Microbix meets FDA on Kinlytic return to U.S. market
Microbix Biosystems (TSX:MBX) has consulted with the FDA regarding the company's plans to return its thrombolytic biologic drug, Kinlytic, to the U.S. market.
Microbix believes the results of its consultation will accelerate its work to obtain financing, complete its re-launch program and then submit an application to FDA for re-approval in the U.S. market. The company has already received expressions of interest to license or acquire Kinlytic and to provide full funding for its re-launch program.
Following its consultation with FDA, the company now intends to accelerate its work to conclude such an agreement.
Microbix has also established that Kinlytic may be produced via contract manufacturing, a factor that should shorten the timeline of its return to market. The company plans to retain a significant interest in the economics of Kinlytic following an agreement to enable its re-launch program.
"Interested investors, including potential licensing partners, were awaiting the outcome of our consultation with the FDA,” Vaughn Embro-Pantalony, president and CEO,” said in a statement.
“We believe the outcome of our consultation indicates the planned path to approval of our lead indication is worthwhile, information that will help us conclude a development agreement to enable the re-launch of Kinlytic," he added.
Currently, only one thrombolytic drug, tissue plasminogen activator, or tPA, is available for dissolving blood clots in hospitals and clinics. Microbix believes that there is significant need for another therapeutic option, both to provide an alternative choice for care providers and patients, and to mitigate the risk of supply disruptions.