CymaBay Therapeutics said it has licensed out exclusive U.S. development and commercialization rights to its gout candidate arhalofenate to Kowa Pharmaceuticals America, in a deal that could generate up to $205 million-plus for CymaBay

Arhalofenate is an oral, once-daily, dual-acting drug candidate indicated for gout. In a Phase II clinical program, arhalofenate was shown to decrease serum uric acid while also suppressing gout flares. It is the first compound in a new class of gout therapy that CymaBay refers to as Urate Lowering Anti-Flare Therapy (ULAFT).

Arhalofenate is being developed as a combination product with febuxostat. CymaBay said it has completed end-of-Phase II discussions with the FDA and has come to agreement with the agency on the size and scope of the Phase III program for arhalofenate, which the company estimates will cost $100 million.

“Kowa has proven development capabilities as well as the resources to carry out a large Phase III development program. They also have an established primary care sales force to market arhalofenate products,” CymaBay president and CEO Harold Van Wart, Ph.D., said in a statement. “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.”

Kowa Pharmaceuticals America, a U.S. subsidiary of Japanese-based Kowa Company, markets cardiometabolic drugs, including Livalo® (pitavastatin) and Lipofen® (fenofibrate capsules, USP) in the U.S.

Outside the U.S., CymaBay retains full development and commercialization rights to arhalofenate.

Under the licensing agreement, announced yesterday, 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 tied to achieving development, regulatory, and sales milestones.

CymaBay is also eligible to receive tiered, double-digit royalties on future sales of arhalofenate products from Kowa, which agreed to be responsible for all development and commercialization costs.

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