BioWorld International Correspondent

BRUSSELS, Belgium - ThromboGenics, the Leuven, Belgium-based firm focused on vascular disease, announced Dec. 6 it is licensing its THR-100 thrombolytic to Bharat Biotech International Ltd.

The deal covers manufacturing, clinical development and commercialization of the product, a novel variant of recombinant staphylokinase, in developing countries and certain industrialized countries.

THR-100 has been developed for acute myocardial infarction and other vascular diseases based on its ability to dissolve blood clots. It has completed Phase II trials in Europe in more than 140 patients for AMI, and has demonstrated efficacy equivalent to tissue plasminogen activator, at significantly lower patient cost, and superior efficacy to both streptokinase and urokinase. Various forms of recombinant staphylokinase have been administered to more than 900 patients for several thrombolytic indications, confirming its fibrin specificity.

The company said that THR-100 also has demonstrated superior efficacy to streptokinase with reduced antigenicity. In addition, THR-100 can 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.

Professor Désiré Collen, CEO of ThromboGenics, told BioWorld International that to bring the product to the market in Europe or the U.S. would be prohibitively expensive for what would be a relatively cheap medicine, since trials in some 20,000 patients would be required to demonstrate comparative efficacy against tPA.

"But there is an area of real need in Asia, Eastern Europe or South America, where the infrastructure is often lacking for highly interventive therapy with tPA," he said, adding that drugs like tPA are too expensive 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," he said.

Under the agreement, ThromboGenics will transfer its THR-100 technology to Bharat Biotech, of Hyderabad, India, which will become the global manufacturer for the finished drug. With input from ThromboGenics, Bharat 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. ThromboGenics will earn double-digit royalties on net sales, and Bharat will assume responsibility for all future costs.

Professor Collen, who founded the company after developing the first tPA for clinical use at his laboratory in the Catholic University of Leuven, pointed out that THR-100 is only a secondary activity for ThromboGenics, which has been quoted on Euronext Brussels since a successful IPO last July. The company's principal area of current development is microplasmin for stroke, for peripheral vascular occlusion, and, most recently, for vitreoretinal disorders. In November, the FDA completed its review of the investigational new drug application for microplasmin intraocular injection, considering the proposed trial safe to initiate.

Jean Marie Stassen, senior director, research and development, said the company now has built up a broad pipeline of potential products to ensure continuity, ranging from anticoagulants to platelet agents and growth factors.

"We are not just a one-hit company," he said.