Microbix Biosystems Inc.’s funding and commercialization partner, Sequel Pharma, LLC, has executed, with support from Microbix, an agreement with a leading international contract development and manufacturing organization (CDMO) for production of the active ingredient of Kinlytic urokinase, a biologic drug for dissolving blood clots.
 
Sequel is a U.S. based specialty pharma company with expertise in developing and commercializing niche drugs. It has committed to provide all funding needed to return Kinlytic to global markets, initially for the $350 million U.S. market for dissolving clots in indwelling venous catheters.
 
Kinlytic is an enzyme derived from human cell cultures that dissolves the material of a blood clot. Kinlytic is already approved for clinical use in the U.S. and the parties’ work is to validate new manufacturing for the drug and to re-enter the market by way of a supplemental biologics licensing application (sBLA).
 
The referenced CDMO agreement is for all actions necessary to resume production of Kinlytic Drug Substance at a scale sufficient for the Catheter Clearance market. The CDMO has undertaken to complete this work over a timeframe specified by Sequel and in line with Microbix’s disclosed project objectives. The work of the CDMO will be overseen by Sequel, with scientific and technical assistance from Microbix.
 
Cameron Groome, CEO and President of Microbix, commented, “We’re very pleased that a detailed agreement has been executed with a very well-qualified CDMO for the production of new Kinlytic Drug Substance. All parties will now move ahead at full speed to revalidate and restart manufacturing using state-of-the-art methods and best practices.”