Tetra Bio-Pharma is setting its sights on cannabinoid-based drugs for rare cancers and eye diseases.
Last week it announced that multiple applications for an Orphan Drug Designation have been submitted to the U.S. Food and Drug Administration.
Cannabinoids designated as Orphan Drugs allow fast track approval, tax credits on clinical research, and reduced registration fees, the company said.
Tetra has expanded its regulatory activities in the U.S. to accelerate making cannabinoid-based prescription drugs accessible to patients.
FDA approvals would give the company a seven-year period of market exclusivity in the U.S.
“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,” said Tetra’s Interim CEO and Chief Scientific Officer Dr. Guy Chamberland
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 has also submitted patent applications to expand its exclusivity for the development of pharmaceutical drug formulations to treat various forms of cancer and ocular disease.
In March 2018, Tetra announced that the U.S. FDA granted an Orphan Drug Designation for Complex Regional Pain Syndrome.
About Tetra Bio-Pharma
A biopharmaceutical leader in cannabinoid-based drug discovery and development focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
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.