September 24, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Acorda Therapeutics announced Wednesday that it will acquire Civitas Therapeutics for $525 million in cash.
Along with the company, Acorda will acquire CVT-301, a Phase 3 candidate for Parkinson’s disease and the rights to ARCUS, Civitas’s pulmonary delivery technology, and a manufacturing facility in Chelsea, Mass.
CVT-301 is a dry powder L-dopa formulation in blister-packed capsules and delivered with a proprietary reusable inhaler. The therapeutics for treatment of OFF episodes of Parkinson’s is expected to begin in early 2014.
If successful, the company plans to submit regulatory filings in the U.S. by the end of 2016.
“We are excited about collaborating with our new colleagues at Acorda to continue development of CVT-301,” said Mark Iwicki, chief executive of Civitas Therapeutics, in a statement. “Our shared conviction in the potential of CVT-301 and the ARCUS technology, combined with a mutual passion for improving the lives of people with neurological diseases, making this acquisition an ideal match of expertise, vision and culture.”
Approximately one million people nationwide suffer from Parkinson’s, and between seven and 10 million worldwide. It is a progressive neurodegenerative disease caused by the gradual decrease of specific neurons that produce dopamine. Symptoms include tremors at rest, rigidity and impaired movement.
Oral levodopa (L-dopa) is the standard treatment. However, oral administration of L-dopa has significant variability in timing and absorption, which results in OFF episodes. An OFF episode is marked by “freezing,” a temporary, inability to move.
“CVT-301 is a potentially transformative therapy for people with Parkinson’s disease to rapidly and predictably treat OFF episodes,” said Acorda President and CEO Ron Cohen in a press release. “Strongly positive data from arecent Phase 2b trial, together with a clearly defined regulatory pathway and extensive IP protection, make this a compelling opportunity, with estimated U.S. sales expected to exceed $500 million.”
Civitas’s ARCUS technology helps to deliver consistent and precise amounts of the drug in an inhaler. Civitas owns a significant patent portfolio related to CVT-301 and ARCUS.
Acorda focuses on nervous system disorders, including Ampyra for patients with multiple sclerosis (MS), Qutenza for neuropathic pain management related to shingles, and Zanaflex, a short-acting drug for management of spasticity.
The company had numerous products in its pipeline, including dalfampridine for individuals with post-stroke walking deficits, NP-1998, a possible treatment for neuropathic pain, and rHlgM22, a demyelinating antibody as a potential treatment for MS.
