- Announced the submission of multiple applications for Orphan Drug Designation for cannabinoids to the U.S. Food and Drug Administration
- For the treatment of various forms of rare cancers and ocular diseases
OTTAWA, Aug. 23, 2018 — Tetra Bio-Pharma Inc. (“Tetra†or “TBPâ€), today announced the submission of multiple applications for Orphan Drug Designation for cannabinoids to the U.S. Food and Drug Administration, for the treatment of various forms of rare cancers and ocular diseases. The applications align with Tetra’s strategy to develop cannabis prescription drug products for the treatment of several rare cancers and to expand its market exclusivity in the treatment of ocular diseases. If successful, the designation of cannabinoids as an Orphan Drug will open the door for fast track approval, tax credits on clinical research, and reduced registration fees, in addition to other opportunities. It further provides Tetra with a 7-year period of market exclusivity in the U.S.
Today’s announcement builds on previous milestones for Tetra in cancer, ocular disease and pain conditions. In May 2017, Tetra announced its partnership with Panag Pharma to develop innovative cannabinoid-based prescription drugs for the treatment of ocular inflammatory and pain conditions. The company also announced it submitted patent applications to expand its exclusivity for the development of pharmaceutical drug formulations to treat various forms of cancer and ocular disease. This latter protection complements the intellectual property owned by Panag Pharma.
In March 2018, Tetra announced that the U.S. FDA granted an Orphan Drug Designation for Complex Regional Pain Syndrome. The company has expanded its regulatory activities in the USA to accelerate making cannabinoid-based prescription drugs accessible to patients.
“Managing rare forms of cancer presents a huge challenge for physicians,†said Dr. Guy Chamberland, M.Sc., Ph.D., interim CEO and Chief Scientific Officer of Tetra Bio-Pharma. “Our R&D team has submitted numerous Orphan Drug Designation applications to the FDA over the past 6 months, which not only holds promise to improve patient care but lines up with our corporate strategy to develop and commercialize cannabinoid prescription drug products for both rare cancers and ocular diseases in the United States.â€
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:Â www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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 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.
Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-817-2514
[email protected]
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energi PR
Lana Power
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416-425-9143 ext. 201