Tetra Receives its 4th FDA Orphan Drug Designation
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TBP.V);(TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for its cannabinoid PPP004 (THC-CBD) in the treatment of epidermolysis bullosa.
Epidermolysis bullosa is a group of rare diseases that cause fragile, blistering skin and is associated with significant pain and reduced quality of life. Patient management is based on lifestyle changes and home care. If unsuccessful in the control of the signs and symptoms of this disease, further treatment will include medications, surgery and rehabilitation. Epidermolysis bullosa is a condition that commonly progresses despite treatment and can cause serious complications and death.
PP004 will be used for management of pain and itch in EB, symptoms that, despite a range of current treatment strategies, significantly affect the quality of life and activities of daily living among EB patients “Our preclinical research was completed for taking PPP004 into human clinical trials. We have a vast experience in the development of topicals with the recent completion of two clinical trials with AwayeÔ and expect to rapidly bring this product into trials. In the coming days, we will be reaching out to physicians specialized in the treatment of this disease to discuss a potential proof of concept clinical trial,” commented Dr. Melanie Kelly CSO, Tetra Bio-Pharma Inc.
“We are very pleased to have received this new Orphan Drug Designation (ODD) from the FDA. Orphan designation qualifies PPP004 for development incentives that include tax credits for clinical trials, 7-years of marketing exclusivity and the marketing application (505(b)(1) NDA application) is not subject to prescription drug user fees. These incentives are critically important to a small biopharma,” said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. Dr. Chamberland further added, “Tetra will be assessing to launch a proof of concept trial in the coming months and will be requesting a Type B meeting with the US FDA to discuss the marketing requirements for this Orphan Drug indication. The Company will provide an update to share holders once the meeting is confirmed.”
About PPP004
PPP004 is a topical cream containing a 1:1 ratio of synthetic cannabinoids delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD) in strengths of 2%, 1%, and 0.5% w/v. The base product is a proprietary formulation utilizing Active Pharmaceutical Ingredients (APIs) sourced from qualified Good Manufacturing Practices (GMP) adherent manufacturers, and GRAS (generally regarded as safe) excipients from well-known suppliers. The cream will be packaged in a metered-dose, airless pump system, designed to deliver a consistent dose of API per actuation of the pump and to protect the APIs from known sources of degradation, namely light and oxygen.
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 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. Could we work in “existing regulatory standards of safety and clinical evidence for pharmaceutical products”.
For more information visit: www.tetrabiopharma.com
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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 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.:
CONTACT:
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
tetra@alphabronze.net
SOURCE: Tetra Bio-Pharma
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