DanCann Pharma A/S: Tetra Bio-Pharma Receives Positive Scientific Advice Assessment (SAA) Report for QIXLEEF™

COPENHAGEN, Denmark, 03 September 2021 - DanCann Pharma A/S (SS: DANCAN) (“DanCann Pharma”) hereby on behalf of Tetra Bio-Pharma Inc. (“Tetra”), announce that Tetra Bio-Pharma - a leader in cannabinoid-derived drug discovery and development – yesterday announced that Tetra has received the Scientific Advice Assessment (SAA) Report from the Malta Medicines Authority. 

DanCann Pharma signed May 5th a definitive distribution agreement with Canadian Tetra Bio-Pharma Inc. concerning the exclusive distribution of the cannabinoid-based medicines Reduvo™ Adversa® and Qixleef™ in Denmark, Norway, Sweden, Finland, and Germany. This press release is passed on from Tetra's own press release, concerning that Tetra has received the Scientific Advice Assessment (SAA) Report from the Malta Medicines Authority. 

• SAA Report endorsed Tetra Bio-Pharma's proposed nonclinical development and quality programs for QIXLEEF™.
• SAA Report provides clarity on clinical requirements for registration in Europe.

Overall, the SAA Report provided positive feedback on Tetra's drug development plan for QIXLEEF™ and eligibility for submitting a Marketing Authorization Application (MAA) under Directive 2001/83/EC (Directive). QIXLEEF™ is the Company's inhaled proprietary drug which has a fixed ratio of THC and CBD. The medication is inhaled through a Class II medical vaporizer.

The SAA Report endorses Tetra's proposed plan to address the nonclinical safety requirements for submitting a MAA for QIXLEEF™. Similarly, the SAA Report endorses the Company's quality program for QIXLEEF™ as a medicine.  In both cases, the SAA Report provides guidance on requirements for MAA approval.

The SAA Report discusses the assessment of both the PLENITUDE© and REBORN© clinical programs with regards to a MAA.  The SAA Report provides guidance on the endpoints and other aspects of the protocol. The REBORN2© trial was identified as pivotal for the MAA because of its dose-response endpoint requirements of the Directive.  Depending on the outcome in the REBORN1© and REBORN2© clinical trials, full Marketing Authorization would require confirmation of the outcome of REBORN1©.

Dr. Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma said "the endorsement of the proposed nonclinical and quality programs is an exciting achievement that affirms the robustness of our drug development approach. The Medicine Authority's response confirms that our development strategy, adjusted with their guidance on the clinical program, could allow QIXLEEF™ to satisfy the requirements of article 8 of the Directive.  The timing of this news is important for us as we try to finalize a single global clinical program for bringing QIXLEEF™ to patients."

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SOURCE Tetra Bio-Pharma Inc.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

About DanCann Pharma

DanCann Pharma A/S (SS: DANCAN) was founded in 2018 and is a Danish biopharmaceutical Company powered by cannabinoids. DanCann Pharma is a vertically integrated, licensed production and distribution Company based in Denmark. The Company focuses on discovering, developing, manufacturing, and commercializing new therapeutic cannabinoids in a wide range of disease areas.

DanCann Pharma A/S (SS: DANCAN) is listed on the Spotlight Stock Market in Copenhagen.

For more information, visit: www.dancann.com

For further information, please contact:

Jeppe Krog Rasmussen, CEO
E-mail: jkr@dancann.com
Website: www.dancann.com