Tetra Bio-Pharma Targets Rare Cancers in the United States
August 23 2018 - 8:00AM
Tetra Bio-Pharma Inc. (“
Tetra” or
“
TBP”), today announced the submission of multiple
applications for Orphan Drug Designation for cannabinoids to the
U.S. Food and Drug Administration, for the treatment of various
forms of rare cancers and ocular diseases. The applications align
with Tetra’s strategy to develop cannabis prescription drug
products for the treatment of several rare cancers and to expand
its market exclusivity in the treatment of ocular diseases. If
successful, the designation of cannabinoids as an Orphan Drug will
open the door for fast track approval, tax credits on clinical
research, and reduced registration fees, in addition to other
opportunities. It further provides Tetra with a 7-year period of
market exclusivity in the U.S.
Today’s announcement builds on previous
milestones for Tetra in cancer, ocular disease and pain
conditions. In May 2017, Tetra announced its partnership with
Panag Pharma to develop innovative cannabinoid-based prescription
drugs for the treatment of ocular inflammatory and pain
conditions. The company also announced it submitted patent
applications to expand its exclusivity for the development of
pharmaceutical drug formulations to treat various forms of cancer
and ocular disease. This latter protection complements the
intellectual property owned by Panag Pharma.
In March 2018, Tetra announced that the U.S. FDA
granted an Orphan Drug Designation for Complex Regional Pain
Syndrome. The company has expanded its regulatory activities
in the USA to accelerate making cannabinoid-based prescription
drugs accessible to patients.
“Managing rare forms of cancer presents a huge
challenge for physicians,” said Dr. Guy Chamberland, M.Sc., Ph.D.,
interim CEO and Chief Scientific Officer of Tetra Bio-Pharma. “Our
R&D team has submitted numerous Orphan Drug Designation
applications to the FDA over the past 6 months, which not only
holds promise to improve patient care but lines up with our
corporate strategy to develop and commercialize cannabinoid
prescription drug products for both rare cancers and ocular
diseases in the United States.”
About Tetra
Bio-PharmaTetra 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,
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
Neither the TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
Forward-looking statementsSome
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 ability to
obtain orphan drug status, 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. While no definitive documentation has yet been signed
by the parties and there is no certainty that such documentation
will be signed. 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.
Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-817-2514 Investors@tetrabiopharma.com
Media Contact: energi PR Lana Power
Lana.Power@energipr.com 514-288-8500 ext. 201 416-425-9143 ext.
201
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