Kinlytic® is a thrombolytic injectable drug, commonly known as a “clot buster”. It has been used to treat over 4 million patients with life-threatening pulmonary embolism and clot obstructed intravenous catheters. Microbix owns the rights to the drug, which is approved in the United States and Canada for treatment of life threatening blockages to blood flow in the lungs (pulmonary embolism) and to remove blood clots from intravenous catheters, essential to patient treatment for drug administration and nutrition. Microbix is planning to return Kinlytic to physicians and their patients by using a two-pronged strategy: (1) Engage a technical partner to manufacture the product, and (2) Engage commercial partners by licensing the market rights for certain countries to address current unmet medical needs.
The active ingredient in Kinlytic is urokinase, a serine protease found normally in the human body. Kinlytic is the low molecular weight form of urokinase (LMW-UK) produced through a biotechnology based cell culture process. Urokinase is effective in clearing clot related blockages via its protein cleaving enzymatic action leading to breakdown of fibrin, a major structural component of blot clots. Physicians have used urokinase to treat over 4 million patients in North America given its well established reputation for efficacy and safety. Kinlytic is the only LMW-UK approved worldwide for patient treatment.
Microbix developed its urokinase manufacturing experience by building on its knowledge of cell culture and purification used in its diagnostic products manufacturing processes. Originally, Microbix planned to compete with Abbott Laboratories by manufacturing a biosimilar drug. Subsequently the Company acquired the Abbokinase assets, which had been rebranded as Kinlytic, including the “NDA approvals” in both the US and Canada. With the acquisition, Microbix became the sole owner of regulatory approvals and know-how for the production of low molecular weight urokinase.