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worth noting....Wednesday November 19, 11:08 am Eastern Time
Company Press Release
SOURCE: Barr Laboratories, Inc.
Massachusetts Rejects DuPont Merck Petition to Block Barr's Generic Coumadin; Science Triumphs Over DuPont Merck's Anti-Consumer, Anti-Competitive Efforts
POMONA, N.Y., Nov. 19 /PRNewswire/ -- Barr Laboratories, Inc. (Amex: BRL - news) today hailed the decision by the Massachusetts Drug Formulary Commission on Tuesday evening to reject a petition by DuPont Merck that would have blocked substitution of Barr's Warfarin Sodium, the generic equivalent of DuPont Merck's Coumadin(R) anti-coagulant. The unanimous vote of the Commission members followed testimony by Roger L. Williams, M.D., Deputy Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and a presentation by Joel Neutel, M.D., Director of Research, Orange County Heart Institute, who recently completed an independent clinical study on the interchangeability of Barr's generic Warfarin Sodium with Coumadin.
Dr. Williams testified about the rigorous standards that generic products must meet to receive FDA approval, and told the panel that generic NTI drugs approved by FDA can be substituted with the full expectation by the patient and physician that they will have the same clinical effect and safety profile as the innovator drug. Dr. Neutel explained that his clinical findings demonstrated that Coumadin and Barr's Warfarin Sodium products have equivalent safety and efficacy and that no additional blood tests are required when the products are interchanged. Full details of this clinical trial, which was announced earlier this week, will be submitted for publication in early 1998.
''In Massachusetts, science has spoken to defeat the anti-consumer and anti-competitive actions of DuPont Merck,'' said Bruce L. Downey, Barr's Chairman, President and CEO. ''When presented with clinical and scientific evidence, the Massachusetts scientific body responsible for reviewing drug products and determining if generic substitution is permitted has voted unanimously in favor of preserving consumer access to safe, effective and more affordable generic medicines. This victory confirms the baseless nature of DuPont Merck's monopolistic attempt to have states implement legislation and regulations to block substitution of our generic version of Coumadin.''
Since January of 1997, DuPont Merck has been engaged in an effort to block competition for their Coumadin product, which has been off patent since 1962. In the past ten years, DuPont Merck has increased the price of this increasingly popular therapy by more than 400%.
Barr's Warfarin Sodium product entered the market in late July, and nearly one-quarter of a million prescriptions have been filled since launch. The Company is supporting Warfarin Sodium with an extensive promotional and educational program that includes materials targeted to the physician, pharmacist and patient, as well as trade advertising, direct mail components, and a toll-free number: 1-888-WARFARIN (927-3274) for patients and health care providers.
Barr Laboratories, Inc. is a leading independent developer, manufacturer, and marketer of high quality generic pharmaceuticals.
SOURCE: Barr Laboratories, Inc.
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