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 production technology from one company to another, or from one country to another, can be a complex process. This milestone proves the commitment from both sides to use their substantial scientific skills to supply THR-100, a novel recombinant therapeutic, to the developing world. With this successful collaboration, we look forward to moving this unique thrombolytic agent quickly into the clinic and toward commercialization."
Commenting on the technology transfer, Dr. Krishna M. Ella, Chairman and Managing Director of Bharat Biotech, said, "Successful transfer of technology from ThromboGenics to Bharat Biotech is a significant milestone in the development of THR-100 as a novel thrombolytic agent. Bharat Biotech has significant expertise in executing technology transfer processes from U.S. and EU companies. We are highly excited about further clinical development of THR-100 and its commercialization."
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuticals for the treatment of a range of vascular diseases. The Company has several programs in Phase II clinical development including microplasmin, which is being evaluated as a treatment for vitreoretinal disorders and as a thrombolytic agent for vascular occlusive diseases, including acute stroke. ThromboGenics also has one program, TB-402 (Anti-Factor VIII), in Phase I clinical trials, and three other drug candidates in preclinical development with preclinical proof-of-principle demonstrated. ThromboGenics has built strong links with the University of Leuven and has exclusive rights to certain therapeutics developed at the University. ThromboGenics is headquartered in Leuven, Belgium and has subsidiaries in Dublin, Ireland, and New York, U.S. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at http://www.thrombogenics.com.
About Bharat Biotech International Limited
Bharat Biotech International Limited is a multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. The Company, established in 1996, is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. Bharat Biotech is one of the first biopharma facilities in India to be audited and approved by the Korean FDA. Bharat Biotech sprawls over a picturesque campus at Genome Valley, Hyderabad, built with an investment of over US $100 million. The facility's Manufacturing, Control Procedures and Protocols conform to the stringent standards laid down by internationally recognized institutions such as USFDA, UKMCA and WHO. The Company's product line includes INDIKINASE(TM) recombinant Streptokinase, REGEN-D(TM) recombinant Epidermal Growth Factor, TYPBAR(TM) Vi Capsular Polysaccharide Typhoid vaccine, BIOGIT(TM) probiotic yeast, and INDIRAB(TM) anti-rabies vaccine. Bharat Biotech also has a strong pipeline of vaccines to combat Malaria, Rotavirus and Japanese Encephalitis. More information is available at http://www.bharatbiotech.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the prospectus.
For further information, please.contact
Prof. Desire Collen, CEO
Stuart Laermer, Chief Business Officer
Bharat Biotech International Limited
Dr. V. Krishna Mohan, President
Citigate Dewe Rogerson
David Dible / Valerie Auffray
|SOURCE ThromboGenics NV|
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