Biotech Values

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Copaxone®/The first innovative drug to be developed in Israel and to receive FDA approval, Copaxone® is a unique immunomodulator therapy for the treatment of Relapsing- Remitting Multiple Sclerosis. Copaxone® is the only non-interferon agent available for MS.

http://www.tevapharm.com/copaxone/

Development

Copaxone® was originally discovered by Professor Sela, Professor Arnon and Dr. Teitelbaum at the Weizmann Institute of Science in Israel. Teva was granted world-wide exclusive license for Copaxone® and became the developer of the product. The efficacy and safety of Copaxone® were demonstrated in three main clinical trials: The first trial, led by Professor M. Bornstein, was performed in a single center, double-blind, placebo controlled trial and included 50 patients.
The second trial was a 2-year, multi-center, randomized, double-blind, placebo controlled trial and was performed in eleven US centers involving 251 patients. This study was led by Professor Kenneth Johnson, Chairman of the Department of Neurology, University of Maryland Medical Center, Baltimore. The third trial, a double-blind, multi-center, multi-country MRI study, involved 29 MS Centers in six European countries and Canada, with the participation of 239 patients. This study was led by Professor G. Comi, Department of Neuroscience, Scientific Institute Ospedale San Raffaele, the University of Milan.


Production

Teva has invested heavily in the preparation of production capacities in two main production sites: the Copaxone® chemical manufacturing facility, a modern, high-tech, computerized manufacturing plant in Netanya, Israel, as well as the fully automated sterile pharmaceutical filling operation in Kfar Sava, Israel. Both are state of the art facilities.

Marketing and Distribution

Copaxone® has been approved for marketing in 47 countries worldwide, including the United States, Israel, Canada, 22 European Union Countries including the new accessors, Switzerland, Australia, Russia, Brazil, and Argentina.

In North America, as of Feb. 2001, under the agreement signed by Teva and Sanofi-aventis, Teva Marion Partners ( TMP) became a wholly owned subsidiary of Teva and was renamed Teva Neuroscience LLC. Teva Marion Partners was formed in 1995 as an equally owned marketing partnership between Teva and Sanofi-aventis, to promote Copaxone® in North America. This role was transferred to Teva Neuroscience which became the flag bearer for marketing Teva's proprietary neurology pipeline in North America. Patients continue to benefit from the many services available from Teva Neuroscience, including MSWatch® site and Shared Solutions™ patient support program. Sanofi-aventis continues to distribute Copaxone® in North American while keeping the existing mutual economic benefits.

In Europe and other international markets, a strategic alliance was formed between Teva and Sanofi-aventis in the marketing of injectable Copaxone®, joining efforts towards the registration and preparation of the marketing infrastructures of Copaxone® in most of Europe's major markets. The distribution is done by Sanofi-aventis.

In addition to providing a solution for the marketing of Copaxone®, a unique aspect of the strategic alliance with Sanofi-aventis is that it enables Teva to lay foundations for its own marketing infrastructure for future products now in development.

Copaxone® was approved for marketing in the U.K. in August 2000, and launched in December. This first approval in a major European market enabled Teva to file for approval all over the European Union under the mutual recognition procedure. Teva has prepared the filing under the European Mutual Recognition Procedure to make Copaxone® available in the remainder of the European Union. The U.K. agreed to act as the reference member state. The successful completion of this procedure enabled Teva to launch Copaxone® in the E.U. toward the end of 2001.


Pre-filled syringe (PFS)
In 2002, Copaxone® was launched as Pre-filled syringe (syringe ready for injection) in USA.
In 2004 Copaxone® was launched as Pre-filled syringe in most of the European markets. The Pre-filled syringe is gradually being launched in other markets.


Commitment
Teva and its marketing partners recognize that multiple sclerosis encompasses more than drug therapy alone. While the company is working to bring this emerging therapy to market, it is also dedicated to working with the multiple sclerosis community to develop solutions that address the far-reaching implications of the disease. As part of this commitment, Teva currently supports a variety of programs and services for the multiple sclerosis community.

See also R&D

For further information: www.copaxone.com