Urokinase (trade name Kinlytic®), also called urokinase-type plasminogen activator (uPA), is a serine protease. Urokinase is used clinically as a thrombolytic agent, often referred to as a “blood clot buster” drug.
Microbix Biosystems Inc. (TSX: MBX) acquired the Urokinase assets that previously belonged to Abbott Laboratories under the name of Abbokinase®. This acquisition augmented the Company’s expertise in Urokinase development and manufacture. Microbix now has a complete solution to serve the Urokinase market with its proven cell culture based technology. Assets include the existing FDA and Health Canada approvals, unique knowhow in the manufacture and testing of approved Urokinase, and key opinion leader relationships. As the sole holder of the Urokinase technology, the Company has forged a number of relationships with research scientists interested in proving the utility of Microbix’ Urokinase for new medical applications including oncology and ophthalmology.
In August 2012 Microbix signed an exclusive global license Agreement with Zydus Cadila, a leading Indian pharmaceutical company with sales in excess of US$1 Billion. Zydus is launching Kinlytic in the US and Canadian markets for traditional uses, the currently approved pulmonary embolism and catheter clearance. Microbix is providing the knowhow and the approved NDA and NDS. Zydus brings an existing biologics manufacturing facility, an experienced development and manufacturing team, and the sales force in the US.
The drug is currently approved in the United States for treatment of pulmonary embolism (PE), and in Canada for PE, coronary occlusion and catheter clearance. The return of Kinlytic to the market in the United States and Canada will require regulatory approval, by supplement to the existing approved marketing application.
The partners are transferring the manufacturing technology for Kinlytic to the Zydus Biologics facility in Ahmedabad, India.
The thrombolytic drug Urokinase, was first approved in the US in 1978 for PE, and coronary occlusion, and then, for catheter clearance in 1981. It was used primarily for dissolving large peripheral clots in arms and legs, and was the standard of care for catheter clearance where it was used to re-establish flow in occluded biomedical catheters. Over 4 million patients have been treated successfully with Urokinase. Many physicians remain loyal to Urokinase due to the drug’s superior and well-documented safety profile as well as cost and efficacy.
Update May 2013
Zydus and Microbix preparing for meeting with the US FDA.