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Tetra Bio-Pharma Inc
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Close 2021-05-04 C$ 0.475
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Tetra products to be sold by DanCann in Europe

2021-05-05 07:12 ET - News Release

Mr. Guy Chamberland reports


Tetra Bio-Pharma Inc. has signed a definitive agreement with DanCann Pharma A/S 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 $1.5-million and expected cumulative royalties in excess of $46-million on DanCann's cumulative sales for Reduvo Adversa, Qixleef and Enjouca from 2021 to 2028.

According to Guy Chamberland, chief executive officer 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 prerevenue 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 $67[-million] to $81-million by 2028, depending on the development of the markets," says DanCann Pharma's chief commercial officer 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 improved bioavailability and consequently to reduced gastrointestinal exposure and side effects. The dosage regimen is likely to become twice a day as opposed to four 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 health care 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 European Medicines Agency. 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 Tetra Bio-Pharma Inc.

Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a Food and Drug Administration and a Health Canada-cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their health care providers. The company's evidence-based scientific approach has enabled it 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 it does, 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.

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