NEW YORK, June 2 (Reuters) - Acorda Therapeutics Inc. (ACOR.O) said on Monday it will seek U.S. marketing approval early next year for the first medicine to improve walking among patients with multiple sclerosis, following highly favorable results of a second late-stage study.
The latest Phase 3 trial involved 240 MS patients in the United States and Canada with some degree of walking disability, divided into groups that either took the Acorda medicine or placebos twice daily.
Almost 43 percent of patients taking the medicine, called fampridine, showed consistent improvement in walking speed during the two-month study, compared with 9.3 percent of patients taking placebos, Acorda said.
The results were highly statistically significant and similar to those seen in an earlier 14-week study of the medicine. Patients who responded to the medicine in both Phase 3 studies, on average, required about 25 percent less time to to walk a distance of 25 feet.
Moreover, leg strength improved by a statistically significant degree among the fampridine group in the latest trial, meeting a secondary goal of the study.
“There is no approved treatment today that addresses walking disability for patients with multiple sclerosis,” Ron Cohen, Acorda’s chief executive, said in an interview late on Sunday.
“Walking disability is a fundamental feature of multiple sclerosis and one of the most worrisome features because it can imply loss of independence,” said Cohen, whose tiny biotechnology company is based in Hawthorne, New York.
Cohen cautioned that although fampridine has been shown to improve the mobility of patients, it does not slow the progression of multiple sclerosis. Therefore, he said it will likely be used alongside standard interferon treatments that do slow progression, which include Biogen Idec Inc’s (BIIB.O) Avonex and the newer treatment Tysabri developed by Biogen Idec and Elan Corp ELN.L.
He noted, however, that the interferon treatments have not been shown to improve walking abilities, as fampridine has done.
Multiple sclerosis is a progressive disease in which the body’s immune system attacks, and thereby wears away, the protective layer of a protein called myelin that insulates nerve fibers in the brain and spinal cord. More than 400,000 Americans are estimated to have the disease, a high percentage of whom eventually develop walking difficulties or related motor problems.
The Acorda drug, which is being developed in partnership with Elan and will guarantee the Irish drugmaker about 20 percent of its net sales, works by preventing potassium from leaking from nerve fibers whose myelin sheath has been denuded.
Cohen said Acorda, based on the favorable results of the two late-stage studies, aims to seek U.S. approval for fampridine in the first quarter of 2009. It could reach the market later that year or in 2010, he said, and might cost between $5,000 to $10,000 per year.
Although industry analysts have estimated the medicine could generate U.S. sales of up to $500 million, and considerable sales overseas, Cohen declined to comment on its commercial potential. (Editing by Lincoln Feast)