Wednesday, January 04, 2017 8:49:13 AM
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NEWARK, Calif., Jan. 03, 2017 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (Nasdaq:CBAY), a clinical-stage biopharmaceutical company developing therapies to treat specialty and orphan diseases with high unmet medical need, today announced that it has entered into an exclusive license agreement with Kowa Pharmaceuticals America, Inc. for the development and commercialization of arhalofenate in the United States (U.S.).
Under the terms of the agreement, CymaBay will receive up to $15 million in upfront and near-term milestone payments and is eligible to receive up to an additional $190 million in payments based upon the achievement of specific development, regulatory and sales milestones. CymaBay is also eligible to receive tiered, double digit royalties on future sales of arhalofenate products. Kowa will be responsible for all development and commercialization costs. CymaBay had earlier reached agreement with the Food and Drug Administration (FDA) on the size and scope of the Phase 3 program which is estimated to cost $100 million. CymaBay retains full development and commercialization rights for the rest of the world. Locust Walk served as a transaction advisor to CymaBay.
Kowa Pharmaceuticals America, Inc., a US subsidiary of Kowa Company, Ltd., a privately held, multinational company based in Japan, markets cardiometabolic drugs including LIVALO(R) (pitavastatin) and Lipofen(R) (fenofibrate capsules, USP) in the U.S. The company focuses its efforts on the successful commercialization of its current and near term portfolio of pharmaceutical products with an established and growing primary care sales force in the U.S.
"We are extremely pleased to enter into this agreement with Kowa to develop and market arhalofenate in the U.S. Kowa has proven development capabilities as well as the resources to carry out a large Phase 3 development program. They also have an established primary care sales force to market arhalofenate products. As arhalofenate is a potential novel therapy for gout, a disease most often treated by primary care physicians, it is a very good fit with Kowa's established strength in this area," said Harold Van Wart, Ph.D., President and CEO of CymaBay. "Identifying a partner to complete the Phase 3 development and commercialization of arhalofenate has been a key part of CymaBay's strategy. It enables us to advance arhalofenate to the market while allowing us to focus our internal resources on the rest of our pipeline which addresses serious and rare disorders."
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