Revive Therapeutics Ltd. (TSX VENTURE:RVV)
(OTCQB:RVVTF) (FSE:31R)
(“Revive” or the
“Company”), a specialty medical cannabis company, today
announced that it has submitted an application to the U.S. Food and
Drug Administration (“FDA”) seeking orphan drug designation of
cannabidiol (“CBD”) for the treatment of hepatic ischemia and
reperfusion injury (“IRI”) during liver transplantation.
“This orphan drug designation application builds
on our pharmaceutical strategy of creating a unique portfolio of
cannabinoid therapies targeting rare inflammatory and liver
diseases and disorders, and supports our business development
activities in partnering with medical-focused licensed producers of
cannabis and pharmaceutical companies,” said Fabio Chianelli,
President of Revive. “We are dedicated to commercializing
novel medical cannabis-based products and therapies as part of our
overall ambition in becoming a leading global specialty medical
cannabis company, and we are excited in the long-term potential of
plant-derived cannabinoid prescription medicines for rare diseases
and disorders, which we believe has been validated by the FDA
approval of the GW Pharmaceuticals plc EPIDIOLEX®. Revive
recently announced that the FDA granted orphan drug designation for
cannabidiol in the treatment of autoimmune hepatitis, a rare liver
disease, and our orphan drug application in liver transplantation
is complementary to our liver disease pharmaceutical strategy.”
Liver ischemia-reperfusion injury is a major
complication of liver transplantation and is one of the leading
causes for post-surgery hepatic dysfunction leading to an increased
risk of postoperative morbidity and mortality. According to
the United Network for Organ Sharing (“UNOS”) there have been
160,722 liver transplants performed between January 1, 1988 and
July 30, 2018. Currently there are 13,773 individuals on the
waiting list for a liver transplant. Quickly restoring blood
supply of ischemic liver 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 liver functions in
the case of acute injuries. 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
liver 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 Liver DiseaseLiver
disease is described as irregular functioning of liver, causing
disorders like hepatitis, fatty liver (NASH), and cirrhosis.
There are over 100 described diseases of the liver affecting
at least 30 million people alone in the U.S. A number of
factors are driving the liver disease treatment market, which
includes rapidly changing lifestyle patterns such as increasing
alcohol consumption, unhealthy diets, and increasing prevalence of
liver diseases. Liver diseases can result from injury to the
liver caused by hepatitis C virus (HCV), hepatitis B virus (HBV),
obesity, chronic excessive alcohol use or autoimmune diseases.
Major drug categories used in the treatment of liver diseases
includes anti-rejection drugs, vaccines, immunosuppressant,
chemotherapy drugs and antiviral drugs. According to Allied
Market Research titled, “World Liver Disease Treatment Market –
Opportunities and Forecast, 2014 - 2022”, the global market for
liver disease treatment is projected to reach approximately $19.5
billion by 2022.
About Revive Therapeutics
Ltd.Revive Therapeutics Ltd. (TSX VENTURE:RVV)
(OTCQB:RVVTF) (FSE:31R) is a specialty medical cannabis company
focused on the research, development and commercialization of novel
cannabinoid-based therapies. Additional information on Revive
is available at www.ReviveThera.com.
For more information please contact:Craig
LeonChief Executive OfficerRevive Therapeutics Ltd.Tel: (416)
272-5525Email: craig@revivethera.comWebsite:
www.revivethera.com
Revive Therapeutics Ltd. Cautionary Note
Regarding Forward-Looking Statements
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.
This news release includes certain information
and statements about management's view of future events,
expectations, plans and prospects that constitute “forward-looking
information” that involves known and unknown risks and
uncertainties, which are not comprised of historical facts, and
most of which are beyond the control of Revive. Forward-looking
statements include estimates and statements that describe Revive’s
future plans, objectives or goals, including words to the effect
that Revive or its management expects a stated condition or result
to occur. Forward-looking statements may be identified by such
terms as “believes”, “anticipates”, “intends”, “expects”,
“estimates”, “may”, “could”, “would”, “will”, or “plan”, and
similar expressions. Specifically, forward-looking statements in
this news release include, without limitation, statements
regarding: Revive’s orphan drug designation of cannabidiol in the
treatment of hepatic ischemia and reperfusion injury (“IRI”) during
liver transplantation; Revive’s orphan drug designation of
cannabidiol in the treatment of autoimmune hepatitis; Revive’s
cannabis pharmaceutical, research and development, and
commercialization strategy; pharmaceutical strategy of creating a
unique portfolio of cannabinoid therapies targeting rare
inflammatory and liver diseases and disorders; Revive’s drug
research and development, and commercialization plans; Revive’s
research, development and commercialization plans for plant-based
therapies, including cannabinoids; Revive’s cannabinoid delivery
technology; Revive’s cannabinoid-based product pipeline; the timing
of operations; and estimates of market sizes and conditions. These
statements involve known and unknown risks, uncertainties, and
other factors that may cause actual results or events, performance,
or achievements of Revive to differ materially from those
anticipated or implied in such forward-looking statements. Since
forward-looking statements are based on assumptions and address
future events and conditions, by their very nature they involve
inherent risks and uncertainties. Revive believes that the
expectations reflected in these forward-looking statements are
reasonable, but there can be no assurance that actual results will
meet management's expectations. In formulating the forward-looking
statements contained herein, management has assumed: that business
and economic conditions affecting Revive will continue
substantially in the ordinary course and will be favourable to
Revive; that clinical testing results will justify
commercialization of the Revive’s drug candidates; that Revive will
be able to obtain all requisite regulatory approvals to
commercialize its drug candidates; that such approvals will be
received on a timely basis; and, that Revive will be able to find
suitable partners for development and commercialization of its drug
repurposing candidates on favourable terms. Although these
assumptions were considered reasonable by management at the time of
preparation, they may prove to be incorrect and no assurance can be
given that such events will occur in the disclosed time frames or
at all.
Factors that may cause actual results to differ
materially from those anticipated by these forward-looking
statements include: uncertainties associated with obtaining
regulatory approval to perform clinical trials and market products;
the need to establish additional corporate collaborations,
distribution or licensing arrangements; Revive’s ability to raise
additional capital if and when necessary; intellectual property
disputes; increased competition from pharmaceutical and
biotechnology companies; changes in equity markets, inflation, and
changes in exchange rates; and other factors as described in detail
in Revive's Management's Discussion & Analysis for the period
ended June 30, 2017 and Revive's other public 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.
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