Acorda Therapeutics to Acquire Civitas Therapeutics

Acorda Therapeutics, Inc. recently announced it entered into an agreement to acquire Civitas Therapeutics, a 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 based in Chelsea, MA.

“This acquisition marks a great day for Acorda and Civitas. Both companies share a passion for developing novel therapies that can restore function to people with neurological diseases. We also see substantial synergies between our capabilities, people and pipelines,” said Ron Cohen, MD, Acorda’s President and CEO. “The acquisition adds an exciting product candidate to Acorda’s pipeline that addresses a significant unmet need in Parkinson’s disease. It also leverages Acorda’s existing development and commercial capabilities and creates an opportunity for us to develop a global presence. In addition, Civitas’ ARCUS technology adds a proprietary platform with the potential for future development opportunities.”

Dr. Cohen added, “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 US sales expected to exceed $500 million.”

There are approximately 1 million people in the US and between 7 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 composed 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 3 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 United States is expected by the end of 2016.

“We are excited about collaborating with our new colleagues at Acorda to continue development of CVT-301. 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, make this acquisition an ideal match of expertise, vision and culture. We are proud of what our team at Civitas achieved with the successful development of CVT-301 through Phase IIb,” said Mark Iwicki, CEO of Civitas Therapeutics.
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.

Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream, leading to the unreliable control of symptoms resulting in the emergence of OFF episodes. These OFF episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients.

The proprietary ARCUS technology, the basis of CVT-301, allows for the consistent and precise delivery of large quantities of drug per inhalation in a simple, patient-friendly, breath-actuated inhaler. The technology delivers a consistent dose to the lung every time across a wide range of patient inhalation flow rates. The technology has been used to successfully deliver more than one million doses to patients in clinical trials of various products. Civitas has an extensive patent portfolio relating to CVT-301 and its ARCUS technology, which covers, among other things, important aspects of the formulated drug product, the inhaler, the method of delivery of drug and manufacturing processes for CVT-301. For more information, visit www.acorda.com.