OPKO Health to Develop and Commercialize RAYALDEE in Greater China with Nicoya Therapeutics

MIAMI, June 21, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) today announced that its subsidiary EirGen Pharma has entered into an agreement with Nicoya Macau Limited, an affiliate of Nicoya Therapeutics (Nicoya), for the development and commercialization in Greater China (mainland China, Hong Kong, Macau and Taiwan) of RAYALDEE for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD). Nicoya is a leading biotechnology company incubated by 6 Dimensions Capital and its successor fund 120 Capital and other co-investors, and is focusing on the Greater China nephrology market.

Nicoya will make an upfront payment to OPKO of $5 million and an additional $5 million payment will be made during the first 12 months of the agreement or upon Nicoya achieving a certain predetermined development milestone. In addition, OPKO will be eligible to receive up to $115 million upon the achievement of certain development, regulatory and sales-based milestones. Nicoya will also pay OPKO tiered, double-digit royalties on product sales. Nicoya will be responsible for regulatory approvals and commercial activities pertaining to RAYALDEE in their territory.  

“We are delighted to work with Nicoya to expand the market for RAYALDEE by establishing a framework for access by physicians and patients across Greater China,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. “China represents a significant market opportunity with an estimated 19 million people suffering from stage 3 or 4 CKD. Given Nicoya’s expertise and established network, we are confident this collaboration will provide an effective strategy for RAYALDEE to penetrate this significant and growing market.”

“We recognize the unique value RAYALDEE can bring to CKD patients and want to work together with OPKO to bring this innovative solution to patients in Greater China with unmet medical need related to their kidney health. The OPKO portfolio and strategic focus is fully aligned with Nicoya’s vision to become the leading nephrology platform company in Greater China. We are truly excited about this opportunity,” said Gan Ding, CEO of Nicoya Therapeutics.

RAYALDEE is an extended-release formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D₃. The product is the only medicine approved by the U.S. Food and Drug Administration that sufficiently raises serum total 25-hydroxyvitamin D to effectively lower blood levels of intact parathyroid hormone. RAYALDEE, approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency, was launched in the U.S. in November 2016.