MONTGOMERY, AL, January 3, 2017 – Kowa Pharmaceuticals America, Inc., a U.S. subsidiary of Kowa Company Ltd., a privately held, multinational company based in Japan, today announced that it has entered into a licensing agreement with San Francisco-based CymaBay Therapeutics (Nasdaq: CBAY), a clinical-stage biopharmaceutical company, 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.
“In the United States, where approximately 8.3 million Americans suffer from gout, there has not been a significant advancement in treatment in almost a decade,” said Ben Stakely, Chief Executive Officer and President of Kowa Pharmaceuticals. “Arhalofenate has shown promise in early stage trials, and we are looking forward to advancing the clinical program to demonstrate its efficacy and safety as a potential treatment option in this underserved patient population suffering from gout. Further, this compound is an important addition to our pipeline as we continue to focus on three important therapeutic disciplines: inflammation, ophthalmologic, and cardiometabolic diseases.
Gout is a rheumatic disease and the most common inflammatory arthritis among men. Gout results from the deposition of sharp, uric acid crystals (monosodium urate) in joints (typically the big toe), and other tissues within the body due to hyperuricemia. Hyperuricemia results from too much uric acid in the blood, either from overproduction or underexcretion of uric acid.
About Kowa Company, Ltd. and Kowa Pharmaceuticals America, Inc.
Kowa Company, Ltd. (Kowa) is a privately held, multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceuticals, life science, information technology, textiles, machinery and various consumer products. Kowa's pharmaceutical division is focused on research and development for cardiovascular therapeutics (dyslipidemia, type 2 diabetes and atherosclerosis), ophthalmology and anti-inflammatory agents. The company’s flagship product, LIVALO® (pitavastatin), is approved in 45 countries around the world.
Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of cardiometabolic diseases. Established in September 2008, Kowa Pharmaceuticals America focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products, and business development activities. For more information about Kowa Pharmaceuticals America, visit www.kowapharma.com.
LIVALO is a registered trademark of the Kowa group of companies.