Numinus Bioscience adds Ketamine and LSD to
licence to produce, assemble and sell a wide variety of
psychedelic compounds
VANCOUVER, BC, March 4, 2021 /CNW/ - Numinus Wellness
Inc. ("Numinus" or the "Company") (TSXV: NUMI), a global
leader in supporting and expanding the safe, accessible and
evidence-based use of psychedelic-assisted psychotherapies (PAP),
has received new amendments under Canada's Controlled Drugs and Substances Act
that enhance the Company's ability to lead psychedelics research
and support the global psychedelics sector.
Numinus Bioscience, which operates a state-of-the-art research
lab in British Columbia, Canada,
recently received amendments to its federal licence to allow the
possession, production, assembly, sale, export, and delivery for a
wide variety of psychedelics including – for the first time –
Ketamine and Lysergic acid diethylamide (LSD). The amendment also
supports Numinus Bioscience's role in these activities related to
Mescaline, N,N-Dimethyltryptamine (DMT), N-Methyl-3,4,
methylenedioxyamphetamine (MDMA), Psilocin and Psilocybin.
"These amendments are not just exciting for Numinus and our
researchers, but also for our partners, clients and potentially
academic collaborators in the psychedelics space," said
Sharan Sidhu, Science Officer and
General Manager for Numinus Bioscience. "The amendments
dramatically expand the work we can do with a far larger group of
psychedelics, and open up market-leading and revenue-generating
opportunities for Numinus in R&D, psychedelic formulations,
research and analysis. Moreover, we can now develop and implement
standardized psychedelics testing on top of our existing high
throughput capabilities, and formulate and produce psychedelic
compounds in finished packaged products for clinical trials,
clinical use under exemption, and export."
Among other valued-added services, the amendments enable Numinus
Bioscience to pursue formulation and stability studies to assemble
finished products for all approved psychedelics.
Previously, Numinus Bioscience conducted R&D and analytical
testing on Psilocybe mushrooms. New amendments allow Numinus
Bioscience to conduct all activities related to possession,
production, sale, export, delivery and assembly for
Psilocybe mushroom fruiting bodies, both whole ground and
extracted, to stakeholders that possess a Section 56 exemption.
In addition, the new amendments allow Numinus Bioscience to
increase the amount of Psilocin and Psilocybin produced at the lab
from 505 grams to 1000 grams annually, consisting of 750 grams of
Psilocybin and 250 grams of Psilocin. Health Canada has also acknowledged that the Company
can continue to supply verified and validated Psilocybe
mushroom spores and tissue culture that do not contain controlled
substances to other licensed dealers and can be listed as a
supplier. In coming quarters, Numinus Bioscience will prepare
to offer the expanded suite of psychedelic products and services
allowed by recent amendments.
"The approvals announced today mark a key milestone in advancing
the integrated services model we are building to research and
ultimately deliver quality therapies to people who may benefit,
across the spectrum of mental health disorders," said Payton Nyquvest, CEO, Numinus. "We know that
currently available treatments for mental health disorders are
often ineffective and can lead to major unwanted side effects. To
date, clinical trials for professionally supervised
psychedelic-assisted psychotherapies have shown safety and
efficacy, with fewer and less severe side effects than conventional
medicines."
As the first public entity to legally cultivate and extract
Psilocybe mushrooms under its dealers' license, Numinus
Bioscience is already a research leader in the psychedelics
industry. The BC lab is licensed by Health Canada.
Note
The safety and efficacy of psychedelic-assisted psychotherapy is
currently under investigation. It has not yet been approved by
Health Canada or the U.S. FDA, does not work for everyone, and
carries risks even in therapeutic settings. These statements are no
guarantee of future Health Canada or FDA approval or availability
of psychedelic-assisted psychotherapy. These statements necessarily
involve known and unknown risks and uncertainties, which may cause
actual outcomes to differ materially from projections.
About Numinus
Numinus Wellness Inc. (TSXV:NUMI) is a health care and research
company creating psychedelic-centred solutions to treat mental
illness, substance abuse and trauma.
Numinus Health delivers treatments through clinics
and virtual services, with clinics in Vancouver and Montreal.
Numinus R&D develops clinical and therapeutic
protocols to use in treatments, in collaboration with research
partners and regulators.
Numinus Bioscience develops formulations and methods for
a safe supply, using Health Canada licences, scientific expertise
and cutting-edge technology.
Learn more at numinus.ca, and follow us on Facebook, Twitter,
and Instagram.
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This news release contains forward-looking statements within
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among others, dependence on obtaining and maintaining regulatory
approvals, including acquiring and renewing federal, provincial,
municipal, local or other licences and any inability to obtain all
necessary governmental approvals licences and permits to operate
and expand the Company's facilities; regulatory or political change
such as changes in applicable laws and regulations, including
federal and provincial legalization, due to inconsistent public
opinion, perception of the medical-use and adult-use marijuana
industry, bureaucratic delays or inefficiencies or any other
reasons; any other factors or developments which may hinder market
growth; the Company's limited operating history and lack of
historical profits; reliance on management; the Company's
requirements for additional financing, and the effect of capital
market conditions and other factors on capital availability;
competition, including from more established or better financed
competitors; and the need to secure and maintain corporate
alliances and partnerships, including with research and development
institutions, customers and suppliers; the development and
implementation of medical protocols and treatment standard
operating procedures for the use of psychedelic therapies; the
Company's goals to develop and implement partnerships with research
organizations and other key players in the integrative mental
health industry; the Company's ability to successfully withstand
the economic impact of COVID-19; the medical benefits, safety,
efficacy, dosing and social acceptance of psychedelics; the
approval and/or success of compassionate access clinical trials;
the cultivation and harvest of psilocybe mushrooms; and the
availability of trained personnel and medical professionals. These
factors should be considered carefully, and readers are cautioned
not to place undue reliance on such forward-looking statements.
Although the Company has attempted to identify important risk
factors that could cause actual actions, events or results to
differ materially from those described in forward-looking
statements, there may be other risk factors that cause actions,
events or results to differ from those anticipated, estimated or
intended. There can be no assurance that forward-looking statements
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could differ materially from those anticipated in forward-looking
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forward-looking statement, even if new information becomes
available as a result of future events, new information or for any
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SOURCE Numinus Wellness Inc.