Tetra Bio-Pharma Granted Two OTC Drug Identification Numbers (DIN) by Health Canada
OTTAWA, Jan. 17, 2020 (GLOBE NEWSWIRE) -- Following its November 26th, 2019 Press Release, Tetra Bio Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF) today announced that Health Canada has granted two Drug Identification Numbers (DIN) for the first over-the-counter (OTC) products to be marketed under its TERPACAN™ banner.
Tetra is in the process of finalizing supply, sales and distribution agreements with several companies, and anticipates launching TERPACAN™ products in Canadian pharmacy retail outlets by mid-2020. Additionally, Tetra will launch these products into the American and European markets in 2020, once it receives final marketing authorization in those countries. In preparation for a late 2020 launch in the United States, Tetra is in the process of finalizing a supply agreement with a contract manufacturer to establish manufacturing, and obtaining a National Drug Code (NDC) number for each drug, a requirement for all OTC drugs sold in the United States.
TERPACAN™ (hemorrhoids) is a topical formulation that will be used for the treatment of hemorrhoids, an itchy, painful and common condition affecting thousands of Canadians. TERPACAN™ (back & muscle pain) is indicated for the temporary relief of aches and pains of muscles and joints associated with backache, lumbago, strains, bruises, sprains, arthritic or rheumatic pain and pain of tendons and ligaments. In Canada the hemorrhoid treatment market has reached $22M, posting a steady 3% CAGR in 2019 while the highly competitive self-care pain treatment market has reached $432M, posting a 1% CAGR1.
“Tetra is focused on bringing well differentiated therapies to patients who are looking for new options to help relieve the pain and discomfort associated with activities of daily living,” said Dr. Guy Chamberland, Tetra Bio-Pharma’s CEO and Chief Regulatory Officer. “Terpacan for back and muscle pain, and Terpacan for hemorrhoids are products that align with our vision. The fact you’ll be able to find this brand at your corner drugstore means easy access for patients and caregivers.”
According to the Canadian Digestive Health Foundation nearly 20 million Canadians experience a digestive problem every year, and hemorrhoids are among the associated conditions creating an opportunity for awareness of self - help remedies. US numbers suggest that the problem affects nearly 4.5% of the US population. 2
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.
For more information visit: www.tetrabiopharma.com 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.
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 646-889-1200 TetraInvestors@LifeSciAdvisors.com
Media Contact US: Andrew Mielach LifeSci Public Relations 646-876-5868 email@example.com
Media Contact Canada: Carol Levine Energi PR Inc. 514-288-8500 ext. 226 firstname.lastname@example.org
Source: Tetra Bio-Pharma
1 The Nielsen Company - total Canadian all outlets (food, drug, mass, select club and dollar store retailers, and convenience stores)
2 Ganz 2013; Sun et al. 2016
3 Stats Canada