Additional clinical data shows increasing effect of Teva's copolymer-1 (copaxone) in multiple sclerosis.

JERUSALEM, Israel--(BUSINESS WIRE)--Oct. 25, 1995--Teva Pharmaceutical Industries Limited (Nasdaq:TEVIY), announced today that clinical data(a) from the extension period of the recent Phase III U.S. clinical trial shows a further improvement in efficacy measures. The improved efficacy is demonstrated by a further reduction in the relapse rate, extended time to first relapse, and in a slowing of the progression of disability, compared to the core 24-month data. These results were presented for the first time at the American Neurological Association Meeting in Washington, DC by Dr. Kenneth Johnson, M.D., professor and chairman, Department of Neurology at the University of Maryland Medical Center and principal investigator in the study.

"The value of this extension data on the overall clinical picture for Copolymer-1 is significant, given issues impacting currently existing interferon treatment," said Dr. Johnson. "The additional months demonstrate lack of resistance over time and reduced time to relapse -- critical areas for the long-term success of therapeutic intervention."

"Two hundred and three of the 215 patients completing the core study chose to continue on to the extension study, without knowing whether they were receiving medication or placebo," said Dr. Johnson. "We believe patients chose to continue in the trials because of the side effects profile. Participating in the trial didn't make them feel sick."

(a) See enclosed appendix

Recently, concerns have arisen about chronic treatment with proteins or polypeptide drugs causing neutralizing antibodies which reduce the effect of these drugs over time. A study on the effects of Copolymer-1 antibody production was presented at a poster session at the ANA meeting. This study shows that specific Copolymer-1 antibodies, while developing in most patients taking the medication, have no apparent effect on the drug's clinical effectiveness.

A July 1995 editorial in "Neurology" by Dr. Jerry Wolinsky was entitled "Copolymer-1: A most reasonable alternative therapy for early relapsing-remitting multiple sclerosis with mild disability". Today's report of additional information on the increasing beneficial effect over time confirms that position. The positive result of this trial with excellent patient tolerance and with no evidence to date of a decline in effectiveness due to neutralizing activity, places Copolymer-1 among the agents which may become available in the near future to combat the long-term effects of MS.

Teva Pharmaceutical Industries Limited, Israel's largest pharmaceutical company, develops, manufactures and markets human pharmaceuticals, bulk pharmaceutical chemicals, medical disposables and veterinary products. The largest supplier of such products to Israel's public and private healthcare markets, the Company has manufacturing facilities in Israel, Western Europe and the United States and over 60 percent of its sales are generated outside of Israel. -0-

Copolymer-1

New Long Term Clinical Data:

Study Highlights

The following are detailed results of the extension period of the 24-month core Phase III study clinical data presented at the American Neurological Association, by Kenneth Johnson, MD, Professor and Chairman, Department of Neurology at the University of Maryland Medical Center and principal investigator of the Phase III Clinical Trial and Extension.

These new clinical findings demonstrate the increased effect of Copolymer-1 in altering the course of multiple sclerosis and expand on the compound's overall efficacy and safety profile.

Reduction in Relapse Rate

o Results show a 32 percent reduction (p=0.002) in the rate of relapses over approximately three years, versus 29 percent (p=0.007) for the Phase III 24-month data in patients taking Copolymer-1 compared with those taking placebo.

o The proportion of relapse free patients was significantly higher and reached statistical significance (p=0.035) during the extension among those taking Copolymer-1 (33.6 percent) compared with patients taking placebo (24.6 percent). In the Phase III 24-month study, these percentages were 33.6 versus 27.0.

Neurologic Disability

o In the approximately 3-year study, Copolymer-1 showed a significant benefit over placebo in terms of neurologic disability (p=0.001). In measuring the effect on disability (as measured by one unit on the Expanded Disability Status Scale), significantly more patients taking Copolymer 1 improved (27.2 percent) versus placebo (12.0 percent). In the Phase III 24-month study, these percentages were 24.8 versus 15.2. More patients taking placebo worsened (31.2 percent) versus those taking Copolymer 1 (18.4 percent). In the 24-month study, the difference was 28.8 percent versus 20.8 percent, respectively.

Neutralizing Antibodies

o A study on the effects of Copolymer-1 antibody production was presented at a poster session at the ANA meeting. This study shows that specific Copolymer-1 antibodies, while developing in most patients taking the medication, have no apparent effect on the drug's clinical effectiveness.

Copolymer-1 was discovered at the Weizmann Institute of Science in Israel and developed by Teva Pharmaceutical Industries, Israel's largest pharmaceutical company and clinically investigated at various leading medical centers in the U.S., Europe and Israel. -0-



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