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| |  BeneFIX Hemophilia B Drug Recommended by Advisory Panel CAMBRIDGE, Mass., Dec. 12, 1996 -- A medical advisory panel convened by the U.S. Food and Drug Administration (FDA) unanimously recommended today that the agency license BeneFIX(TM), Coagulation Factor IX (Recombinant), the first recombinant blood clotting therapy for hemophilia B. Developed and manufactured by Genetics Institute, Inc. through biotechnology, plasma-free, albumin-free BeneFIX eliminates the risk of transmitting blood-borne viruses such as hepatitis which have been associated with Factor IX therapies made from human plasma. The panel included in its recommendation that the company conduct post-licensure studies to supplement the data presented today, and also that the labeling contain appropriate dosing guidance. The FDA will consider the panel's recommendations in its ongoing review of Genetics Institute's Biological License Application for BeneFIX. The Company is unable to predict if or when regulatory approval will be granted. An inherited disorder that almost exclusively affects males, hemophilia B is caused by a deficiency or defect in Factor IX, one of a number of proteins involved in blood clotting. Factor IX deficiency results in frequent hemorrhages that can be crippling and, at times, life-threatening. The disorder affects about 7,000 people in North America, Europe and Japan (approximately 3,000 patients in the U.S.). As a result of viral contamination from earlier plasma-derived clotting therapies, over 20% of U.S. hemophilia patients are HIV positive and over 70% have hepatitis. Since BeneFIX is made through recombinant technology, without the addition of blood or plasma products, it eliminates the risk of potential blood-borne viral contamination. Further, the supply of BeneFIX does not depend on blood donors. Genetics Institute expects to be able to manufacture product at levels sufficient to meet worldwide demand. Genetics Institute scientists today presented clinical and other data demonstrating to the advisory panel the safety and effectiveness of BeneFIX. The clinical trials indicated that BeneFIX has a favorable safety and efficacy profile. The adverse reactions reported in the BeneFIX clinical trials were comparable to those associated with other Factor IX products. The same data are being used for applications to the Canadian Health Protection Branch and the European Medical Evaluation Agency. Genetics Institute (Nasdaq: GENIZ) is a leading biopharmaceutical firm engaged in the discovery, development, and commercialization of human pharmaceuticals through recombinant DNA and other technologies. American Home Products Corporation (NYSE: AHP) holds a majority interest in Genetics Institute. AHP is one of the world's largest research-based pharmaceutical and health care products companies, and is a leading developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It is also a leader in vaccines, generic pharmaceuticals, biotechnology, agricultural products, animal health care, medical devices and food products. The statements in this release that are not historical facts are forward-looking statements that involve risks and uncertainties, including, without limitation, the discovery, timely development and acceptance of new products and technologies; the achievement of product development milestones by the Company's collaborative partners and licensees; the impact of competitive products; the timely receipt of regulatory clearances required for clinical testing, manufacturing and marketing of products; the regulation of the Company's business generally; the ability to match manufacturing capacity to product demand; the disposition of legal proceedings involving patents and other matters; and the other risks and uncertainties detailed from time to time in the Company's periodic reports, including quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may differ from the forward-looking statements.
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