Jerusalem, September 14, 2001 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced that an interim analysis of its Coral (oral Copaxone) trial showed a trend for a treatment effect in favor of the higher oral dose in patients who were treated for more than a year, although the difference has not reached statistical significance. The independent Data Safety Monitoring Committee (DSMC) that has been monitoring the trial has recommended continuing the trial to its completion by October 2001. As previously reported by Teva, the oral formulation could not be available for commercial use prior to 2003.
Professor Henry McFarland the chairman of the DSMC said, "We are deeply impressed by Teva's commitment to develop the first oral therapy for relapsing remitting multiple sclerosis patients. The trial should provide meaningful insight into the possible effect of the oral treatment. The DSMC recommends that the trial continue to its completion, although there is only a small likelihood that the final results of the study will be different than the interim results."
Prof. Giancarlo Comi, the Chairman of the Clinical Steering Committee said: "We have been very surprised by the relatively few number of relapses during the trial compared to the same patients' relapse rates in the prior year. This may compromise the study's ability to detect a statistically significant effect. After all the information will be analyzed and considering the favorable safety profile, we may recommend to the company to conduct further trials."
Eli Hurvitz, President and CEO of Teva said: "Our business is robust, and we expect to continue to fulfill the market's expectations for the years 2001, 2002, 2003 and beyond. The positive global market environment for generic pharmaceuticals and our significant ANDA pipeline in the U.S. will continue to support our strong growth objectives. While we are disappointed by the interim results we are encouraged by the positive trends seen in the trial. If these trends do not achieve statistical significance at the end of the trial it will take us longer to complete the development of oral Copaxone. The sales of Copaxone in its injectable form continue to grow very nicely. The results of additional clinical and MRI data released recently show why Copaxone is well on the way to becoming the premier therapy for MS."
Mr. Hurvitz added further: "Out of respect for the terrible tragedy that occurred last week, Teva decided to postpone its 100 Anniversary events and celebration. Teva wishes to convey its deepest condolences to the American people and to all of its friends, clients, employees and their families in the United States.
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.
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 current 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 their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, the availability of product liability coverage in the current insurance 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 ("FDA") 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, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, 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 ("SEC"). 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.