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COPAXONE Produced Significantly Greater Reduction in Relapse Rate Compared to Beta Interferon Therapies.


KANSAS CITY Kansas City, two adjacent cities of the same name, one (1990 pop. 149,767), seat of Wyandotte co., NE Kansas (inc. 1859), the other (1990 pop. 435,146), Clay, Jackson, and Platte counties, NW Mo. (inc. 1850). , Mo. -- Robust Treatment Effects Similar to Pivotal Trials Demonstrate Value of Retrospective Database Comparison Studies in Mirroring Clinical Practice

Results from a still on-going independent study published in the European Journal European Journal is a weekly Deutsche Welle (DW) news program produced in English. It is broadcast from Brussels, Belgium and primarily covers political and economic developments across the European Union and the rest of Europe, as well as issues of particular concern to  of Neurology demonstrate COPAXONE(R) (glatiramer acetate glatiramer acetate (glahtear´a-meer as´tāt),
n a medication used to decrease or stop a relapse of multiple sclerosis.
 injection) is associated with lower relapse rates than interferon therapies in patients with relapsing-remitting multiple sclerosis (RRMS RRMS Relapsing/Remitting Multiple Sclerosis
RRMS Rosemont Ridge Middle School (West Linn, Oregon)
RRMS Rocky Run Middle School (Virginia)
RRMS Recoverable Resource Management Services
). Compared to interferon beta interferon beta Fibroblast interferon IFN-β A 20 kD anti-viral protein with 30% 'homology' with IFN alpha, encoded on chromosome 9, produced by fibroblasts in response to viruses or polyribonucleotides  1b (Betaferon(R)), interferon beta 1a (Avonex(R)), and 22 microgram microgram /mi·cro·gram/ (µg) (mi´kro-gram) one millionth (10-6) of a gram.

mi·cro·gram
n.
Abbr.
 interferon beta 1a (Rebif(R) 22), COPAXONE(R) produced a statistically significant greater reduction in annual relapse rates at 24 months after initiation of treatment versus pre-study rates. Additionally, a significantly higher percentage of patients remained on COPAXONE(R) for the duration of the study compared to the beta interferons.

The open-label, non-randomized study, conducted at the Jewish Hospital, Berlin, Germany, evaluated 283 RRMS patients treated for at least six months. Patient numbers per treatment group were as follows: 79 for Avonex(R), 77 for Betaferon(R), 48 for Rebif(R) 22, and 79 for COPAXONE(R). No statistical significance existed between treatment groups at baseline for gender, age, pre-study duration of disease, EDSS EDSS Expanded Disability Status Scale
EDSS Equine Digit Support System
EDSS Executive Decision Support System
EDSS Equipment Deployment and Storage System
EDSS Electronic Document Storage System
EDSS Electronic Data Storage System
EDSS Electronic Document Submission System
 scores, and pre-study two-year relapse rates. Primary efficacy endpoints for the study included annualized annualized

Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared.
 relapse rates compared to pre-treatment baseline and across the four treatment arms, number of relapse-free patients, mean EDSS score changes, and progression rate (number of patients with a change of one step or more on EDSS). Tolerability to study medications was assessed based on dropouts due to absence of perceived efficacy or adverse reactions adverse reactions,
n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration.
.

By the sixth month of the study, all treatments produced statistically significant reductions in annualized relapse rates relative to baseline. No differences were seen in the clinical onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring.  among the therapies. By 12 months, COPAXONE(R) (glatiramer acetate injection) achieved a statistically greater relapse-rate reduction than Betaferon(R), and at 24 months after initiation of treatment, relapse-rate reductions were greater with COPAXONE(R) (-0.81, p less than 0.001) compared to all beta interferons. Although not reaching statistical significance, the percentage of relapse-free patients, 24 months after treatment initiation, was 58.2 percent for COPAXONE(R), compared to 35.4, 45.5, and 45.8 percent for Avonex(R), Betaferon(R), and Rebif(R) 22, respectively. Additionally, there was a trend toward more patients remaining progression-free with COPAXONE(R) (based on a less than one point increase in EDSS); 87.5 percent of COPAXONE(R) patients compared to 74.5, 71.7, and 73.3 percent for Avonex(R), Betaferon(R), and Rebif(R) 22, respectively.

A significantly higher percentage of patients continued COPAXONE(R), due to efficacy perception or lack of side effects Side effects

Effects of a proposed project on other parts of the firm.
 or both, compared to the beta interferons. Highest discontinuation dis·con·tin·u·a·tion  
n.
A cessation; a discontinuance.

Noun 1. discontinuation - the act of discontinuing or breaking off; an interruption (temporary or permanent)
discontinuance
 rates between six and 24 months were observed with Avonex(R); 32.9 percent (26 patients), and the lowest with COPAXONE(R); 8.9 percent (seven patients; p less than 0.001).

Relapse-rate reductions in this comparative study were comparable to those previously reported in phase III placebo-controlled clinical trials with these agents at 24 months relative to baseline, supporting the validity of the observations and conclusions. Specifically, in the placebo-controlled studies, Avonex(R) and Betaferon(R) were associated with 50-percent reductions, Rebif(R) 22 demonstrated a 40-percent reduction, and COPAXONE(R) demonstrated a 60-percent reduction compared to baseline relapse rates. In the current study, relapse-rate reductions compared to pre-treatment baselines were 37 percent for Avonex(R), 34 percent for Betaferon(R), 43 percent for Rebif(R) 22, and 70 percent for COPAXONE(R) at 24 months. These similarities between the phase III trials and this open-label trial open-label trial Clinical research A trial in which doctors and participants know which therapy is being administered. See Blinding.  were noted, in spite of differing pre-study patient characteristics and different clinical courses of placebo groups. This underlines the clinical usefulness of database comparison studies in which the proven efficacy from pivotal studies is mirrored in routine practice.

About COPAXONE(R)

Current data suggest COPAXONE(R) (glatiramer acetate injection) is a selective MHC class II MHC Class II molecules are found only on a few specialized cell types, including macrophages, dendritic cells and B cells, all of which are professional antigen-presenting cells (APCs).  modulator Modulator

Any device or circuit by means of which a desired signal is impressed upon a higher-frequency periodic wave known as a carrier. The process is called modulation. The modulator may vary the amplitude, frequency, or phase of the carrier.
. COPAXONE(R) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE(R) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all the European countries. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in  Ltd. and sanofi-aventis. In North America, COPAXONE(R) is marketed by Teva Neuroscience.

Teva Pharmaceutical Industries Ltd. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: TEVA), headquartered in Israel, is among the top 25 pharmaceutical companies in the world. Close to 90 percent of Teva's sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE(R). COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary 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.

COPAXONE(R) Comparative Efficacy and Safety/Page Four

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement under the U. S. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products (so called "authorized generics") or successfully extend the exclusivity period of their branded products, the effects of competition on Copaxone(R) sales, Teva's ability to rapidly integrate the operations of acquired businesses, including its acquisition of Sicor Inc., regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to completion of appellate litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
, including that relating to Neurontin, 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 Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, 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.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Jun 9, 2005
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