To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Trexall (Methotrexate) For Neoplastic Disease, Psoriasis And Rheumatoid Arthritis URL: http://www.pslgroup.com/dg/1F5E22.htm Doctor's Guide March 22, 2001
POMONA, NY -- March 22, 2001 -- Barr Laboratories, Inc. announced that the U.S. Food & Drug Administration (FDA) has approved the Company's proprietary Methotrexate Tablets USP, 5, 7.5, 10 and 15 mg. This represents the second Barr proprietary product approved by FDA this year. The Company said the product will be marketed under the Trexall™ brand name by DuPont Pharmaceuticals Company, under terms of a product marketing agreement finalized last year. DuPont will begin detailing Trexall directly to target physicians beginning in mid-May 2001. Trexall represents new dosage strengths of an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. "Our higher dosage Trexall product is designed to meet the patient needs of today's treatment trends," said Bruce L. Downey, Chairman and CEO of Barr Laboratories, Inc. "Prior to Trexall's approval, Methotrexate tablets were only available in the 2.5 mg tablet strength. However, some patients must take a dosage of up to 20 mg at one time. Trexall will offer physicians the option of prescribing higher dosage strengths utilizing scored tablets. This should simplify drug therapy and increase patient convenience and compliance." "We are pleased to have an experienced partner in the launch of our second internally developed proprietary product this fiscal year," Mr. Downey continued. "The marketing effort will include physician detailing and product sampling, supplying support materials to physicians, pharmacists and patients and establishing an 800-number and a web-site designed to educate patients and providers about this new treatment choice." "Partnering with well-established sales and marketing forces allows Barr to continue to focus our internal resources on the development of innovative proprietary products," added Mr. Downey. Under the terms of the Company's Proprietary Product Marketing Agreement with DuPont that was finalized in March 2000, Barr will be responsible for manufacturing and trade sales of Trexall and DuPont will assume responsibility for detailing the product to rheumatologists. DuPont will receive royalty payments based on sales during the term of the agreement. Barr's application for this proprietary strength used Lederle Laboratories' Rheumatrex 2.5 mg tablet as the reference drug. The market for Methotrexate in its current form, both brand and generic, totals approximately US$32 million annually. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.