Following what apparently were productive meetings with the U.S. Food and Drug Administration, Microbix Biosystems Inc. (TSX:MBX) says it is working on a plan to brign it its thrombolytic biologic drug, Kinlytic® Urokinase, to the U.S. market. The clot-busting drug has a storied history, first approved in 1978 as Abbott Laboratories' (NYSE:ABT) urokinase and becoming the market leader under the brand name Abbokinase with $300 million in revenue in 1998 before being removed from the market over safety concerns. The FDA was worried that manufacturing of Abbokinase was not adequately protecting against infections in the neonatal kidney cells being used in the therapy.
Once the market star, the treatment laid dormant, eventually landing under the ownership of Microbix via the company acquiring the assets related to urokinase from ImaRx Therapeutics.
Microbix has manufactured the human protein at commercial scale with requisite precautions to re-introduce Kinlytic as competitor to tPA (tissue plaminogen activator), the only approved thromolytic drug available today. Microbix believes it's ready to re-launch its product under the Kinlytic brand name with the blessing of regulators into a U.S. thrombosis market exceeding $1 billion annually. The company further says that it has many parties interested in the re-launch of Kinlytic that have been waiting for the outcome of the consult with the FDA.
Market participants seem to think that prescription writers will turn back to using the drug, as measured by shares of MBX on the move in Monday morning trading. MBX stock is up 18.4% at 29 cents per share as the morning session winds to a close.
