Akanda and Tetra Bio-Pharma said 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 QIXLEEF 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.
QIXLEEF is a proprietary botanical inhaled investigational new drug currently being studied in two U.S. Food and Drug Administration (FDA) authorized clinical trials: REBORN, 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 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.
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 QIXLEEF clinical drug development and marketing authorization from its Portugal operations. The supply of the active pharmaceutical ingredient starts in the third quarter of 2022 and is anticipated to increase incrementally over the succeeding years based on growing demand and commercializing of Tetra’s cannabinoid-derived medicines.
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. Upon FDA approval, the anticipated supply commitments could reach over 10 metric tons per year.