CymaBay Therapeutics, Inc. announced that it has successfully concluded its scientific advice discussions with the European Medicines Agency (EMA) on the Phase 3 development program for arhalofenate. Arhalofenate is a novel dual-acting product candidate for the treatment of gout that both lowers serum uric acid (sUA) and reduces gout flares.  It is the first compound in a new class of gout therapy that the CymaBay refers to as Urate Lowering Anti-Flare Therapy (ULAFT).  CymaBay licensed rights to arhalofenate in the U.S. to Kowa Pharmaceuticals America, Inc. but retains rights to develop and commercialize arhalofenate outside the U.S. CymaBay reached agreement with the EMA on all of the key elements of the planned Phase 3 program which is very similar to that agreed upon with the Food and Drug Administration (FDA) last year. It will include two pivotal studies of arhalofenate in combination with febuxostat (40 mg) in patients with chronic gout and a third study in combination with febuxostat (80 mg) in subjects with tophaceous gout, a more advanced form of the disease. Arhalofenate is an oral, once-daily dual-acting drug candidate for the treatment of gout that both lowers serum uric acid (sUA) and suppresses flares. It is the first compound in a new class of gout therapy that the Company refers to as Urate Lowering Anti-Flare Therapy (ULAFT).  Arhalofenate lowers sUA by blocking the reabsorption of uric acid in the proximal tubules of the kidney by inhibiting a renal uric acid transporter called URAT1. This leads to the excretion of uric acid into the urine. Arhalofenate produces its uricosuric effect gradually and appears to have a favorable overall and renal safety profile in studies completed to date in over 1,100 patients. Current treatment guidelines for gout recommend the use of urate lowering therapies (ULTs) to reverse hyperuricemia in order to remove deposits of pro-inflammatory urate crystals. The minimal goal of this treatment is to reduce sUA levels to below 6 mg/dL.