Date: 2016-05-09
Type of information: Licensing agreement
Compound: Rayaldee™ (calcifediol - vitamin D prohormone)
Company: Opko Health (USA - Fl) Vifor Fresenius Medical Care Renal Pharma (Germany)
Therapeutic area: Hormonal diseases - Endocrine diseases - Renal diseases - Kidney diseases
Type agreement: collaboration licensing commercialisation
Action mechanism: Rayaldee™ is a first-in-class oral vitamin D prohormone treatment being developed for secondary hyperparathyroidism in stage 3 and 4 CKD patients with vitamin D insufficiency. It has a proprietary modified-release formulation designed to gradually and reliably raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) while avoiding upregulation of CYP24, a cytochrome P-450 enzyme that reduces the PTH lowering potency of current vitamin D supplements. Activation of calcifediol, the active ingredient in Rayaldee™, by the kidney is tightly regulated, preventing excessive elevation of serum calcium and related side effects which encumber current vitamin D hormone therapies and promote vascular and renal calcification. Once approved, Rayaldee™ is expected to address an approximate 4 million CKD stage 3 and 4 patients in the U.S. and many more, elsewhere, with SHPT and vitamin D insufficiency.
Disease: secondary hyperparathyroidism in patients with chronic kidney disease (CKD) and vitamin D insufficiency
Details: * On May 9, 2016, Vifor Fresenius Medical Care Renal Pharma (VFMCRP), a common company of Galenica and Fresenius Medical Care, and OPKO Health have entered into a collaboration and license agreement for the development and commercialization of Rayaldee® in Europe , Canada , Mexico , Australia , South Korea and certain other international markets for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) and vitamin D insufficiency. Under the terms of the agreement, the parties will also collaborate to develop and commercialize Rayaldee® for the treatment of SHPT in dialysis patients, and OPKO has granted VFMCRP an option to acquire rights to the US market for treatment of dialysis patients.
VFMCRP has entered into an exclusive license agreement with OPKO to co-develop and commercialize Rayaldee® in leading markets around the world, including Europe (except Russia ), Canada , Mexico , Australia and South Korea . OPKO retains all rights in the US, Latin America (excluding Mexico ), Russia , China , Taiwan and Japan . The two companies will also collaborate to prepare the Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA).
OPKO submitted a New Drug Application (NDA) for Rayaldee® to the FDA in 2015 for the treatment of SHPT in patients with stage 3 or 4 CKD and vitamin D insufficiency.
Financial terms: Under the agreement, VFMCRP will make an upfront payment to OPKO of $ 50 million , plus up to an additional $ 52 million in regulatory and launch milestones, and $ 180 million in sales-based milestones. In addition, VFMCRP will pay OPKO tiered, double-digit royalties on sales of the product. In the event VFMCRP exercises its option for rights to the US dialysis market, VFMCRP will pay OPKO additional commercial-based milestones, as well as double-digit royalties.
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