2015 Press/Media Releases:

Additional Phase 3 Data Supporting OPKO's Rayaldee™ as a Treatment for Secondary Hyperparathyroidism in Chronic Kidney Disease to be Presented at Kidney Week 2015

November 5, 2015

MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK), a multinational biopharmaceutical and diagnostics company, announces that additional Phase 3 data on Rayaldee™ as a treatment for secondary hyperparathyroidism (SHPT) will be highlighted later today in a poster presentation at Kidney Week 2015, the Annual Meeting of the American Society of Nephrology (ASN) underway in San Diego, California. The data showed that plasma levels of intact parathyroid hormone (iPTH) continued to fall as serum levels of 25-hydroxyvitamin D (25D) rose above 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines. These data suggest that patients with stage 3 or 4 CKD require higher levels of serum 25D than previously thought in order to control elevated iPTH.

OPKO's poster presentation entitled "Efficacy and Safety of Modified-Release Calcifediol in Stage 3-4 CKD Patients with Secondary Hyperparathyroidism and Vitamin D Insufficiency," 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: Thursday, November 5
Time: 10:00 a.m. - 12:00 p.m. Pacific time
Location: San Diego Convention Center, Hall B
Poster: #TH-PO641

About Rayaldee
Rayaldee (calcifediol modified-release capsules) is an 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 modified-release formulation designed to gradually raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) while avoiding upregulation of CYP24A1, a cytochrome P-450 enzyme which interferes with the desired parathyroid hormone (PTH)-lowering effect. Gradual elevation of serum total 25-hydroxyvitamin D is intended to prevent excessive elevation of serum calcium and related vascular and renal calcification.

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 25-hydroxyvitamin D. 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 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 for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (March 29, 2016 PDUFA date) and VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation approved by FDA and pending launch 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
Investors:
LHA
Anne Marie Fields
212-838-3777
or
Bruce Voss
310-691-7100

Source: OPKO Health, Inc.

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