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Long-Term Data Demonstrated Significantly Better Patient Adherence to COPAXONE(R) versus Interferons in Multiple Sclerosis Treatment.


COPAXONE([R]) Patients Also Demonstrated Robust Response at Six Years

KANSAS CITY, Mo. -- A retrospective follow-up analysis of an ongoing prospective study of 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
) patients (n=285) taking immunomodulatory therapies (IMTs), found that after six years more than half of the patients (41/79) taking 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) had remained on treatment continuously, whereas less than thirty percent of patients (55/206) taking one of the 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  (IFN-[eth]) class of drugs remained in the study (p< 0.0001). The study, which included patients receiving either COPAXONE([R]), Avonex([R]) (IFN-[eth]-1a IM), Betaseron([R]) (IFN-[eth]-1b SC), or Rebif([R]) (IFN-[eth]-1a SC), was presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS ECTRIMS European Committee for Treatment and Research in Multiple Sclerosis ), in Madrid, Spain.

The results of this follow-up analysis reinforced and extended the four-year results presented at the 15th Meeting of the European Neurological Society (ENS) in 2005, which demonstrated better adherence in COPAXONE([R]) patients versus those taking interferon therapies.

"The significantly higher treatment adherence rate demonstrated by COPAXONE([R]) patients in this study, coupled with a robust response to treatment, may be meaningful to clinicians when it comes to recommending an initial IMT IMT,
n.pr See inspiratory muscle training.
 to patients," said Dr. Judith Haas, Head of the Department of Neurology, Jewish Hospital, Berlin, Germany and lead investigator of this study. "Drop-out rates are an excellent surrogate marker surrogate marker Lab medicine A parameter or measured to detect a pathologic condition when a more specific test doesn't exist, is impractical or not cost-effective; surrogate testing has been used for non-A, non-B hepatitis, measuring ALT and antibodies to HBV  of the long-term efficacy of IMTs, and an important consideration in treating RRMS."

In addition to measuring patient adherence to IMTs, the study compared the efficacy of the various treatments, using relapse rate as primary efficacy parameter and the Kurtzke Expanded Disability Status Scale The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis.[1] The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these.  (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
) score as a secondary parameter. Data showed that patients taking COPAXONE([R]) (n=41) had a significantly reduced relapse rate in comparison with Avonex([R])(n=20) (p=0.047). There were no significant differences between therapies in any other primary or secondary endpoints.

About the Study

Researchers in this study conducted a retrospective analysis of an ongoing prospective study of patients (n=285), and compared patients who remained continuously on their original treatments (completers, n=96) to those who switched to another therapy or dropped out of the study (n=189). Within the database, 33 percent of all patients were completers. By treatment, the rate of completers was 52 percent of COPAXONE([R])patients (41/79), 29 percent of Rebif([R]) patients (14/49), 27 percent of Betaseron([R]) patients (21/77), and 25 percent of patients taking Avonex([R])(20/80).

In order to make efficacy comparison from study baseline, only completers were included in the study's efficacy analysis.

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 RRMS. The most common side effects Side effects

Effects of a proposed project on other parts of the firm.
 of COPAXONE([R]) are redness, pain, swelling, itching, or a lump or an indentation in·den·ta·tion
n.
A notch, a pit, or a depression.
 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 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, 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. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

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.

Safe Harbor 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 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 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 the generic versions of Allegra[R], Neurontin[R], Oxycontin Ox·y·con·tin

A trademark for the drug oxycodone.


oxycodone hydrochloride

ETH-Oxydose, OxyContin, OxyFast, Oxy-IR, Oxynorm (UK), Roxicodone, Supeudol (CA)

Pharmacologic class: Opioid agonist
[R] and Zithromax[R], the effects of competition on Copaxone[R] sales, including as a result of the reintroduction of Tysabri[R] 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 The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.

Roughly parallel to the U.S.
 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Clinical report
Date:Oct 3, 2006
Words:1038
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