Momentum Public Relations
Press Release: August 23, 2018
Tetra Bio-Pharma Inc.(“Tetra” or “TBP”), 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.”
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
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