Health Canada Accepts New Drug Submission for REDUVO(TM) as a Treatment for Patients with Chemotherapy-induced Nausea and Vomiting

Rhea-AI Summary

Tetra Bio-Pharma has announced that Health Canada has accepted its New Drug Submission (NDS) for REDUVO™, a treatment for chemotherapy-induced nausea and vomiting (CINV). This marks a significant milestone as the company transitions from pre-revenue to revenue-generating status. If approved, REDUVO™ will receive a Notice of Compliance (NOC) and a Drug Identification Number (DIN), allowing Tetra to market the drug in Canada. The company anticipates reimbursement for REDUVO™ from provincial and private healthcare plans, addressing a critical need for alternative therapies in CINV management.

Positive

• Health Canada has accepted the New Drug Submission for REDUVO™, advancing Tetra from a pre-revenue to a revenue-generating company.
• If approved, REDUVO™ will receive a Notice of Compliance and a Drug Identification Number, enabling market availability in Canada.
• The expected reimbursement for REDUVO™ from provincial and private healthcare plans could enhance market potential.

Negative

• None.

This news release constitutes a "designated news release" for the purposes of the Company's prospectus supplement dated May 28, 2021 to its short form base shelf prospectus dated April 1, 2020

• The Company approaches a significant milestone advancing from a pre-revenue biotech to in revenue

OTTAWA, ON / ACCESSWIRE / June 2, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development announced today that Health Canada has accepted its New Drug Submission (NDS) for REDUVO™ and has formally entered the final review phase in the drug review process. If successful, REDUVO™ will be issued a Notice of Compliance (NOC) as well as a Drug Identification Number (DIN) which permits Tetra to market the drug in Canada and indicates the drug's official approval in Canada.

REDUVO™ is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO™ is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.

"There is a need for alternative therapies for patients experiencing CINV who don't respond well to the conventional drugs used to control nausea and vomiting. Prevention of CINV remains a priority to reduce further illness in patients receiving chemotherapy. Tetra anticipates that REDUVO™ will be publicly and privately reimbursed by provinces and Canadian private healthcare plans," said Chief Executive Officer Dr. Guy Chamberland. "We will continue to work closely with Health Canada as we seek to bring this therapy to patients as soon as possible."

About Chemotherapy-induced Nausea and Vomiting
Chemotherapy-induced nausea and vomiting is one of the most common side effects of chemotherapy treatment. Some studies indicate that untreated CINV can affect up to 70% to 80% of all people undergoing chemotherapy¹. Patients who poorly manage CINV may have a decreased quality of life.

About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived 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.

References:

1. Chemotherapy-Induced Nausea and Vomiting-Adult. Source: https://www.ons.org/pep/chemotherapy-induced-nausea-and-vomitingadult?display=pepnavigator&sort_by=created&items_per_page=50

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.:
Tetra Bio-Pharma Inc.
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
Email: investors@tetrabiopharma.com
media@tetrabiopharma.com

SOURCE: Tetra Bio-Pharma

View source version on accesswire.com:
https://www.accesswire.com/650014/Health-Canada-Accepts-New-Drug-Submission-for-REDUVOTM-as-a-Treatment-for-Patients-with-Chemotherapy-induced-Nausea-and-Vomiting

FAQ

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

The acceptance of the New Drug Submission (NDS) for REDUVO™ signifies a major step for Tetra Bio-Pharma, moving it toward generating revenue.

What is REDUVO™ developed by Tetra Bio-Pharma used for?

REDUVO™ is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting, as well as weight loss and severe nausea in HIV-infected patients.

What approval does REDUVO™ need from Health Canada?

REDUVO™ requires a Notice of Compliance (NOC) and a Drug Identification Number (DIN) from Health Canada to be marketed in Canada.

When was Tetra Bio-Pharma's New Drug Submission for REDUVO™ accepted?

The New Drug Submission for REDUVO™ was accepted by Health Canada on June 2, 2021.