Mountain Valley MD Files for Acceleration of Patent Examination for Solubilized Ivermectin

VANCOUVER, BC, Dec. 24, 2020 /CNW/ - Mountain Valley MD Holdings Inc. (the "Company" or "MVMD") (CSE: MVMD) (FRA: 20MP) is pleased to announce that it has filed for an accelerated review of its macrocyclic lactone solubilization patent with the United States Patent and Trademark Office ("USPTO").

To support the accelerated patent examination request, the Company has provided the USPTO with new formulation analyses of different diluted concentrations of its Quicksol™ Ivermectin in solution, data that the company had fast-tracked for completion and validation by a third-party CRO.

The Company previously confirmed its ability to make the anti-parasitic drug Ivermectin highly water-soluble without the use of organic solvents, improving its water solubility by nearly 5,000 times and that it had completed its initial safety and improved efficacy in pre-clinical validation with a leading third-party preclinical contract research organization ("CRO").  The pre-clinical trials confirmed a significant improvement in the Ivermectin pharmacokinetics and efficacy when applied through its Quicksome™ and Quicksol™ technologies versus existing oral and subcutaneous forms.

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.

"Despite all of the media coverage of the COVID-19 vaccine rollout, we feel it is important that people understand that a large percentage of the world will not benefit from the current vaccination efforts due to extensive logistical and economic complexities," stated Mike Farber, Director of Life Sciences at Mountain Valley MD.  "And then when you layer on the percentage of the global population that have known health challenges due to pre-existing conditions and allergic reactions to vaccines, MVMD believes that solubilized Ivermectin therapeutic will become a critical alternative."

The Company has been closely monitoring the global studies and reports that demonstrate the efficacy of the drug Ivermectin as a therapeutic for COVID-19, including the ongoing work from the Front Line COVID-19 Critical Care Alliance ("FLCCC Alliance")* and its recent publication outlining the evidence base supporting the efficacy of Ivermectin as a therapeutic to fight COVID-19, including data from 7,825 patients across 24 trials.  Additionally, according to a meta-analysis recently performed by an independent research consortium, it was calculated that the chances that Ivermectin is ineffective in COVID-19 to be 1 in 67 million**.

The Company also notes recent advancements in Belize***, where the Ministry of Health and Wellness formally approved Ivermectin as a prescribed treatment option for persons with COVID-19.  According to the Acting Director of Health Services, Dr Melissa Diaz-Musa, Belize's medical response team along with the Ministry of Health extensively reviewed supporting research on Ivermectin and its use in protocols in other countries and found significant evidence that Ivermectin has been beneficial in reducing viral replication and helping with prophylaxis against COVID-19.

"Seeing the extensive collection of evidence of the role of Ivermectin as a broad therapeutic application to support COVID-19 suppression and beyond is a significant validation of our work in this area," stated Dennis Hancock, President and CEO of Mountain Valley MD.  "Having a third party CRO confirm the exceptional water solubility of Mountain Valley MD's Ivermectin complex formulation and its dramatic improvement we have seen in the pharmacokinetics versus oral Ivermectin tablets and solvent based subcutaneous injections supports the expedited opening of our patent and its global protection."

MVMD patent application covers all highly solubilized macrocyclic lactones, including Ivermectin and Selamectin, which have also been shown to be effective in the treatment of tuberculosis even with limited solubility.  The Company believes its solubility technology can dramatically enhance the efficacy of both inhaled and injected Selamectin or Ivermectin providing a novel effective therapeutic for tuberculosis.

REFERENCES/SOURCES

* One Page Summary of the Clinical Trials Evidence for Ivermectin in COVID-19
https://covid19criticalcare.com/wp-content/uploads/2020/12/One-Page-Summary-of-the-Clinical-Trials-Evidence-for-Ivermectin-in-COVID-19.pdf

** Ivermectin is Effective for COVID-19: Meta Analysis of 26 Studies
https://ivmmeta.com/

*** Ministry of Health and Wellness approves Ivermectin as a COVID-19 Treatment
https://lovefm.com/ministry-of-health-and-wellness-approves-ivermectin-as-a-covid-19-treatment/

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

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 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™ technology to its ground-breaking work for the oral 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.

For more Company information and contact details, visit www.mountainvalleymd.com.

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 ability to extrapolate the intellectual property to multiple viral applications; the patentability of the intellectual property; the effect and implications of the intellectual property with respect to both ivermectin as well as other drugs and generally to human and animal drug treatments, the ability for licensees to obtain FDA approval more quickly, the effectiveness of current and future COVID-19 vaccines and therapeutics.

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.

SOURCE Mountain Valley MD Holdings Inc.

Dennis Hancock, President and Chief Executive Officer, Mountain Valley MD Holdings Inc., Telephone: [phone], Email: [email protected], www.mountainvalleymd.com