Tetra Bio-Pharma Signs a Definitive Distribution Agreement with DanCann Pharma to Monetize Its Dronabinol and Botanical Product Portfolios

May 05, 2021 at 03:00 AM EDT

This Definitive Agreement is expected to generate an excess of $47,5M CAD in revenue for Tetra

OTTAWA, ON / ACCESSWIRE / May 5, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF)(FSE:JAM1), a leader in cannabinoid-derived drug discovery and development announced today the signing of a Definitive Agreement with DanCann Pharma A/S (SS: DANCAN) for the exclusive distribution of Reduvo™ Adversa®, QIXLEEF™ and ENJOUCA™ in Denmark, Norway, Sweden, Finland, and Germany.

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 as Tetra's medicinal cannabis product ENJOUCA™.

The Agreement encompasses a sum of upfront and milestone payments of up to $1,5M CAD, and expected cumulative royalties in excess of $46M CAD on DanCann's cumulative sales for Reduvo™ Adversa®, QIXLEEF™ and ENJOUCA™ from 2021 to 2028.

According to Guy Chamberland, CEO at Tetra Bio-Pharma: "I am glad that we were able to sign this definitive agreement with DanCann Pharma. Both organizations strongly believe that cannabinoid-derived medicines will help improve the quality of life of patients suffering from pain and chemotherapy induced nausea and vomiting (CINV). We look forward to working with DanCann Pharma in the Nordic Countries and Germany. Both organizations set the bar very high when it comes to delivering impactful therapeutic value medicines to patients. This partnership will strengthen our business model and demonstrates that Tetra keeps delivering on our commitment to shareholders to monetize our assets and transitioning from a pre-revenue biopharma company to an in-revenue biopharma company."

"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 have mutual expectations for the sales to commence during the first half of 2022. DanCann Pharma estimates reaching peak sales of CAD 67 - 81 million by 2028, depending on the development of the markets" says DanCann Pharma's CCO John Morell Frellsen.

About Tetra's Three Products Covered in This Definitive Agreement:
Reduvo™ Adversa® is a dronabinol administered product through an innovative mucoadhesive-tablet delivery system. It is indicated for the treatment of patients living with CINV 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 and 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 twice a day as opposed to 4 times a day. This new technology signifies important intellectual property.

QIXLEEF™ is a botanical cannabinoid-derived medicine, anticipated to become the first prescription drug product for this class to be dispensed through pharmacies and prescribed by healthcare professionals. QIXLEEF™ is inhaled via vaporization 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 manage their pain.

About DanCann Pharma
DanCann Pharma A/S (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
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.

Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

For further information, please contact Tetra Bio-Pharma Inc.:

Tetra Bio-Pharma Inc.
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
Email: investors@tetrabiopharma.com
media@tetrabiopharma.com

SOURCE: Tetra Bio-Pharma

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Tetra Bio-Pharma Signs a Definitive Distribution Agreement with DanCann Pharma to Monetize Its Dronabinol and Botanical Product Portfolios

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