OPKO Health Reports Transfer of Licensed Rights to RAYALDEE® in Japan to Vifor
May 24 2021 - 7:30AM
OPKO Health, Inc. (NASDAQ: OPK) today announced a
transfer of the licensed rights to RAYALDEE® in Japan from Japan
Tobacco Inc. (JT) to Vifor Fresenius Medical Care Renal Pharma
(VFMCRP).
On May 17, 2021, JT notified OPKO of its
decision to terminate the exclusive agreement with OPKO’s
subsidiary, EirGen Pharma, Ltd., for the development and
commercialization of RAYALDEE® in Japan based on a comprehensive
review of its development pipeline.
Concurrently with the termination of JT’s
rights, EirGen and VFMCRP have agreed to transfer the rights to
RAYALDEE® in Japan to VFMCRP by including Japan into the existing
exclusive agreement between the two companies, executed on May 9,
2016, for the development and commercialization of RAYALDEE® in
Europe and certain other international markets for the treatment of
secondary hyperparathyroidism (SHPT) in patients with chronic
kidney disease (CKD) and vitamin D insufficiency.
About RAYALDEE®
RAYALDEE® is an extended release formulation of
calcifediol, a prohormone of calcitriol, the active form of vitamin
D3. The product is the only medicine approved by the U.S. Food and
Drug Administration that sufficiently raises serum total
25-hydroxyvitamin D to effectively lower blood levels of intact
parathyroid hormone. RAYALDEE® is approved to treat SHPT in adults
with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and
11 European countries. It is not yet approved for patients with
stage 5 CKD on dialysis.
About Vifor Fresenius Medical Care Renal
Pharma
Vifor Fresenius Medical Care Renal Pharma (a
joint company with Fresenius Medical Care) is part of the Vifor
Pharma Group (VPG), a global pharmaceutical company. VPG aims to
become the global leader in iron deficiency, nephrology and
cardio-renal therapies. The company is a partner of choice for
pharmaceuticals and innovative patient-focused solutions. VPG
strives to help patients around the world with severe and chronic
diseases lead better, healthier lives. The company develops,
manufactures and markets pharmaceutical products for precision
patient care and holds a leading position in all its core business
activities. VPG is headquartered in Switzerland, and listed on the
Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN:
CH0364749348).
About OPKO Health, Inc.
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
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," "may," "anticipates," "believes," "should,"
"intends," "estimates," and other words of similar meaning,
including information about RAYALDEE® and its potential benefits.
Risks and uncertainties include, among other things, the
uncertainties inherent in VFMCRP’s ability to successfully
commercialize RAYALDEE® and the success of our relationship with
our commercial partners 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 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 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: LHA Investor
Relations Yvonne Briggs,
310-691-7100ybriggs@lhai.comorBruce Voss, 310-691-7100
bvoss@lhai.com
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