Hawthorne, NY, January 8, 2002 – Taro Pharmaceutical Industries Ltd. (NASDAQ/NMS: TARO) reported today that its UK subsidiary, Taro Pharmaceuticals (UK) Ltd., has received approval from the United Kingdom Medicines Control Agency for Taro’s Marketing Authorization Applications for Warfarin Tablets.
The approvals cover Warfarin Tablets in all four strengths currently in use in the UK, 0.5 mg, 1 mg, 3 mg, and 5 mg. Taro’s Warfarin Tablets are bioequivalent to Goldshield’s Marevan® brand of warfarin tablets. The annual UK market for warfarin tablets was estimated by industry sources to be approximately US$30 million.
Taro plans to use the UK authorization to seek approval for its Warfarin Tablets throughout the European Union. Taro currently markets Warfarin Tablets in nine strengths in the U.S., Canada, and Israel. The Company has manufactured Warfarin Tablets in Israel for over 40 years under the brand name Coumadin®* and will market Warfarin Tablets in the UK under the generic name.
Warfarin is an anticoagulant indicated for the prevention and treatment of blood clotting disorders, and is used in the prevention of thromboembolic complications associated with heart attacks and certain rhythm disorders of the heart such as atrial fibrillation.
Expanding Taro’s UK Product Line
“Taro has been manufacturing Warfarin Tablets for more than 40 years, and patients in the UK can now benefit from this affordable, high-quality medication,” said Barrie Levitt, M.D., F.A.C.C., Chairman of the Company.
Taro markets other prescription medications in the UK, including the anticonvulsant Teril® (carbamazepine) Retard, a generic equivalent to Novartis’ Tegretol® Retard, and several products used in treating hypertension, diabetes and other disorders.
Taro is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
* In Israel, Coumadin® is a registered trademark of Taro Pharmaceuticals U.S.A., Inc. Elsewhere in the world, Coumadin® is a registered trademark of the DuPont Pharmaceuticals Company. There is no affiliation between the two companies.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include comments regarding Taro’s expectations to market Warfarin Tablets in the UK and the Company’s plans to market Warfarin Tablets in Europe. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions, slower than anticipated penetration of new markets, changes in the Company’s financial position, regulatory actions, and other risks detailed from time to time in the Company’s SEC reports, including its Prospectus dated October 1, 2001, and its 2000 Annual Report on Form 20-F.
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