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Thursday, March 27, 2003 Adar2 23, 5763 Israel Time: 10:37 (GMT+2) Teva says clinical trials of Parkinson's drug successful By Ilan Mosnaim Generic drug giant Teva Pharmaceuticals yesterday released two positive announcements: the successful completion of the Rasagiline phase III clinical program in Parkinson's disease; and U.S. approval for its versions of a drug to reduce glucose in the bloodstream. Teva and its drug testing partner, H. Lundbeck, yesterday said two phase III clinical trials of Rasagiline in patients with advanced Parkinson's disease had been successfully completed. Both trials achieved statistically significant results, Teva said. Each study, which compared single daily dosages of Rasagiline to a placebo as an added treatment to Levodopa, demonstrated significant reductions in the duration of the "off" time in which patients are unable to function normally. Rasagiline is now expected to be submitted for regulatory approval in North America and Europe during the second half of 2003, Teva said in its press release. Rasagiline was developed by Teva based on the original research of professors Moussa Youdim and John Finberg from the Haifa Technion School of Medicine in Israel. Youdim heads the Eve Topf Neurodegenerative Disease Research and Teaching Center at the Faculty of Medicine at the Technion, where he develops drugs for neurodegenerative conditions. Under its agreement with Teva, Lundbeck will market Rasagiline in Europe and other overseas markets in a joint effort with Teva, while Teva retains exclusive marketing rights in the rest of the world, including North America. Meanwhile, Teva has received tentative U.S. Food and Drug Administration approval to market Metformin HCl extended-release tablets, in 50-mg dosage, the Israeli drugmaker announced yesterday. The brand-name product sells for about $410 million a year, Teva said. Metformin HCl Extended-Release Tablets are the AB-rated generic equivalent of Bristol-Myers Squibb's antihyperglycemic drug, Glucophage XR. The tablets are prescribed together with dietary changes to lower blood glucose levels in patients with type two diabetes. Teva did not disclose whether it filed for approval under Paragraph four, which would grant it a six- month period of marketing exclusivity. Analyst Ori Hershkovitz of Leader&Co says Bristol-Myers' patent on Glucophage expires in October 2003, after which Teva could start marketing its generic version. If Teva gets exclusivity, Hershkovitz estimates it could command revenues of $70 million in the first year, with a 35-percent profit margin - meaning, it could increase Teva's net by $25 million. Without exclusivity, Hershkovitz estimates, its sales would increase by $20-30 million, contributing $3-5 million profits in the first year. SOURCE: Ha'aretz Daily, Israel http://www.haaretzdaily.com/hasen/pages/ShArt.jhtml?itemNo=277418&cont rassID=2&subContrassID=2&sbSubContrassID=0&listSrc=Y * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn