OTTAWA,
ON, June 6, 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 announces the launch of its new wholly owned subsidiary
'Tetra Bio-Pharma Australia Pty Ltd' ("TBP-AU"), an
Australian-based research company focused on the execution of
clinical trials in Australia. This
represents Tetra's second foreign subsidiary and is in line with
the Company's global expansion strategy for QIXLEEF™, and other
future drug candidates.
The new subsidiary follows the recent announcement of Tetra's
partnership with Cannvalate Pty Ltd for the performance of
clinical trials of Tetra's drug candidates in Australia. Accordingly, TBP-AU will benefit
from a 43.5% tax credit on all money spent on clinical trials in
Australia.
"We look forward to working with our strategic partners and
building value for our current and future investors. These are very
exciting times for us as we continue to drive scientific excellence
and deliver on the promise of cannabinoid-derived transformative
medicines to improve patient health and quality of life," said CEO
Dr. Guy Chamberland.
Regulatory Update -
REDUVO™
The Company is also pleased announce it has completed the Annual
Licence Review process for our Health Canada Drug Establishment
Licence (DEL) and meets the regulatory requirements of C.01A.009 of
the Food and Drug Regulations to maintain our DEL for the
distribution of pharmaceuticals, like REDUVO™, in Canada. Any company that intends to distribute
pharmaceutical drugs in Canada
must obtain a DEL as per Health Canada regulatory requirements.
On December 30, 2020, the Company
submitted its first New Drug Submission (NDS) for REDUVO™ to
Health Canada to obtain a Drug Identification Number (DIN) for the
prescription drug. The Company is in discussions with Health Canada
to address final commentary on the submission. REDUVO™ remains a
top priority and the Company is ready to launch manufacturing
activities as soon as possible following regulatory approval.
About REDUVO™
REDUVO™ is a soft gel capsule used to treat
chemotherapy-induced nausea and vomiting (CINV) and weight loss and
severe nausea in people living with HIV infection. The active
pharmaceutical ingredient in REDUVO™ is dronabinol, also known as
THC, a synthetic form of the active natural substance in
cannabis.
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 visit: 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.