TORONTO, June 27, 2018 (GLOBE NEWSWIRE) -- 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 Leon
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: (416) 272-5525
Email: 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.