QUEBEC CITY–(BUSINESS WIRE)–Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD), a clinical stage botanical pharmaceutical corporation focused on developing a unique portfolio of botanical prescription drugs and cosmeceutical products, announced today that it has obtained, from Health Canada, a Research licence pursuant to the Cannabis Act and Cannabis Regulations.
The licence gives Devonian the ability to begin its pharmaceutical cannabis research program at its facility in Montmagny, Quebec. The licence also includes satellite research sites located at the laboratories of Dr Suha Jabaji, PhD (Department of Plant Science, McGill University) and Dr Louis Flamand, PhD, MBA (Department of Microbiology and Immunology, Laval University).
“We can now initiate our cannabinoids-based pharmaceutical program with the vision that such products could be developed under the US-Food and Administration’s Botanical Drug Regulation1. The US Food and Drug Administration (FDA) established a clear regulatory pathway for botanical drugs. The US FDA’s botanical path considers a plant extract to be a drug. The rationale behind this regulatory approach is that the observed efficacy of such extract has been associated with the action of multiple components including any synergistic effects also called the ‘‘entourage effects’’. Botanical drug development therefore involves methods that allow the isolation and characterisation of synergistic bioactive components and plays a significant role in sustaining efficacy of this class of drugs. Devonian’s core strategy is to develop prescription drugs, including those based on cannabinoids, within the Botanical Drug Regulatory pathway.,” said Dr. André P. Boulet, PhD., President & CEO of Devonian.
Devonian Health Group Inc. is a late stage botanical pharmaceutical corporation with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription botanical drugs from plant materials and algae for the treatment of inflammatory-autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a US-FDA set of regulatory guidelines favouring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Acquired in 2018, Altius Healthcare Inc., its commercialization partner, brings opportunities for further diversification and growth potential. Devonian is traded publicly on the TSXV Exchange (TSXv:GSD).
For more information, visit www.groupedevonian.com.
- Botanical Drug Development, Guidance for Industry. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), December 2016.
Forward Looking Statements
This press release contains forward-looking statements about Devonian’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Devonian’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical and dermo-cosmeceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Devonian to take advantage of business opportunities in the pharmaceutical and dermo-cosmeceutical industries, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Devonian’s prospectus dated April 21st, 2017 under the heading “Risk Factors” related to Devonian’s business. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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