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|September 19, 2008 3:20 p.m.|
|Copaxone® Demonstrated Protective Effect in Patients with Clinically Isolated Syndrome Suggestive of Multiple Sclerosis|
PreCISe Data Presented at World Congress on Treatment and Research in Multiple SclerosisJerusalem, Israel, September 19, 2008 - New data from PreCISe, in clinically isolated syndrome patients, have demonstrated that COPAXONE® (glatiramer acetate injection) significantly improved neuro-axonal integrity in patients presenting with a first clinical event suggestive of multiple sclerosis (MS) versus patients who received placebo (p=0.03), as measured by proton magnetic resonance spectroscopy (MRS). This effect was maintained over two years of treatment.
The data represent the first evidence of neuro-axonal protection by a disease modifying therapy in patients presenting with a first clinical event suggestive of MS.
Data were derived from an ancillary study from the Phase III, randomized, placebo-controlled PreCISe trial, which demonstrated that patients treated with COPAXONE® (n=243) had a 45 percent reduction in the risk of developing clinically definite multiple sclerosis (CDMS) compared to those on the placebo (n=238).
"These newly announced data, so far shown in RRMS patients treated with COPAXONE®, provide more evidence that treatment may control the neuronal damage associated with MS disease pathology," said Douglas Arnold, M.D., Professor of Neurology, McGill University and the primary investigator of this ancillary study. "The PreCISe trial demonstrated a significant benefit of COPAXONE® on both clinical and MRI disease activity, along with further reinforcing the excellent safety profile."
The data were presented along with two other presentations from the PreCISe study at the World Congress on Treatment and Research in Multiple Sclerosis, in Montreal, Canada. Additional data derived from the PreCISe study demonstrated that COPAXONE® significantly delayed time to conversion to CDMS and reduced magnetic resonance imaging (MRI) disease activity. The effect was robust among the PreCISe study population (n=481), as a whole and also in subgroups of patients (segmented by gender, age, type of unifocal manifestation as well as steroid treatment for the initial attack, and MRI findings at study baseline). Based on these data, applications for marketing authorization for the extension of its indication to include the treatment of patients with a first clinical event suggestive of MS were submitted in Europe and in the U.S. and are currently under review.
About the PreCISe Data
The study, "Treatment with glatiramer acetate protects axons in patients with clinically isolated syndromes: evidence from the PreCISe trial," determined that patients with clinically isolated syndrome (CIS) who received COPAXONE® showed improvement in their cerebral neuro-axonal integrity relative to patients treated with placebo.
Proton MRS was performed in a subgroup of patients in the PreCISe trial (n=34) to measure the concentration of N-acetulaspartate (NAA) levels. NAA/CR measurements were acquired each year from each patient enrolled at 10 clinical sites in seven countries. Patients terminated at the time of relapse.
Patients who received COPAXONE® showed significant improvement in their cerebral neuro-axonal integrity compared to patients treated with placebo, who showed the decline expected from natural history studies. Paired changes in NAA/CR ratio differed significantly between both patients treated with COPAXONE® (+0.14, n=11) compared to those treated with placebo (-0.33, n=9, p=0.03) at one year, and the change maintained at two years (COPAXONE® n=6, +0.17; placebo n=3, -0.23, p=0.15).
Previously announced PreCISe studies included:
"Treatment with glatiramer acetate reduces MRI-detectable disease activity in patients at presentation with CIS suggestive of MS"
"Treatment with glatiramer acetate delays conversion to CDMS in patients with CIS: subgroup analyses"
COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® is now approved in 51 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.
See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.
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This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our 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 risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra® , Neurontin®, Lotrel® and Protonix®, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, our ability to successfully identify, consummate and integrate acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc., potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").