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 release disclosures each year between now and
the filing of a sBLA for the project, which may occur in calendar
2026 or 2027.
Cameron Groome, CEO and President of Microbix,
commented, “We’re very pleased that a detailed agreement has been
executed with a very well-qualified CDMO for the production of new
Kinlytic Drug Substance. All parties will now move ahead at full
speed to revalidate and restart manufacturing using
state-of-the-art methods and best practices.”
Dr. Ken Hughes, COO of Microbix, also commented,
“It is a pleasure to be working with Sequel, in this instance to
identify and brief well-qualified CDMOs about Kinlytic, and to
solicit and receive well-reasoned proposals from several such
parties. We thank each of the CDMOs that participated in this Drug
Substance contracting process and hope to have the opportunity to
work with them on other aspects of this program, or in our future
endeavors.”
About Microbix Biosystems
Inc.Microbix Biosystems Inc. creates proprietary
biological products for human health, with over 100 skilled
employees and annualized sales now 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 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 reagents or media
to support molecular diagnostic testing (e.g., its DxTM™ for
patient-sample collection). Microbix is traded on the TSX and
OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking InformationThis
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:
Cameron Groome, CEO(905) 361-8910 |
Jim Currie, CFO(905) 361-8910 |
Deborah Honig, Investor RelationsAdelaide Capital Markets(647)
203-8793 ir@microbix.com |
|
|
|
Copyright © 2024 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, and QAPs™ are trademarks of Microbix
Biosystems Inc.
Microbix Biosystems (TSX:MBX)
Historical Stock Chart
From Jul 2024 to Aug 2024
Microbix Biosystems (TSX:MBX)
Historical Stock Chart
From Aug 2023 to Aug 2024