Genzyme Transgenics Receives Milestone Payment for Completion of Purification Facility
First US Purification Facility for Transgenically-Produced Therapeutics
FRAMINGHAM, Mass., Jan. 8 /PRNewswire/ -- Genzyme Transgenics Corporation (Nasdaq: GZTC - news) announced today that it has received a $2.0 million milestone payment from SMI Genzyme Ltd. (SMIG). The payment was triggered by a successful independent audit of Genzyme Transgenics' recombinant human antithrombin III (rhATIII) production facility, which has been designed to produce commercial quantities of rhATIII.
''We have achieved a critical milestone toward the launch of rhATIII, the completion of the first U.S. production facility for transgenic recombinant therapeutic proteins,'' said James A. Geraghty, president and chief executive officer of Genzyme Transgenics. ''We are currently producing rhATIII in this plant for use in our phase III pivotal trial scheduled to begin in the first quarter of 1998. The production capacity of the facility, which exceeds 30 kilograms per year, ensures that pending full completion to GMP compliance and FDA approval, we will have adequate ATIII supplies to support product launch and early market demand.''
SMI Genzyme Ltd. is a joint venture between Genzyme Transgenics and Sumitomo Metals formed in 1990 to develop transgenic technology and specifically, recombinant human ATIII in the milk of transgenic goats.
Genzyme Transgenics Corporation announced the results of its rhATIII phase II clinical trial in December, 1997. Analysis of these data confirmed the safety of rhATIII at all administered doses, and supported its ability to affect the anticoagulation response to heparin in patients undergoing coronary artery bypass grafting (CABG). Jerrold Levy, M.D., professor of anesthesiology at Emory University and the trial's principal investigator, reported that administration of rhATIII increased the level of ATIII activity in patients up to 600 percent and resulted in greater inhibition of thrombin activity than could be achieved with heparin alone.
The phase III trial, expected to begin in the first quarter of 1998, will measure the effect of rhATIII in patients who show an inadequate response to heparin as measured by a standard bedside test for clotting: activated clotting time. A second, simultaneous study will seek to establish the comparability of transgenic-derived rhATIII to plasma-derived ATIII, which is currently approved in Europe for use in acquired ATIII deficiency disorders.
Antithrombin III is a plasma protein that helps regulate blood clotting. It is marketed in Europe for the treatment of inherited and acquired ATIII deficiencies and in the U.S. for hereditary deficiencies. Acquired ATIII deficiency occurs in numerous disease states, including severe burns, septicemia, liver disease, disseminated intravascular coagulation and vascular surgery. Currently, ATIII is prepared from pooled human blood plasma.
Genzyme Transgenics and Genzyme General believe that transgenically- produced ATIII, which could be produced at volumes greater than those available from plasma sources, may ultimately replace plasma-sourced material. The companies also believe that new applications may increase the potential market for this product.
The current market in Europe and Asia for plasma-sourced ATIII deficiency totals about $200 million.
Genzyme Transgenics applies transgenic technology to enable the development and production of recombinant proteins and monoclonal antibodies for medical uses. The company's contract research organization businesses provide pre-clinical development and testing services to pharmaceutical, biotechnology, medical device and other companies. Genzyme Transgenics is also developing idiotypic vaccines in collaboration with the National Cancer Institute. Genzyme Corp. [Nasdaq:GENZ - news] owns approximately 43 percent of the outstanding stock of Genzyme Transgenics and has allocated these shares to Genzyme General.
This news release contains forward-looking statements based on current management expectations, including statements about the commencement of the rhATIII pivotal clinical trials and the potential therapeutic utility of rhATIII.
Actual results may differ materially from these projections depending on the timing and content of decisions made by the U.S. Food and Drug Administration.
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SOURCE: Genzyme Transgenics |
