Avicanna Announces USPTO Issuance of Patent SEDDS Technology

Patent No. US 11,998,632 B2 (“Patent”) covers Avicanna’s self-emulsifying drug delivery system (“SEDDS”) oral cannabinoid composition and methods of treating neuropathic pain

TORONTO, June 19, 2024 (GLOBE NEWSWIRE) — Avicanna Inc. (“Avicanna” or “Company”) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN), a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products, is pleased to announce the United States Patent and Trademark Office (“USPTO”) issuance of the Patent covering Avicanna’s SEDDS oral cannabinoid compositions and methods for treating neuropathic pain.

“We are delighted to announce the USPTO’s issuance of the Patent covering our SEDDS drug delivery technology. Research, development, and evaluation of the potential role of cannabinoids in advanced drug delivery systems for therapeutic benefit have been at the core of the Company’s mission since inception. We are appreciative of the work done by our scientists that have brought us to this milestone, and we are excited about the possibilities of further clinical applications for cannabinoid treatments in neuropathic pain and working closely with healthcare providers to support patients in need,” stated Aras Azadian, CEO.

About the SEDDS Technology

Due to the highly lipophilic nature and poor water-solubility of cannabinoids, the formulations currently available in the Canadian market have been generally described as having poor absorption and high variability of onset. SEDDS oral delivery systems offer a route for non-invasive and non-inhalation administration of cannabinoids.^1-4 

Avicanna’s SEDDS technology demonstrated shelf-life stability with more than 90% of the total cannabinoid(s) remaining after 6 months in accelerated conditions. CBD and THC dissolution profiles were also tested in biorelevant media which mimic human intestinal fluid and demonstrated more than 90% dispersion within one hour with continued stabilization of the emulsion.

About Avicanna Inc. 

Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of cannabinoid-based products and formulations for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform including R&D and clinical development leading to the commercialization of more than thirty proprietary, evidence-based finished products and supporting four commercial stage business pillars.

Medical Cannabis formulary (RHO Phyto™): The formulary offers a diverse range of proprietary products including oral, sublingual, topical, and transdermal deliveries with varying ratios of cannabinoids, supported by ongoing patient and medical community education. RHO Phyto is an established leading medical brand in Canada currently available nationwide to patients across several medical channels and continues to expand into new international markets.

Medical cannabis care platform (MyMedi.ca): MyMedi.ca is a medical cannabis care platform formed with the aim to better serve medical cannabis patients’ needs and enhance the patient journey. MyMedi.ca is operated by Northern Green Canada Inc. and features a diverse portfolio of products and bilingual pharmacist-led patient support programs. MyMedi.ca also provides specialty services to distinct patient groups such as veterans and collaborates with public and private payers for adjudication and reimbursement. MyMedi.ca provides educational resources to the medical community to facilitate the incorporation of medical cannabis into health care regimens.

Pharmaceutical products (Trunerox™) and pipeline: Leveraging Avicanna’s scientific platform, vertical integration, and real-world evidence, Avicanna has developed a pipeline of proprietary, indication-specific pharmaceutical products that are in various stages of clinical development. These cannabinoid-based drug candidates aim to address unmet medical needs in dermatology, chronic pain, and various neurological disorders. Avicanna’s first indication-specific pharmaceutical drug, Trunerox™, was approved Q1 2024 by the Health Authority of Colombia INVIMA as an adjuvant treatment for seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome in Colombia. Trunerox™ has not been approved as a drug in Canada by Health Canada.

Active pharmaceutical ingredients (Aureus Santa Marta™): Active pharmaceutical ingredients are supplied by the Company’s majority owned subsidiary Santa Marta Golden Hemp SAS which is a commercial-stage business dedicated to providing a various forms high-quality CBD, THC and CBG to the Company’s international partners for use in the development and production of food, cosmetics, medical, and pharmaceutical products. The business unit also forms part of the Company’s supply chain and is a source of reliable input products for its consumer retail, medical cannabis, and pharmaceutical products globally.

References:

¹ Maji, et al., Solid self emulsifying drug delivery system: Superior mode for oral delivery of hydrophobic cargos. Journal of Controlled Release, 337, 2021;646-660.

² Salawi A. Self-emulsifying drug delivery systems: a novel approach to deliver drugs. Drug Deliv. 2022 Dec;29(1):1811-1823.

³ Khaled, A.; Ayat, A. A.; Mahmoud, E.-B., Self-Emulsifying Drug Delivery Systems: Easy to Prepare Multifunctional Vectors for Efficient Oral Delivery. In Current and Future Aspects of Nanomedicine, Islam Ahmed Hamed, K., Ed. IntechOpen: Rijeka, 2019; p Ch. 4

⁴ Pathak, Ashish Kumar et al. “Recent advances in self emulsifying drug delivery system – A review.” Drug Invention Today (2010): 123-129.

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 news release may be identified using words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe”, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. 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 April 1, 2024 filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com. The statements in this news 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.