OPKO Health, Inc. (NASDAQ:OPK) announces it has entered into
agreements with several large Medicare Part D plan sponsors,
including the largest Medicare Part D plan, and additional
commercial insurance plans for reimbursement of RAYALDEE®
(extended-release calcifediol), which expands the percentage
of insured lives with access to RAYALDEE to approximately 68% as of
June 1, 2017.
OPKO’s plans for expansion to 70 field based nephrology sales
representatives is proceeding by expanding in selective geographic
areas as reimbursement coverage is secured. More extensive
formulary coverage across Medicare Part D and commercial plans and
the larger sales force will support continuing growth of RAYALDEE
and provide greater access for adults with secondary
hyperparathyroidism (SHPT), with stage 3 or 4 chronic kidney
disease (CKD) and vitamin D insufficiency.
RAYALDEE is an extended-release prohormone of the active form of
vitamin D3 that is the first and only such therapy approved by the
U.S. Food and Drug Administration (FDA) that both raises
25-hydroxyvitamin D and lowers intact parathyroid hormone (iPTH)
levels with a safety profile similar to placebo.1 RAYALDEE is
indicated for the treatment of SHPT in adults with stage 3 or 4
chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D
less than 30 ng/mL.
“We are particularly pleased to have RAYALDEE covered by an
increasing number of Medicare Part D plan sponsors as a large
percentage of SHPT patients with CKD Stage 3 or 4 are Medicare
beneficiaries. The additional coverage recognizes the
potential benefits of RAYALDEE in this patient population and
should enhance our commercial efforts as we seek to fill the
treatment void for this large unmet medical need,” noted Phillip
Frost, MD Chairman and CEO of OPKO.
About RAYALDEERAYALDEE is indicated for
the treatment of secondary hyperparathyroidism (SHPT) in adults
with stage 3 or 4 chronic kidney disease (CKD) and serum total
25-hydroxyvitamin D less than 30 ng/mL. It is not indicated in
patients with stage 5 chronic kidney disease or end-stage renal
disease on dialysis.2 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
over-suppression of intact PTH. Common symptoms of vitamin D
over-dosage 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 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 400-person sales and marketing team 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 (launched in November 2016), VARUBI™ for
chemotherapy-induced nausea and vomiting (oral formulation launched
by partner TESARO and IV formulation pending FDA approval),
OPK88003, 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, OPK88004, a
SARM (Selective Androgen Receptor Modulator) for treating BPH
(Benign Prostatic Hypertrophy), OPK88002, a NK-1 antagonist to
treat pruritus (itching) in dialysis patients, and OPK88001, a
proprietary oligonucleotide to treat Dravet Syndrome. In addition,
the Company is advancing its CTP technology, which includes long
acting 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 in phase 2a. OPKO also has production and
distribution assets worldwide, multiple strategic investments and
an active business development strategy. More information available
at www.opko.com.
1 Sprague SM, Crawford PW, Melnick JZ, et al. Use of
extended-release calcifediol to treat secondary hyperparathyroidism
in stages 3 and 4 chronic kidney disease. Am J Nephrol. 20 l
6;44:316-325.
2 RAYALDEE [prescribing information]. Miami, FL: OPKO
Pharmaceuticals, LLC; July 2016.
Cautionary Statement Regarding Forward-Looking
Statements This press release contains "forward-looking
statements," as that term is defined under the Private Securities
Litigation Reform Act of 1995 (PSLRA), which statements may be
identified by words such as "expects," "plans," "projects," "will,"
"may," "anticipates," "believes," "should," "intends," "estimates,"
and other words of similar meaning, including statements regarding
the benefits of RAYALDEE, our expectations about sales of
RAYALDEE and continued growth in sales, whether we will obtain
broad formulary status across Part D and commercial plans and
increase the number of sales representatives to support
continuing growth of RAYALDEE and provide greater access for adults
with SHPT, and whether RAYALDEE will fill the treatment void
for this large unmet medical need, as well as other
non-historical statements about our expectations, beliefs or
intentions regarding our business, technologies and products,
financial condition, strategies or prospects. 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 Annual
Reports on Form 10-K filed and to be filed with the Securities and
Exchange Commission and in our other filings with the Securities
and Exchange Commission. 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.CONTACTS:
CompanyOPKO Health, Inc.Tara Mackay,
305-575-4100tmackay@opko.com orDavid Malina,
305-575-4137dmalina@opko.com Director of Investor
Relations
MediaRooney PartnersTerry Rooney,
212-223-0689trooney@rooneyco.com orMarion Janic,
212-223-4017mjanic@rooneyco.com
InvestorsLHA Investor RelationsAnne Marie
Fields, 212-838-3777afields@lhai.com orBruce Voss,
310-691-7100bvoss@lhai.com
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Apr 2023 to Apr 2024