Acorda Therapeutics has 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 3 treatment candidate for OFF episodes of Parkinson’s disease (PD). The acquisition also includes rights to Civitas’ proprietary ARCUS TM 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, M.D., 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 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.”
There are approximately one million people in the U.S. and between seven to ten 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 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 2b,” 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.
MTS Health Partners, L.P. and Lazard served as Acorda Therapeutics’ financial advisors, and Cadwalader, Wickersham & Taft LLP served as its legal advisor in connection with the transaction. J.P. Morgan and BofA Merrill Lynch served as Civitas Therapeutics’ financial advisors and Ropes & Gray LLP served as its legal advisor.