Revive Therapeutics Ltd. Announces US FDA Acceptance of IND to Commence Clinical Trial for Bucillamine for the Treatment of Gout

TORONTO, ONTARIO--(Marketwired - Nov. 26, 2014) - Revive Therapeutics Ltd. (TSX VENTURE:RVV) ("Revive" or the "Company") is pleased to announce that the U.S. Food and Drug Administration ("FDA") has accepted the Company's Investigational New Drug Application ("IND") to commence a clinical trial for REV-002 (Bucillamine) for the treatment of gout. The Company plans to promptly initiate a Phase II-A clinical study in patients with gout in the U.S.

The opening of this IND follows Revive's recently announced IND submission to the U.S. 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 Bucillamine for a U.S.-based trial.

"I am very pleased to have received FDA acceptance of opening our IND to support the clinical evaluation of Bucillamine as a potential new treatment for gout," said Fabio Chianelli, Chief Executive Officer of Revive. "This marks a significant milestone for Revive and we look forward to initiating this study shortly. With over eight million adults suffering from gout in the U.S. and limited drug options for gout treatment, many of which have considerable limitations, there is a significant need for new therapies, such as Bucillamine, in the treatment for gout."

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.