Healthcare Industry News:  Teva Neuroscience 

Biopharmaceuticals Neurology

 News Release - April 11, 2007

First Pharmacoeconomic Analysis with Long-Term Data Showed COPAXONE(R) Was More Cost-Effective Than Interferon Beta Therapies for Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)

The Newly Published Analysis Also Demonstrated the Negative Effect of Neutralizing Antibodies on Cost and Outcomes of Interferon Beta Therapy in RRMS

KANSAS CITY, Mo.--(HSMN NewsFeed)--A comparison of the long-term economic outcomes of four immunomodulatory drug therapies combined with symptom management versus symptom management alone revealed that COPAXONE® (glatiramer acetate injection) was the most cost-effective treatment strategy for relapsing-remitting multiple sclerosis (RRMS). The study provides the first pharmacoeconomic evaluation of the cost-effectiveness of multiple sclerosis (MS) therapies that includes long-term treatment outcomes and costs associated with missed days from work. The study also evaluated the impact of neutralizing antibody (NAb) development in pharmacoeconomic measures among patients treated with the interferon beta (IFN-(beta)) class of drugs. The findings of the study, "Cost-effectiveness of Four Immunomodulatory Therapies for Relapsing-Remitting Multiple Sclerosis: A Markov Model Based on Long-term Clinical Data," were published in the April issue of the Journal of Managed Care Pharmacy.

"The recent availability of data demonstrating the long-term treatment outcomes of immunomodulatory therapies in MS allowed us to assess the cost-effectiveness of various RRMS treatment strategies. Findings of this study indicated that of the four therapies used to manage MS and in comparison with symptom management alone, the use of COPAXONE® was the best strategy in terms of outcomes and costs," said Kenneth Johnson, M.D., professor of Neurology and director of the Maryland Center for Multiple Sclerosis, School of Medicine, University of Maryland. "A treatment that reduces relapses or slows the progression of disability, as measured by the Expanded Disability Status Scale (EDSS), may assist in lowering resource utilization and in turn help to offset the cost of therapy," Johnson added.

Cost-effectiveness and cost-utility analyses are useful tools for assessing the relationship between added costs and potential benefits (e.g., improved patient outcomes) of therapies. Previous economic models made assumptions regarding the impact of IFN-(beta) on treatment effects (e.g., constant treatment effects over time) because of data limitations, which also made it difficult to examine the impact NAbs have on cost-effectiveness, as they may inhibit the effectiveness of IFN-(beta) treatment. The model used in the present analysis assumed that NAbs would impact the probability of relapse only after the second year of continuous interferon treatment and therefore potentially negatively affect treatment cost and outcomes for therapies susceptible to the development of NAbs.

"The development of NAbs have been shown to reduce the efficacy of IFN-(beta) therapies on magnetic resonance imaging (MRI) outcomes, relapse rate and disability progression, which in turn may affect the cost and outcomes associated with these therapies," Johnson said. "Although the results of this study provide decision makers with relevant data to evaluate the cost-effectiveness of immunomodulatory treatments versus symptom management in treating RRMS, it is important to consider the results in context, given that head-to-head randomized clinical trials comparing the immunomodulatory therapies are necessary to validate the projections from the pharmacoeconomic analyses."

About the Study

A literature-based Markov model was developed to estimate the economic outcomes of five treatment strategies: symptom management (e.g., physical therapy/exercise and pharmacological treatment) alone and symptom management combined with COPAXONE® (glatiramer acetate injection), IM-IFN(beta)1-a (Avonex®), SC-IFN(beta)1-a (Rebif®), or SC-IFN(beta)1-b (Betaseron®) in patients diagnosed with RRMS. This is the first economic model in MS to incorporate long-term data on treatment effects, account for differences among clinical trial designs of the immunomodulatory therapies and present the results in terms of cost-utility and cost-effectiveness. The model design took into account disease modifying therapy (DMT) acquisition costs, state-specific MS-related medical costs and the cost of lost worker productivity.

The analysis found that the total cost per patient over the time horizon of a patient's lifetime for COPAXONE® was estimated to be 34.7 percent, 16.8 percent and 14.5 percent less than Rebif®, Betaseron® and Avonex®, respectively. Sensitivity analyses showed the results to be sensitive to changes in health state utilities, the percentage reduction in disease progression rates as measured by EDSS in the first two years of therapy used to estimate immunomodulatory therapy treatment effects, model time horizon and immunomodulatory therapy acquisition costs.

The authors of this study note that limitations included reliance on clinical trial data, no inclusion of cost and utilities associated with adverse events, assumptions surrounding the discontinuation and switching of therapies and estimation of clinical outcomes, lack of sufficient head-to-head clinical trials and clinical trial relapse rate criteria associated with this analysis.

About MS

MS is a chronic neurodegenerative inflammatory disease of the central nervous system with an overall prevalence rate of approximately 400,000 people. The annual cost of MS (in 1994 $US) is estimated to be between $6.8 and $13.6 billion, composed largely of indirect costs for formal/informal care and lost earnings. Previous research finds that costs associated with MS rise at an exponential rate with increasing MS disability levels.


Current data suggest COPAXONE® is a selective MHC class II modulator. 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 48 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd (NASDAQ:TEVA ). COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the 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. Close to 90 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.

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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 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, 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® and Neurontin®, 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, 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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Source: Teva Pharmaceutical

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