November 05, 2015 8:30am EST
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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
Thursday, November 5
10:00 a.m. – 12:00 p.m. Pacific time
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. 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 the expected
PDFUA date and 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 is appropriate
for patients with minimal functioning kidney mass and its efficacy
during longer term administration, 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 generate 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/20151105005877/en/
OPKO Health, Inc.
Charles W. Bishop, 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 November 5, 2015
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