ThromboGenics Announces License Agreement with Bharat Biotech for Novel Thrombolytic Agent
ThromboGenics NV announced that it has completed a license agreement with Bharat Biotech International Limited for manufacturing, 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 treatment 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.
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