08:58 AM EDT, 03/14/2024 (MT Newswires) -- Microbix Biosystems Inc. ( MBXBF ) on Thursday said its funding and commercialization partner, Sequel Pharma, LLC has executed, with support from Microbix, an agreement with an international contract development and manufacturing organization (CDMO) to produce 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, starting with the US$350 million US market for dissolving clots in indwelling venous catheters.
Kinlytic, an enzyme derived from human cell cultures that dissolves the material of a blood clot, is already approved for clinical use in the US and the parties' work is to validate new manufacturing for the drug and to re-enter the market via a supplemental biologics licensing application (sBLA).
The CDMO agreement is for all actions necessary to resume production of Kinlytic Drug Substance at a scale sufficient for the catheter clearance market within a set timeframe. The work of the CDMO will be overseen by Sequel, with scientific and technical assistance from Microbix.