Data from Longest, Continuous Study of MS Treatment Presented at EuropeanCommittee for Treatment and Research in MSJERUSALEM--(Business Wire)--Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today presented data thatdemonstrated patients treated for 10 and 15 years with COPAXONE® (glatirameracetate injection) had significant reduction in disease severity. These data,generated from the longest continuous prospective study of any disease modifyingtherapy in relapsing remitting multiple sclerosis (RRMS), were presented todayat the 25th Congress of the European Committee for Treatment and Research inMultiple Sclerosis (ECTRIMS) in Düsseldorf, Germany. The long-term analysis utilized the universal MS Severity Score (MSSS) to evaluate the accumulation of disease severity in long-term COPAXONE® patientsactively on therapy and those who withdrew early from the 15 year ongoingCOPAXONE® clinical trial1. Results demonstrated that 51 percent of long-termCOPAXONE® treated patients shifted to lower severity grades (p<0.0001). Incontrast, 41 percent of patients who withdrew from COPAXONE® showed adeterioration in MSSS grades, when compared to their baseline severity grades.Patients remaining on long-term treatment (treatment exposures of 10.12±1.32years and 13.6±1.3 years), had improved median MSSS scores of 1.84 and 1.69 at10 and 15 years, compared to MSSS scores at start, 3.62 and 3.50, respectively.Median MSSS score for withdrawn patients worsened to 6.01 at long-term follow-upversus 4.30 at treatment initiation. "This study, along with other MSSS studies, is paving the way to enableneurologists to predict the progression of disease severity in MS patients,"said Joseph Herbert, M.D., associate professor, NYU Department of Neurology andprincipal investigator of the study. "The demonstrated positive impact oflong-term COPAXONE® treatment on slowing disease progression provides hope to MSpatients and further emphasizes the importance of early treatment initiation." About the AnalysisThe modified intention-to-treat cohort (mITT, N=232) included all study patientsreceiving ≥1 COPAXONE® dose. Of mITT, 108 and 100 patients were ongoing in thetrial at 10 and 15 years, respectively. Of the 124 patients who withdrew by the10th year of the study, 50 patients returned for a long-term follow-up. MSSSscores were generated at the onset of COPAXONE® treatment, at last patientobservation for all those who were on COPAXONE® and withdrew, at 10 and 15 yearvisits for ongoing patients and at 10 year long-term follow-up for withdrawnpatients who returned. At the 10 year long-term follow-up, mean disease duration for withdrawn patientswas 18.54 ± 5.91 years and mean time since leaving study for the withdrawnpatients was 5.44±2.89 years. Median MSSS scores for ongoing patients were 1.84and 1.69 at 10 and 15 years, compared to MSSS scores at COPAXONE® (glatirameracetate injection) therapy start, 3.62 and 3.50, respectively. For 50 withdrawnpatients, median MSSS score was 6.01 at LTFU vs. 4.30 at COPAXONE® treatmentinitiation. During the study, there was a significant difference between ongoing patients at10 and 15 years and those who eventually withdrew, in the shift toward lowerdisease severity categories from COPAXONE® start to last patient observation onCOPAXONE® (p<0.0001). There was a significant difference in disease severitybetween ongoing patients at 10 years and withdrawn patients at 10 year long-termfollow up. Only 11 percent of ongoing, compared with 41 percent of withdrawnpatients, had shifted to higher severity scores; while 51 percent of ongoing,compared to only 24 percent of withdrawn, had shifted to lower severity scores(p<0.0001). The study was supported by Teva Neuroscience. About COPAXONE®COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS,including patients who have experienced a first clinical episode and have MRIfeatures consistent with multiple sclerosis. The most common side effects ofCOPAXONE® are redness, pain, swelling, itching, a lump or an indentation at thesite of injection, weakness, infection, pain, nausea, joint pain, anxiety, andmuscle stiffness. COPAXONE® is now approved in 51 countries worldwide, including the UnitedStates, Canada, Mexico, Australia, Israel, and all European countries. In NorthAmerica, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiaryof Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE® ismarketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE® isa registered trademark of Teva Pharmaceutical Industries Ltd. See additional important information at http://www.copaxone.com/pi/index.htmlorcall 1-800-887-8100 for electronic releases. For hardcopy releases, please seeenclosed full prescribing information. About TevaTeva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top20 pharmaceutical companies in the world and is the world's leading genericpharmaceutical company. The Company develops, manufactures and markets genericand innovative human pharmaceuticals and active pharmaceutical ingredients, aswell as animal health pharmaceutical products. Over 80 percent of Teva's salesare in North America and Europe. About Teva NeuroscienceTeva Neuroscience is dedicated to investigating, developing and marketingground-breaking products and technologies, with emphasis on cutting-edgetreatments for patients who are living with neurological conditions, includingmultiple sclerosis (MS) and Parkinson`s disease (PD). Therapies marketed by TevaNeuroscience include COPAXONE® (glatiramer acetate injection) forrelapsing-remitting multiple sclerosis (RRMS) and AZILECT® (rasagiline tablets)for the treatment of PD. Teva Neuroscience`s suite of innovative products continues to demonstrate thecompany`s commitment to fulfilling unmet medical needs and has helped thecompany evolve into a global leader in RRMS. Teva Neuroscience is a NorthAmerican division of Teva Pharmaceutical Industries Ltd., the world`s largestgeneric drug company. Teva Neuroscience is proud of the role it plays inproviding effective treatment options to patients worldwide. For moreinformation, please visit www.tevaneuro.com or www.tevaclinicaltrials.com. Teva's Safe Harbor Statement under the U.S. Private Securities Litigation ReformAct of 1995:This release contains forward-looking statements, which express the currentbeliefs and expectations of management. Such statements are based onmanagement's current beliefs and expectations and involve a number of known andunknown risks and uncertainties that could cause our future results, performanceor achievements to differ significantly from the results, performance orachievements expressed or implied by such forward-looking statements. Importantfactors that could cause or contribute to such differences include risksrelating to: our ability to successfully develop and commercialize additionalpharmaceutical products, the introduction of competing generic equivalents, theextent to which we may obtain U.S. market exclusivity for certain of our newgeneric products and regulatory changes that may prevent us from utilizingexclusivity periods, potential liability for sales of generic products prior toa final resolution of outstanding patent litigation, including that relating tothe generic versions of Neurontin, Lotrel and Protonix,the current economicconditions, competition from brand-name companies that are under increasedpressure to counter generic products, or competitors that seek to delay theintroduction of generic products, the effects of competition on our innovativeproducts, especially Copaxone sales, dependence on the effectiveness of ourpatents and other protections for innovative products, the impact ofconsolidation of our distributors and customers, the impact of pharmaceuticalindustry regulation and pending legislation that could affect the pharmaceuticalindustry, our ability to achieve expected results though our innovative R&Defforts, the difficulty of predicting U.S. Food and Drug Administration,European Medicines Agency and other regulatory authority approvals, theuncertainty surrounding the legislative and regulatory pathway for theregistration and approval of biotechnology-based products, the regulatoryenvironment and changes in the health policies and structures of variouscountries, supply interruptions or delays that could result from the complexmanufacturing of our products and our global supply chain, our ability tosuccessfully identify, consummate and integrate acquisitions, the potentialexposure to product liability claims to the extent not covered by insurance, ourexposure to fluctuations in currency, exchange and interest rates, significantoperations worldwide that may be adversely affected by terrorism, political oreconomical instability or major hostilities, our ability to enter into patentlitigation settlements and the intensified scrutiny by the U.S. government, thetermination or expiration of governmental programs and tax benefits, impairmentof intangible assets and goodwill, environmental risks,and other factors thatare discussed in this report and in our other filings with the U.S. Securitiesand Exchange Commission ("SEC").1. Continuous Long-Term Immunomodulatory Therapy in Relapsing MultipleSclerosis: Results from the 15-Year Analysis of the U.S. Prospective Open-labelStudy of Glatiramer Acetate, C. Ford et al. Teva Pharmaceutical Industries Ltd.Elana Holzman, +972-(3)-926-7554orTeva North AmericaKevin Mannix, 215-591-8912 Copyright Business Wire 2009