MBXBF - Microbix's Clot-Buster Drug Project Advances | Benzinga
MISSISSAUGA, Canada, March 14, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX:MBX, OTCQX:MBXBF, Microbix®)), a life sciences innovator, manufacturer, and exporter, announces that its funding and commercialization partner, Sequel Pharma, LLC ("Sequel"), has executed, with support from Microbix, an agreement with a leading international contract development and manufacturing organization ("CDMO") for production of the active ingredient (i.e., "Drug Substance") of Kinlytic® urokinase ("Kinlytic"), 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 US$ 350 million U.S. market for dissolving clots in indwelling venous catheters ("Catheter Clearance").
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.
It is Microbix's intention to update its shareholders on further Kinlytic-related achievements as they become meaningful. Anticipated future disclosures related to Kinlytic may include, among other matters, successful production of Drug Substance, contracting for manufacture of clinically-formulated drug ("Drug Product"), first production of Drug Product, and clinical, regulatory, or commercial milestones. It is anticipated that Microbix will make two to three Kinlytic-related news ...