Tetra Bio-Pharma Provides Update on Its New Drug Submission Application in Canada
Tetra Bio-Pharma has advanced the New Drug Submission (NDS) for its REDUVO soft gel capsules, responding to Health Canada’s request for additional information. A successful application will grant Canada's only Drug Identification Number (DIN) for a THC-based prescription drug, expected to enter the market in the second half of 2021. The Canadian market for such drugs is estimated at $80M CDN by 2022. REDUVO aims to treat chemotherapy-induced nausea and vomiting as well as AIDS-related anorexia.
- Tetra has responded promptly to Health Canada's request, keeping their timeline on track.
- REDUVO could capture an estimated $80M CDN market by 2022.
- The pressure to meet regulatory requirements raises uncertainty regarding the NDS approval timeline.
- 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 / ACCESSWIRE / 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
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
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.
1 Compuscript Data 2020 (IQVIA) for total Nabilone market, combined with the expected penetration by REDUVO™
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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FAQ
What is REDUVO and its significance for Tetra Bio-Pharma (TBPMF)?
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