Creso Pharma Limited (ASX:CPH, OTC:COPHF, FRA:1X8) (‘Creso Pharma’ or ‘the Company’) is
pleased to advise that wholly-owned, Canadian based psychedelics subsidiary, Halucenex Life Sciences
Inc. (“Halucenex”) has been invited to register as a potential supplier to Health Canada’s Special Access
Program (“SAP”), following recent regulatory changes.
The amendments to the SAP were announced in the Government of Canada’s official newspaper, the
Canada Gazette on 5 January 2022ii and reverse a 2013 decision that prohibited a range of restricted
drugs, including psilocybin to be used as treatments for mental health and other conditions.
Halucenex will progress the approval process following favorable legislative shifts by the governing
body, which if obtained and subject to discretion from Health Canada on a case-by-case basis, will
allow the sale of some restricted drugs, including psychedelic substances by medical professionals for
the purposes of emergency treatment.
Under the new regulatory framework, medical practitioners will, on behalf of patients with serious or
life-threatening conditions, be able to request restricted drugs through the SAP. If an individual’s
application has been granted through the SAP, doctors and patients may be directed to Halucenex as
a potential supplier of psychedelic drugs (subject to Halucenex’s SAP application being successful).
This presents an opportunity for Halucenex, as it will enable the Company to supply psilocybin to
healthcare professionals seeking evolutionary treatments for patients through the SAP. Being classed
as a potential supplier is expected to unlock a number of near-term revenue generating opportunities
through the sale to medical professionals and patients, as well as the ability for Halucenex to
established itself as one of Canada’s first potential providers through the SAP.
The Company is in well progressed discussions with Health Canada to advance approval. Halucenex
has responded to a request for a dataset from the regulator, which provides background to support
the safety and efficacy of the Company’s GMP grade psilocybin as a treatment, as well as anticipation
of dealership readiness to meet SAP demand for quality-controlled drugs containing psilocybin.
Discussions are expected to continue over the coming weeks and the Company looks forward to
providing additional updates throughout the authorization process.
Upon potential approval, Halucenex will begin working with its network of medical professionals and
clinics to advance educational initiatives and potential supply agreements. The Company has strong
links to a range of veterans affairs organizations, which it will leverage to progress potential sales.
Halucenex founder and CEO, Mr Bill Fleming said: “Psychedelic medicines remain on a strong
upward trajectory for both research and compassionate use purposes and this recent shift from Health
Canada shows the potential direction towards more liberal policies as public demand increases.“
“Halucenex is well positioned to capitalise as a supplier to the SAP upon regulatory approval . If successful
in the application process, Halucenex has a large supply of GMP grade, synthetic psilocybin which can be
sold to doctors and patients. Further, we continue to work through growing protocols for botanical
psilocybin, which can also be supplied in the future. Post approval, we anticipate a number of revenue
generating opportunities to materialise as Halucenex progresses its transition to a leading drug
development and supply company.”
Authority and Contact Details
This announcement has been authorised for release by the Board of Directors of Creso Pharma
For further information, please contact:
Creso Pharma Limited
P: +61 (0) 497 571 532
About Creso Pharma
Creso Pharma Limited (ASX:CPH) brings the best of cannabis to better the lives of people and animals.
It brings pharmaceutical expertise and methodological rigor to the cannabis world and strives for the
highest quality in its products. It develops cannabis and hemp derived therapeutic, nutraceutical, and
life style products with wide patient and consumer reach for human and animal health.\
Creso Pharma uses GMP (Good Manufacturing Practice) development and manufacturing standards
for its products as a reference of quality excellence with initial product registrations in Switzerland. It
has worldwide rights for a number of unique and proprietary innovative delivery technologies which
enhance the bioavailability and absorption of cannabinoids. To learn more please visit:
Forward Looking Statements
This announcement contains forward-looking statements with respect to Creso and its respective
operations, strategy, investments, financial performance and condition. These statements generally
can be identified by use of forward-looking words such as “may”, “will”, “expect”, “estimate”,
“anticipate”, “intends”, “believe” or “continue” or the negative thereof or similar variations. The actual
results and performance of Creso could differ materially from those expressed or implied by such
statements. Such statements are qualified in their entirety by the inherent risks and uncertainties
surrounding future expectations. Some important factors that could cause actual results to differ
materially from expectations include, among other things, general economic and market factors,
competition and government regulation.
The cautionary statements qualify all forward-looking statements attributable to Creso and persons
acting on its behalf. Unless otherwise stated, all forward-looking statements speak only as of the date
of this announcement and Creso has no obligation to up-date such statements, except to the extent
required by applicable laws.