Avicanna Files a Patent to Protect its Advanced Oral Cannabinoid Platform and its Applications for Neurological Diseases

Proprietary formulations include a range of liquids, capsules, powders, and controlled release tablets utilizing Avicanna’s self-emulsifying drug delivery systems (SEDDS) technology

The advanced formulations offer enhanced stability, bioavailability and controlled release of cannabinoids including (CBD, THC, CBG, CBN and THCv)

Avicanna intends to utilize the technology in its medical and pharmaceutical products and develop these formulations for treatment of neurological diseases and disorders

TORONTO, Dec. 06, 2021 (GLOBE NEWSWIRE) — Avicanna Inc. (“Avicanna” or the “Company“) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based pharmaceuticals is pleased to announce that it has filed a provisional patent application in the United States Patent and Trademark Office for a novel oral cannabinoid technology (the “Formulation Candidates”), which is intended to be commercialized globally for medical and pharmaceutical applications including treatment of various neurological diseases and disorders.

Oral administration of cannabinoids is the most convenient route for non-invasive drug delivery. However, due to the highly lipophilic nature and poor water-solubility of cannabinoids the elementary formulations currently available on the market generally have poor bioavailability and lack consistent drug delivery. Avicanna’s proprietary compositions have been specifically designed to alter the hydrophobic nature of cannabinoids, resulting in enhanced drug solubility which leads to better absorption and bioavailability either sublingually or orally, thereby increasing efficacy of cannabinoids.

“Our novel formulations overcome the current limitations of cannabinoid finished products in the market today and offer enhanced absorption of varying cannabinoid profiles with controlled delivery. We expect this will yield better patient outcomes and clinical results,” stated Dr. Frantz Le Devedec, Executive Vice President of Research and Product Development at Avicanna.

The patent application entitled “Oral cannabinoid compositions and methods of treating neurological diseases and disorders” claims formulations that have been developed through Avicanna’s R&D platform utilizing the company’s proprietary self-emulsifying drug delivery systems (SEDDS) technology and include a range of drug delivery formats with varying release and absorption profiles including:

Sustained and controlled release tablets – designed for linear release of the drug over time and thereby maximizing pharmacological properties and reducing side effects particular to cannabinoids.

Oral capsules c self-emulsifying cannabinoid technology designed to enhance absorption through a fast and effective dispersion mechanism.

Sublingual tablets – designed to provide rapid absorption of cannabinoids through the sublingual membrane to reduce first pass metabolism and provide a solution for acute symptom management and

Water-soluble formulations – nano-emulsion technology designed for instant dispersion and dissolution of cannabinoids which can be utilized for convenient titration in drug delivery and beverages.

“This patent submission is another example of our drug delivery platforms used to develop industry leading products as we continue to innovate and lead the path with advanced, standardized and evidenced based cannabinoid solutions. We are optimistic about the potential of these formulations across several of our commercial and clinical platforms globally,” stated Aras Azadian, Chief Executive Officer of Avicanna.

Avicanna intends to conduct further pre-clinical studies in the coming months in order to formalize this provisional application and will incorporate the technology into its clinical pipeline in 2022. If granted, this patent application will provide Avicanna with protection on the use of the Formulation Candidates for neurological diseases, alone or in combination with other therapies.

About Avicanna

Avicanna is a Canadian commercial-stage biopharmaceutical company established in cannabinoid research, development, and evidence-based products for the global consumer, as well as medical and pharmaceutical market segments. In leading global cannabinoid advancements, Avicanna conducts most of its research in Canada at its R&D headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto, located in the MaRS Discovery District. The company actively collaborates with leading Canadian academic and medical institutions. Avicanna has established an industry-leading scientific platform including advanced R&D and clinical development which has led to the commercialization of over twenty products across four main market segments:

• Medical Cannabis & Wellness Products: Marketed under the RHO Phyto™ brand, or Magisterial Preparations, these medical and wellness products are an advanced line of pharmaceutical-grade cannabis products containing varying ratios of cannabidiol (“CBD”) and tetrahydrocannabinol (“THC”). The product portfolio contains a full formulary of products including oral, sublingual, topical, and transdermal deliveries that have controlled dosing, enhanced absorption and stability studies supported by pre-clinical data. The advanced formulary is marketed with consumer, patient and medical community education and training. Avicanna’s medical and wellness product portfolio also forms the foundation of the Company’s pharmaceutical pipeline with the contribution of the formulations that form the basis of the products as well as the data generated from sales and participation of the products in real world evidence studies.
• CBD Derma-Cosmetic Products: Marketed under the Pura H&W™ or Pura Earth™ brands, these registered, clinically tested, derma-cosmetic products include a portfolio of functional CBD topical products.
• Pharmaceutical Pipeline: Leveraging Avicanna’s scientific platform, vertical integration, and real-world evidence, Avicanna has created a pipeline of patent-pending drug candidates which are indication-specific and in various stages of clinical development and commercialization. These cannabinoid-based drug candidates provide solutions for unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicanna’s first pharmaceutical preparation (Trunerox) is in the drug registration stage in South America.
• Cannabis Raw Materials, Seeds, and Bulk Formulations: Marketed under the Aureus™ brand, the Company’s raw material business has successfully completed sales to 11 countries. Aureus offers cannabis dried flower, standardized seeds, full spectrum extracts, and cannabinoid distillates, isolated cannabinoids (CBD, THC, cannabigerol (“CBG”) and other rare cannabinoids), and bulk formulations derived from hemp and cannabis cultivars through its sustainable, economical, and industrial-scale subsidiaries based in Colombia. The majority of the Aureus products are produced at Santa Marta Golden Hemp S.A.S. (“SMGH”), the Company’s majority-owned subsidiary, which is also Good Agricultural and Collection Practices (“GACP”) certified and has United States Department of Agriculture (“USDA”) National Organic Program certification for its hemp cultivar.

SOURCE Avicanna Inc.

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Cautionary Note Regarding Forward-Looking Information and Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe”, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions and includes statements with respect to the Company’s ability to generate data to support a final patent application, the Company’s ability to conduct further research on the Formulation Candidate, the grant of any patent for the Formulation Candidate.  Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, the availability of licenses, approvals and permits, and the utility and application of certain drugs and products. Although the Company believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on the forward looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company’s annual information form dated September 3, 2021 and final short form prospectus dated November 27, 2020, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com. The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.