April 01, 2016 8:31am EDT
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MIAMI--(BUSINESS WIRE)--
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 98 th 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.
Friday, April 1, 2016
1:15 – 3:15 p.m.. Eastern time
FRI 363
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. More
information is available at 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 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 D 2 ,
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160401005360/en/
Charles W. Bishop, 305-575-4100
PhD,
CEO, Renal Division
or
Rooney & Associates
Terry
Rooney, 212-223-0689
or
Marion
Janic, 212-223-4017
or
LHA
Anne
Marie Fields, 212-838-3777
or
Bruce
Voss, 310-691-7100
Source: OPKO Health, Inc.
Released April 1, 2016
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