- REDUVO would have Canada’s only Drug Identification Number for a THC-based prescription drug
- The addressable market is estimated to be $80M CDN by 2022
OTTAWA, ON / April 14, 2021 / Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a biopharmaceutical pioneer in immunomodulator drug discovery and development announce they have advanced the REDUVO soft gel capsules New Drug Submission (NDS) file by responding to a request for more information from Health Canada, as previously announced on March 15, 2021. This review is part of the overall requirement for Tetra to be able to sell and distribute REDUVO soft gel capsules in Canada.
On Friday April 9th, 2021, Tetra submitted all the requested information to the Office of Submissions and Intellectual Property (OSIP) and the Therapeutic Products Directorate (TPD) of Health Canada. The additional information supporting the NDS and the proposed regulatory pathway have been provided as requested. This will now allow Health Canada to process the response and assess the requested information for completeness.
A successful application will provide Tetra with its first Drug Identification Number (DIN) for a THC-based prescription drug. A DIN is a unique eight-digit number assigned to a drug that has undergone a robust assessment by Health Canada and is authorized for sale in Canada. The Company anticipates that REDUVO will be publicly reimbursed by Canadian provinces and territories. The new drug name, REDUVO, is also under examination by Health Canada.
REDUVO will allow Tetra to establish a revenue stream based on a synthetic cannabinoid drug for major markets in Chemotherapy-induced Nausea and Vomiting (CINV). The addressable Canadian market is estimated to be $80M CDN by 20221. REDUVO will be indicated in AIDS-related anorexia associated with weight loss and severe nausea, and vomiting associated with cancer chemotherapy.
Dr. Guy Chamberland, CEO and CRO of Tetra commented, “Our regulatory team was able to address the points raised and has submitted the response to Health Canada within the allowable timeframe. If the response is determined to be complete, the application will enter the next phase of review. This is basically the scientific evaluation phase of the NDS application and is the final review phase of the review process. Having submitted the response within the allowable timeframe allows Tetra to maintain its anticipated launching of REDUVO in the second half of 2021.”
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1) is a biopharmaceutical pioneer in immunomodulator 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
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