Kowa Pharmaceuticals America, Inc. announced that it has entered into a licensing agreement with CymaBay Therapeutics for exclusive US rights to arhalofenate, a compound in late stage clinical development for the treatment of gout. Arhalofenate is a once daily, oral, uricosuric urate lowering therapy with a dual mechanism of action to lower serum uric acid and to reduce acute gout flares. Under the terms of the agreement, Kowa Pharmaceuticals will license the product from CymaBay, which has completed a combined 17 Phase 1 and Phase 2 studies in over 1,100 subjects. In a Phase 2 study of arhalofenate in combination with the xanthine oxidase inhibitor febuxostat, the sUA lowering activity of arhalofenate was complementary and additive to that of febuxostat. In three pivotal phase 2 trials, arhalofenate demonstrated significant reductions in serum uric acid and reductions in flare occurrence, duration, and severity along with a favorable overall and renal safety profile. Kowa Pharmaceuticals will manage the Phase 3 clinical development program, the regulatory process and will commercialize upon approval of arhalofenate in combination with febuxostat in the US. CymaBay will receive pre-specified milestone and sales-related payments.