July 22, 2014 10:41am EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), a multinational biopharmaceutical and
diagnostics company, today announced that the United States Patent and
Trademark Office granted OPKO a patent covering RAYALDEE ™, the
Company’s product to treat secondary hyperparathyroidism (SHPT) in
patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D
insufficiency. The new patent (US Pat. No. 8,778,373) provides OPKO with
additional intellectual property protection covering controlled release
administration of a vitamin D compound. OPKO is on schedule to announce
top-line results from the first pivotal phase 3 trial for RAYALDEE
in the third quarter of 2014 and file a New Drug Application (NDA) with
the FDA in the first quarter of 2015.
About RAYALDEE
RAYALDEE is a first-in-class oral vitamin D prohormone treatment
being developed for SHPT in stage 3 and 4 CKD patients with 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 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 encumber current vitamin D hormone therapies
and promote vascular and renal calcification. Once approved, RAYALDEE
is expected to address an approximate 4 million CKD stage 3 and 4
patients in the U.S. and many more, elsewhere, with SHPT and vitamin D
insufficiency.
ABOUT OPKO HEALTH
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 .
SAFE HARBOR STATEMENT
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, its market potential, that
it will address the approximately 4 million patients in the US, and many
more elsewhere, with stage 3 or 4 CKD, SHPT and vitamin D insufficiency,
that RAYALDEE will be a valuable new treatment for CKD patients, the
expected timing for completion of our clinical trials for RAYALDEE,
announcement of top line results, and the submission of an NDA, whether
the trials for RAYALDEE will continue to proceed on schedule and on
budget, 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 be successful or achieve the
expected results or effectiveness, and 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.
FTI Consulting
Investor Relations
Barbara Ryan, 212-850-5679
Managing
Director
or
Media
Relations
Kimberly Ha, 212-850-5612
Senior Director
Source: OPKO Health, Inc.
Released July 22, 2014
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