Microbix Consults with FDA Regarding Plans for Kinlytic® Urokinase – Project Activity Now Expected to Accelerate
TORONTO May 1, 2017 – Microbix Biosystems Inc. (TSX: MBX) (“Microbix” or the “Company”) a developer and marketer of biological products and technologies, announces that it has consulted with the U.S. Food and Drug Administration (the “FDA”) regarding the Company’s plans to return its thrombolytic biologic drug, Kinlytic® Urokinase (“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.
The global use of thrombolytic drugs (a.k.a., clot-busters) has been increasing every year. In the United States alone, thrombolytic sales now exceed US$1 billion per year. Urokinase was previously used in major worldwide health care markets, but there is now a monopoly. 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.
Urokinase was originally launched by Abbott Laboratories and was the leading thrombolytic drug in the market until a manufacturing disruption. Abbott then sold the NDA regulatory file and all assets to another party, from which Microbix later acquired them. Microbix has previously manufactured this natural human protein at commercial scale and performed numerous biochemical and functional analyses on the product that demonstrate its ability to undertake the reintroduction of this drug into the marketplace.
Vaughn Embro-Pantalony, President and CEO of Microbix, commented on the relevance of the FDA consultation to the Company, “Interested investors, including potential licensing partners, were awaiting the outcome of our consultation with the FDA. 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.”
Mr. Embro-Pantalony continued, “Microbix has preserved and worked to update the U.S. and Canadian regulatory files for Urokinase in order to enable its return to market. The need for an alternative thrombolytic agent continues to grow.
Microbix Biosystems Inc. specializes in the development of proprietary biological and technology solutions for human health and wellbeing in the global therapeutic, vaccine and diagnostic markets. The Company manufactures a wide range of highly purified infectious microorganism antigens for the global diagnostics industry, with such sales now exceeding $10 million per year. The Company also applies its biological expertise and technology platforms to create other innovative products and technologies. Currently it is commercializing two such proprietary products, (1) Kinlytic® Urokinase, a biologic thrombolytic drug used to treat blood clots, and (2) Lumisort™, a technology platform for ultra-rapid and efficient sorting of somatic cells that can be used to enrich cell populations of interest, such as in sexing semen. Established in 1988, Microbix is a publicly traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada.
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, the risks associated with its revenue business, development projects such as those referenced herein, operations in foreign jurisdictions, engineering and construction generally, production (including control over costs, quality, quantity and timeliness of delivery of products), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
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