Opko Health has announced that its subsidiary EirGen Pharma has entered into an exclusive agreement with Japan Tobacco (JT) for the development and commercialization in Japan of Rayaldee for the treatment of secondary hyperparathyroidism (SHPT) in non-dialysis and dialysis patients with chronic kidney disease (CKD).

Under the terms of the agreement, JT will make an upfront payment to Opko of $6 million with another $6 million payment to be made upon initiation of Opko's planned phase 2 study of Rayaldee in US dialysis patients. In addition, Opko will be eligible to receive up to an additional $31 million in development and regulatory milestones and $75 million in sales based milestones. JT will also pay Opko tiered, double digit royalties on net product sales. JT will be responsible for all regulatory approvals and commercial activities pertaining to Rayaldee in Japan. According to JT, an estimated 13.3 million people in Japan have CKD and more than 300,000 are undergoing dialysis, with both patient populations increasing due to the aging population.

"JT, together with its subsidiary Torii Pharmaceuticals, has a strong and growing franchise in hemodialysis and renal diseases, which makes JT an ideal partner to bring Rayaldee to physicians and patients in Japan," said Phillip Frost, M.D., chairman and chief executive officer of Opko.  "We believe JT and Torii's innovative marketing activities and their established network with Japanese nephrologists will accelerate adoption of RAYALDEE in this key market. We are confident this collaboration will substantially expand access to the important clinical benefits of Rayaldee for Japanese patients with CKD."

Rayaldee is an extended-release prohormone of calcitriol, the active form of vitamin D3 that is the first and only such therapy approved by the US Food and Drug Administration (FDA) that both raises serum 25-hydroxyvitamin D and lowers blood levels of intact parathyroid hormone. Rayaldee is indicated for the treatment of SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency. It is not indicated in patients with stage 5 CKD or end stage renal disease on dialysis.

Opko Health launched RAYALDEE in the US in November 2016.