Healthcare Industry News:  Betaseron 

Biopharmaceuticals Neurology

 News Release - August 21, 2006

First Patient Enrolled in Study to Evaluate Impact of Regular Neutralizing Antibody (NAb) Testing on Multiple Sclerosis Treatment Patterns

Largest Study of Its Kind Will Examine Changes in Treatment Management of Tested and Non-Tested Patients Receiving a High-Dose Interferon

KANSAS CITY, Mo.--(HSMN NewsFeed)--Aug. 21, 2006--Teva Neuroscience, Inc., announced today the initiation of the first-ever study designed to examine how the implementation of regularly scheduled interferon beta (IFN-(beta)) neutralizing antibody (NAb) tests in multiple sclerosis (MS) patients receiving high-dose IFN-(beta) therapy ultimately affects treatment patterns, versus the usual care of IFN-(beta) patients. The study, called the NAbs Count Study, began enrollment in approximately 130 centers across the United States with the first patient entering the trial on July 25, 2006.

Studies have shown that the presence of IFN-(beta) NAbs may negatively alter the therapeutic effectiveness of the commercially available IFN-(beta) class of disease modifying drugs commonly used to treat multiple sclerosis, which includes IFN-(beta)-1a SC (Rebif®), IFN-(beta)-1b SC (Betaseron®), and IFN-(beta)-1a IM (Avonex®), and that NAbs developed in five percent to 45 percent of all multiple sclerosis patients treated with these drugs (1, 2, 3). Despite the evidence that patients who develop NAbs are likely to become IFN-(beta) non-responders, and present an increased risk of relapses and disease progression, NAbs testing has not been a part of routine clinical practice (4).

"The initiation of the NAbs Count Study underscores Teva's long-standing commitment to the MS community," said Judy Abdalla, Senior Director Medical Affairs, Teva Neuroscience. "We are excited to be working with some of the top medical centers in the United States to gather information that could provide additional information on what guides multiple sclerosis treatment decisions."

The European Federation of Neurological Societies (EFNS) released guidelines recommending that IFN-(beta) NAbs testing be conducted in all IFN-(beta)-treated MS patients at 12 and 24 months of therapy. The EFNS guidelines also recommend that testing should be repeated in patients who test positive for NAbs and therapy with IFN-(beta) should be discontinued in patients with high titers of NAbs sustained at repeated measurements with 3- to 6-month intervals (5).

About the Study

The NAbs Count Study is a 12-month, randomized, controlled, open-label, parallel group study taking place in approximately 130 study sites in the United States. Patients 18 years of age and older with a diagnosis of MS who have been receiving high-dose IFN-(beta) therapy at approved doses - either Rebif® or Betaseron® - continuously for at least 12 months are eligible. The study is expected to enroll approximately 2,440 subjects.

Patients will be randomized to one of two study groups. One group of patients (Regularly Scheduled NAb Testing Arm) will be scheduled for multiple IFN-(beta) NAb tests (up to 3 NAb tests over a nine-month period) with a follow-up visit at 12 months. The other cohort of patients (Usual Care Arm) will be observed for 12 months under usual care conditions, which typically do not include regularly scheduled NAb tests. As the primary endpoint of the study, researchers will evaluate the differences between study arms in the proportion of subjects whose high-dose IFN-(beta) therapy was changed during a 12-month follow-up period. Patients and health care providers interested in learning more about the study can visit www.clinicaltrials.gov and enter the trial's identifier code of NCT00336557 for more information.

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 rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the expected reintroduction of Tysabri® into the market, 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, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results 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 publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Please see enclosed additional important information.

(1)Avonex® Prescribing Information, www.avonex.com (2)Rebif® Prescribing Information, www.rebif.com (3)Betaseron ® Prescribing Information, www.Betaseron.com (4)Giovannoni G, Goodman A. Neutralizing anti-IFN-{beta} antibodies: How much more evidence do we need to use them in practice? Neurology 2005; 65(1):6-8.

(5)P.S. Sorensen, et al. "Guidelines on use of anti-IFN-(beta) antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFN-(beta) antibodies in multiple sclerosis" European Journal of Neurology 2005, 12: 817-827


Source: Teva Neuroscience

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