Acorda Therapeutics is throwing its Parkinson’s disease drug tozadenant in the trash after the patient deaths during phase 3 trial. This is the end of the oral adenosine A2a receptor antagonist that the biotech cashed out $363 million for just last year.
Last week, Acorda identified issues with the phase 3 trial when five patient deaths resulted from sepsis which required the biotech to halt new enrollment. Acorda has now also ended the dosing of patients that are currently enrolled in the trial after new information presented from the phase 3 program.
Acorda has not provided full details on the new findings, stating only that its related to “agranulocytosis and associated serious adverse events” and made the company unsure whether “weekly white blood cell count screening would sufficiently ensure patient safety.” The uncertainties were enough to cause Acorda to end the trial.
“Patient safety is our top priority,” said Acorda CEO Ron Cohen, M.D. adding, “While we are deeply disappointed by this outcome, we remain committed to the Parkinson’s community”. Acorda confirmed its dedication to the disease last year with the $363 million cash acquisition of Biotie. This gave Acorda the rights to tozadenant, which its data suggested its ability to reduce “off” times in Parkinson’s patients that are taking the combination of carbidopa and levodopa.
The company predicted tozadenant generating sales up to $400 million, making tozadenant main candidate in a basket up drugs to generate $1 billion annually for biotech. The other main candidate of the anticipated franchise was CVT-301 was not approved by the FDA due to Acorda failing to submit all required information. These instances increase the uncertainty about the company’s ability to generate the $500 million a year it had predicted.
Acorda’s candidate pipeline failures have taken place during the countdown to the loss of patent protection for Ampyra, the company’s star drug. Tozadenant and CVT-301 were anticipated to be on market in time to offset the blow from the new generic competition for Ampyra.