ThromboGenics Announces License Agreement With Bharat Biotech for Novel Thrombolytic Agent

LEUVEN, Belgium, December 7 /PRNewswire/ --

- Deal Paves Way for Commercialization in Developing Countries

ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on vascular disease, today announced that it has completed a license agreement with Bharat Biotech International Limited (Hyderabad, India) for manufac-turing, clinical development and commercialization of THR-100*, a novel variant of Recombinant Staphylokinase, in developing countries and certain industrialized countries. THR-100 is a thrombolytic agent developed for treatment of acute myocardial infarction (AMI or heart attack) and other vascular diseases based on its ability to dissolve blood clots. In return for granting this license, ThromboGenics will earn double digit royalties on net sales. Bharat Biotech will assume responsibility for all future costs.

THR-100 has completed Phase II clinical trials in Europe for treat-ment of AMI in over 140 patients. In the clinic, THR-100 has demonstrated efficacy equivalent to tPA, or tissue plasminogen activator (considered the "gold standard" for thrombolytic therapy), but at significantly lower patient cost than tPA. THR-100 has also shown superior efficacy to both streptokinase and urokinase, the most commonly used thrombolytic agents in the developing world for the treatment of AMI and other thrombotic conditions.

The objective of the agreement between ThromboGenics and Bharat Biotech is to develop and commercialize THR-100 as a replacement for established thrombolytics, such as streptokinase and urokinase, in developing markets. As part of this license deal, ThromboGenics will transfer its THR-100 technology to Bharat Biotech, which will become the global manufacturer for the finished drug. With input from ThromboGenics, Bharat Biotech will be responsible for developing the commercial manufacturing process, implement a clinical development plan for Phase III trials, and gain marketing authorization to commercialize THR-100, initially in India. Entry into markets outside of India is also planned as part of this alliance.

THR-100 has been shown to be one of the most fibrin-selective plasminogen activators known to date. In clinical trials conducted by ThromboGenics, various forms of recombinant staphylokinase have been administrated to over 900 patients for several thrombolytic indications, confirming its fibrin specificity. THR-100 has also demonstrated superior efficacy to strepto-kinase with reduced antigenicity, or allergic reaction, a common side effect in streptokinase therapy. In addition, THR-100 offers the flexibility to be administered as a single bolus injection (for rapid administration), double bolus injection or continuous intravenous infusion, depending on the clinical indication for which it is used.

ThromboGenics has developed a robust, proprietary, and scaled-up process for production of THR-100, and owns a series of patents on its technology. The company has also created additional proprietary, patent pending, next generation variants of this drug, the rights to which are included in this license.

Commenting on today's announcement, Prof. Desire Collen, CEO of ThromboGenics, said: "We believe that Bharat Biotech, one of India's leading biopharmaceutical companies, will be an excellent partner for bringing THR-100 to market. This agreement is a major step forward in the introduction of an important new thrombolytic therapy in developing regions. Drugs like tPA are too expensive for the average citizen in most parts of the developing world, and existing therapies such as streptokinase and urokinase are only effective at the cost of side effects. It is our belief that THR-100 has the potential to be a vast improvement over existing treatments for heart attack, leading to enhanced health care options in the developing world."

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, has always been a strong believer in the innovation and development of next generation vaccines and therapeutics which address the needs of the developing world and beyond. Bharat Biotech has been at the forefront of this quest by developing and commercializing novel vaccines and therapeutics for the developing world at affordable costs. Commenting on the partnership with ThromboGenics, Dr. Ella said: "ThromboGenics has been on the cutting edge of research and development of new products for vascular diseases. This partnership will help us bring a thrombolytic molecule to the developing world that is comparable in efficacy to tPA at affordable costs. It is an honour for Bharat Biotech to partner with ThromboGenics, and I look forward to further developing this partnership into a successful enterprise."

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 five other drug candidates in preclinical development with preclinical proof-of-principle demonstrated, including TB-402 (Anti-Factor VIII) and TB-403 (Anti-PlGF). The Company 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 Ireland and the U.S. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at www.thrombogenics.com.

About Bharat Biotech International Limited

Bharat Biotech International Limited, Hyderabad, India, is a multidimensional biotech-nology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat Biotech, established in 1996, is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. Bharat Biotech is one of the first bio-pharma facilities in India to be audited and approved by Korean Food & Drug Administration (KFDA). Bharat Biotech sprawls over a picturesque campus at Genome Valley, Hyderabad, built with an investment of over USD 50 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. Bharat has set new benchmarks in innovation and quality that epitomizes the tremendous progress of Indian biotechnology in the global arena.

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.

* formerly known as Sak42D