Revive Therapeutics Ltd. (TSX VENTURE:RVV)
(OTCQB:RVVTF) (FSE:31R)
("Revive" or the
"Company"), a company focused on the research, development
and commercialization of novel cannabinoid-based therapies, today
announced that the U.S. Food and Drug Administration (“FDA”) has
granted orphan drug designation for cannabidiol (“CBD”) in the
treatment of autoimmune hepatitis (“AIH”) to Revive.
"We are very pleased to receive orphan drug
designation for CBD in the treatment of AIH from the FDA as it
allows us to confidently advance our research and development plans
with our strategic collaboration partner WeedMD Inc.," 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 and liver 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. We are excited about the long-term
potential of plant-derived cannabinoid prescription medicines,
which we believe has been validated by the FDA approval of the GW
Pharmaceuticals plc EPIDIOLEX® (cannabidiol) oral solution for the
treatment of seizures associated with Lennox-Gastaut syndrome or
Dravet syndrome in patients two years of age or older.”
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 Autoimmune Hepatitis
AIH is a rare autoimmune disease causing
inflammation to the liver, which not treated properly, may cause
liver fibrosis or cirrhosis, liver failure requiring a liver
transplant, and even death. The prevalence of AIH is estimated at
75,000 patients in the U.S. The current standard of care for AIH is
the use of steroids alone or steroids combined with azathioprine.
It has been noted in medical literature that the current standard
of care when used in a certain period of time has caused severe
treatment-related side effects in 13%, treatment failure in 9%,
incomplete response in 13%, and relapse after drug withdrawal up to
86% of patients with AIH (Source: World J Gastroenterol. 2010 Feb
28; 16(8): 934–947). Therefore, given the unwanted outcomes
associated with a steroid-based therapy, an alternative
steroid-free treatment option such as CBD, with its known safety
profile, may provide a potential solution for an improved treatment
strategy for those patients unresponsive to, intolerant of, or
non-adherent with a steroid-based therapy for AIH.
About Liver Disease
Liver disease is described by 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) is 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.com Website:
www.revivethera.com
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 autoimmune hepatitis; Revive’s cannabis research and
development supply agreement with WeedMD; Revive’s Collaboration
Agreement for Medical Cannabis Products and Therapies with WeedMD;
Revive’s Collaboration with Sanyal Biotechnology LLC.; 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 license agreement with Wisconsin
Alumni Research Foundation; Revive’s cannabinoid-based product
pipeline; the timing of operations; and estimates of market
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.
Revive Therapeutics (TSXV:RVV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Revive Therapeutics (TSXV:RVV)
Historical Stock Chart
From Apr 2023 to Apr 2024