Revive Therapeutics Receives FDA
Orphan Drug Designation for Bucillamine in the Prevention of
Ischemia-Reperfusion Injury During Liver Transplantation
TORONTO, February 15, 2022 -- Revive Therapeutics Ltd.
("Revive" or the "Company") (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences
company focused on the research and development of therapeutics for
medical needs and rare disorders, is pleased to announce that
the U.S. Food and Drug Administration ("FDA") has granted Orphan
Drug Designation ("ODD") for Bucillamine for the prevention of
ischemia-reperfusion injury ("IRI") during liver
transplantation.
Michael Frank, CEO of Revive commented: "We are very pleased
to receive orphan drug designation from the FDA for Bucillamine for
the prevention of ischemia-reperfusion injury during liver
transplantation. The ODD validates
our strategy in pursuing novel uses of Bucillamine for rare
disorders and life-threatening conditions, including infectious
diseases and preventing IRI during other organ
transplantations."
Currently, there is no approved treatments available for
IRI. 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 post-operative morbidity and
mortality. According to the United
Network for Organ Sharing ("UNOS") there were 8,906 liver
transplants in 2020 and at the time of the ODD submission there
were 11,664 on the waiting list for a liver transplant.
Although many therapeutic strategies have
been shown to be effective in controlled experimental models, most
have yielded equivocal results in clinical practice or have yet to
reach human clinical trials.
Revive believes the use of Bucillamine during liver
transplantation has the potential to be a safe and effective
approach to address the unmet medical need for a novel strategy to
limit or prevent IRI. Bucillamine, a cysteine derivative that
contains two donatable thiol groups, in the context of IRI is
capable of replenishing the thiol group in glutathione, thereby
reactivating this endogenous defense against oxidant injury.
In addition, Bucillamine appears to have
anti-inflammatory effects unrelated to its antioxidant
effect. Bucillamine has the
potential to address the shortage of quality organs by reducing the
susceptibility to IRI of steatotic livers thereby making these
livers available for transplants.
Bucillamine also has the potential to
improve graft function and patient outcome by preventing or
lessening IRI.
The Orphan Drug Act grants special status to a drug or
biological product to treat a rare disease or condition upon
request of a sponsor. This status
is referred to as orphan designation (or sometimes "orphan
status"). The FDA grants ODD status
to products that treat rare diseases, providing incentives to
sponsors developing drugs or biologics.
The FDA defines rare diseases as those
affecting fewer than 200,000 people in the United States at any
given time. ODD would qualify Bucillamine for certain benefits and
incentives, including seven years of marketing exclusivity if
regulatory approval is ultimately received for the designated
indication, potential tax credits for certain clinical drug testing
costs, activities, eligibility for orphan drug grants, and the
waiver of the FDA New Drug Application filing fee of approximately
USD $2,400,000.
About Revive Therapeutics
Ltd.
Revive is a life sciences company focused on the research and
development of therapeutics for infectious diseases and rare
disorders, and it is prioritizing drug development efforts to take
advantage of several regulatory incentives awarded by the FDA such
as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric
Disease designations. Currently, the Company is exploring the use
of Bucillamine for the potential treatment of infectious diseases,
with an initial focus on severe influenza and COVID-19. With its
acquisition of Psilocin Pharma Corp., Revive is advancing the
development of Psilocybin-based therapeutics in various diseases
and disorders. Revive's cannabinoid pharmaceutical portfolio
focuses on rare inflammatory diseases and the company was granted
FDA orphan drug status designation for the use of Cannabidiol (CBD)
to treat autoimmune hepatitis (liver disease) and to treat ischemia
and reperfusion injury from organ transplantation. For more
information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the
Canadian Securities Exchange nor its Regulation Services Provider
has reviewed or accepts responsibility for the adequacy or accuracy
of this release.
Cautionary
Statement
This
press release contains 'forward-looking information' within the
meaning of applicable Canadian securities legislation. These
statements relate to future events or future performance. The use
of any of the words "could", "intend", "expect", "believe", "will",
"projected", "estimated" and similar expressions and statements
relating to matters that are not historical facts are intended to
identify forward-looking information and are based on Revive's
current belief or assumptions as to the outcome and timing of such
future events. Forward looking information in this press release
includes information with respect to the Company's cannabinoids,
psychedelics and infectious diseases programs. Forward-looking
information is based on reasonable assumptions that have been made
by Revive at the date of the information and is subject to known
and unknown risks, uncertainties, and other factors that may cause
actual results or events to differ materially from those
anticipated in the forward-looking information. Given these risks,
uncertainties and assumptions, you should not unduly rely on these
forward-looking statements. The forward-looking information
contained in this press release is made as of the date hereof, and
Revive is not obligated to update or revise any forward-looking
information, whether as a result of new information, future events
or otherwise, except as required by applicable securities laws. The
foregoing statements expressly qualify any forward-looking
information contained herein. Reference is made to the risk factors
disclosed under the heading "Risk Factors" in the Company's annual
MD&A for the fiscal year ended June 30, 2021, which has been
filed on SEDAR and is available under the Company's profile
at www.sedar.com.
