WASHINGTON _ Yet another drug aimed at preventing the painfuland paralyzing relapses of multiple sclerosis may soon be on themarket. Following the advice of its advisory panel, the FDA issued anapprovable letter for Copaxone to Teva Pharmaceutical IndustriesLtd. on Friday.
The FDA's move wasn't unexpected. An advisory panel unanimouslyfound that the drug decreased the frequency of multiple sclerosis(MS) relapses. The panel also found, with one abstention, that Tevahad proven the drug safe. (See BioWorld Today, Sept. 20, 1996, p.1.)
Upon FDA approval, Copaxone _ synthetic polypeptides made offour amino acids _ will be the third drug in three years approved totreat MS, a progressive nerve-destroying disease. The other twodrugs, Avonex made by Biogen Inc., of Cambridge, Mass., andBetaseron made by Chiron Corp., of Emeryville, Calif., are versionsof interferon.
A spokesman for Teva, of Jerusalem, said the company would haveno comment on the news which was released on Monday.
The approvable letter is likely to make Teva stock more attractive toinvestors. "This stock is one of my best picks; I think it is anuncommon value," said Kenneth Nover, vice president of EquityResearch at A.G. Edwards, in St. Louis. "As far as medical need, inmany cases Copaxone will likely be the first line of therapy becauseof the low level of side effects."
Copaxone is not associated with the flu-like side effects of the othertwo drugs. However, 15 percent of patients taking Copaxone reportedbrief symptoms of coronary distress lasting less than 30 minutes _ aside effect that resulted in the one abstention on the advisorycommittee.
The FDA's final approval will be contingent upon fulfilling certainpost-approval requirements. "At A.G. Edwards, we understand thatthere is nothing exceptional being requested by the FDA at this timein order for Teva to get final approval," Nover said. "In other words,as we understand it there are no requests for special trials. The FDAis requiring that the company prove they have the capability tomonitor side effects which is a normal request."
Nover said he expects that Copaxone will receive final approval bythe end of this year and the drug will be ready for the market by earlynext year at the latest.
Upon approval Copaxone will be marketed by Teva Marion Partnersin Kansas City, Mo. _ a partnership between Teva PharmaceuticalsUSA, Inc. and Hoechst Marion Roussel Inc., also of Kansas City.
Teva's stock (NASDAQ:TEVIY) on Monday gained $0.625 to closeat $44.625 per share. n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.