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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."
About ThromboGenics
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
ThromboGenics
Prof. Desire Collen, CEO
Tel: +32-0-16-34-61-94
Stuart Laermer, Chief Business Officer
Tel: +1-212-201-0920
Bharat Biotech International Limited
Dr. V. Krishna Mohan, President
Tel: +91-40-2348-0567
Citigate Dewe Rogerson
David Dible / Valerie Auffray
Tel: +44-0-207-638-95-71
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