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The initial registration is the final step in authorization of the brand's launch of the full suite of 9 products which will be permitted to be sold in the European Union and United Kingdom.
The registration marks Avicanna's Pura Earth CBD products as the first registered CBD-based derma-cosmetic brand in the European Union backed with human clinical studies.
TORONTO, June 9, 2020 /CNW/ - Avicanna Inc. ("Avicanna" or the "Company") (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN), a biopharmaceutical company focused on the development, manufacturing and commercialization of organic and sustainable plant-derived cannabinoid-based products, is pleased to announce that the Company has satisfied all regulatory requirements to successfully register the first three products of its premium CBD-based derma-cosmetic product line, Pura Earth™, on the European Commission's Cosmetic Product Notification Portal (the "CPNP"). The first group of products registered with the CPNP are Pura Earth's Anti-Aging Cream, Intensive Moisturizing Cream and Clear Skin Gel products.
In addition to the clinical studies conducted on two of the registered products, the Company has provided the CPNP with long-term stability studies on its initial SKUs along with primary skin irritation evaluations for the entire portfolio in order to certify the safety and stability of the Pura Earth formulations. Two additional SKUs will be registered in Q3 followed by the rest of the portfolio in Q4.
Aras Azadian, CEO of Avicanna said: "We take pride in our scientific and evidence-based approach within all of our product categories including our consumer products and have taken the appropriate steps to ensure our products would meet the European Union quality and safety standards prior to commercialization. We are thrilled to be getting closer to launch, what we believe to be, the most advanced and the only clinically backed CBD derma-cosmetic line into the European marketplace with potential for incredible success."
About Avicanna Inc.
Avicanna is an Ontario, Canada based corporation focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products through its two main business segments, cultivation and research and development.
Avicanna's two majority-owned subsidiaries, Sativa Nativa S.A.S. and Santa Marta Golden Hemp S.A.S., both located in Santa Marta, Colombia are the base for Avicanna's cultivation activities. These two companies are licensed to cultivate and process cannabis for the production of cannabis extracts and purified cannabinoids including cannabidiol (CBD) and tetrahydrocannabinol (THC).
Avicanna's research and development business is primarily conducted out of Canada at its headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto. Avicanna's scientific team develops products, and Avicanna has also engaged the services of researchers at the Leslie Dan Faculty of Pharmacy at the University of Toronto for the purpose of optimizing and improving upon its products.
Avicanna's research and development and cultivation activities are focused on the development of its key products, including plant-derived cannabinoid pharmaceuticals, phyto-therapeutics, derma-cosmetics, and Extracts (defined as plant-derived cannabinoid extracts and purified cannabinoids, including distillates and isolates), with a goal of eventually having these products manufactured and distributed through various markets.
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 ability of Avicanna to register additional products with the CPNP, the Company's ability to maintain any product registrations with the CPNP in good standing, and the Company's ability to commercialize the Anti-Aging Cream, Intensive Moisturizing Cream and Clear Skin Gel products in the United Kingdom.. 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; and the availability of licenses, approvals and permits.
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, the delay or failure to receive regulatory approvals, and the risk factors set out in the Company's annual information form dated April 15, 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.