Tetra Bio-Pharma Receives EMA Orphan Drug Designation for a Novel Topical Therapeutic Containing CBD
Tetra Bio-Pharma has received orphan drug designation from the European Medicines Agency (EMA) for its proprietary cannabidiol (CBD) therapeutic, PPP004, aimed at treating epidermolysis bullosa (EB). This marks the third orphan drug designation for PPP004, which is now ready for human clinical trials. The drug's unique formulation aims to alleviate pain and promote wound healing in EB patients. This designation offers advantages like a reduced drug development cost, an accelerated review process, and market exclusivity for ten years, enhancing Tetra's competitive position in the market.
- Received EMA orphan drug designation for PPP004, facilitating accelerated drug development.
- PPP004 is ready for human clinical trials, indicating progress in development.
- Orphan drug status may lead to cost reductions and market exclusivity for 10 years.
- None.
- Novel proprietary cannabidiol (CBD) therapeutic has been classified as an orphan medicinal product for the indication of epidermolysis bullosa (EB).
- Drug is ready for human clinical trials.
OTTAWA, ON, May 18, 2022 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development today announced that the European Medicines Agency (EMA) has classified PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB). The designation represents PPP004's third orphan drug designation (ODD) as a treatment for EB.
"This important designation is a milestone in the development of PPP004 as Tetra continues to execute its regulatory strategy in Europe. It also highlights the critical need for effective treatment options for people living with EB", said Dr. Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma.
PPP004 is a topical preparation containing either a standardized amount of CBD or a defined ratio of THC and CBD. The base product is a proprietary pharmaceutical-grade formulation composed of Active Pharmaceutical Ingredients (APIs) that are manufactured as per Good Manufacturing Practices (GMP) requirements, and excipients classified as GRAS (generally regarded as safe). The cream will be packaged in a metered-dose, airless pump system, designed to deliver a measured dose of API consistently per actuation and to protect the APIs from known sources of degradation, namely light and oxygen. PPP004 was developed to help manage pain and itch in patients with EB and promote wound healing.
- PPP004 containing CBD only has been granted ODD by both the U.S. FDA and the EMA for treatment of EB.
- PPP004 containing a combination of THC and CBD has been granted ODD from the U.S. FDA for treatment of EB.
EMA Orphan Drug Designation is granted to investigational therapies intended to treat, prevent, or diagnose life-threatening or chronic debilitating conditions or conditions that affect fewer than 5 in 10,000 people in European Union. An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the Company to easily gain market shares in a competitive free environment.
Epidermolysis bullosa is a group of rare medical conditions that result in blistering of the skin and mucous membranes. Blisters occur with minor trauma or friction and are painful. Its severity can range from mild to fatal. Epidermolysis bullosa has no cure, though mild forms may improve with age. Treatment focuses on caring for blisters and preventing new ones.
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians, and insurance companies.
For more information: www.tetrabiopharma.com
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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.
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FAQ
What is the significance of the orphan drug designation received by Tetra Bio-Pharma for TBPMF?
When will Tetra Bio-Pharma begin human clinical trials for PPP004?
What is PPP004 and how is it related to TBPMF?
How does orphan drug designation benefit Tetra Bio-Pharma (TBPMF)?
