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

Company signs LOI for Nordics and Germany

OTTAWA, ON / ACCESSWIRE / February 25, 2021 /Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX:TBP)(OTCQB:TBPMF), a biopharmaceutical pioneer in immunomodulator drug discovery and development announced the signing of a Letter of Intent with DanCann Pharma A/S (SS: DANCAN) for the exclusive distribution of Reduvo™ Adversa® and QIXLEEF™ 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 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.

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

Tetra Bio-Pharma (TSX:TBP)(OTCQB:TBPMF) is a biopharmaceutical pioneer in immunomodulator 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 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.:

Investor Contact:

Tetra Bio-Pharma Inc
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
investors@tetrabiopharma.com

Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
tetra@alphabronze.net

Media Contact:

energi PR
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
carol.levine@energipr.com

SOURCE: Tetra Bio-Pharma

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