Healthcare Industry News:  PreCISe trial 

Biopharmaceuticals Neurology

 News Release - April 28, 2009

Long-Term Study with COPAXONE Indicated Protective Effect on Brain Tissue in Multiple Sclerosis Patients

New Data Presented at 61st Annual Meeting of the American Academy of Neurology

JERUSALEM--(HSMN NewsFeed)--New data presented today provided evidence that long-term treatment with COPAXONE(R) (glatiramer acetate injection) may offer sustained protection from neuronal/axonal injury. This protective effect was reflected biologically by a significant increase in N-acetylaspartate (NAA), a specific marker of neuronal mitochondrial function, in treated versus non-treated relapsing-remitting multiple sclerosis (RRMS) patients. These six-year results augment previously published findings suggesting that treatment with COPAXONE(R) may provide a neuroprotective effect in RRMS patients1, 2.

The study, “Six-Year Prospective Multi-Voxel Brain MRS Study of Two Cohorts in RRMS To Examine the Effect of Glatiramer Acetate on Neuronal/Axonal Metabolic Injury,” is the largest (n=46) and longest study of its kind to date. In the study, patients taking COPAXONE(R) for six years experienced an improvement in neuronal mitochodrial function, as quantified by an increase in neuronal NAA levels and evaluated by 1H- Magnetic Resonance Spectroscopy (1H-MRS). Decreased neuronal NAA levels are reflective of neuronal/axonal injury.

“The potential ability to prevent or repair brain tissue damage in RRMS patients is an important treatment consideration given the degenerative pathology of this life-long condition,” said Omar Khan, M.D., Professor of Neurology, Director, Multiple Sclerosis Center, Wayne State University and lead investigator of the study. “These data further substantiate our previous research into the potential neuroprotective effect of COPAXONE(R), as well as the use of NAA measures as a reliable marker for assessing a patient’s disease progression and response to treatment.”

Similar results were reported from a different study examining the effect of COPAXONE(R) in Clinically Isolated Syndrome (CIS) patients. The study demonstrated patients who received COPAXONE(R) improved in their cerebral neuroaxonal integrity relative to patients treated with placebo. Patients on placebo showed a decline in NAA consistent with that demonstrated in historical control studies.

1. Khan, O. (2008). Long-Term Study of Brain 1H-MRS Study in Multiple Sclerosis: Effect of Glatiramer Acetate Therapy on Axonal Metabolic Function and Feasibility of Long-Term 1H-MRS Monitoring in Multiple Sclerosis. Neuroimaging 2008.

2. Arnold, D. et al. (2008, September). Treatment with Glatiramer Acetate Protects Axons in Patients with Clinically Isolated Syndromes: Evidence from the PreCISe trial. Presented at ECTRIMS, Montreal, Canada. Multiple Sclerosis 2008 14 (Suppl 1): S5.

About the Study

Forty-nine patients, divided into two cohorts of previously treatment-naïve RRMS patients, underwent serial brain 1H-MRS scanning. Group 1 (n=22) included patients who started COPAXONE(R) therapy at enrollment (n=18) and during the course of the study (n=4). Mean age, disease duration and Expanded Disability Status Scale (EDSS) were 43.5 years, 8.2 years and 2.77, respectively. Mean NAA/Cr at baseline was 1.97 + 0.24 and 2.20 + 0.16 (+11.6 percent) at year 6 (p<0.05). Group 2 (n=31) included patients who started GA therapy at enrollment. Mean age, disease duration and EDSS were 35.1 years, 5.8 years and 2.53, respectively. Mean NAA/Cr at baseline was 1.99 + 0.1 and 2.12 + 0.08 (+6.53 percent) at year 6 (p<0.05). Twelve untreated RRMS patients were also scanned for two years and showed a significant decline in NAA/Cr over the two years of follow-up. Additionally four untreated patients initiated COPAXONE(R) during the course of the study and demonstrated considerable improvement in the mean NAA/Cr ratio, as well as clinical stability during total study observation. Finally, nine healthy volunteers were scanned annually for controls. Further analysis is ongoing. The study was in part supported by Teva Neuroscience.


COPAXONE(R) is indicated for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI (Magnetic Resonance Imaging) features consistent with multiple sclerosis. The most common side effects of COPAXONE(R) 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(R) is now approved in 52 countries worldwide, including the United States, Canada, Mexico, Australia, Israel and all European countries. In North America, COPAXONE(R) is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA ). In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.

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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.

Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

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, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin(R), Lotrel(R) and Protonix(R), the current economic conditions, 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 effects of competition on our innovative products, especially Copaxone(R) sales, dependence on the effectiveness of our patents and other protections for innovative products, the impact of consolidation of our distributors and customers, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, our ability to achieve expected results though our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the uncertainty surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, the regulatory environment and changes in the health policies and structures of various countries, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, our ability to successfully identify, consummate and integrate acquisitions, including the integration of Barr Pharmaceuticals, Inc., the potential exposure to product liability claims to the extent not covered by insurance, our exposure to fluctuations in currency, exchange and interest rates, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, our ability to enter into patent litigation settlements and the intensified scrutiny by the U.S. government, the termination or expiration of governmental programs and tax benefits, impairment of intangible assets and goodwill, environmental risks, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").

Source: Teva Pharmaceutical

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