Bharat Biotech has initiated a phase III trial in India with THR-100 in patients suffering an acute myocardial infarction. The trial is expected to recruit approximately 120 patients.
The Hyderabad based vaccine and bio-therapeutics major has entered into a license agreement with ThromboGenics for the manufacture, clinical development and commercialization of THR-100. The key objective of the agreement was to look at commercialization of THR-100 as a replacement for established thrombolytics, such as streptokinase and urokinase, in developing markets.
THR-100, a novel variant of Recombinant Staphylokinase, is a thrombolytic agent developed by ThromboGenics for the treatment of AMI and other vascular diseases, based on its ability to dissolve blood clots.
Bharat Biotech anticipates that the phase III trial with THR-100 will be completed in the second half of 2011. The results of this phase III trial will pave the way for this novel thrombolytic to be filed for marketing approval by Bharat Biotech with Indian regulatory authorities, stated its spokesperson.
The company which has been one of the first bio-pharma facilities in India to be audited and approved by Korean Food & Drugs Administration (KFDA) is also a WHO pre-qualified manufacturer of Hepatitis-B vaccines for supply to UNICEF and global procurement agencies. It is also one of the largest manufacturers of anti-rabies vaccines in India known as ‘Indirab’ which is a market leader in India and several countries globally. Further, it also manufactures vaccines for typhoid, polio, and pentavalent combination vaccines, besides being present in the wound healing segment with its Regen-D, epidermal growth factor for diabetic foot ulcers and burns.