`
` Website: www.tevapharm.com
`
`Contact:
`
`Elana Holzman
`Kevin Mannix
`
`Teva Pharmaceutical Industries Ltd.
`Teva North America
`
`972 (3) 926-7554
`(215) 591-8912
`
`
`
`
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`
`
`For Immediate Release
`
`
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`TEVA PROVIDES UPDATE ON FORTE TRIAL
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`
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`Jerusalem, Israel July 7, 2008 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today
`announced top-line results from a Phase III study designed to assess the efficacy, safety and
`tolerability of glatiramer acetate (GA) 40mg as compared to the approved COPAXONE® 20mg in
`the treatment of relapsing-remitting multiple sclerosis (RRMS). The 40mg dose did not
`demonstrate increased efficacy in reducing the relapse rate; however, the higher dose maintained
`the favorable safety and tolerability profile of COPAXONE® 20mg.
`
`Seventy-eight percent (78%) of COPAXONE® 20mg treated patients remained relapse-free
`throughout the study. Moreover, patients that completed one year of treatment with COPAXONE®
`20mg experienced a very low annualized relapse rate of 0.27. This robust effect was also
`reflected in a remarkable reduction of inflammatory activity as measured by MRI.
`
`“While the trial did not demonstrate an enhanced efficacy at the higher dose level, the study
`reaffirms that COPAXONE® 20mg, the leading multiple sclerosis therapy, remains the optimal
`treatment dose with unmatched long term efficacy confirmed over 10 years,” said Moshe Manor,
`Group Vice President – Global Innovative Resources. “Teva is committed to ongoing
`research in the field of multiple sclerosis and will continue to move forward towards providing
`additional treatment options to multiple sclerosis patients”.
`
`Teva will continue to analyze the study results to better understand the effect of GA 40mg on
`patients. The Company is also evaluating the use of GA for additional indications.
`
`About the Study
`A randomized, double-blind study, designed to assess the efficacy, safety and tolerability of 40mg
`glatiramer acetate, as compared to the currently approved COPAXONE® (glatiramer acetate)
`20mg dose.
`
`The study was conducted in 136 centers in North America, Argentina, Europe and Israel, and
`included 1,155 patients with RRMS. The trial’s primary clinical outcome measure was rate of
`confirmed relapses.
`
`About COPAXONE®
`Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC (Major
`Histocompatability Complex) class II modulator. COPAXONE® is indicated for the reduction of the
`frequency of relapses in RRMS. COPAXONE® is very well tolerated and the most common side
`effects of COPAXONE® are redness, pain, swelling, itching, or a lump or an indentation at the site
`of injection, weakness, infection, pain, nausea, joint pain, anxiety and muscle stiffness.
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`COPAXONE® is now approved in 51 countries worldwide, including the United States, all
`European countries, Canada, Mexico, Australia and Israel. In Europe, COPAXONE® is marketed
`by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is
`marketed by Teva Neuroscience, Inc.
`
`See additional important information at http://www.COPAXONE.com/pi/index.html or call 1-800-
`887-8100 for electronic releases.
`
`About Multiple Sclerosis
`Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is
`estimated that 400,000 people in the United States are affected by this disease, and that over
`one million people are affected worldwide. MS is a progressive, demyelinating disease of the
`central nervous system affecting the brain, spinal cord and optic nerves.
`
`Patients with MS may experience physical symptoms and/or cognitive impairments, including
`weakness, fatigue, ataxia, physical dysfunction, bladder and bowel problems, sensory effects,
`and visual impairment. MS also has a significant impact on the sufferers' social functioning and
`overall quality of life.
`
`About Teva
`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 innovative R&D focuses on
`developing novel drugs for diseases of the central nervous system.
`
`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 Teva'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 risks relating to: Teva's ability to accurately predict future
`market conditions, 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®, Famvir® and Protonix®, Teva's ability to
`successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic
`equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and
`regulatory changes that may prevent Teva 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, 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, Teva's ability to
`successfully
`identify, consummate and
`integrate acquisitions
`(including
`the pending acquisition of Bentley
`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 Teva's Annual Report on
`Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak
`only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-
`looking statement, whether as a result of new information, future events or otherwise.
`
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`YEDA EXHIBIT NO. 2010
`MYLAN PHARM. v YEDA
`IPR2017-00195
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