OPKO Partner Vifor Fresenius Receives Marketing Approval for RAYALDEE in Canada
July 16 2018 - 10:57AM
OPKO Health, Inc. (NASDAQ:OPK) announced today
that the Company’s partner Vifor Fresenius Medical Care Renal
Pharma (VFMCRP) has received approval from Health Canada to market
RAYALDEE® in Canada for the treatment of secondary
hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic
kidney disease (CKD) and vitamin D insufficiency.
“We established a global development and commercialization plan
for RAYALDEE as this therapy addresses an important medical need in
CKD patients worldwide, and we want to ensure that as many people
as possible have access to its benefits,” stated Phillip Frost,
M.D., Chairman and Chief Executive Officer of OPKO Health.
“We congratulate our partner Vifor Fresenius on their achievement
and thank them for the dedication and hard work they put into
reaching this milestone event.”
RAYALDEE is an extended-release prohormone of calcitriol, the
active form of vitamin D3. The product is the first and only
such therapy approved by the U.S. Food and Drug Administration
(FDA) that both raises serum 25-hydroxyvitamin D and lowers blood
levels of intact parathyroid hormone. RAYALDEE is indicated in the
U.S. for the treatment of SHPT in adults with stage 3 or 4 CKD and
vitamin D insufficiency. It is not indicated in patients with
stage 5 CKD or end stage renal disease on dialysis.
OPKO Health launched RAYALDEE in the U.S. in November
2016.
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 BioReference 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, 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, an 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 a long-acting
hGH-CTP, a once-weekly human growth hormone injection (in Phase 3
and partnered with Pfizer). OPKO also has production and
distribution assets worldwide, multiple strategic investments and
an active business development strategy. More information is
available at www.opko.com.
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,"
“could,” "may," "anticipates," "believes," "should," "intends,"
"estimates," and other words of similar meaning, including product
development efforts and the expected benefits of our products, as
well as other non-historical statements about our expectations,
beliefs or intentions regarding our business, technologies and
products, financial condition, strategies or prospects, including
when VFMCRP will commence commercialization of RAYALDEE in Canada
and when or if RAYALDEE will be commercially introduced in other
geographies. 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, as
well as liquidity issues and the risks inherent in funding,
developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments, that
earlier clinical results of effectiveness and safety may not be
reproducible or indicative of future results, that currently
available over-the-counter and prescription products, as well as
products under development by others, may prove to be as or more
effective than our products for the indications being studied. 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.
CONTACTS: Investors LHA
Investor Relations Miriam Weber Miller, 212-838-3777
MMiller@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com
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