Healthcare Industry News: sanofi-aventis
News Release - October 25, 2007
Study Showed Patients Using COPAXONE(R) Had Significantly Lower Risk of Relapse and Lower Medical Costs Compared to Patients Using Rebif(R) in Relapsing-Remitting Multiple Sclerosis (RRMS)Continuous Use Patients Treated With COPAXONE(R) Experienced Pronounced Results
KANSAS CITY, Mo.--(HSMN NewsFeed)--A retrospective study comparing outcomes of relapsing-remitting multiple sclerosis (RRMS) patients treated either with COPAXONE® (glatiramer acetate injection) or high-dose interferon beta-1a (Rebif®)demonstrated that patients continuously treated with COPAXONE® had a significantly lower risk of relapse (p=0.0049) and experienced significantly lower two-year total medical costs (p<0.0001) than those continuously treated with interferon beta-1a (Rebif®).
The results of the study, “A Comparison of Outcomes Among Multiple Sclerosis Patients Treated with Glatiramer Acetate Injection or High-Dose Interferon Beta-1a,” were presented on October 22, 2007, at the 10th European International Society for Pharmacoeconomics and Outcomes Research (E-ISPOR) meeting, in Dublin, Ireland. The study analyzed medical claims of patients (n=845) from United Healthcare to examine the association between use of a drug and two-year direct medical costs and risk of relapse.
“Medical costs are an increasingly important factor in treating a chronic disease such as multiple sclerosis,” said MerriKay Oleen-Burkey, PhD, director of Outcomes Research at Teva Neuroscience and study investigator. “Findings of this study not only indicated that COPAXONE® provided patients with a significant treatment benefit by lowering risk of relapse, but lowered the financial burden associated with the disease, in terms of medical costs,” Oleen-Burkey added.
About the Study
In the retrospective database analyses of United Healthcare medical claims for the time period from September, 2001 to June, 2006, multivariate regressions were used to examine the association between the use of COPAXONE® and interferon beta-1a (Rebif®) and two-year direct medical costs and relapses. The study analyzed both intent-to-treat (ITT) (n=845) and continuous use (CU) (n=410) patient cohorts. The ITT cohort included patients with an RRMS diagnosis who initiated therapy on either COPAXONE® or interferon beta-1a (Rebif®), and had continuous insurance overage from 6 months prior to drug initiation through 24 months after drug initiation.
The CU cohort consisted of patients who used the medication of interest within 28 days of the end of the two-year period. Patients who initiated treatment with COPAXONE® (glatiramer acetate injection) in the ITT cohort experienced a significantly lower risk of relapse (odds ratio = 0.543, p=0.0305) and lower two-year direct medical costs ($7,244, p=0.0002) compared to those who began treatment with interferon beta-1a (Rebif®). Patients who were treated with COPAXONE® in the CU cohort experienced a significantly lower risk of relapse (odds ratio=0.213, p=0.0049) and significantly lower two-year total medical costs ($12,098, p<0.0001).
Current data suggest COPAXONE® (glatiramer acetate injection) 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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