Press release from Companies

Publicerat: 2021-02-25 13:00:00

DanCann Pharma A/S: DanCann Pharma A/S signs a Letter of Intent with Canadian Tetra Bio-Pharma Inc. for the exclusive distribution of Reduvo™ Adversa[® ]and Qixleef™ in Scandinavia and Germany

COPENHAGEN, Denmark, 25 February 2021 - DanCann Pharma A/S (SS: DANCAN) ("DanCann Pharma" or the "Company") is pleased to announce the signing of a Letter of Intent 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.

Pursuant to registration with the European Medicines Agency (EMA), DanCann Pharma will handle the exclusive sales and distribution in the Nordics and Germany for the products, Reduvo™ Adversa® and Qixleef™. In addition, the agreement covers Tetra’s OTC product Enjouca™.

Reduvo™ Adversa® (dronabinol using a novel mucoadhesive-tablet route of administration) are indicated for the treatment of CINV patients (Chemotherapy-Induced Nausea and Vomiting) and for AIDS-related anorexia associated with weight loss. Qixleef™ and Enjouca™ are indicated for the treatment of uncontrolled pain in advanced cancer patients as well as for breakthrough pain.

Reduvo™ Adversa® technology will allow DanCann to launch a largely improved dronabinol version in the Nordic countries & Germany. The clinical benefits are numerous including: illimited first-pass metabolism leading to an improved bioavailability and consequently to reduced gastro-intestinal exposure and side-effects. The dosage regimen is likely to become BID as opposed to QID. This new technology signifies important intellectual property.

Qixleef™ is a botanical cannabinoid-derived medicine, planned to become the first prescription product to be dispensed through pharmacies and prescribed by healthcare professionals. QIXLEEF™ is inhaled through a Health Canada approved class 2 medical device. It is well characterized and will benefit from data protection, once approved by the EMA. The indications for this product are expected to be for advanced cancer pain and breakthrough pain.

Lastly, ENJOUCA™ is a medical cannabis therapeutic option (a non-registered) which will help European patients to manage their pain.    

"We have very high expectations for the collaboration with Tetra Bio-Pharma. They have a unique portfolio within the pain management and CINV segments, and we look forward to introducing these lines to our markets. We estimate the first sale to commence during second half of 2021, leaving us sufficient time to prepare our sales organization. DanCann estimates reaching peak sales of DKK 340 - 410 million by 2028, depending on the final outcome and scope of the agreement," says DanCann Pharma’s CCO, John Morell Frellsen.

According to DanCann Pharma’s CEO, Jeppe Krog Rasmussen: "The industry – and hereby also the patients – have had some challenges and restrictions regarding the Danish Pilot Programme with medical cannabis (non-registered), with this agreement we are now entering into a completely new path around approved pharmaceuticals with cannabinoid-derived medicines, where these restrictions are assumed to be minimal. This provides a good spread of risk across our portfolio, as well as a much more transparent business plan and future. This is another major step in DanCann Pharma’s vision of improving the health and quality of life for patients with unmet health challenges. By bringing novel products based on cannabinoid derived medicines to the market, we will be able to unleash the true clinical potential of cannabis."According to Steeve Néron, CCO at Tetra Bio-Pharma Inc: "DanCann Pharma and Tetra Bio-Pharma share many of the same values that drive our business – a firm belief that cannabinoid-derived medicines can help improve the quality of life of patients suffering from pain. Physicians and other healthcare professionals are receptive to cannabinoid-derived medicines but have been seeking robust scientific evidence supported by a traditional pharma infrastructure such as a pharmacovigilance program, medical information, medical science liaisons, and so on.   We look forward to working with DanCann Pharma in the Nordic Countries and Germany and to intensifying this first European partnership for Tetra. We are very confident that our respective organizations will deliver impactful therapeutic value to Scandinavian and German patients accompanied by financial success for both DanCann and Tetra."

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. For more information visit: www.dancann.com

About Tetra Bio-Pharma Inc.

Tetra Bio-Pharma (TSX:TBP)(OTCQB:TBPMF), is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a FDA and a Health Canada approved 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

For further information, please contact:

Jeppe Krog Rasmussen, CEO, DanCann Pharma A/S
jkr@dancann.com
www.dancann.com

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