Mountain Valley MD Commencing Trials in Bangladesh, Striking Pharmaceutical Production Agreements
TORONTO, ON - March 16, 2021 - Mountain Valley MD Holdings Inc. (the “Company” or “MVMD”) (CSE: MVMD) (FRA:20MP) (OTCQB: MVMDF) is pleased to announce it is commencing husbandry animal trials under the supervision of The People's Republic of Bangladesh’s Ministry of Fisheries & Livestock for the Company’s injectable solubilized Ivermectin technology, Ivectosol™ 1%.
“We are very excited to be welcoming Mountain Valley MD to The People's Republic of Bangladesh and are proud that they have selected our country for important research projects and as a key production hub for its solubilized Ivectosol™ 1% product,” stated Bangladesh’s Foreign Minister H.E. Dr. A. K. Abdul Momen, M.P.
MVMD is working with its local partner R&G Group inside Bangladesh to quickly advance its research and development, and manufacturing capabilities inside the country.
MVMD’s Ivectosol™ 1%, a fully solubilized form of the anti-parasitic drug Ivermectin, will be tested in cattle, goat and poultry under the supervision of the Bangladesh Government's approved and authorized laboratories and research institutes. The tests will be conducted by way of intra-muscular needleless injection of Ivectosol™ 1% in an effort to demonstrate superior pharmacokinetics in terms of CMAX (peak serum concentration that a drug achieves) and AUC (area under the curve) with advanced drug withdrawal time control, versus current commercially available forms.
The trials are scheduled to commence in early April, 2021 and are anticipated to take 30 days. The trial results are scheduled to be reviewed and approved by the Ministry of Fisheries & Livestock and Ministry of Health and will enable the Company to advance against immediate commercialization opportunities. The Company is finalizing production supply agreements with key Bangladesh pharmaceutical partners to produce its Ivectosol™ 1% for use and distribution throughout Bangladesh and as a production hub for broader global distribution. The production scheduling and pricing are currently being finalized under non-disclosure agreement (“NDA”), including securing the sufficient Ivermectin Active Pharmaceutical Ingredient (“API”) quantity for anticipated global demand.
“We’ve been extremely impressed by the speed and pace with which the Government of the People’s Republic of Bangladesh continues to provide our teams with incredible support for the testing and preparedness of an accelerated commercialization pathway for Ivectosol™ 1%,” stated Dennis Hancock, President and CEO of Mountain Valley MD. “Our pharmaceutical partners are both FDA and EU compliant and support our broader objectives to scale for global production. Securing top quality manufacturing within a competitive cost structure is critical to align with one of the core tenets of MVMD’s mission to ensure accessibility to our technology for even the most disadvantaged nations.”
The Company’s plan to pursue the broad husbandry and companion animal markets with its Ivectosol™ 1% technology opens up new applications such as poultry and duck that were not previously possible based on viscosity limitations of the generic Ivermectin drug. When looking at the numerous advantages the Company believes its Ivectosol™ 1% will offer to treat and prevent parasites in cattle, swine, goats and poultry, the combined annual consumption market size of more than 67 billion* animals become immediately addressable.
“Our government and its pharmaceutical partners realize the potential of this transformational project to not only impact our husbandry animal health, but also lay the groundwork to apply immediate effort on key human health applications,” stated Dr. Abdullah Al Mahamud (PhD Fellow) of Bangladesh Agricultural University, Mymensingh. Dr. Mahamud will be overseeing the trials.
The Company’s Ivectosol™ 1% solution uses no harmful organic solvents and is the viscosity of water, which enables novel needleless injector applications. The Company believes the use of needle-free injection systems with a solubilized Ivermectin will deliver significant benefits to livestock and poultry producers, including increased efficacy and elimination of needles that transfer disease and risk of breaking into food supply, improved administration simplicity with reduced labour and safer handling protocols, minimized tissue damage that traditionally negatively impacts yields, and precision dosing that helps to eliminate human error.
The study is also anticipated to demonstrate superior ease of administration with elimination of typically heavy restraint requirements, elimination of injection pain for the animal through needleless application, while dramatically reducing the risk of potentially fatal clostridial infection common with traditional injection site penetration from large gauge needles.
“Ivectosol™ 1% has proven to have significant dose sparing advantages over any existing competitive product today, using up to 1/8th of the Ivermectin drug based on our previous studies,” stated Mike Farber, Director of Life Sciences at Mountain Valley MD. “Dose sparing with a drug that has leading animal and human health implications, including COVID-19 viral clearance, is a critical part of our business plan to provide low cost and highly effective drugs.”
As previously communicated, MVMD’s solubility technology applied to the Ivermectin drug is the only form in the world that uses strictly excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection and sublingual applications as well as significantly broader husbandry and companion animal treatments based on its low viscosity.
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REFERENCES/SOURCES
* Global Animal Statistics & Charts: 2020 Update
ABOUT MOUNTAIN VALLEY MD HOLDINGS INC.
Mountain Valley MD is building a world-class biotech and life sciences company organization centred around the implementation of its patented Quicksome™ oral drug formulation and delivery technologies and its Quicksol™ solubilization technology for macrocyclic lactones, to innovate industry leading products that are sought out globally.
MVMD’s proposition for delivering Quicksome™ formulations that have rapid onset, high bioavailability, low variability and precision dosing is core to the Company’s success across key health and wellness categories. Consistent with its vision towards “Helping People Live Their Best Life”, MVMD applies its Quicksome™ and Quicksol™ technologies to its ground-breaking work for advanced delivery of vaccines and pharmaceutical drugs as well as the development of products for pain management, weight loss, energy, focus, sleep, anxiety, and more.
The Company’s patented Quicksome™ desiccation technology utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats that are consumed orally. The result is a new generation of product formulations that are capable of delivering vaccines, drugs and nutraceuticals into the body faster, with greater impact, efficiency and accuracy.
The Company’s patented Quicksol™ solubilization technology covers all highly solubilized macrocyclic lactones (including the drugs Ivermectin and Selamectin). MVMD’s solubility technology applied to the Ivermectin drug is the only form in the world that only uses excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection and sublingual applications as well as significantly broader husbandry and companion animal treatments based on its low viscosity.
For more Company information and contact details, visit www.mountainvalleymd.com.
SOURCE: Mountain Valley MD Holdings Inc.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
Certain statements contained in this news release may constitute forward-looking information. Forward-looking information is often, but not always, identified by the use of words such as "anticipate", "plan", "estimate", "expect", "may", "will", "intend", "should", and similar expressions. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information.
The Company's actual results could differ materially from those anticipated in this forward-looking information as a result of regulatory decisions, competitive factors in the industries in which the Company operates, prevailing economic conditions, and other factors, many of which are beyond the control of the Company.
The Company is making forward-looking statements, including but not limited to with respect to: the commencement, execution and completion of the husbandry animal trials for its proprietary Ivectosol™ 1% technology; the results and implications thereof; the ability to commercialize Ivectosol™ 1%; the ability to secure final contracts with Bangladesh pharmaceutical partners; and generally the impact of Ivectosol™ 1% technology on applicable industries and markets.
The Company believes that the expectations reflected in the forward-looking information are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking information should not be unduly relied upon. Any forward-looking information contained in this news release represents the Company's expectations as of the date hereof and is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward-looking information whether as a result of new information, future events or otherwise, except as required by applicable securities legislation.
For further information:
Dennis Hancock
President and Chief Executive Officer
Mountain Valley MD Holdings Inc.
Telephone: 647-725-9755
Email: [email protected]
