Tetra Bio-Pharma Inc. (OTCQB:TBPMF) announced its Orphan Drug development strategy and provided a management update. The company said it is focusing on generating intellectual property including use, manufacturing, and innovative molecule protection. Tetra said it received a U.S. Food and Drug Administration (FDA) Orphan Drug Designation for secondary cannabidiol (CBD) formulation of its cannabinoid topical drug PPP004 in the treatment of epidermolysis bullosa.
“Each ODD application is driven by scientific data generated by Tetra’s research and development department and in line with a commercialization strategy. Tetra is positioning itself as a world leader in cannabinoid drug development and increasing its ODD portfolio provides opportunities that will allow us to generate value for shareholders. Over the coming weeks, Tetra shall expand on its commercial ophthalmic and topical drug programs,” said Dr. Chamberland CEO & CRO, Tetra Bio-Pharma Inc.
Management said it views Tetra’s Orphan Drug program similar to securing a pipeline of innovative molecules that target cannabinoid receptors. Chamberland said, “Many drugs fail during preclinical development and only a few make it to marketing approval for use in humans. A pipeline is critical to any pharmaceutical company’s survival and Tetra is delivering this security for its long-term growth. The ODD strategy has been expanded during COVID-19 and is part of Tetra’s strategy to secure first drug approvals and work with commercial partners to launch potential products sooner. As Tetra’s portfolio of Orphan Drug candidates expands, management is assessing which drug development will remain exclusively developed by Tetra and which drugs development programs will be advanced through strategic partnerships.”
The Orphan Drug Act was created to provide the industry with incentives to develop drugs that are designed to treat or prevent, diseases affecting fewer than 200,000 people in the United States. An application for Orphan Drug Designation (ODD) includes critical aspects such as the scientific mechanism of action for the drug’s role in the target disease, the prevalence of the rare disease in the USA. Typically, the mechanistic rationale involves the company providing experimental data supporting the claim that its drug may be effective.
If granted, an ODD provides the drug with a status that gives exclusive marketing and development rights as well as financial benefits to help recover part of the costs of clinical development. More specifically a 50% tax credit on the cost of clinical trials performed in the USA, a 7-year marketing exclusivity following drug approval, a fast-track type approach to file and review submissions, waiver of the new drug approval fees (estimated at $3 million US), as well as other financial benefits.
The Orphan Drug development strategy does not bring on additional new expenses to the corporation as these products were already advancing through the various drug development stages. The ODDs provide Tetra with the ability to optimize its commercialization strategy for its ophthalmic drug PPP003 and topical formulations referred to as PPP004.
During the COVID-19 crisis, Tetra said it has not suspended or slowed down any of its regulatory and clinical activities and continues to find ways to advance its clinical trials. SERENITY remained Tetra’s top priority and the company is increasing the number of clinical sites while clearing schedule 1-type and export licenses (USA & Mexico) for each site. On April 14, 2020, Tetra has announced that Dr. Sue Sisley’s Scottsdale Research Institute received the renewal of its Schedule 1 license from the US Drug Enforcement Agency (DEA). Tetra is continuing to expand its clinical sites to be ready to accelerate patient enrollment in the USA for its PLENITUDE© and SERENITY© trials.