Healthcare Industry News:  sanofi-aventis 

Biopharmaceuticals Neurology

 News Release - October 25, 2007

New Long-Term Analysis of Clinical Treatment Outcomes Demonstrated COPAXONE(R) is More Cost Effective Than Tysabri(R) for Treatment of Relapsing-Remitting Multiple Sclerosis

Markov Model Updated to Include Tysabri(R)

KANSAS CITY, Mo.--(HSMN NewsFeed)--In a Markov cost-effectiveness model, a comparison of the long-term economic outcomes associated with COPAXONE® (glatiramer acetate injection), and Tysabri® (natalizumab) combined with symptom management versus symptom management alone demonstrated that COPAXONE® was less costly and more effective over a patient’s lifetime than Tysabri® for relapsing-remitting multiple sclerosis (RRMS). Results, announced today at the 10th Annual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) congress in Dublin, Ireland, incorporate Tysabri® in an analysis of an updated Markov model previously published in the Journal of Managed Care Pharmacy in April 2007.

This is the first cost-effectiveness model comparing COPAXONE® and Tysabri® for treatment of multiple sclerosis (MS) to take into consideration long-term treatment outcomes, where available, effects on employment productivity and the effects of neutralizing antibodies (NAbs). Results from this analysis show incremental cost per quality-adjusted life years (QALY) for patients on COPAXONE® and Tysabri® compared to symptomatic treatment alone was $208,879, and $525,463, respectively.

“The results are consistent with the previously published analysis of this Markov model, which evaluated use of COPAXONE® and the beta interferons compared to symptom management alone for the treatment of relapsing-remitting MS. Both analyses demonstrated that in the presence of long-term treatment outcomes, COPAXONE® was the preferred treatment strategy in terms of outcomes and costs,” said MerriKay Oleen-Burkey, Ph.D., Director, Health Outcomes Research at Teva Neuroscience, Inc. “COPAXONE® continues to show its value in reducing relapses and slowing detrimental change in EDSS, a measure of disability. Now we can confidently say in this model, it’s less costly and more effective over a patient’s lifetime than other treatments for RRMS.”

Positive neutralizing antibodies (NAbs), is an immune system response to the injection of protein-based products such as Tysabri®, which may inhibit its effectiveness and cause patients to have increased relapses. The model used in the present analysis assumed that NAbs would impact the probability of relapse only after the second year of continuous Tysabri® treatment and thereafter negatively affect treatment cost and outcomes to some degree.

“Cost-effectiveness and cost-utility analyses are useful tools for assessing the relationship between added costs and potential treatment benefits,” stated Dr. Oleen-Burkey. “Although this study offers decision makers with relevant data to evaluate the cost-effectiveness of treatments for RRMS versus symptom management alone, it is important to point out that head-to-head randomized clinical trials comparing the immunomodulatory therapies are necessary to validate the projections from pharmacoeconomic models.”

About the Study

A previously published literature-based Markov model has been updated to include Tysabri®. The updated study estimates the economic outcomes of symptom management combined with COPAXONE® (glatiramer acetate injection) and Tysabri® compared to symptomatic treatment (e.g., physical therapy/exercise and pharmacological treatment) alone in patients diagnosed with RRMS. This new lifetime model considered long-term treatment outcomes where available, the potential impact of NAbs and the effects on employment/productivity. The model design took into account the acquisition costs of the MS therapies, state-specific MS-related medical costs, the cost of lost worker productivity and the additional costs for monitoring, diagnosis and treatment of progressive multifocal leukoencephalopathy (PML), a possible serious adverse event for patients on Tysabri®.

The analysis indicated that COPAXONE® and Tysabri® were both more effective and more costly than symptomatic treatment alone. The total lifetime costs per patient for COPAXONE® were estimated to be 14 percent less than for Tysabri®, their lifetime QALYs were comparable at 9.303 and 9.300, respectively. The incremental cost per QALY versus symptomatic treatment alone was $208,879 for COPAXONE® and $525,463 for Tysabri®. Results demonstrated that COPAXONE® was less costly and more effective than Tysabri® in treating MS over a patient’s lifetime.

The authors of this study note that limitations include reliance on clinical trial data, no inclusion of cost and utilities associated with adverse events except PML, assumptions surrounding the discontinuation and switching of therapies and estimation of clinical outcomes, lack of 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. 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 Neuroscience

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