Results from the longest ever MS treatment trial were presented at the American Academy of Neurology this month. The six-year, open label study showed delaying treatment with COPAXONE(tm) could increase the likelihood of permanent disability.

http://www.newswise.com/articles/2001/5/MSTRIAL.FHK.html

Fleishman-Hillard, Kansas City
11-May-01

JERUSALEM (May 10, 2001) -- Results from the longest ever multiple sclerosis (MS) treatment trial were presented at the American Academy of Neurology this month. The six-year, open label study showed delaying treatment with COPAXONE(tm) (glatiramer acetate for injection) could increase the likelihood of permanent disability.

"Delayed therapy was associated with greater risk of disability as shown in all measures of the expanded disability status scale (EDSS)," said Kenneth Johnson, M.D., University of Maryland, Baltimore. "Also, the relapse rate progressively fell, reinforcing the rationale for using COPAXONE(tm) as a first line drug early in the course of relapsing-remitting MS."

Of patients always on COPAXONE(tm), 69 percent showed neurological improvement of 1 EDSS step or remained stable, compared with 57 percent if COPAXONE(tm) treatment was delayed by approximately 30 months (p=0.066). The proportion of patients getting worse was less in the group always on COPAXONE(tm), 31 percent vs. 43 percent. Moreover, of patients always on COPAXONE(tm) who were relapse-free over six years, three out of 26 (11 percent) were worse by one EDSS step, whereas nine out of 21 (43 percent) of those relapse-free in the placebo/active group were worse (p<0.03). This suggests the patients whose therapy was delayed were probably entering a secondary progressive stage of MS, whereas those always on COPAXONE(tm) were neurologically stable due to treatment.

The open label trial was an extension of the multi-center, placebo-controlled pivitol clinical trial on COPAXONE(tm) (glatiramer acetate for injection). After approximately 30 months of being randomized to either COPAXONE(tm) or placebo, 208 patients chose to continue in an open-label study in which all received COPAXONE(tm); 101 were always on COPAXONE(tm), while 107 received placebo for the first 30 months and then switched to COPAXONE(tm).

The patients who received uninterrupted COPAXONE(tm) therapy showed a steady decline in relapse rate, from a mean of 1.5 at study entry to a mean of 0.42 over the six years (95 percent confidence interval = 0.34--0.51), a 72 percent reduction (p=0.0001). These patients, after six years of study, are now experiencing, on average, only one relapse every 4.5 years (annualized rate 0.23 in year six) and 26 out of 101 remain completely relapse-free. Patients did not do as well on placebo but they also experienced a decline in relapses which by year six was similar to those always on COPAXONE(tm). A fifth remained relapse-free.

"COPAXONE(tm) showed that for patients receiving glatiramer acetate from the onset, neurological deterioration became progressively less likely the longer they remained on treatment," said Dr. Johnson.

COPAXONE(tm) is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis. It reduced relapse rates by a mean of 29 percent in a 24-month study (1.19 vs. 1.68 for placebo, p=0.055).

Some patients report a short-term reaction right after injecting COPAXONE(tm). This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.

Teva Pharmaceutical Industries, Ltd. was granted approval by the U.S. Food and Drug Administration (FDA) in December 1996, to market COPAXONE(tm) (glatiramer acetate for injection). The drug was launched in April 1997. COPAXONE(tm) is marketed in the United States by Teva Neuroscience, based in Kansas City, Mo., subsidiary of Teva Pharmaceutical Industries, Ltd.

For more information about multiple sclerosis call Shared Solutions(tm) at 1-800-887-8100.

This report contains forward-looking statements, which express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include the impact of pharmaceutical industry regulation, the difficulty of predicting FDA and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, fluctuations in currency, exchange and interest rates, operating results, the impact of the year 2000 issue and other factors that are discussed in the Company's Annual Report on Form 20-F and the Company's other filings with the U.S. Securities and Exchange Commission.
 

COPAXONE(tm) is a registered trademark of Teva Pharmaceutical Industries, Ltd.
Shared Solutions(tm) is a registered trademark of Teva Neuroscience LLC.
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CONTACT:

Aharon Schwartz
Teva Pharmaceuticals Industries, Ltd.
011-972-392-67277
Aharon.Schwartz@teva.co.il

Holly Gibson
Fleishman-Hillard, Inc.
816/512-2349
gibsonh@fleishman.com

Larry Downey
Teva Neuroscience
816-966-4753
larry.downey@aventis.com