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July 11, 2008 3:14 p.m.
Teva Pharmaceutical Industries Ltd. Statement Regarding COPAXONE®
Jerusalem, Israel, July 11, 2008 -
  • Teva believes that COPAXONE® (glatiramer acetate injection) will remain a proprietary, market-leading product for the reduction of relapses in patients with relapsing-remitting multiple sclerosis (RRMS). The Company's intellectual property estate, regulatory filings worldwide and technical and scientific leadership should ensure that COPAXONE® continues to provide a novel, safe and efficacious approach to managing the disease for the foreseeable future.

  • Although attempts may be made, Teva anticipates minimal risk for generic competition over the product's lifecycle, as mitigated by several critical factors. COPAXONE® is protected by multiple patents (seven in the Orange Book) which cover the chemical composition of COPAXONE®, pharmaceutical compositions containing it, and methods of using it. These patents will not expire until May 24, 2014.

  • COPAXONE® is a very complicated product to develop and manufacture. The active ingredient is a complex mixture of polypeptides. Teva's proprietary reaction of the four activated amino acids results in the synthesis of complex mixtures of sequences.

  • The variability and complexity of the composition of the polymers makes any attempt to replicate this formulation extremely difficult at best. Teva is aware from our own research that variations in the synthetic process can cause different sequences to be formed, ultimately compromising the mode of action of the product.

  • Although the mechanism of action of COPAXONE® is not entirely known, it is believed that when injected subcutaneously, COPAXONE® results in a very complex cascade of immunological reactions. After injection, COPAXONE® is very rapidly broken down into its component parts and is rendered undetectable in the body. Typical bioequivalence studies are therefore meaningless. The absence of biomarkers or other surrogate measures of therapeutic activity means that clinical trials would be necessary to determine safety and efficacy. Also, the fact that COPAXONE® is an immunomodulator makes safety aspects based upon potential impurities critical in terms of immunogenicity.

  • Proving sameness of an equivalent formulation would require that the new mixture of polypeptides be characterized through chemical, biological, immunological and safety testing to ensure that the active product ingredient (API) is identical to the mixture of polymers used in COPAXONE®. Currently, the characterization of a glatiramoid product, such as COPAXONE®, is extremely difficult, and therefore it is extremely difficult to prove that two mixtures of this nature are, in fact, the same.

  • Due to the extraordinarily complex chemistry of COPAXONE® and the product's difficult-to-characterize formulation, regulatory agencies including the Food and Drug Administration (FDA) may require that any generic contender meet stringent clinical standards in demonstrating equivalence. In fact, biologics divisions of certain regulatory agencies worldwide have been involved in regulatory reviews of COPAXONE®. Teva anticipates that it would be highly unlikely for a generic contender to prove clinical equivalence without conducting lengthy and large-scale clinical trials to prove safety and efficacy.

  • Currently, there is no known existing chemical substance that would fill the role as a generic competitor for COPAXONE®. Should a generic version of COPAXONE® be developed, and should that generic not intrude on Teva's extensive and rigorously-enforced intellectual property estate, and should that hypothetical formulation prove viable in the expensive, large-scale clinical trials which may be required, a data submission followed by a review by U.S. and/or European regulatory agencies would follow. Experience demonstrates this would require several years. It is important to note that as a new chemical entity, this product would now require an extensive sales and marketing force in order to compete in the marketplace and ensure reimbursement and uptake.

  • Teva is the world's leading manufacturer of generic products and is intimately familiar with the specifics of bringing generic products to market. We are confident that our platform - based on our currently marketed neuroscience products along with our innovative pipeline, ongoing success in securing market exclusivity for large generic launches and our vision for ongoing leadership in the generic, biogeneric and biosimilar markets - will continue to generate substantial value for patients, health care providers and investors worldwide.

About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's 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 percent 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 accurately predict future market conditions, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel®, Famvir® and Protonix®, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, the effects of competition on our innovative products, especially Copaxone® sales, 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, our ability to achieve expected results though our innovative R&D efforts, Teva's ability to successfully identify, consummate and integrate acquisitions (including the pending acquisition of Bentley Pharmaceuticals, Inc.), potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, 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 or revise any forward-looking statement, whether as a result of new information, future events or otherwise.