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15 European Countries Agree to Approve Copaxone, Announces Teva Pharmaceutical and Aventis Pharma; Initial Launches Scheduled for Fourth Quarter 2001.


Business Editors

JERUSALEM, Israel--(BUSINESS WIRE)--Aug. 7, 2001

Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in  Ltd. (Nasdaq: TEVA) and Aventis Pharma AG, the pharmaceutical company of Aventis (NYSE NYSE

See: New York Stock Exchange
: AVE) announced today that 15 European countries agreed to approve Copaxone(R) (glatiramer acetate glatiramer acetate (glahtear´a-meer as´tāt),
n a medication used to decrease or stop a relapse of multiple sclerosis.
) for the reduction in frequency of relapses in patients with relapsing-remitting multiple sclerosis. Copaxone(R) will be marketed in Europe by Teva Pharmaceuticals and Aventis Pharma.

Following the successful completion of the Mutual Recognition Procedure(MRP (Material Requirements Planning) An information system that determines what assemblies must be built and what materials must be procured in order to build a unit of equipment by a certain date. ) in Europe, Copaxone(R) will be launched in the various countries in Europe, starting in the last quarter of 2001 after granting of national marketing authorizations. Among the first launch countries will be Germany with the largest population of MS patients in Europe.

As first-line therapy, Copaxone(R) will offer patients with Multiple Sclerosis a new treatment option. Copaxone(R) is a new class of disease modifying therapy that has been shown in controlled clinical trials controlled clinical trial,
n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo.
 to be effective and generally well-tolerated (Johnson et al, V 50, March 1998). Copaxone(R) has also clearly shown important reductions in relapse rates and significant effect on magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures.  (MRI 1. (application) MRI - Magnetic Resonance Imaging.
2. MRI - Measurement Requirements and Interface.
) monitored activity and burden of disease. Copaxone(R) has demonstrated continued efficacy over six years. In clinical trials, treatment with Copaxone(R) has not been associated with evidence of the development of neutralizing antibodies. Furthermore, Copaxone(R) is the only drug available for patients who do not benefit from or cannot tolerate beta-interferon.

Copaxone(R) was approved in the U.S.A. in 1996 followed by 22 other countries including Canada, Israel, Australia, UK and Switzerland. In Europe, the U.K. was the reference member state in the MRP, based on its marketing authorization granted to Copaxone(R) in August 2000.

Copaxone(R) is the fastest growing MS therapy in the United States with a market share of 26% of total prescriptions (IMS (1) See IP Multimedia Subsystem.

(2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS.
 June 2001). Copaxone(R) is growing at more than twice the rate of the MS market.

Over 4000 Patients in Europe have already been receiving Copaxone(R) treatment for several years, through different programs, including compassionate use compassionate use Pharmacology The use of an agent to treat Pts for whom conventional therapies have failed, or for whom no other drug exists; CU refers to the use of an agent on humanitarian grounds before it has received regulatory–FDA–approval  programs. It is estimated that there are at least 150,000 relapsing-remitting MS patients in Europe. Although the number of MS patients is similar to that of the U.S., the untreated MS population in Europe is about twice as large.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 40 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are in North America and Europe. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.

Aventis (NYSE: AVE), a world leader in pharmaceuticals and agriculture, is dedicated to improving life through the discovery and development of innovative products. In 2000, Aventis generated group sales Group sales

Block sale (of large amounts) of securities to institutional investors.


group sales

The distribution of a new security issue to institutional clients.
 of 22.3 billion euros and employed approximately 92,500 people in its Pharma and Agriculture businesses. Aventis announced in November 2000 that it intends to focus on pharmaceuticals and plans to divest its activities in agriculture. Aventis was launched in December 1999 through the merger of Hoechst AG of Germany and Rhone-Poulenc SA of France. Corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.

Aventis Pharma AG is the pharmaceutical company of Aventis. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. Aventis Pharma focuses on important therapeutic areas such as cardiology, oncology, infectious diseases, arthritis, allergies and respiratory disorders, diabetes and the central nervous system disorders Nervous system disorders

A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency
. Aventis Pharma has its corporate headquarters in Frankfurt, Germany. Aventis Pharma encompasses Aventis Pasteur, a world leader in vaccines based in Lyon, France, and Aventis Behring, a world leader in therapeutic proteins headquartered in King of Prussia, Pennsylvania For Kings of Prussia, see List of rulers of Prussia

King of Prussia is an unincorporated community in Upper Merion Township, Montgomery County, Pennsylvania, United States. As of the 2000 census, its population was 18,511.
, USA.

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 beliefs and expectations of management. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks and uncertainties that could cause the Company'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 the impact of pharmaceutical industry regulation, the difficulty of predicting FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on a strategy of acquiring companies and on strategic alliances, exposure to product liability claims, dependence on patent and other protections for our innovative products, fluctuations in currency, exchange and interest rates, operating results, and other factors that are discussed in the Company's Annual Report on Form 20-F and the Company's 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 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:4EUGE
Date:Aug 7, 2001
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