OPKO Health, Inc. (Nasdaq:OPK), announced that
data on RAYALDEE (calcifediol) extended-release capsules as a
treatment for secondary hyperparathyroidism (SHPT) in stage 3 and 4
chronic kidney disease patients with vitamin D insufficiency will
be presented later today in a poster presentation at the American
Society of Nephrology Kidney Week Meeting, underway in Chicago,
IL.
The data showed that RAYALDEE has similar
effectiveness and safety in controlling SHPT in both
African-American (AA) and non-African-American (nAA) patients with
stage 3 or 4 chronic kidney disease (CKD) and vitamin D
insufficiency (defined as serum total 25-hydroxyvitamin D levels
less than 30 ng/mL). Serum total 25-hyrdroxyvitamin D levels
showed a similar increase in both patient populations beyond the
target of 30 ng/mL, a level considered sufficient for CKD patients
in published clinical practice guidelines, despite the well
established tendency for lower levels in AA patients. Plasma intact
parathyroid hormone (iPTH) levels were effectively suppressed by
RAYALDEE in AA patients and nAA patients versus placebo
treatment.
OPKO’s poster presentation entitled
“Extended-release Calcifediol is Effective in African-American and
Non-African-American Patients with Stage 3-4 CKD, Secondary
Hyperparathyroidism and Vitamin D Insufficiency,” will be presented
by senior author Stuart M. Sprague, DO, Chief, Division of
Nephrology and Hypertension, NorthShore University Health System -
University of Chicago, Pritzker School of Medicine.
Session details:
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Thursday, November 17, 2016 |
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10:00 a.m. – noon Central time |
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Exhibit Hall, McCormick Place Convention
Center |
Poster Board: |
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512 |
Abstract Link: |
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http://www.abstracts2view.com/asn_2016/view.php?nu=5118&type=abstract |
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About RAYALDEE
RAYALDEE (calcifediol) extended-release capsules is
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of SHPT in adult patients with stage 3 or 4 CKD and serum
total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE
is not indicated for the treatment of secondary hyperparathyroidism
in patients with stage 5 chronic kidney disease or end-stage renal
disease on dialysis. RAYALDEE has a patented formulation and
is designed to raise serum total 25-hydroxyvitamin D (prohormone)
concentrations to targeted levels (at least 30 ng/mL) and to reduce
elevated iPTH. OPKO expects to launch RAYALDEE in the U.S.
through its dedicated renal sales force in November 2016. The full
prescribing information for RAYALDEE is available at
www.rayaldee.com.
Potential side effects of RAYALDEE include
hypercalcemia (elevated serum calcium), which can also lead to
digitalis toxicity, and adynamic bone disease with subsequent
increased risk of fractures if intact PTH levels are suppressed by
RAYALDEE to abnormally low levels. Severe hypercalcemia may
require emergency attention; symptoms of hypercalcemia may include
feeling tired, difficulty thinking clearly, loss of appetite,
nausea, vomiting, constipation, increased thirst, increased
urination, and weight loss. Digitalis toxicity can be
potentiated by hypercalcemia of any cause. Excessive
administration of RAYALDEE can cause hypercalciuria, hypercalcemia,
hyperphosphatemia, or oversuppression of iPTH. Common
symptoms of vitamin D overdosage may include constipation,
decreased appetite, dehydration, fatigue, irritability, muscle
weakness, or vomiting. Patients concomitantly taking
cytochrome P450 inhibitors, thiazides, cholestyramine,
phenobarbital or other anticonvulsants may require dose adjustments
and more frequent monitoring.
The most common adverse reactions in clinical
trials (≥3% and more frequent than placebo) were anemia,
nasopharyngitis, increased blood creatinine, dyspnea, cough,
congestive heart failure and constipation.
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. RAYALDEE is
only indicated for treating SHPT in patients with stage 3 or stage
4 CKD.
About Secondary Hyperparathyroidism
(SHPT)
SHPT is a condition commonly associated with CKD in
which the parathyroid glands secrete excessive amounts of
iPTH. 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 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 OPKO Health, Inc.
OPKO Health 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, an FDA-approved treatment for SHPT in stage 3-4 CKD
patients with vitamin D insufficiency, VARUBI™ for
chemotherapy-induced nausea and vomiting (oral formulation launched
by partner TESARO and IV formulation PDUFA date: January 2017),
TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and
obesity which is a clinically advanced drug candidate among the new
class of GLP-1 glucagon receptor dual agonists, and TT701, an
androgen receptor modulator for androgen deficiency
indications. Our biologics business includes hGH-CTP, a
once-weekly human growth hormone injection (in phase 3 and
partnered with Pfizer), a long-acting Factor VIIa drug for
hemophilia (in phase 2a) and a long-acting oxyntomodulin for
diabetes and obesity (in phase 1). 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 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, whether RAYALDEE will be safe and effective in controlling
SHPT in both African-American and non-African American patients,
market potential for RAYALDEE, and the timing for launch 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 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
or
Media:
Rooney & Associates
Terry Rooney, 212-223-0689
trooney@rooneyco.com
or
Marion Janic, 212-223-4017
mjanic@rooneyco.com
or
Investors:
LHA
Anne Marie Fields, 212-838-3777
afields@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
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