Sequel Pharma Reconfirms Kinlytic® urokinase Support for Catheter Clearance Indication
MISSISSAUGA, CANADA, November 16, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the reconfirmation of its agreement (“Agreement”) with Sequel Pharma, LLC (“Sequel”) to return Kinlytic® urokinase (“Kinlytic”) to market, initially for dissolving blood clots that block venous catheters (“Catheter Clearance”) in the United States (“U.S.”), followed by other geographies and clinical indications.
Sequel is a U.S. based specialty pharma company with expertise in developing and commercializing niche drugs. A further payment of US$ 2.0 million has been received by Microbix relating to this reconfirmation.
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 Agreement provides for Sequel to fund and undertake the necessary work to complete the sBLA and return Kinlytic® to the U.S. for the clinical indication of Catheter Clearance, currently a market of at least US$ 350 million per year. Long-term venous catheters are used to administer pharmaceuticals, nutrition, or dialysis, often needing to remain in place for extended periods. About 25% of such catheters become blocked with blood clots which, if not cleared, require costly surgical catheter replacement.
Microbix received a closing payment of US$ 2.0 million in May 2023. Following a satisfactory consultation with the U.S. Food and Drug Administration (“FDA”) to reconfirm and build upon prior regulatory guidance, Microbix has received this second payment of a further US$ 2.0 million. The parties are now proceeding toward filing of the sBLA, with funding for needed work fully provided by Sequel. As detailed in May, Microbix will receive further milestone and royalty payments tied to the re-launch of Kinlytic.
Advancement of the Agreement is initially expected to influence Microbix’s results for the fourth quarter of fiscal 2023 (“Q4 2023” ending September 30, 2023) and the first quarter of fiscal 2024 (“Q1 2024” ending December 31, 2023). In Q4 2023, Microbix expects to reverse an impairment of the value of its Kinlytic assets recorded in fiscal 2020, resulting in an increase to net earnings of approximately C$ 3.1 million. In Q1 2024, Microbix expects to record additional revenues of US$ 3.0 million, comprised of US$ 1.0 million of the May 2023 closing payment and the full US$ 2.0 million of the current milestone payment.
Cameron Groome, CEO and President of Microbix commented, “Reconfirming our fully-funded partnership to return Kinlytic to widespread clinical use is a most fitting tribute to Microbix’s founder, Bill Gastle, whose vision drove this important program. We are now delighted to be working closely with Sequel leadership to restore availability of this clinically-important biologic drug. We expect that Kinlytic will return to the U.S. market, meaningfully help patients, and significantly contribute to Microbix’s revenues and net earnings.”
Microbix will update shareholders about Kinlytic, the Agreement, and its overall operations via a webinar hosted by Adelaide Capital at 10:00 AM ET on Friday, November 17, 2023. Participants can register here: https://us02web.zoom.us/webinar/register/WN_ssbGvk0gT9arZNyp6BkHcQ.
The session will also be live-streamed and a replay will be posted on Adelaide Capital’s YouTube Channel here: https://www.youtube.com/channel/UC7Jpt_DWjF1qSCzfKlpLMWw.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots, and viral transport medium (DxTM™), to stabilize patient samples for lab-based molecular diagnostic testing. Microbix is traded on the TSX and OTCQX, 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, discussion of Sequel, the Agreement, Kinlytic® or its relevance, Microbix’s products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about 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. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by many material factors, some of which are beyond its 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 Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or https://www.sedarplus.ca for recent Microbix news and filings.
For further information, please contact Microbix at:
Adelaide Capital Markets
Copyright © 2023 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, and QAPs™ are trademarks of Microbix Biosystems Inc.