OTTAWA, March 27, 2019 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced it is ready to submit its PPP001 cannabinoid-derived drug as a herbal medicinal product to the European Medicines Agency. The pre-marketing application of PPP001 as a herbal medicinal product specifically for the European market in no way changes Tetra’s planned schedule to restart its Phase 3 Oncology Drug Development program for advanced cancer pain that was temporarily suspended in February 2019.
Tetra Bio-Pharma has gathered impressive scientific, clinical and safety data on PPP001, a dry pellet made of 3 strains of cannabis that generates a unique composition of medicinal products when administered to patients with Tetra’s class II medical devices and by smoking or vaporization.
“The European Union has shown an increased interest in the potential of both cannabinoid-derived drugs and medical cannabis as a means of alleviating a range of health conditions,” says Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “I am confident that our data on PPP001 gives us a unique and strong advantage that will result in marketing authorization in the European Economic Union with the current formulation. However, let me be clear that Tetra Bio-Pharma’s core strategy is about cannabinoid derived prescription medicines and we are working hard to restart our clinical trial as planned.”
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 authorized, and FDA reviewed, clinical trials 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
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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: the anticipated benefits of the Proposed Transaction for Tetra; completion and expected timing of the Proposed Transaction; whether the terms of the Proposed Transaction will be as described in this press release; whether the Proposed Transaction will be successful; the receipt of required regulatory approvals (including stock exchange) in respect of the Proposed Transaction)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 PPP001, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, 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. 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.
Senior Vice-President, Marketing & Medical Affairs
Pierre Boucher, CPA, CMA
Partner, Executive Vice-President
514-731-0000 ext. 237
Source: Tetra Bio-Pharma Inc