Transfer Paves the Way for the Phase III Clinical Development and
Commercialization of THR-100 in Developing Countries
LEUVEN, Belgium, September 4 /PRNewswire/ -- ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on vascular disease, today announced the successful completion of the technology transfer to Bharat Biotech International Limited (Hyderabad, India) for the manufacture of THR-100, a novel variant of Recombinant Staphylokinase.THR-100 is a thrombolytic agent developed for the treatment of acute myocardial infarction (AMI or heart attack) and other vascular diseases, based on its ability to dissolve blood clots.
ThromboGenics had earlier (December 6, 2006) announced the completion of a license agreement with Bharat Biotech to manufacture, develop and commercialize THR-100 as a replacement for established thrombolytics, such as streptokinase and urokinase, in developing countries. THR-100 has completed Phase II clinical trials in Europe for treatment of AMI, and is expected to enter Phase III in India later this year.
With this announcement, ThromboGenics has completed the successful transfer of its robust, proprietary and scaled-up process for the production of THR-100, a recombinant protein. Bharat Biotech will use its manufacturing capabilities, along with technological expertise acquired from ThromboGenics, to produce clinical-grade material for upcoming clinical trials. By absorbing the THR-100 manufacturing technology at different scales, while maintaining required yield and purity, Bharat Biotech has demonstrated its ability and capacity to produce this recombinant protein with the desired performance, quality and cost-effectiveness.
Prof. Desire Collen, CEO of ThromboGenics, commented on today's
announcement: "We are pleased that ThromboGenics and Bharat Biotech have
successfully completed the technology transfer needed for the production of
THR-100. Transfer of biopharmaceutical
|SOURCE ThromboGenics NV|
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