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September 24, 2014

Acorda Buys Civitas and Its Phase III PD Candidate for $525M

  • Acorda Therapeutics said today it will acquire Civitas Therapeutics for $525 million cash, in a deal that gives the neurological treatment worldwide rights to the Phase III Parkinson’s disease drug candidate CVT-301.

    Acorda’s acquisition also includes rights to Civitas’ ARCUSTM pulmonary delivery technology and manufacturing facility in Chelsea, MA, which has commercial-scale capabilities.

    “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,” Ron Cohen, M.D., Acorda's President and CEO, said in a statement. “It also leverages Acorda’s existing development and commercial capabilities and creates an opportunity for us to develop a global presence.”

    The deal also helps fulfill Acorda’s goal, articulated two years ago, of adding to its neurodegenerative disease drug pipeline.

    CVT-301—which uses the ARCUS platform—is designed to treat the unexpected and rapid return of PD symptoms—“off” episodes—that result from the difficulty of consistently maintaining drug levels within a therapeutic range, and that have been poorly addressed by current standard of care, oral levodopa (L-dopa).

    CVT-301 is being developed as a self-administered, adjunctive, as needed, inhaled L-dopa therapy for off episodes, providing rapid delivery of L-dopa to the brain to be used in conjunction with a Parkinson’s disease patient’s individually optimized oral L-dopa regimen. The treatment consists of a dry powder L-dopa formulation contained within blister-packed capsules, administered via a pocket-size, reusable inhaler.

    “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,” Dr. Cohen said.

    Back in April at the 66th Annual American Academy of Neurology Meeting in Philadelphia, Civitas presented results from the Phase IIb CVT-301-003 trial showing that CVT-301 met its primary endpoints for efficacy, safety and tolerability of two doses. The study designed to assess on-demand use of CVT-301 in 86 Parkinson’s disease patients experiencing motor fluctuations over a one-month period. Patients self-administered CVT-301 as-needed to treat approximately 4,500 OFF episodes, at an average of approximately two treatments per day.

    CVT-301 achieved clinically important and statistically significant reduction in average motor score using the Unified Parkinson’s Disease Rating Scale Part 3 (UPDRS III) versus placebo at time points ranging from 10 to 60 minutes post-administration.

    Also, clinically important and statistically significant improvements in UPDRS III were seen for both tested doses at every time point including 10 minutes, the earliest time point tested, Civitas reported. CVT-301 clinical studies conducted to date have been funded in part by grants from The Michael J. Fox Foundation for Parkinson’s Research.

    Acorda hopes CVT-301 will avoid the fate of Plumiaz (diazepam), rejected in May by the FDA with a Complete Response Letter indicating that the company’s application for the epilepsy nasal spray candidate “cannot be approved in its present form,” according to a company statement that did not detail the letter’s findings. The company did say, however, that it did not expect to win approval this year for Plumiaz, which is designed to treat people with epilepsy who experience cluster seizures,

    In announcing the Civitas acquisition, Dr. Cohen added that U.S. sales of CVT-301 are expected to exceed $500 million. Before that can happen, however, CVT-301 will need to succeed in a Phase III trial assessing how it treats off episodes in people with Parkinson’s. The pivotal study is expected to begin enrolling its first patients early next year. Should CVT-301 pass that test, Acorda plans to file for U.S. regulatory approval—an action expected by the end of 2016.

    On August 25, Civitas secured $55 million in Series C financing that the company said was intended to fund the Phase III study, as well as for development of additional, early stage pipeline programs. Just two days later, the company filed a registration statement with the U.S. Securities and Exchange Commission for an initial public offering whose number of shares and price range had yet to be determined.

    Of the purchase price, $35 million will go toward funding Civitas’ change-in-control costs related to payments to top executives. Subject to customary closing conditions, the acquisition is expected to be completed in the fourth quarter of 2014. The deal is expected to be completed by year’s end, subject to customary closing conditions.

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