Staphylokinase

A significant opportunity

Staphylokinase – another thrombolytic agent developed by ThromboGenics – has successfully completed Phase II clinical trials. Staphylokinase could be used in cardiovascular disease to dissolve blood clots, which are responsible for causing an acute myocardial infarction (AMI ), or heart attack. In terms of efficacy, staphylokinase has been shown to be comparable to tissue plasminogen activator (tPA), one of the most widely used thrombolytics to treat acute myocardial infarction, while potentially being available at a much lower cost. A thrombolytic agent with a similar efficacy to tPA and a significantly lower price could be of substantial importance in advancing the standard of care of patients receiving thrombolytic therapy.

Clinical development

Phase II clinical development of recombinant staphylokinase for the treatment of heart attack has been completed. The compound has been administered to over 900 patients suffering from thrombotic disease, with 700 of these administrations occurring in AMI patients. No significant unexpected, drug-related adverse reactions were reported in any of the clinical trials and staphylokinase has demonstrated comparable efficacy to tPA (reopening of the heart artery was demonstrated by angiography).

Partnership on THR-100

ThromboGenics entered into a license agreement with Bharat Biotech International Limited (India) in December 2006. The terms of the agreement cover the manufacturing, clinical development and commercialisation. Under the terms of the agreement ThromboGenics will receive double-digit royalties on net sales and Bharat Biotech will assume responsibility for all future costs.

Partnership on THR-174

Data from preclinical studies suggest that this second generation staphylokinase may have potential to provide an even better efficacy and safety profile and, most importantly, reduced immunogenic response compared to earlier versions of staphylokinase, as well as to some other earlier established thrombolytics such as streptokinase. This means that THR-174 could potentially be administered to patients more than once, allowing treatment of subsequent cardiac events and improving quality of care.

ThromboGenics has completed a license agreement with Rhein Minapharm (Egypt) for the production, clinical development and commercialization of THR-174 in the Middle East, Africa and other countries. In return for granting this license, ThromboGenics will receive upfront and milestone payments, and will earn doubledigit royalties on net sales while Rhein Minapharm will assume responsibility for all future costs.