Microbix Biosystems Inc announced that Kinlytic (urokinase for injection) has been approved in Canada for marketing and export. Health Canada's issuance of a Drug Identification Number for Kinlytic gives Microbix the opportunity to market the product in Canada and export the clot-busting therapy to markets worldwide.
Urokinase, which Microbix has re-branded as Kinlytic, has been administered to over four million patients and generated peak annual worldwide sales of more than US$ 300 million, prior to Abbott Laboratories discontinuing sales in 1999 due to manufacturing issues. In 2008, Microbix completed the acquisition of all urokinase assets from ImaRx Therapeutics, Inc, making Microbix the only worldwide source of low-molecular-weight urokinase.
According to IMS data, the total Canadian clot-busting market exceeds US$ 26 million for the last twelve months and has grown 20 per cent on a year-over-year basis. Significant underserved markets also exist for urokinase in a large number of countries and Microbix expects to rapidly submit regulatory filings for approval in those countries.
Microbix will submit an application to Health Canada for approval of its acquired urokinase inventory and targets its release for mid-year 2010. The inventory will supply market needs for nearly three years and generate revenue of about US$ 30 million. Microbix plans to use this revenue to scale up Kinlytic manufacturing at its Skyway production facility in time to re-supply its inventory with capacity to produce US$ 70 million worth of product annually.
Mark A Cochran, Microbix chief business officer said, "Microbix is pleased to bring back to the medical community an effective and safe therapy with life-saving benefits. We now have the potential to expand the drug's indications into larger markets such as catheter clearance, oncology and ophthalmology and to use the existing product sales to accelerate urokinase production at our facility in Toronto."
Approval in Canada also allows the company to provide Kinlytic for use in clinical trials in Canada and other countries. To this end, Microbix has been in discussions with several companies to license its product for studies in new indications such as urology, oncology and ophthalmology. In earlier studies, the therapy has shown promise for treating colon, prostate and other solid tumours. The company sees significant licensing and revenue opportunities ahead for Kinlytic for these new indications.
Urokinase has been used to treat patients in the United States and Canada for over 30 years. The therapy has been shown to be effective in dissolving large clots in the peripheral circulation system and for clearing blocked catheters used in oncology and dialysis treatments.
Dr Karthikeshwar Kasirajan, assistant professor of Surgery, Department of Surgery, Emory University School of Medicine, and a physician who has treated patients with urokinase for many years said, "Based on my years of experience in the clinic, urokinase is the best thrombolytic agent for dissolving acute thrombi. I have come to rely on this product as my treatment of choice as it is the safest thrombolytic and results in better outcomes for patients. Its absence has negatively impacted both clinicians and patients, and so I am very pleased that Microbix is reintroducing urokinase to the medical community."
Microbix Biosystems Inc is a leader in sales of virology products and focused on influenza vaccine (Virusmax) manufacturing, and development of animal semen sex selection technology (SST) and Kinlytic, an anti-thrombotic agent for pulmonary embolism.