Revive Therapeutics Ltd.
TSX VENTURE : RVV

Revive Therapeutics Ltd.

September 11, 2014 07:00 ET

Revive Therapeutics Ltd. Names Dr. Robert A. Terkeltaub, MD, as Principal Investigator for Upcoming Gout Study

TORONTO, ONTARIO--(Marketwired - Sept. 11, 2014) - Revive Therapeutics Ltd. (TSX VENTURE:RVV) ("Revive") today announced that it has named world-renowned gout expert, Dr. Robert A. Terkeltaub, MD, as Principal Investigator of Revive's upcoming clinical study for gout. Revive expects to file an Investigational New Drug application to treat gout with the U.S. Food and Drug Administration before the end of this year.

Dr. Robert A. Terkeltaub, MD, is Professor of Medicine in the Rheumatology Allergy Immunology Division at the University of California San Diego. Dr. Terkeltaub received his medical degree at McGill University in Montreal, Canada, and completed residency and training programs at Montreal General Hospital in Clinical Rheumatology and Internal Medicine. Dr. Terkeltaub's clinical practice has long had a heavy emphasis on gout, including difficult disease. Dr. Terkeltaub is founding and executive director of the allied health professional run gout clinic in San Diego. Dr. Terkeltaub has been the recipient of nearly 30 years of continuous federal research funding, and also of numerous teaching awards at the University of California at San Diego. Dr. Terkeltaub regularly serves on NIH and arthritis research foundation Study Sections and is Co-Editor of Arthritis and Rheumatology. Dr. Terkeltaub's research focuses principally on gout, degenerative arthritis, and interfaces between metabolism and inflammation. As a clinical investigator, he has been a Principal Investigator of multiple clinical trials in gout. He has published over 80 papers on gout and crystal-induced inflammation, and is Editor of 2 textbooks on these conditions. Dr. Terkeltaub is senior and corresponding author of the 2012 landmark American College of Rheumatology management guidelines on gout and hyperuricemia.

"I am excited that Dr. Terkeltaub, MD, joins Revive as Principal Investigator for our upcoming clinical study for gout," said Fabio Chianelli, Chief Executive Officer of Revive. "Dr. Terkeltaub's unparalleled experience will assist Revive in forming a strong clinical development plan and ensure the most optimal positioning of our gout drug candidate, REV-002, to patients who suffer from gout."

"I am very pleased to assist in advancing Revive's clinical development program for gout," said Dr. Robert Terkeltaub, MD, Principal Investigator for Revive. "There remains significant unmet need for novel therapies targeted towards preventing and/or treating gouty inflammation and lowering serum uric acid levels. The majority of gout patients have comorbidities that increase adverse events and potential drug interactions of the current generation of therapeutics for gout. Hence agents that can successfully control gout, without inducing more drug-related gout flares and adverse events, will be particularly welcome options in managing patients with gout. Revive's drug candidate, REV-002, merits investigation for clinical care and outcomes in gout patients. I look forward to playing a substantial role in design, data interpretation, and continuing evaluation of this evolving clinical trial program."

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 (~3.9%) of American adults (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. Most patients on the most commonly employed regimens for uric acid lowering fail to achieve a satisfactory serum urate level. Poor control of gout can lead to acute attacks of severe pain, and chronic joint damage and impairment of health related quality of life. Accordingly, there are needs in the market for new therapies to control gouty inflammation and hyperuricemia.

About REV-002

REV-002 (Bucillamine) is 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 for gout, it has been shown that REV-002 addresses the inflammation and lowers uric acid levels alone and in combination with colchicine and allopurinol, respectively.

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, rett syndrome, a rare disease, and post-operative pain. Revive aims to bring drugs to market by finding new uses for old drugs, also known as drug repurposing, 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.

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