- 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.
About PPP004
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.
About Epidermolysis
Bullosa
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.
About Tetra Bio-Pharma
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
Neither the TSX Exchange nor its Regulation Services Provider
(as that term is defined in the policies of the TSX Exchange)
accepts responsibility for the adequacy or accuracy of this
release.
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.
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SOURCE Tetra Bio-Pharma Inc.