Tetra Bio-Pharma to File PPP001 With the European Medicines Agency
March 27 2019 - 6:30AM
Tetra Bio-Pharma Inc.
("Tetra" or
the "Company") (TSX-V: TBP)
(OTCQB: TBPMF), today announced it is ready to submit its
PPP001 cannabinoid-derived drug as a herbal medicinal product to
the European Medicines Agency. The pre-marketing application of
PPP001 as a herbal medicinal product specifically for the European
market in no way changes Tetra’s planned schedule to restart its
Phase 3 Oncology Drug Development program for advanced cancer pain
that was temporarily suspended in February 2019.
Tetra Bio-Pharma has gathered impressive
scientific, clinical and safety data on PPP001, a dry pellet made
of 3 strains of cannabis that generates a unique composition of
medicinal products when administered to patients with Tetra’s class
II medical devices and by smoking or vaporization.
“The European Union has shown an increased
interest in the potential of both cannabinoid-derived drugs and
medical cannabis as a means of alleviating a range of health
conditions,” says Guy Chamberland, CEO and CSO of Tetra Bio-Pharma.
“I am confident that our data on PPP001 gives us a unique and
strong advantage that will result in marketing authorization in the
European Economic Union with the current formulation. However, let
me be clear that Tetra Bio-Pharma’s core strategy is about
cannabinoid derived prescription medicines and we are working hard
to restart our clinical trial as planned."
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 authorized, and FDA reviewed,
clinical trials 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 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:
the anticipated benefits of the Proposed Transaction for Tetra;
completion and expected timing of the Proposed Transaction; whether
the terms of the Proposed Transaction will be as described in this
press release; whether the Proposed Transaction will be successful;
the receipt of required regulatory approvals (including stock
exchange) in respect of the Proposed Transaction)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
PPP001, the applicability of the discoveries made therein, the
successful and timely completion and uncertainties related to the
regulatory process including the applications for Orphan Drug
Designation, 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. 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.
Investor
Contacts: |
|
|
|
Tetra
Bio-Pharma
|
Maison
Brison |
Steeve Neron
|
Pierre Boucher, CPA,
CMA |
Senior Vice-President,
Marketing & Medical Affairs |
Partner, Executive
Vice-President |
438-899-7575 |
514-731-0000 ext.
237 |
|
Investors@tetrabiopharma.com |
|
|
Media
Contact : |
|
Energi
PR |
|
Carol Levine, APR,
FCPRS
|
Marissa Zanti |
CEO
|
Vice-President,
Healthcare |
514-288-8500 ext.
226 |
416-425-9143 ext.
204 |
Carol.levine@energipr.com
|
Marissa.zanti@energipr.com |
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