Revive Therapeutics Ltd. Submits Pre-IND Package to the US FDA for Its Gout Drug Candidate, REV-002
05 June 2014 - 9:00PM
Marketwired
Revive Therapeutics Ltd. Submits Pre-IND Package to the US FDA for
Its Gout Drug Candidate, REV-002
TORONTO, ONTARIO--(Marketwired - Jun 5, 2014) - Revive
Therapeutics Ltd. (TSX-VENTURE:RVV) ("Revive") announced today that
it has submitted a pre-Investigational New Drug (pre-IND) package
to the U.S. Food and Drug Administration (FDA) for its gout drug
candidate, REV-002.
The submitted pre-IND package provides the FDA with information
on Revive's REV-002, as well as a clinical trial plan for a
proposed U.S. clinical trial. The FDA's response to the pre-IND
package will serve as a guide to Revive's preparation of a full IND
application.
This pre-IND submission follows Revive's recently announced
meeting request letter submitted to the FDA and its announcement
that it has signed a material transfer agreement (the "MTA") with a
global pharmaceutical company headquartered in Osaka, Japan. The
MTA has allowed Revive to obtain access to confidential information
and clinical trial supply of REV-002 for a US-based trial.
Fabio Chianelli, Chief Executive Officer of Revive Therapeutics
Ltd., commented, "I am very pleased with this accomplishment as it
paves the way for Revive's second product scheduled for a human
clinical trial and its first product for a human clinical trial in
the U.S., the largest market for gout related products."
About Gout
There were 14.3 million diagnosed prevalent cases of chronic
gout in the major pharmaceutical markets in 2012, which is forecast
to increase to 17.7 million by 2021 (Source: Decision Resources
2012). The prevalence of gout in the U.S. affects
approximately 8.3 million (4%) Americans and the prevalence of
increased uric acid levels (hyperuricemia) affects 43.3 million
(21%) adults in the U.S (Source: Arthritis Rheum. 2011 Oct;
63(10):3136-41). It is estimated that the gout disease treatment
market value will increase from $989 million in 2013 to $2.28
billion by 2018 (Source: GlobalData 2014). Gout is a
painful disorder caused by elevated serum uric acid (sUA) in the
body due to under excretion of uric acid and/or over production of
uric acid. A recent study suggested that only 43% of patients on
current standard of care treatment achieved target goals for sUA
(<6mg/dL) (Source: the LASSO study, 2013). Elevated
levels of sUA may lead to acute attacks of severe pain, such as
flares and inflammation. Accordingly, there is a need in the market
for a therapy to control both sUA and inflammation.
About REV-002
REV-002 is bucillamine being repurposed by Revive as a potential
new treatment for gout. Bucillamine is a disease-modifying
anti-rheumatic drug, which is prescribed for rheumatoid arthritis
in Japan and South Korea. In animal studies, it has been shown that
bucillamine had a synergistic effect in combination with
allopurinol in lowering circulating uric acid. In addition, REV-002
offers the opportunity to address the acute flares in gout.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. is a Canadian public company
(TSX-VENTURE:RVV) focused on acquiring, developing and
commercializing treatments for major market opportunities such as
gout, postoperative pain, and rare diseases. Revive aims to bring
drugs to market by finding new uses for old drugs, also known as
drug repurposing or drug repositioning, and improving the
therapeutic performance of existing drugs for underserved medical
needs. Additional information on Revive is available at
www.revivethera.com.
The information in this news release includes certain
information and statements about management's view of future
events, expectations, plans and prospects that constitute forward
looking statements that may not be based on historical fact,
including without limitation statements containing the words
"believe", "may", "plan", "will", "estimate", "continue",
"anticipate", "intend", "expect" and similar expressions. These
statements are based upon assumptions that are subject to
significant risks and uncertainties. Because of these risks and
uncertainties and as a result of a variety of factors, the actual
results, expectations, achievements or performance may differ
materially from those anticipated and indicated by these forward
looking statements. Such factors include, among others, Revive's
stage of development, lack of any product revenues, additional
capital requirements, risk associated with the completion of
clinical trials and obtaining regulatory approval to market
products, the ability to protect intellectual property, dependence
on business partners and the prospects for negotiating joint
ventures, distribution and licensing arrangements and their timing.
Specifically, certain risks and uncertainties that could cause such
actual events or results expressed or implied by such
forward-looking statements and information to differ materially
from any future events or results expressed or implied by such
statements and information include, but are not limited to; the
risks and uncertainties that Revive may not be able to successfully
develop and obtain regulatory approval for its products;
intellectual property disputes; future operating results are
uncertain and likely to fluctuate; ability to raise additional
capital; successfully establishing additional corporate
collaborations, distribution or licensing arrangements;
establishing marketing and the costs of launching products may be
restricting; Revive's lack of experience in commercial
manufacturing; increased competition from pharmaceutical and
biotechnology companies; and other factors as described in detail
in Revive's filings on SEDAR (www.sedar.com), including, without
limitation, Revive's Filing Statement dated November 26, 2013 filed
on SEDAR on November 27, 2013. 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. Although Revive
believes that the expectations reflected in forward looking
statements are reasonable, it can give no assurances that the
expectations of any forward looking statements will prove to be
correct. 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.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Revive Therapeutics Ltd.Fabio ChianelliChief Executive
Officer905-605-5535 (ext.
10)fabio@revivethera.comwww.revivethera.com
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