Healthcare Industry News:  Betaseron 

Biopharmaceuticals Neurology

 News Release - June 20, 2006

COPAXONE(R) Reduced Relapses By 75 Percent in Both Treatment-Naive Multiple Sclerosis Patients and Those Failing Betaseron(R)

More than 80 Percent of All Patients Experienced an Improved or Stable Kurtzke Expanded Disability Status Scale (EDSS) Score

KANSAS CITY, Mo., June 20 (HSMN NewsFeed) -- Both relapsing-remitting multiple sclerosis (RRMS) patients switching from Betaseron® (interferon beta-1b) to COPAXONE® (glatiramer acetate injection) and treatment-naive RRMS patients achieved reductions in relapse rate compared to those experienced in the two years prior to study entry, according to a recent study published in Acta Neurologica Scandinavica. In this study, COPAXONE® was shown to reduce annual relapse rate by 75 percent in both patients switching from Betaseron® and in patients who were treatment-naive; a high proportion of patients remained relapse free (treatment-naive, 69.5 percent; prior interferon beta-1b, 68.4 percent) for the entire trial duration of 3.5 years. In addition, the majority of patients (>80 percent in both cohorts) demonstrated an improved or stable Kurtzke Expanded Disability Status Scale (EDSS) score (a measure of neurological disability) over the course of COPAXONE® treatment.

"The importance of using immunomodulatory treatment to manage disease activity and disability in RRMS is already established," said Howard Zwibel, M.D., Medical Director of Baptist Health Doctors Hospital Multiple Sclerosis Center and the primary investigator of this study. "In this study, treatment with COPAXONE® showed clinical benefit, both to patients who had failed treatment with Betaseron® and as a first-line option for patients who were new to treatment with disease modifying drugs."

About the Study

In this 3.5 year, prospective, open-label study, a total of 805 RRMS patients were divided into two patient cohorts. One cohort consisted of patients who had previously taken Betaseron® (prior IFNB-1b cohort, n=247), had discontinued due to lack of efficacy or tolerability and were switched to COPAXONE® (glatiramer acetate injection), and the other cohort included patients who were treatment-naive upon entering the study (treatment-naive cohort, n=558) and initiated therapy with COPAXONE®.

Baseline characteristics differed between the two patient cohorts; patients in the prior INFB-1b cohort were older, showed signs of more advanced disease and had higher baseline EDSS scores than patients in the treatment- naive cohort. Mean COPAXONE® (glatiramer acetate injection) treatment duration was 14.8 (prior INFB-1b cohort) and 20.3 months (treatment-naive cohort).

Compared with the two years prior to study entry, annual relapse rates decreased by 75 percent in both the prior INFB-1b cohort (0.42+/-0.84) and the treatment-naive cohort (0.34+/-0.71), (p=0.1482). A high population of patients in the trial remained entirely relapse free; 68.4 percent of prior IFNB-1b patients (n=169) and 69.5 percent of treatment-naive patients (n=388), (p=0.9). For patients who remained relapse free, the mean duration of COPAXONE® treatment was 453 and 565 days in the prior IFNB-1b and treatment- naive cohorts, respectively.

Data from the last available neurological assessments of patients in this trial indicated that more than 80 percent of patients in the prior INFB-1b and treatment-naive cohorts had "stable or improved" EDSS scores compared with EDSS scores at study entry (defined as an increase of less than 1.5 points overall). Fewer than 10 percent of patients in either cohort experienced protocol-defined sustained progression of disability; thus, patients in the prior IFNB-1b cohort received significant therapeutic benefit from COPAXONE® despite more advanced disease and less mean treatment duration with COPAXONE®. Furthermore, regardless of entry EDSS scores, at both 12 and 18 months into the trial and at last observation, mean changes in EDSS were less than 0.5 steps in both cohorts.

"COPAXONE® (glatiramer acetate injection) was effective, well-tolerated and safe in this study," said Dr. Zwibel. "The efficacy results shown here are similar to the results of another recent treatment-switch study published in June 2006 in the European Journal of Neurology, where data showed that patients who switched from Avonex® (interferon beta-1a) to COPAXONE® experienced a significant decrease in relapse rate as well as sustained or improved EDSS scores."

Adverse events reported during COPAXONE® treatment (any causality) were similar in type and frequency between study cohorts. The most frequently reported adverse event was local injection-site reaction, which was reported by 61.5% of patients in the treatment-naive cohort and 38.5% of patients who received prior therapy with IFNB-1b. More than 97% of injection-site reactions in both cohorts were rated as mild or moderate in severity. Overall, 16 percent of patients reported an immediate post-injection reaction (IPIR).

There was no apparent difference between study cohorts in patients' reasons for discontinuing participation in the study; the most frequently cited reason was patient decision. Of the 88 patients (treatment naive, n=61; prior IFNB-1b, n=27) who discontinued the study due to adverse effects, 30 reported an injection-site reaction; 11 discontinued due to a transient, self- limited IPIR.

About COPAXONE®

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, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 44 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.

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. Over 80% of Teva's sales are in North America and Europe.

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.


Source: Teva Pharmaceutical

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