Revive Therapeutics Ltd.
TSX VENTURE : RVV

Revive Therapeutics Ltd.

November 18, 2015 07:00 ET

Dr. Lee S. Simon Joins Revive Therapeutics as Senior Clinical and Regulatory Affairs Advisor

TORONTO, ONTARIO--(Marketwired - Nov. 18, 2015) - Revive Therapeutics Ltd. ("Revive" or the "Company") (TSX VENTURE:RVV) today announced that Dr. Lee S. Simon, M.D. will join the Company as senior clinical and regulatory affairs advisor for the Company.

Dr. Simon is presently a Principal in SDG LLC. and has extensive experience with the U.S. FDA drug approval process having served as the FDA's Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products (2001-2003) and served prior to that on multiple FDA advisory committees. He has been a clinical Rheumatologist for over 25 year and has extensive experience in drug development as a senior investigator for Celebrex® (celecoxib) and led the team to obtain the FDA approval of Krystexxa® (pegloticase) for the treatment of chronic treatment failure gout in the U.S. Dr. Simon was a senior consultant to Pharmacia/Searle on COX-2 development and he also served as Head regulatory consultant to Leerink Swann/Medacorp in Boston, MA. Dr. Simon joins Revive as the Company focuses on advancing its lead product, REV-002 (Bucillamine), which is being developed for the treatment of acute gout flares.

"Lee's experiences in drug development for inflammation and pain will be valuable to Revive as we advance our clinical and regulatory strategies for REV-002 (Bucillamine) for the treatment of acute gout flares," said Fabio Chianelli, Chief Executive Officer of Revive. "Lee has been successful in creating drug development programs in inflammation, including gout, and has had a long history of success in developing key innovative clinical and regulatory strategies that have brought important therapies to market rapidly, such as Celebrex® and Krystexxa®."

"Gout patients deserve more therapies to treat the various complicated manifestations of their disease, and it is important to develop more and new therapies to treat acute gout flares to minimize the impact of pain and inflammation of gout on the lives of our patients. The drug Bucillamine may be one more to deliver the benefits we are searching for," said Dr. Lee S. Simon, M.D., senior clinical and regulatory affairs advisor of Revive.

About Revive Therapeutics Ltd.

Revive Therapeutics Ltd. (TSX VENTURE:RVV) is focused on commercializing treatments for gout, and rare diseases such as Cystinuria, Wilson's disease and Rett syndrome. Additional information on Revive is available at www.ReviveThera.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute "forward looking statements", which are not comprised of historical facts. 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: the granting of a patent for REV-002; the potential efficacy and commercial viability of REV-002 for treatment of gout and Bucillamine for the treatment of cystinuria; expansion of the REV-002 clinical testing program; the Company's drug research and development plans; 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. The Company 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 Company'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. 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; the Company'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 Annual Information Form for the period ended June 30, 2014 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.

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.

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