Acorda drops Parkinson's drug less than a week after reporting deaths in study
Shares of Acorda Therapeutics (ACOR) are in focus in morning trading after the biopharmaceutical company scrapped development of an investigational treatment for Parkinson's disease less than a week after reporting five deaths in a clinical study. DISCONTINUATION OF TOZADENANT PROGRAM: Acorda Therapeutics announced this morning that it will stop developing tozadenant, its investigational drug for Parkinson's diease. Acorda said it will immediately discontinue dosing all participants that are currently enrolled in the drug studies. The company made its decision after reviewing new information from its Phase 3 program related to agranulocytosis, an acute condition involving a severe and dangerous lowered white blood cell count, and associated serious adverse events. Citing a lack of confidence that it could ensure patient safety by weekly white blood cell count screening, Acorda said it decided to discontinue the clinical development program. Data from the patients who completed the CL-05 study will be available in the first quarter 2018 and will be submitted for presentation at future medical conferences. FIVE DEATHS REPORTED IN STUDY: The news of the tozadenant study discontinuation comes less than week after Acorda said five people died in trials for the drug. The company said it would stop enrolling patients for two long-term safety studies on tozadenant after it found seven cases of sepsis in mid- and late-stage trials, five of which were fatal; four of the sepsis cases were associated with agranulocytosis. At the time, Acorda CEO Ron Cohen said he was "committed to continuing" the tozadenant program and that he believed the drug could still be a "meaningful product." This morning, Cohen said that "While we are deeply disappointed by this outcome, we remain committed to the Parkinson's community, which is in great need of new therapeutic options." ACORDA'S DRUGS: Tozadenant, which the company acquired last year when it bought Biotie Therapies for $363M, belongs to a class of drugs called A2a receptor antagonists that can help improve motor symptoms in patients with Parkinson's disease. In addition to tozadenant, Acorda has faced the loss of exclusivity on its Ampyra drug for multiple sclerosis and a refusal to file letter from the Food and Drug Administration for Inbrija, its other Parkinson's drug. ANALYST COMMENTARY: In a note to clients, H.C. Wainwright analyst Raghuram Selvaraju reiterated his Buy rating on the stock, saying the impact of tozadenant on Acorda's valuation was being "overstated." He attributed only a small contribution of about $1 per share from tozadenant in his valuation and considers recent weakness in Acorda's stock price as overdone and a buying opportunity. PRICE ACTION: After dropping nearly 8% in pre-market trading, Acorda has reversed earlier losses and is now up nearly 7% to $18.98. Shares are up just over 1% year-to-date.