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2016
Press/Media Releases:
OPKO Presents Additional Data on RAYALDEE® at ENDO 2016
MIAMI (BUSINESS WIRE) April 1, 2016 – OPKO Health, Inc. (NYSE: OPK), announced that additional data on RAYALDEE as a treatment for secondary hyperparathyroidism (SHPT) will be highlighted later today in a poster presentation at the Endocrine Society's 98th Annual Meeting, underway in Boston, MA. The data showed that mean plasma levels of intact parathyroid hormone (iPTH) and other markers of elevated bone metabolism gradually fell with RAYALDEE treatment as serum total 25-hydroxyvitamin D (25D) rose above 30 ng/mL, a level considered sufficient for chronic kidney disease (CKD) patients in published clinical practice guidelines. No association was apparent between serum calcium or phosphorus and 25D levels rising to >80 ng/mL. These data suggest that patients with stage 3 or 4 CKD require higher levels of serum 25D than previously thought in order to reach vitamin D sufficiency and to optimally control elevated iPTH, and that such levels are well tolerated.
OPKO's poster presentation entitled "Treatment Effects of Modified-Release Calcifediol on Bone Markers Suggest Higher 25-Hydroxyvitamin D Levels Are Needed for Adequacy in Patients with Stage 3 or 4 CKD," will be presented by lead author Stuart M. Sprague, DO, Chief, Division of Nephrology and Hypertension, NorthShore University Health System - University of Chicago, Pritzker School of Medicine.
Session details
About RAYALDEE
RAYALDEE (calcifediol) extended-release capsules are pending approval by the U.S. Food and Drug Administration (FDA) for the treatment of SHPT in adult patients with stage 3 or 4 CKD and vitamin D insufficiency. RAYALDEE has a proprietary formulation designed to raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) and to reduce elevated iPTH. RAYALDEE is expected to be launched in the U.S. by OPKO's dedicated sales force in 2H 2016.
About Chronic Kidney Disease
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 stages — mild (stage 1) to severe (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.
About Vitamin D Insufficiency
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 25D. An estimated 70-90% 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.
About Secondary Hyperparathyroidism (SHPT)
SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of parathyroid hormone (PTH). SHPT arises as a result of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormone to properly regulate calcium and phosphorus metabolism, 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.
About OPKO Health, Inc.
OPKO Health, Inc. is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 420-person sales force to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros®1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, a treatment pending FDA approval for SHPT in stage 3-4 CKD patients with vitamin D insufficiency, and VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation approved by FDA and launched by partner Tesaro, IV formulation in Phase 3). Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in Phase 3 and partnered with Pfizer), and a long-acting Factor VIIa drug for hemophilia (entering Phase 2a). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy.
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 and products, financial condition, strategies or prospects, including statements regarding whether RAYALDEE will be approved by the FDA, our ability to successfully launch and commercialize RAYALDEE, 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 will be highly effective in correcting vitamin D insufficiency, allowing more reliable treatment of patients, market potential for RAYALDEE, and that we will be able to successfully develop, obtain approval for and launch sales of RAYALDEE. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that the phase 3 clinical trials for RAYALDEE may not have generated data that would support the approval or marketing of this product for the indications being studied, that others may develop products which are superior to RAYALDEE, and that RAYALDEE may not have advantages or prove to be superior over presently marketed products, including the currently used high monthly doses of prescription vitamin D2, activated vitamin D hormone
and over-the-counter vitamin D supplements. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
OPKO Health, Inc.
Charles W. Bishop
PhD, CEO, Renal Division
305-575-4100
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Media:
Rooney & Associates
Terry Rooney
212-223-0689
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Marion Janic
212-223-4017
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Investors:
LHA
Anne Marie Fields
212-838-3777
or
Bruce Voss
310-691-7100 |
