Hyderabad: BELGIAN biotech firm ThromboGenics has entered into a licence agreement with Hyderabad-based Bharat Biotech International for manufacturing, clinical development and commercialisation of THR-100, a novel variant of recombinant staphylokinase, in developing countries. THR-100 is a thrombolytic agent used for the treatment of acute myocardial infarction (AMI) and other vascular diseases.

As per the pact, ThromboGenics will transfer its THR-100 technology to Bharat Biotech, which will become the global manufacturer for the finished drug. Bharat Biotech will be responsible for developing the commercial manufacturing process, implementing a clinical development plan for phase-III trials, and gaining marketing authorisation to commercialise THR-100, initially in India. The scope of the agreement also includes entry into markets outside India, a company statement said.

In return for granting this licence, ThromboGenics will earn double-digit royalty on net sales while Bharat Biotech will assume responsibility for all future costs.

The Belgian firm also has a proprietary and scaled-up process for the production of THR-100, and owns a series of patents on its technology. The licence also includes rights to ThromboGenics additional proprietary, patent pending, next generation variants of this drug.

THR-100 has completed phase-II clinical trials in Europe for treatment of AMI in over 140 patients. Bharat Biotech chairman Dr Krishna Ella said, in a statement, "this partnership will help us bring a thrombolytic molecule to the developing world at affordable costs."