Tetra Bio-Pharma To Monetize Its Dronabinol And Botanical Product Portfolios

Subject to registration with the European Medicines Agency (EMA), DanCann Pharma will handle the exclusive sales and distribution in the Nordics and Germany for Reduvo™ Adversa® and QIXLEEF™, a botanical cannabinoid-derived medicine, as well the over the counter (OTC) medicinal cannabis product ENJOUCA™.

The agreement encompasses a sum of upfront and milestone payments of up to $2,25M CDN and a confidential royalty level on DanCann net sales for Reduvo™ Adversa®, QIXLEEF™ and ENJOUCA™.

Reduvo™ Adversa® is a dronabinol administered product through an innovative mucoadhesive-tablet delivery system. It is indicated for the treatment of patients living with Chemotherapy-Induced Nausea and Vomiting (CNIV) as well as those suffering from AIDS-related anorexia associated with weight loss.

The Reduvo™ Adversa® technology will allow DanCann to launch a largely improved version of dronabinol in the Nordic countries & Germany. The clinical benefits are numerous including: limited first-pass metabolism leading to an improved bioavailability and consequently to a 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 for this class 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 medicinal cannabis therapeutic option (non-registered) which will help European patients to manage their pain.

According to Steeve Néron, CCO at Tetra Bio-Pharma: "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.

"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 $55M DKK by 2026," says DanCann Pharma's CCO John Morell Frellsen.