Tuesday December 1, 8:14 am Eastern Time
Company Press Release
SOURCE: Genzyme Transgenics Corporation
Genzyme Transgenics Receives United States Patent for Transgenic Production of Antithrombin III in Goat's Milk
Transgenically-Produced Anti-Clotting Therapeutic in Phase III Clinical Trials
FRAMINGHAM, Mass., Dec. 1 /PRNewswire/ -- Genzyme Transgenics Corporation (Nasdaq: GZTC - news) was today granted U.S. Patent 5,843,705, ''Transgenically Produced Antithrombin III'' by the United States Patent and Trademark Office. The patent covers recombinant human antithrombin III (rh AT III) produced in the milk of transgenic goats. Currently in phase III clinical trials in Europe and the United States, rh AT III is Genzyme Transgenics' lead product.
''This patent provides Genzyme Transgenics exclusive rights for the production of rh AT III in the milk of transgenic goats,'' said Sandra Nusinoff Lehrman, Genzyme Transgenics' president and chief executive officer. ''The patent also grants composition of matter exclusivity with regard to unique molecular and pharmacological properties of Genzyme Transgenics' rh AT III.''
Plasma-derived rh AT III is currently sold in Europe and Japan for acquired AT III deficiency, which occurs in a broad range of disorders, including cardiopulmonary bypass (CPB)-induced deficiency, sepsis, and organ transplantation, among others. In the United States, plasma-derived AT III is marketed for the treatment of hereditary AT III deficiency. Genzyme Transgenics believes that the recombinant form of AT III may have several advantages over plasma-derived AT III, including greater pricing flexibility and an enhanced safety profile.
Following successful completion of phase I and II clinical trials, Genzyme Transgenics and Genzyme General [Nasdaq:GENZ - news] initiated three phase III pivotal studies with rh AT III in May 1998. Two identical trials are underway evaluating rh AT III's safety and efficacy in patients scheduled for surgery requiring cardiopulmonary bypass (CPB). A third trial is designed to measure transgenically-produced rh AT III comparability to plasma-derived AT III. Genzyme Transgenics and Genzyme General have formed a joint venture to develop and commercialize rh AT III worldwide, excluding Asia. In Asia, the product is being developed by a joint venture established between Genzyme Transgenics and Sumitomo Metals, Inc.
Genzyme Transgenics Corporation applies transgenic technology to enable the development and production of recombinant proteins and monoclonal antibodies for medical uses. Primedica Corporation, Genzyme Transgenics' contract research organization, provides preclinical development and testing services to pharmaceutical, biotechnology, medical device, and other companies.
Genzyme Corp. develops and markets therapeutic and surgical products and diagnostic products and services. A division of the biotechnology and health care products company Genzyme Corp., Genzyme General has its own common stock intended to reflect its value and track its performance.
Genzyme Corp. owns approximately 41 percent of the outstanding stock of Genzyme Transgenics and has allocated these shares to Genzyme General.
This news release contains forward-looking information, including statements about potential indications for rh AT III and the potential advantages of rh AT III over plasma-derived AT III. Actual results may differ materially from these projections depending on clinical trial results, the actual safety profile of rh AT III, the timing and content of decisions made by the U.S. Food and Drug Administration, the accuracy of the companies' market research and information about potential new indications, the availability of third-party reimbursement for rh AT III, and market acceptance of rh AT III.
SOURCE: Genzyme Transgenics Corporation |
