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`
`News Release
`New Study Demonstrated
`Significant Reduction in
`Annualized Relapse Rate and
`Halting of Disability
`Progression in MS Patients
`Switching to Copaxone®
`
`Additional Study Data Showed 70 Percent of Patients had Improved or
`Stabilized Cognition Following Treatment with Copaxone®
`Jerusalem, Israel, April 14, 2011 - Data presented at the 63rd Annual
`Meeting of the American Academy of Neurology (AAN) in Honolulu, HI
`
`Jerusalem, Israel, April 14, 2011 - Teva Pharmaceutical Industries Ltd.
`(NASDAQ: TEVA) today announced preliminary data from two studies,
`Coptimize and QualiCop.
`The global Coptimize study, which followed 688 patients from 19 countries,
`demonstrated that patients who switched to Copaxone® (glatiramer acetate
`injection) from other approved disease modifying therapies experienced a
`significant reduction of 61 percent (p<0.0001; signed rank test) in ARR.
`Switching to Copaxone® treatment also halted the progression of disability
`of patients in the trial. A majority of patients reported better overall
`wellbeing and less adverse events after switching to Copaxone®.
`
`The QualiCop study indicated a significant improvement of cognitive
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`MYLAN PHARMS. INC. EXHIBIT 1083 PAGE 1
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`function and depressive symptoms over 24 months. Additionally, patients
`on Copaxone® experienced improved overall multiple sclerosis functional
`composite (MSFC) scores; the MSFC measures leg function/ambulation,
`arm/hand function and cognitive function. The study followed 734 patients
`who were either treatment nave or previously-treated with other approved
`injectable and infused disease modifying therapies for relapsing-remitting
`multiple sclerosis. In both studies, patients treated with Copaxone also
`demonstrated stable EDSS (no disease progression) during the study
`periods.
`
`"These data provide evidence that multiple sclerosis (MS) patients who are
`not responding optimally to other therapies may benefit from treatment with
`glatiramer acetate (GA)," said Professor Tjalf Ziemssen, MD, Head of MS
`center Dresden, Germany and principal investigator on both the Coptimize
`and QualiCop studies. "These data demonstrated beneficial effects of
`Copaxone® treatment beyond the already established effect on clinical
`disease activity and safety profile. Improvements in factors that impact
`patients' quality of life measures such as mobility, depression and cognitive
`performance, may lead to improved compliance and adherence to therapy."
`The results of both the Coptimize and QualiCop studies were presented this
`week at the 63rd Annual Meeting of the American Academy of Neurology
`(AAN) in Honolulu, Hawaii
`
`About the Coptimize Study
`The Coptimize study is an international, non-interventional, longitudinal
`study, recruiting relapsing-remitting multiple sclerosis (RRMS) patients
`switching to Copaxone® from other injectable and infused disease modifying
`therapies approved for RRMS within three to six months of screening. The
`150 clinics in 19 countries participating in the Coptimize study collected
`data from about 688 enrolled patients, and leveraged a web-based database
`to document patients' switch rationale and outcomes, including relapse rate,
`expanded disability status scale (EDSS), magnetic resonance imaging (MRI),
`QoL, fatigue and depression, as well as safety and tolerability measures.
`
`The median disease duration of patients in the study was one year, and the
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`median EDSS score at the time of switch was 2.5. The analysis included 648
`patients, most of whom reported better efficacy and safety profiles following
`a switch to Copaxone® treatment (p<0.0001; binomial test).
`
`Among 428 patients who had at least one visit post month 0, there was a
`significant reduction of 61 percent in ARR from 0.85 pre-switch to 0.33
`post-switch to COPAXONE® (p<0.0001; signed rank test). Disability
`progressions as measured by EDSS were stable during the 12 months.
`
`About the QualiCop Study
`The QualiCop study is a prospective, observational, open label, multicenter
`non-interventional study of treatment-nave and previously treated RRMS
`patients. Over the course of the two-year study, a series of 11 examinations
`were conducted using various assessments and questionnaires to evaluate
`QoL (functional assessment of multiple sclerosis, FAMS), fatigue (fatigue
`scale for motor and cognitive functions, FSMC) and cognition (Paced
`Auditory Serial Addition Test, PASAT) and Multiple Sclerosis Inventory
`Cognition, MUSIC tests).
`Compared to baseline findings indicate that treatment with Copaxone®
`resulted in improved overall MSFC scores. A robust improvement in
`cognitive function in patients treated with Copaxone® was observed as
`measured by the PASAT and MUSIC test (p<0.001).
`ABOUT COPAXONE®
`Copaxone® is indicated for the reduction of the frequency of relapses in
`relapsing-remitting multiple sclerosis, including patients who have
`experienced a first clinical episode and have MRI features consistent with
`multiple sclerosis. The most common side effects of Copaxone® are redness,
`pain, swelling, itching, or a lump at the site of injection, flushing, rash,
`shortness of breath, and chest pain.
`Copaxone® (glatiramer acetate injection) is now approved in more than 50
`countries worldwide, including the United States, Russia, 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. 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.sharedsolutions.com/pdfs/PrescribingInformation.aspx or call
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`1-800-887-8100 for electronic releases.
`
`ABOUT TEVA
`Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global
`pharmaceutical company, committed to increasing access to high-quality
`healthcare by developing, producing and marketing affordable generic drugs
`as well as innovative and specialty pharmaceuticals and active
`pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
`largest generic drug maker, with a global product portfolio of more than
`1,450 molecules and a direct presence in about 60 countries. Teva's
`branded businesses focus on neurological, respiratory and women's health
`therapeutic areas as well as biologics. Teva's leading innovative product,
`Copaxone®, is the number one prescribed treatment for relapsing-remitting
`multiple sclerosis. Teva employs approximately 40,000 people around the
`world and reached $16.1 billion in net sales in 2010.
`
`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®, Lotrel®, Protonix® and Gemzar®, the extent to which any
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`manufacturing or quality control problems damage our reputation for high
`quality production, the effects of competition on sales of our innovative
`products, especially Copaxone® (including potential generic and oral
`competition for Copaxone®), the impact of continuing consolidation of our
`distributors and customers, our ability to identify, consummate and
`successfully integrate acquisitions (including the acquisition of ratiopharm),
`interruptions in our supply chain or problems with our information
`technology systems that adversely affect our complex manufacturing
`processes, intense competition in our specialty pharmaceutical businesses,
`any failures to comply with the complex Medicare and Medicaid reporting
`and payment obligations, our exposure to currency fluctuations and
`restrictions as well as credit risks, the effects of reforms in healthcare
`regulation, adverse effects of political or economical instability, major
`hostilities or acts of terrorism on our significant worldwide operations,
`increased government scrutiny in both the U.S. and Europe of our
`agreements with brand companies, dependence on the effectiveness of our
`patents and other protections for innovative products, our ability to achieve
`expected results through our innovative R&D efforts, the difficulty of
`predicting U.S. Food and Drug Administration, European Medicines Agency
`and other regulatory authority approvals, uncertainties surrounding the
`legislative and regulatory pathway for the registration and approval of
`biotechnology-based products, potentially significant impairments of
`intangible assets and goodwill, potential increases in tax liabilities resulting
`from challenges to our intercompany arrangements, our potential exposure
`to product liability claims to the extent not covered by insurance, the
`termination or expiration of governmental programs or tax benefits, current
`economic conditions, any failure to retain key personnel or to attract
`additional executive and managerial talent, 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").
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