Acorda Therapeutics, best-known for Ampyra, which improves walking in people with multiple sclerosis, is splashing out $525 million in cash to buy Civitas Therapeutics.
The attraction of privately-held Civitas is CVT-301, a treatment which is about to go into Phase III for ‘off’ episodes of Parkinson’s disease. The latter is a system comprised of a dry powder levadopa formulation administered via a pocket-size, reusable inhaler; a Phase III study is expected to begin enrolling in early 2015.
Acorda chief executive Ron Cohen said CVT-301 is “a potentially transformative therapy for people with PD to rapidly and predictably treat ‘off’ episodes. He added that “strongly positive data” from a 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”.
The current standard of care is oral levodopa and Acorda notes that “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”, namely off episodes.
Acorda markets three Food and Drug Administration-approved therapies, notably Ampyra (prolonged-release fampridine) marketed outside the USA as Fampyra by Biogen Idec.