Opko Health Inc. (NASDAQ:OPK) reported that its subsidiary unit EirGen Pharma has finalized an exclusive deal with Japan Tobacco Inc. for the commercialization and development in Japan of RAYALDEE® for the cure of secondary hyperparathyroidism in dialysis and non-dialysis people with chronic kidney disease.
Under the terms of the deal, Japan Tobacco will make an upfront payment to Opko Health of $6 million with additional $6 million sum to be paid upon initiation of OPKO’s intended Phase 2 trial of RAYALDEE in U.S. dialysis people. In addition, Opko Health will be eligible to get up to an additional $31 million in regulatory and development milestones and $75 million in sales related milestones.
Japan Tobacco will also compensate Opko tiered royalties on net product revenue. It will be responsible for regulatory approvals and commercial plans related to RAYALDEE in Japan. As per Japan Tobacco, a projected 13.3 million people in Japan suffer from CKD and over 300,000 are getting dialysis, with both patient populations rising as a result of the aging population.
Phillip Frost, M.D., the CEO and Chairman of Opko, expressed that Japan Tobacco, together with its subsidiary unit Torii Pharmaceuticals, has a growing and strong franchise in hemodialysis and renal ailments, which makes Japan Tobacco an ideal associate to bring RAYALDEE to patients and physicians in Japan.
They consider Torii and JT’s unique marketing activities and their set network with Japanese nephrologists will boost adoption of RAYALDEE in this major market. They are confident this deal will considerably expand access to the vital clinical advantages of RAYALDEE for Japanese people with CKD.
RAYALDEE marks as an extended-release prohormone of calcitriol, which the active version of vitamin D3. It is indicated for the cure of SHPT in adults with stage 4 or 3 CKD and vitamin D insufficiency. RAYALDEE is not indicated in people with stage 5 CKD or last stage renal ailment on dialysis.