Apex Labs Granted Dealer's Licence by Health Canada

14 Feb 2024
www.prnewswire.com
Phase 2
Authorized to sell psilocybin through Health Canada's Special Access Program.
VANCOUVER, BC, Feb. 14, 2024 /PRNewswire/ - Apex Labs Ltd. (
APEX or the
Company), a pharmaceutical company transforming the standard of mental health care with psilocybin is pleased to announce the approval by Health Canada of APEX's Controlled Drugs and Substances Dealer's Licence (
DL). The DL authorizes APEX to sell psilocybin, including APEX-52 microdose and APEX-90 macrodose psilocybin drug products developed in collaboration with licensed dealers in Canada and the United States. The DL authorizes sale under Health Canada's Special Access Program (
SAP). APEX's psilocybin products have previously been used to dose Veteran patients both in clinical trials and through the SAP.
"Receiving this licence is a significant achievement for APEX alongside our tremendous progress actively dosing patients through our Early Access Program (
EAP) and gearing up to launch multiple clinical trials," says Tyler Powell, co-Founder and CEO. "We are grateful to Health Canada for processing APEX's licence application so quickly, signaling the importance of access to controlled and regulated psilocybin."
This DL simplifies the supply chain and broadens communication for APEX's psilocybin products by allowing direct sales for the SAP or investigator-led clinical trials.
"APEX worked with Health Canada to issue this Dealer's Licence less than four months from application with no observations. Health Canada's responsiveness and clarity made for a simple and straightforward process," says Dr. David Wood, Principal of R-Group Legal, regulatory counsel and strategic advisor to APEX since 2020.
"This Dealer's Licence will enable APEX to make access to psilocybin a reality for a greater number of Veterans and Canadians with unmet mental health challenges," adds Mr. Powell.
APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care with psilocybin treatments. By bringing data supported, clinically evaluated drugs to market for depression in PTSD, APEX's strategy is focused on developing pharmaceutical products through phased clinical programs evaluating safety and efficacy across multiple indications, alongside a robust Early Access Program.
APEX sees Veterans as a patient base with the most severe unmet need, supporting Veteran patients first and expanding to broader global patient communities.
PATHFINDER-52 and
SUMMIT-90 are statistically powered multi-center randomized, double-blind, placebo-controlled phase 2b studies leveraging APEX-52 microdose and APEX-90 macrodose psilocybin drug assets with patient pre-screening underway. Both have been approved by Health Canada by way of a No Objection Letter (
NOL).
The APEX Early Access Program (EAP) supports physicians applying through Health Canada's SAP for access to the APEX-90 macrodose psilocybin product for treatment outside of clinical trials where patients are suffering from severe disease states and otherwise meet the criteria for the SAP.
Visit
apexlabs.com for more information and follow APEX on
LinkedIn,
Twitter and
Instagram
Forward-Looking Statement
This release contains certain "forward looking statements" and certain "forward-looking information" as defined under applicable Canadian securities laws. Forward-looking statements and information can generally be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "continue", "plans" or similar terminology. Forward-looking statements and information are based on forecasts of future results, estimates of amounts not yet determinable and assumptions that, while believed by management to be reasonable, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the to control or predict, that may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out here in, including but not limited to: receiving of Health Canada Dealers Licence, the Company evaluating the safety and efficacy of APEX-52 (psilocybin) and APEX-90 (psilocybin) in treating depression in Veterans and patients with Post-Traumatic Stress Disorder; statements related to APEX-52 and APEX-90, including manufacturing, dosing, and trial details; statements made by the Company's CEO, and key advisors with respect to Health Canada's Dealer's Licence; the Company's efforts around the Early Access Program; statements made relating to Canadian Veteran patients; the inherent risks involved in the general securities markets; uncertainties relating to the availability and costs of financing needed in the future; the inherent uncertainty of cost estimates and the potential for unexpected costs and expenses, currency fluctuations; regulatory restrictions, liability, competition, loss of key employees and other related risks and uncertainties. The Company undertakes no obligation to update forward-looking information except as required by applicable law. Such forward-looking information represents managements' best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information.
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