January 12, 2021 | Montréal, Québec
5N Plus Inc. (“5N Plus”), a leading global producer of specialty chemicals and engineered materials, and Microbion Corporation (“Microbion”), a clinical-stage pharmaceutical company focused on the development of compounds for the treatment of resistant and difficult-to-treat infections, jointly announced today that the parties have entered into a strategic relationship for the development, manufacturing and commercial drug substance supply of Microbion’s new class of antibiotic and antibiofilm drugs. Under the terms of the agreement, 5N Plus has taken an equity stake in Microbion and will assume responsibility for the manufacturing of Bismuth-based Active Pharmaceutical Ingredients (API) required in Microbion’s family of drug products currently under development, including the company’s lead API, pravibismane. Microbion retains responsibility for the development, manufacturing and commercialization of the final drug products currently under development.
In recent years, effective treatments for bacterial infections have become ever more critical, as some bacteria have become increasingly resistant to existing drug therapies. Microbion’s approach has been to develop a new class of microbial bioenergetic inhibitors that arrest the activities of a broad range of offending pathogens. Pravibismane, the first in this new class of anti-infectives, has demonstrated impressive antibacterial and antibiofilm activity against a wide range of Gram-negative and Gram-positive pathogens, including multiple priority pathogens or “superbugs” as identified by the US Centers for Disease Control and Prevention (CDC). As the world’s leading producer of Bismuth-based API compounds, 5N Plus is uniquely positioned to support Microbion in the development of this new class of compound. In the initial phase of the collaboration between the two companies, 5N Plus will be supporting Microbion’s clinical development programs.
Pravibismane suspension for topical/local administration is currently in Phase 2 for the treatment of diabetic foot ulcer infections and orthopedic-device infections. Inhaled pravibismane is in late pre-clinical studies for the treatment of chronic lung infections. The inhaled pravibismane program is receiving up to US$17.1M in non-dilutive development funding support from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) and the Cystic Fibrosis Foundation, as previously announced by Microbion. Microbion Corporation has closed a Series A financing of US$25M from GHS Fund (Quark Venture LP and GF Securities). Developing pravibismane for targeted, localized administration provides not only the ability to treat specific areas of severe unmet medical need, but also is an approach that can result in significant commercial opportunity within the anti-infectives field.
Mr. Paul Tancell, Executive Vice President of Eco-Friendly Materials at 5N Plus, commented: “We are delighted to be able to support Microbion in their journey to develop a much-needed class of new antibacterial drugs. Whilst there remains more development ahead of us, the initial results are simply impressive, with pravibismane indicating both a high level of antibacterial activity and that of patient safety.” Mr. Tancell added: “We will support Microbion with our wide expertise in the development and production of Bismuth-based APIs as they move through the clinical trials to registration”. Mr. Tancell concluded: “The potential market for pravibismane is significant and we are well positioned to benefit from the growth of this market.”
Mr. Karim Lalji, Chairman of Microbion Corp. and CEO of Microbion Pharma Corp., commented: “We are pleased with the development and supply partnership entered into with 5N Plus as we recognize their team as leaders in Bismuth-based material manufacturing. We will be working closely with 5N Plus to develop methods to efficiently and cost-effectively manufacture pravibismane. Furthermore, their purchase of an equity stake of the company further validates the potential promise of pravibismane and Bismuth-based compounds to treat a variety of serious, chronic infections for the betterment of patients.”
About 5N Plus Inc.
5N Plus is a leading global producer of engineered materials and specialty chemicals with integrated recycling and refining assets to manage the sustainability of its business model. The Company is headquartered in Montreal, Québec, Canada and operates R&D, manufacturing and commercial centers in several locations in Europe, the Americas and Asia. 5N Plus deploys a range of proprietary and proven technologies to manufacture products which are used as enabling precursors by its customers in a number of advanced electronics, optoelectronics, pharmaceutical, health, renewable energy and industrial applications. Many of the materials produced by 5N Plus are critical for the functionality and performance of the products and systems produced by its customers, many of whom are leaders within their industry.
Microbion is a clinical-stage biopharmaceutical company developing pravibismane as the first product in a new class of anti-infective drugs with a mechanism of action that functions as a microbial bioenergetic inhibitor for the local treatment of antibiotic-resistant and difficult to treat infections. Pravibismane has antibacterial efficacy against a broad spectrum of pathogens, including multiple priority pathogens or “superbugs” identified by the US CDC. In addition to antibacterial efficacy, pravibismane has also demonstrated the ability to eradicate microbial biofilms. This dual antimicrobial action may offer a much-needed, novel clinical approach to treat infections. Microbion has been granted QIDP and Fast Track designations for multiple indications and Orphan Drug Designation for the treatment (management) of pulmonary infections in patients with cystic fibrosis by the US FDA. In addition, Microbion has completed two clinical trials of pravibismane in diabetic foot ulcer (DFI) and orthopedic implant-related infections and is continuing the clinical advancement of pravibismane for these indications. The International Nonproprietary Name (INN) recommended by the WHO of pravibismane is the first member in the bismane class which represents a novel class of anti-infective drugs. Microbion Corporation has previously closed a Series A financing of US$25M from GHS Fund (Quark Venture LP and GF Securities). For more information visit: www.microbioncorp.com.
5N Plus Forward-Looking Statements and Disclaimer
Certain statements in this press release may be forward-looking within the meaning of applicable securities laws. Forward-looking information and statements are based on the best estimates available to the Company at the time and involve known and unknown risks, uncertainties or other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A description of the risks affecting the Company’s business and activities appears under the heading “Risk and Uncertainties” of the 5N Plus’ 2019 MD&A dated February 25, 2020 and note 10 of the unaudited condensed interim consolidated financial statements for the three and nine-month periods ended September 30, 2020 and 2019 available on www.sedar.com.
The Company is not aware of any significant changes to its risk factors previously disclosed, however since January 2020, the gradual outbreak of the novel strain of the coronavirus, COVID-19 and its declaration as a pandemic by the World Health Organization, has resulted in governments worldwide enacting emergency measures to combat the spread of the virus. These measures have caused material disruption to businesses globally resulting in an economic slowdown. While the Company has been able to mitigate the short-term impact from the crisis without significant loss of production capacity and customer demand, it is not possible to reliably estimate the length, severity and long-term impact the global pandemic may have on the Company's financial results, conditions and cash flows. The outbreak of the COVID-19 should be considered a new risk factor.
Forward-looking statements can generally be identified by the use of terms such as “may”, “should”, “would”, “believe”, “expect”, the negative of these terms, variations of them or any similar terms. No assurance can be given that any events anticipated by the forward-looking information in this press release will transpire or occur, or if any of them do so, what benefits that 5N Plus will derive therefrom. In particular, no assurance can be given as to the future financial performance of 5N Plus. The forward-looking information contained in this press release is made as of the date hereof and the Company has no obligation to publicly update such forward-looking information to reflect new information, subsequent or otherwise, unless required by applicable securities laws. The reader is warned against placing undue reliance on these forward-looking statements.
Microbion Safe Harbor Statement
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CARB-X funding for the pravibismane project is sponsored by Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust and Germany’s Federal Ministry of Education and Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.
Chief Financial Officer
5N Plus Inc.