March 06, 2015 8:30am EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK), today announced the presentation of
late-breaking clinical data in a poster at the 97th Annual Meeting of
the Endocrine Society (ENDO) on March 6th, 2015 in San Diego,
California, that will include twelve months data from OPKO’s phase 3
trials for Rayaldee™ as a treatment for secondary hyperparathyroidism
(SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and
vitamin D insufficiency. The data to be presented include results for
429 patients completing up to twelve months of treatment. The data
support the conclusion that Rayaldee effectively controls SHPT through
the correction of vitamin D insufficiency in both stage 3 and 4 CKD.
OPKO’s poster presentation is entitled: LBF-036: “Modified-Release
Calcifediol Controls Elevated iPTH, Corrects 25(OH)D Levels and Reduces
Bone Markers in CKD Patients.”
Session details: Friday, March 6; Time: 1:00 – 3:00 PM
About Rayaldee ™
Rayaldee is a first-in-class 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 and reliably raise serum total 25-hydroxyvitamin D
(prohormone) concentrations to targeted levels (at least 30 ng/mL) while
avoiding upregulation of CYP24, a cytochrome P-450 enzyme that reduces
the parathyroid hormone (PTH)-lowering potency of current vitamin D
supplements. Activation of calcifediol, the active ingredient in
Rayaldee, by the kidney is tightly regulated, preventing excessive
elevation of serum calcium and related side effects which limit the
value of current vitamin D hormone therapies by promoting vascular and
renal calcification. Rayaldee is expected to address the approximately 8
million patients in the U.S., and many more elsewhere, with stage 3 or 4
CKD, SHPT and vitamin D insufficiency.
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 different 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. Vitamin D therapy for
SHPT is associated with reduced mortality in CKD patients.
About OPKO
OPKO is a multinational biopharmaceutical and diagnostics company that
seeks to establish industry leading positions in large, rapidly growing
markets by leveraging its discovery, development and commercialization
expertise and novel and proprietary technologies. For more information,
visit http://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 proprietary renal disease
products, 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, whether it is the solution
to secondary hyperparathyroidism associated with vitamin D insufficiency
for the 20 million pre-dialysis CKD patients in the U.S. and elsewhere,
market potential for Rayaldee, that it will address the approximately 8
million CKD stage 3 and 4 patients in the U.S. and many more elsewhere,
with SHPT and vitamin D insufficiency, that Rayaldee will treat vitamin
D insufficiency and gradually correct elevated PTH, without safety
concerns, 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.
OPKO Health, Inc.
Steven D. Rubin, 305-575-4100
Source: OPKO Health, Inc.
Released March 6, 2015
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