Tetra Bio-Pharma Provides Status of Its New Drug Submission Application in Canada

Rhea-AI Summary

Tetra Bio-Pharma announced that its Dronabinol Soft Gel capsules New Drug Submission (NDS) has successfully cleared the screening phase with Health Canada. This marks a significant step towards obtaining Canada's first Drug Identification Number (DIN) for a THC-based prescription drug, Reduvo™. The addressable market in Canada is estimated at $80M CDN by 2022. Tetra anticipates launching Reduvo™ in the second half of 2021, establishing a revenue stream for treating chemotherapy-induced nausea and vomiting. The company aims for public reimbursement through an aggressive market access strategy.

Positive

• Completion of the screening phase for the New Drug Submission signals progress towards approval.
• Estimated addressable market of $80M CDN for Reduvo indicates strong revenue potential.
• Anticipated launch of Reduvo in the second half of 2021 marks a transition to revenue-generating status.

Negative

• None.

• Reduvo™ would be Canada's only DIN for a THC-based prescription drug
• The addressable market is estimated to be $80M CDN by 2022

OTTAWA, ON / ACCESSWIRE / March 15, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF), a biopharmaceutical pioneer in immunomodulator drug discovery and development announce that the Dronabinol Soft Gel capsules New Drug Submission (NDS) file submitted to Health Canada on December 30, 2020 has completed the screening phase.

The dossier at Health Canada completed the screening phase. To facilitate the product approval, and due to the nature of the data supporting the NDS, Health Canada has recommended an unconventional regulatory pathway and therefore requested additional information to fulfill all requirements of that proposed prescription drug approval pathway. The positive feedback and communication received from Health Canada, which are part of the regular review process, do not increase the expected review timeline. Tetra is working towards submitting the response to Health Canada within the allowable timeframe.

A successful application will provide Tetra with its first Drug Identification Number (DIN) for a THC-based prescription drug. 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, "We are pleased to have successfully cleared this critical step in the NDS application. The application will now enter the next phase of review, thereby allowing Tetra to maintain its anticipated launching of REDUVO™ in the second half of 2021. This drug launch for Tetra is a major milestone as it moves the Company from a pre-revenue biotech to in revenue for 2021 which is great news for Tetra employees and shareholders. We anticipate strong demand for the only THC-based drug in Canada that will be prescribed by physicians. Through an aggressive Market Access Strategy, Tetra anticipates that REDUVO™ will be publicly reimbursed by provinces and territories in Canada."

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 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: nleroux@tetrabiopharma.com

SOURCE: Tetra Bio-Pharma

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https://www.accesswire.com/635381/Tetra-Bio-Pharma-Provides-Status-of-Its-New-Drug-Submission-Application-in-Canada

FAQ

What is the significance of Tetra Bio-Pharma's New Drug Submission for TBPMF?

The submission's successful screening phase brings Tetra closer to launching its THC-based drug, Reduvo, potentially opening a significant revenue stream.

What is the market potential for Tetra Bio-Pharma's Reduvo in Canada?

The addressable market for Reduvo is estimated to be $80M CDN by 2022.

When does Tetra Bio-Pharma expect to launch Reduvo?

Tetra Bio-Pharma anticipates launching Reduvo in the second half of 2021.

How will Tetra Bio-Pharma approach market access for Reduvo?

The company plans an aggressive market access strategy to ensure public reimbursement for Reduvo.