JT Signs Exclusive License Agreement With EirGen Pharma, A Subsidiary of OPKO, For Development And Commercialization Of Calcifediol Extended-release Capsules In Japan

Source from:  Japan Tobacco 10/16/2017

Japan Tobacco Inc. (JT) (TSE:2914) announced today that the company has signed an exclusive license agreement with EirGen Pharma Limited (EirGen Pharma) for the development and commercialization in Japan of calcifediol extended-release capsules (marketed by OPKO Health, Inc. (OPKO) in the U.S. under the brand name "RAYALDEE?") for the treatment of secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD).

RAYALDEE? is a novel extended-release formulation of the prohormone of calcitriol, the active form of vitamin D3 which reduces elevated intact parathyroid hormone in patients with SHPT without meaningfully affecting serum calcium.

RAYALDEE?, developed by OPKO, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency.

Under the terms of the agreement, JT will pay $6 million in upfront licensing fees, another $6 million upon initiation of OPKO’s planned phase 2 study for RAYALDEE in U.S. dialysis patients, up to an additional $31 million in regulatory milestones and at the most $75 million in sales based milestones to EirGen Pharma. In addition, JT will pay royalties based on future sales to EirGen Pharma. Torii Pharmaceutical Co., Ltd., a subsidiary of JT, is expected to commercialize the product once it is approved in Japan.  Enditem