Revive Therapeutics Announces FDA Grants Orphan Drug Designation for Cannabidiol in the Prevention of Ischemia and Reperfusio...
November 07 2018 - 8:00AM
Revive Therapeutics Ltd. (TSX VENTURE: RVV) (OTCQB: RVVTF)
(FSE:31R) ("Revive" or the “Company”), a specialty
cannabis company focused on the research, development and
commercialization of novel cannabinoid-based products, today
announced that the U.S. Food and Drug Administration (“FDA”) has
granted orphan drug designation for cannabidiol (“CBD”) in the
prevention of ischemia and reperfusion injury (“IRI”) resulting
from solid organ transplantation.
"We are very pleased to receive orphan drug
designation for CBD in the prevention of IRI resulting from solid
organ transplantation, such as liver, kidney, heart and lung, as it
complements on our first FDA granted orphan drug designation for
cannabidiol in the treatment of autoimmune hepatitis, a rare liver
disease, and provides us with a unique cannabinoid pharmaceutical
product pipeline that is in line with our overall ambition in
becoming a leading global specialty medical cannabis company,” said
Fabio Chianelli, President of Revive. "This milestone builds
on Revive’s pharmaceutical strategy in developing novel cannabinoid
therapies targeting both broad and rare inflammatory diseases and
it supports our near-term product and business development strategy
in commercializing novel cannabis-based therapies and potential
partnering opportunities with licensed producers of cannabis and
pharmaceutical companies.”
According to the U.S. Organ Procurement and
Transplantation Network, there are approximately 115,000 patients
waiting for solid organ transplants in the United States, with the
four most common organs transplanted being liver, kidney, heart and
lung. IRI in organ transplantation can result in a higher incidence
of acute and chronic rejection, as well as long-term morbidity and
mortality. Quickly restoring blood supply of ischemic organs as
soon as possible is crucial for avoiding or reducing injury from
ischemia, whereas strategies used to attenuate the damage induced
by reperfusion, including ischemic preconditioning, ischemic
postconditioning, and machine perfusion. These strategies are
expensive, sometimes hard to perform in clinical surgeries, and
difficult in maintaining organ functions in the case of acute
injuries. With the shortage of organs and expensive medical
strategies, it is clear that therapies need to be researched to
optimize the quality of the organs that are available and to
attenuate injury to transplanted organs. Revive believes that the
immunosuppressant and anti-inflammatory protective effects of CBD
may provide a novel, more beneficial strategy to attenuate the
damage induced by ischemia and reperfusion during solid organ
transplantation.
Under the Orphan Drug Act of 1983, the FDA
provides incentives for companies developing treatments that are
expected to provide significant therapeutic advantage over existing
treatments, and that target rare medical conditions affecting fewer
than 200,000 U.S. patients per year. Incentives include
seven-year market exclusivity, tax credits on U.S. clinical trials,
fast-tracking of regulatory proceedings, and exemption from certain
fees, such as waiver of filing fees under the Prescription Drug
User Fee Act (PDUFA), and orphan drug grants.
About Revive Therapeutics
Ltd.
Revive Therapeutics Ltd. (TSX VENTURE: RVV)
(OTCQB: RVVTF) (FSE: 31R) is a specialty cannabis company focused
on the research, development and commercialization of novel
cannabinoid-based products. Revive is commercializing
patent-protected, best-in-class cannabis-based products with first
mover advantage in the multi-billion cannabis and wellness
market. The Company’s first product is a proprietary
hemp-based cannabidiol (“CBD”) chewing gum, RELICANN™, for the
health and wellness and medical cannabis market offering a better
alternative over conventional products. The Company’s novel
cannabinoid delivery technology is being advanced to fill the unmet
medical needs for diseases and disorders such as pain,
inflammation, and wound care. Revive’s cannabinoid pharmaceutical
portfolio focus’ on rare inflammatory and liver diseases, which the
FDA granted to the Company orphan drug designation for CBD in the
treatment of autoimmune hepatitis and in the prevention of
prevention of ischemia and reperfusion injury resulting from solid
organ transplantation, such as such as liver, kidney, heart and
lung transplantation.
For more information,
visit: www.ReviveThera.com.
Neither the TSX-V nor its Regulation Services
Provider (as that term is defined in the policies of the TSX-V)
accepts responsibility for the adequacy or accuracy of this
release.
Revive Therapeutics Ltd. Cautionary Note
Regarding Forward-Looking Statements
This news release may contain forward-looking
information that is based on certain assumptions and involves known
and unknown risks and uncertainties and other factors that could
cause actual events to differ materially from current assumptions
and expectations. These statements should not be read as guarantees
of future performance or results. Such statements involve known and
unknown risks, uncertainties and other factors that may cause
actual results, performance or achievements to be materially
different from those implied by such statements. A more complete
discussion of the risks and uncertainties facing the Company
appears in the Company’s Management's Discussion & Analysis for
the period ended June 30, 2017 and continuous disclosure filings,
all of which may be viewed on SEDAR (www.sedar.com). Given these
risks and uncertainties, readers are cautioned not to place undue
reliance on such forward-looking statements and information, which
are qualified in their entirety by this cautionary statement.
Except as required by law, Revive disclaims any intention and
assumes no obligation to update or revise any forward-looking
statements to reflect actual results, whether as a result of new
information, future events, changes in assumptions, changes in
factors affecting such forward-looking statements or otherwise.
For more information, please
contact:Craig LeonChief Executive OfficerRevive
Therapeutics Ltd.Tel: (416)
272-5525Email: craig@revivethera.comWebsite: www.Revivethera.com
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