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|June 04, 2010 3:36 p.m.|
|Teva Announces Positive Results From a Study Assessing a New Formulation of COPAXONE®|
|Jerusalem, June 4, 2010 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced positive results from a study assessing a new lower-volume injection of Copaxone® (glatiramer acetate) containing the currently approved dose in half the injection volume. |
The SONG study ('Study of New Glatiramer Acetate Formulation') explored the safety and tolerability of a 20mg/0.5mL injection of Copaxone® versus the current formulation of 20 mg/1.0mL. These findings were presented at the 24th Annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in San Antonio, Texas.
"Copaxone® has proven long-term efficacy, safety and tolerability with more than one million patient years of treatment," said Dr. Ronald Murray, FAAN, a lead study investigator and Director of the MS Clinic of Colorado. "We are encouraged by these data as they suggest that a 0.5mL dose of glatiramer acetate may enhance patients' experience with the most frequently prescribed MS therapy."
The SONG study enrolled 148 relapsing-remitting MS patients (RRMS) at 21 sites in the United States. Data demonstrated that both the 1.0mL and 0.5mL products were safe and well tolerated. Patients receiving the lower-volume injection reported significantly less pain immediately following and five minutes after administration (p<0.0001). Although the presence of injection site reactions (swelling, redness, itching, lumps) was not high for either group, patients reported fewer and less severe reactions within five minutes (p<0.0001) and 24 hours (p<0.0001) post-administration with the 20mg/0.5mL product. No serious adverse events were reported in the study.
"Copaxone® is the global market leading RRMS treatment, and Teva is continuously pursuing research focused on further enhancing the patient treatment experience with the product," said Moshe Manor, Teva's Group Vice President, Global Branded Products. "Our investment in research has already translated to increased benefits for Copaxone® patients, including an expanded indication to treat early-stage MS-like symptoms in patients at risk of progression to an MS diagnosis, as well as device improvements such as a thinner needle to reduce injection discomfort and an auto inject device to better facilitate treatment delivery."
About the Study
Patients (N=148) enrolled in an open-label randomized two-arm single crossover study. Half of the patients (n=76) were randomized to inject 20mg/1.0mL daily for the first 14 day period (Period 1); the other half of the patients (n=72) injected 20mg/0.5mL daily during Period 1. During the second 14 day period (Period 2), the groups switched their injection volume formulation. Patients completed a daily diary reporting pain occurring immediately and at 5 minutes post injection, as well as the presence and severity of injection site reactions within 5 minutes and 24 hours of injection. Safety, tolerability, clinical and laboratory assessments occurred during the course of the study. Adverse events were reported by 12.5 percent of patients when injecting 20mg/1.0mL and by 18.1 percent of patients when injecting 20mg/0.5mL. Overall, the AE profile of Copaxone in patients treated with either formulation was consistent with Copaxone's observed safety profile in placebo-controlled pivotal trials and post-marketing experience.
Copaxone® (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in RRMS, 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® is now approved in 51 countries worldwide, including the United States, Canada, Russia, 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. (NASDAQ:TEVA). 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.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.
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 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®, and Protonix®, current economic conditions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on our innovative products, especially Copaxone® sales, dependence on the effectiveness of our patents and other protections for innovative products, especially Copaxone®, the impact of consolidation of our distributors and customers, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, our ability to achieve expected results though our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the uncertainty surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, the regulatory environment and changes in the health policies and structures of various countries, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, the effects of reforms in healthcare regulation, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, potential tax liabilities that may arise should our agreements (including intercompany arrangements), be challenged successfully by tax authorities, our ability to successfully identify, consummate and integrate acquisitions and other business combinations (including our pending acquisition of ratiopharm), the potential exposure to product liability claims to the extent not covered by insurance, our exposure to fluctuations in currency, exchange and interest rates, as well as to credit risk, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, our ability to enter into patent litigation settlements and the increased government scrutiny of our agreements with brand companies in both the U.S. and Europe, the termination or expiration of governmental programs and tax benefits, impairment of intangible assets and goodwill, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2009, in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").