TORONTO, Feb. 13, 2024 (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 products is pleased to announce the Company’s first indication-specific drug registration for Trunerox™ issued by INVIMA, the Health Authority of Colombia.
“The approval of our first pharmaceutical product is an exceptionally significant milestone and a major step towards our long-term vision as a biopharmaceutical company with the aim to serve patients with unmet medical needs. It is also rewarding to be able to deliver this medication for such a critical medical condition at an accessible price through our vertical,” stated Aras Azadian, CEO.
The Trunerox drug approval (Registro Sanitario como medicamento) was issued by INVIMA, after a detailed process of verification of all legal, technical, and pharmacological requirements were fulfilled in accordance with Decree 677 of 1995 and other applicable regulations. The approval allows Avicanna to manufacture and commercialize Trunerox in Colombia with approved indications and claims associated to the treatment for seizures related to Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS). Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) are two of the various, rare epileptic disorders classified as epileptic encephalopathies.
Trunerox is Avicanna’s proprietary oral formulation with 10% cannabidiol (CBD) and is manufactured with good manufacturing practices GMP at Altea Farmacéutica in Bogota, Colombia utilizing CBD manufactured at the Avicanna’s majority-owned subsidiary Santa Marta Golden Hemp SAS.
About Avicanna Inc.
Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of evidence-based cannabinoid-based products for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform including R&D and clinical development that has led to the commercialization of more than thirty products across various market segments:
- Medical Cannabis & Wellness Products (RHO Phyto™): The formulary offers a diverse range of proprietary formulations including oral, sublingual, topical, and transdermal deliveries with varying ratios of cannabinoids and is supported with ongoing patient, and medical community education. RHO Phyto has been established as a leading medical brand in Canada and is currently available nationwide to patients across several medical channels and continues to expand into new international markets.
- Pharmaceutical Preparations and Pipeline: Leveraging Avicanna’s scientific platform, vertical integration, and real-world evidence, Avicanna has developed an extensive a pipeline of patent-pending drug candidates that are indication-specific and in various stages of clinical development and commercialization. These cannabinoid-based drug candidates look to address 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.
About 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 diverse portfolio of products and a pharmacist led patient support programs. MyMedi.ca also provides specialty services to distinct patient groups such as veterans and collaborating with public and private providers for adjudication and reimbursement and educational resources to facilitate the incorporation of medical cannabis into health care regimens.
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 March 31, 2023 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.
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