UPDATE 1-Acorda drug aids walking in MS patients, shares fly
June 2nd, 2008 | by admin |(Adds details on safety findings, analyst comment, shares)
By Ransdell Pierson
NEW YORK, June 2 (Reuters) - Acorda Therapeutics Inc.(ACOR.O: Quote, Profile, Research) on Monday said it will seek U.S. approval early nextyear for the first medicine to improve walking for patientswith multiple sclerosis, lifting its shares 31 percent.
The tiny U.S. biotechnology company said its decision tofile the marketing application was based on favorable resultsfrom a second-late stage study of the medicine. Data on theproduct, which is being developed in partnership with Irishdrugmaker Elan Corp (ELN.N: Quote, Profile, Research) (ELN.L: Quote, Profile, Research), were unveiled early onMonday.
The latest Phase 3 trial involved 240 MS patients in theUnited States and Canada with some degree of walkingdisability, divided into groups that either took the Acordamedicine or placebos twice daily.
Almost 43 percent of patients taking the medicine, calledfampridine, showed consistent improvement in walking speedduring the two-month study, compared with 9.3 percent ofpatients taking placebos, Acorda said.
The results were highly statistically significant andsimilar to those seen in an earlier 14-week study of themedicine. Patients who responded to the medicine in both Phase3 studies, on average, required about 25 percent less time toto walk a distance of 25 feet.
Moreover, leg strength improved by a statisticallysignificant degree among the fampridine group in the latesttrial, meeting a secondary goal of the study.
“There is no approved treatment today that addresseswalking disability for patients with multiple sclerosis,” RonCohen, Acorda’s chief executive, said in an interview late onSunday.
