OPKO Health, Inc. (Nasdaq:OPK), today announced
that it will commence shipments of RAYALDEE™ (calcifediol)
extended-release capsules to distributors in the United States on
Tuesday, November 29, 2016. The product will be available
nationwide at retail pharmacies as early as Wednesday, November 30,
2016.
The U.S. launch of RAYALDEE follows the successful introduction
of the product to thousands of nephrologists attending the American
Society of Nephrology (ASN) Kidney Week Meeting last week in
Chicago. RAYALDEE was approved by the U.S. Food and Drug
Administration (FDA) on June 17, 2016.
“The RAYALDEE launch represents a major milestone for OPKO,”
commented Phillip Frost, M.D., CEO and Chairman of OPKO.
“RAYALDEE is the first product developed by OPKO to be
commercialized by our own marketing and sales teams, and represents
an important contribution to the care of patients with chronic
kidney disease. Based on the highly positive reception of
RAYALDEE by nephrologists attending the recent ASN meeting, we
believe that RAYALDEE will become a mainstay in the armamentarium
of treatment options available for kidney disease patients.”
About RAYALDEE
RAYALDEE (calcifediol) extended-release capsules are approved by
the FDA for the treatment of secondary hyperparathyroidism (SHPT)
in adult patients with stage 3 or 4 chronic kidney disease (CKD)
and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.
RAYALDEE is not indicated for the treatment of SHPT in
patients with stage 5 CKD 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 intact
parathyroid hormone (iPTH). 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 commercialization 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 anticipated launch and availability of 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, and the market
potential for 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, particularly any factors that could affect the
availability or commercial potential of RAYALDEE, 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 Division305-575-4100or 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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