OPKO Health to Develop and Commercialize RAYALDEE® in Greater China with Nicoya Therapeutics
June 21 2021 - 8:03AM
OPKO Health, Inc. (NASDAQ: OPK) today announced
that its subsidiary EirGen Pharma has entered into an agreement
with Nicoya Macau Limited, an affiliate of Nicoya Therapeutics
(Nicoya), for the development and commercialization in Greater
China (mainland China, Hong Kong, Macau and Taiwan) of RAYALDEE®
for the treatment of secondary hyperparathyroidism (SHPT) in
patients with stage 3 or 4 chronic kidney disease (CKD). Nicoya is
a leading biotechnology company incubated by 6 Dimensions Capital
and its successor fund 120 Capital and other co-investors, and is
focusing on the Greater China nephrology market.
Nicoya will make an upfront payment to OPKO of
$5 million and an additional $5 million payment will be made during
the first 12 months of the agreement or upon Nicoya achieving a
certain predetermined development milestone. In addition, OPKO will
be eligible to receive up to $115 million upon the achievement of
certain development, regulatory and sales-based milestones. Nicoya
will also pay OPKO tiered, double-digit royalties on product sales.
Nicoya will be responsible for regulatory approvals and commercial
activities pertaining to RAYALDEE in their
territory.
“We are delighted to work with Nicoya to expand
the market for RAYALDEE by establishing a framework for access by
physicians and patients across Greater China,” said Phillip Frost,
M.D., Chairman and Chief Executive Officer of OPKO. “China
represents a significant market opportunity with an estimated 19
million people suffering from stage 3 or 4 CKD. Given Nicoya’s
expertise and established network, we are confident this
collaboration will provide an effective strategy for RAYALDEE to
penetrate this significant and growing market.”
“We recognize the unique value RAYALDEE can
bring to CKD patients and want to work together with OPKO to bring
this innovative solution to patients in Greater China with unmet
medical need related to their kidney health. The OPKO portfolio and
strategic focus is fully aligned with Nicoya’s vision to become the
leading nephrology platform company in Greater China. We are truly
excited about this opportunity,” said Gan Ding, CEO of Nicoya
Therapeutics.
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, approved to treat SHPT in adults
with stage 3 or 4 CKD and vitamin D insufficiency, was launched in
the U.S. in November 2016.
About Nicoya Therapeutics
Nicoya Therapeutics group is a renal-focused
biopharma company based in China. Led by a market-leading
management team, Nicoya has capabilities spanning from research and
development to clinical trial execution to marketing and sales of
in-licensed and wholly owned products. Nicoya Therapeutics is
incubated by 6 Dimensions Capital and its successor fund 120
Capital, a group of cross-border leading investment funds in the
healthcare industry. Other co-investors in Nicoya include Mubadala
Investment Company and Beijing Guokonghuayao Investment. Among 6
Dimensions Capital’s incubated platform companies in China are
Innovent (HKEX:1801), CStone Pharmaceuticals (HKEX: 2616),
Ocumension (HKEX:1477, The leading China ophthalmology platform)
and Cutia Therapeutics (China’s leading dermatology platform).
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
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 statements regarding
product development efforts as well as other non-historical
statements about our expectations, products, beliefs or intentions
regarding our business, financial condition, strategies or
prospects including statements regarding expectations about
RAYALDEE and the success of the collaboration and licensing
agreement with Nicoya, whether Nicoya will successfully develop,
obtain regulatory approval for, launch or commercialize RAYALDEE in
China, Hong Kong, Macau and Taiwan whether the parties will
successfully develop RAYALDEE for the treatment of SHPT in dialysis
patients, whether we will be successful in accelerating adoption of
RAYALDEE in China, Hong Kong, Macau and Taiwan whether payment
milestones and royalty obligations will ever be triggered, and the
expected market 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
under the heading “Risk Factors” in our other filings with the
Securities and Exchange Commission as well as risks inherent in
funding, developing and obtaining regulatory approvals of new,
commercially-viable products and treatments, including the risks
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 D2, 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.
Contacts:
LHA Investor RelationsYvonne
Briggs, 310-691-7100ybriggs@lhai.com orBruce Voss, 310-691-7100
bvoss@lhai.com
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