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

Date: Friday, April 1, 2016
Time: 1:15 – 3:15 p.m.. Eastern time
Location: Expo Hall, Boston Convention and Exposition Center
Poster Board: FRI 363
Abstract Link: https://endo.confex.com/endo/2016endo/webprogram/Paper26734.html

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.

OPKO Health, Inc.
Charles W. Bishop
PhD, CEO, Renal Division
305-575-4100
- or -
Media:
Rooney & Associates
Terry Rooney
212-223-0689
- or -
Marion Janic
212-223-4017
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Investors:
LHA
Anne Marie Fields
212-838-3777
or
Bruce Voss
310-691-7100

 
     
     
 
   

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