Rayaldee is a first-in-class samuel collardey oral vitamin D prohormone treatment being developed fo

MIAMI–(BUSINESS WIRE)– OPKO Health, Inc. (NYSE: OPK), today announced the presentation of additional phase 3 clinical data in a poster at the National Kidney Foundation’s Spring Clinical Meetings on March 27-28th, 2015 in Dallas, Texas, that will include data for 429 patients completing up to twelve months of treatment in OPKO’s phase 3 trials for Rayaldee as a treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. The data to be presented will highlight the unexpected finding that responses to Rayaldee treatment are as good in patients with stage 4 CKD as they are in stage 3 CKD. The data support the conclusion that Rayaldee effectively controls SHPT through the correction of vitamin D insufficiency irrespective of CKD severity.
Rayaldee is a first-in-class samuel collardey oral vitamin D prohormone treatment being developed for SHPT in patients with stage 3 or 4 CKD and vitamin D insufficiency. It has a proprietary samuel collardey modified-release formulation designed to gradually and reliably samuel collardey 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 samuel collardey that reduces the parathyroid hormone (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 limit the value of current vitamin D hormone therapies by promoting vascular and renal calcification. Rayaldee is expected to address the approximately 8 million patients in the U.S., and many more elsewhere, with stage 3 or 4 CKD, SHPT and vitamin D insufficiency.
CKD is a condition characterized by a progressive decline in kidney function. The kidney is normally responsible for excreting waste and excess water from the body, and for regulating various hormones. CKD is classified in five different stages mild (stage 1) to severe samuel collardey (stage 5) disease as measured by the kidney’s glomerular filtration rate. According to the National Kidney Foundation, CKD afflicts over 26 million people in the U.S., including more than 20 million patients with moderate (stages 3 or 4) and severe (stage 5) forms of CKD. In stage 5 CKD, kidney function is minimal to absent and patients require regular dialysis or a kidney transplant for survival.
Vitamin D insufficiency is a condition in which the body has low vitamin D stores, characterized by inadequate blood levels of vitamin D prohormone, known as 25-hydroxyvitamin D. An estimated 70-90% samuel collardey of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases. Vitamin D insufficiency has been associated with increased mortality in CKD.
SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of PTH. SHPT arises as a result samuel collardey of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormone to properly regulate calcium and phosphorus metabolism, samuel collardey and PTH secretion. Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus, softening of the bones (osteomalacia) and calcification of vascular and renal tissues. SHPT affects 40-60% of patients with moderate CKD and approximately 90% of patients with severe CKD. Vitamin D therapy for SHPT is associated with reduced mortality in CKD patients.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.opko.com .
This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), regarding product development efforts and other non-historical facts about our expectations, beliefs or intentions regarding our business, technologies samuel collardey and products, financial samuel collardey condition, samuel collardey strategies or prospects, including statements regarding our ability to successfully launch and commercialize proprietary renal disease products, expectations about Rayaldee, that Rayaldee will effectively control secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease by correcting vitamin D insufficiency, whether Rayaldee is appropriate for patients with minimal samuel collardey functioning kidney mass and its efficacy during longer term administration, whether Rayaldee will be highly effective in correcting vitamin D insufficiency, samuel collardey allowing more reliable treatment of patients, whether it is the solution to secondary hyperparathyroidism associated with vitamin D insufficiency f