Acorda Therapeutics, a biotechnology company based in Ardsley, N.Y., has entered into an agreement to acquire Civitas Therapeutics, a Chelsea, Mass.-based, privately held biopharmaceutical company, for $525 million in cash. Acorda will obtain worldwide rights to CVT-301, a phase III treatment candidate for OFF episodes of Parkinson’s disease (PD). The acquisition also includes rights to Civitas’ proprietary ARCUS pulmonary delivery technology and manufacturing facility with commercial-scale capabilities.

Ron Cohen, M.D., Acorda's president and CEO, said, “CVT-301 is a potentially transformative therapy for people with Parkinson’s disease to rapidly and predictably treat OFF episodes. Strongly positive data from a recent phase IIb 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.”

There are approximately one million people in the U.S. and between seven to 10 million worldwide diagnosed with PD. Symptoms include tremors at rest, rigidity and impaired movement. The current standard of care is oral levodopa (L-dopa). While efficacious, there are significant challenges in creating a dosing regimen that consistently maintains drug levels within a therapeutic range. This can lead to unexpected and rapid return of PD symptoms, referred to as OFF episodes. These are poorly addressed by available therapies.

CVT-301 is a system comprised of a dry powder L-dopa formulation that is contained within blister-packed capsules and administered via a proprietary, pocket-size, reusable inhaler. CVT-301 can provide rapid delivery of L-dopa in conjunction with a patient’s optimized oral L-dopa regimen.

The pivotal phase III study for treatment of OFF episodes in people with PD is expected to begin enrolling in early 2015 and if successful, a filing for regulatory approval in the U.S. is expected by the end of 2016.

Of the total consideration, $35 million will be used to pay costs related to a Civitas change-in-control. Subject to customary closing conditions, the acquisition is expected to be completed in the fourth quarter of 2014.