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
March 27, 2003 Adar2 23, 5763
By Ilan Mosnaim