Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TBP.V)(TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce its Orphan Drug development strategy and provide a management update.
Tetra is focused on generating intellectual property including use, manufacturing, and innovative molecule protection. Taking a first drug to the market approach is an important priority for Tetra as this strategy will secure financial benefits in market exclusivity and protection for Tetra and our shareholders.
Yesterday, Tetra received 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.
Management views Tetra’s Orphan Drug program similar to securing a pipeline of innovative molecules that target cannabinoid receptors. Tetra’s Chief Executive Officer and Chief Regulatory Officer commented, “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, applicable only to the US market, was created to provide 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.
There are important financial benefits to corporations that follow an Orphan Drug development path. If granted, an ODD provides the drug with a status which 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.
“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,” commented Dr. Chamberland CEO & CRO, Tetra Bio-Pharma Inc.
During the COVID-19 crisis, Tetra 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 we are 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.
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.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSXV:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, 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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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 success of this product or any other product, 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. 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.:
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
SOURCE: Tetra Bio-Pharma
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