Post by dnr08 on Jun 21, 2021 12:05:28 GMT
OPKO Health to Develop and Commercialize RAYALDEE® in Greater China with
Nicoya Therapeutics
MIAMI, June 21, 2021 (GLOBE NEWSWIRE) -- 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 D[3]. 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.
Nicoya Therapeutics
MIAMI, June 21, 2021 (GLOBE NEWSWIRE) -- 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 D[3]. 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.