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Tetra Bio-Pharma Confirms Submission of Two OTC DIN Applications to Health Canada


OTTAWA, Nov. 26, 2019 (GLOBE NEWSWIRE) -- Tetra Natural Health (“TNH”) a wholly owned subsidiary of Tetra Bio-Pharma Inc., (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF) today announced that it has submitted two over-the-counter (OTC) DIN applications to Health Canada. The first application, submitted on November 15th, is for the treatment of hemorrhoids. The second application, submitted today, November 26th, is for the temporary relief of aches and pains of muscles and joints associated with backache, lumbago, strains, bruises, sprains and arthritic or rheumatic pain, pain of tendons and ligaments. 

Tetra has created this OTC product line containing beta-caryophyllene to bring self-care therapies that act on the CB2 receptor directly to pharmacies and patients. Tetra intends to commercially launch these OTC pain medications in the $19 billion OTC market1. Dr. Guy Chamberland, CEO and CRO of Tetra Bio-Pharma noted, "Tetra has always had a focus on bringing evidence-based therapies to patients, and this OTC drug line is part of that vision."

Tetra continues to expect commercial launch in Canada in pharmacy retail outlets in early 2020, and is in commercial agreement discussions with various companies for the sale and distribution of these products. Tetra also plans to launch these products in the United States market in 2020. In preparation for a U.S. launch, Tetra is in discussions with a contract manufacturer to set up the manufacturing and to obtain a National Drug Code (NDC) number from the U.S. Food and Drug Administration (FDA) for each drug, which is required for all OTC drugs sold in the U.S.

1 References:
Over-the-Counter Pain Medication Market will Exhibit a Steady 4.0% CAGR through 2028: Future Market Insights.  February 20, 2019
U.S. Topical Pain Relief Market Outlook – 2025.  Sayali Shinde , Onkar Sumant. Allied Market Research. June 2019.
Global Topical Pain Relief Market.  Allied Market Research. April 2019. 

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. 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 bio pharma industry by regulators, physicians and insurance companies.

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Source: Tetra Bio-Pharma

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture 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 this trial, the ability to obtain orphan drug status, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

Investor Contact:
Bruce Mackle
LifeSci Advisors LLC

Media Contact:
Andrew Mielach
LifeSci Public Relations

Carol Levine
Energi PR
514-288-8500 ext. 226


Source: Tetra Bio-Pharma

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