Akanda to supply Tetra Bio-Pharma with cannabis for FDA traials

Product and services from Akanda’s EU GMP Holigen facility will be utilized in this trial. (CNW Group/Tetra Bio-Pharma Inc.)

LONDON and MONTREAL — Akanda Corp. and Tetra Bio-Pharma, jointly announced that Akanda will supply Tetra with pharmaceutical grade cannabis flower in a microdose cap form, for use in a Storz & Bickel Mighty Medic Vaporizer for global commercialization of Tetra’s QIXLEEFTM and related products. In addition, Akanda will act as a Contract Development and Manufacturing Organization (CDMO) for Tetra’s clinical drug and commercial supply programs. With this project, Akanda becomes a CDMO in addition to being an EU GMP cannabis manufacturer, marking Akanda’s first entry into cannabinoid drug development, which is a new and growing market opportunity for the company, while Tetra secures a stable supply of ingredients and regulatory-approved services to satisfy clinical trials and commercialization.

QIXLEEF™ is a proprietary botanical inhaled investigational new drug currently being studied in two U.S. Food and Drug Administration (FDA) authorized clinical trials: 1) REBORN©1, a Phase 2 study authorized by the FDA to evaluate inhaled cannabinoids against a class of immediate-release oral opioids for the management of breakthrough cancer pain, and 2) PLENITUDE©, a Phase 2 multicenter clinical trial authorized by the FDA to evaluate the safety and efficacy of inhaled cannabinoids to relieve uncontrolled pain in patients with advanced cancer. The companies estimate the total addressable market (TAM) for QIXLEEF™ to be nearly $1.7 billion by 20281.

Under the multi-year agreement, Akanda will supply Tetra with THC and CBD flower, and will provide regulatory, quality and pharmaceutical manufacturing services for the QIXLEEFTM clinical drug development and marketing authorization from its Portugal operations.

Akanda will provide Tetra with a range of services, including regulatory affairs, quality control and stability testing through Akanda’s internal lab, as well as manufacturing capabilities.

“This supply agreement with Tetra is a major milestone in Akanda’s journey in becoming a cannabis platform company serving all regulated markets in the EMEA region,” commented Tej Virk, CEO of Akanda. “In supporting a terrific partner with a mission to improve patient health and quality of life though cannabinoid-derived medicine, we are demonstrating that cannabis can fit into the traditional public sector model, with the expectation of reimbursement. Simultaneously, we are productively utilizing our diverse capabilities to support clinical trials for pharma grade cannabinoids. If approved, we expect to provide flower for the authorized compound, potentially creating a significant, incremental revenue stream for Akanda. This opportunity could only have been possible with our state-of-the-art facilities that we gained through the acquisition of Holigen in May.”