alkermes
As part of the deal, Acorda will also obtain Civitas’ manufacturing plant in Chelsea, Massachusetts which has produced clinical trial material and is capable of producing commercial products.
“This facility is geared specifically for the ARCUS technology and I'm sure it could be adapted for other means,” Cohen said.
Civitas is owned by a group of investors which includes the pharma firm Alkermes. In an SEC filing yesterday, Alkermes revealed it will receive $30m “for the sale of certain commercial-scale pulmonary manufacturing equipment used by Civitas,” along with approximately $29m for its six 6% equity interest in Civitas.
Acorda is the US commercial partner for Alkermes’ multiple sclerosis drug Ampyra, but when asked Cohen said the manufacturing of the drug was done by Alkermes and making Ampyra from the Chelsea facility would not be an option.