SHANGHAI and MIAMI, September 14, 2021 (GLOBE NEWSWIRE) – LeaderMed Health Group Limited, an Asia-based pharmaceutical development company, and OPKO Health, Inc. (NASDAQ: OPK), a diversified diagnostic-focused healthcare company and Pharmaceuticals, announce the formation of a joint venture to develop, manufacture and market two of OPKO’s long-acting drugs clinically in Greater China and eight other Asian territories.
Under the terms of the agreements, OPKO will grant the joint venture the exclusive rights to develop, manufacture and market (a) OPK88003, an oxyntomodulin analogue under development for the treatment of obesity and diabetes, and (b) the factor VIIa-CTP, a new long-acting coagulation factor under development to treat hemophilia, in exchange for a 47% stake in the joint venture. In addition, OPKO will receive an upfront payment of $ 1 million and be reimbursed for the clinical trial equipment and technical support it provides to the joint venture.
LeaderMed will be responsible for financing the operations, development and marketing efforts of the joint venture and will initially invest, along with its union partners, $ 11 million in exchange for a 53% stake. OPKO retains all rights to oxyntomodulin and factor VIIa-CTP in all other geographic areas.
“Through this joint venture, we have the opportunity to expand the global availability of two of our new long-acting development products and establish a presence in China in partnership with collaborators who have significant experience and In-depth knowledge of the Asian biopharmaceutical opportunity, ”said Phillip Frost, MD, President and CEO of OPKO.
“LeaderMed Group is an innovative pharmaceutical development company with its own pipeline of licensed products. Our capabilities include an experienced management team with demonstrated success in bringing biopharmaceuticals and pharmaceuticals to market in China and globally, cGMP facilities to manufacture clinical grade products, and a corporate charter that recognizes and protects the intellectual property of clients. We are excited about the opportunity to rapidly provide innovative and superior treatment for obesity and diabetes to hundreds of millions of patients in China and Asia, as well as treatment for hemophilia, an orphan indication ”, added Dr. Joanne Jiang, Executive Director. Manager of the LeaderMed Group and architect of the joint venture.
Oxyntomodulin is a naturally occurring hormone produced in the colon that binds to GLP-1 and glucagon receptors, regulating both glycemic appetite and lipid metabolism. OPKO Health is developing OPK88003, a long-acting oxyntomodulin analogue, once weekly, for the treatment of type 2 diabetes and obesity. OPK88003 has been successfully studied in two phase 2 clinical trials in patients with type 2 diabetes, studying weight loss and reduction in glycosylated hemoglobin (HbA1c or A1c), a marker of sugar metabolism. Supported by the LeaderMed-OPKO joint venture, it is positioned to be the first dual target drug approved for diabetes and obesity in the Chinese and Asian markets.
About Factor VIIa-CTP
Factor VIIa-CTP is a novel long-acting recombinant factor VIIa using OPKO’s proprietary technology to extend its circulatory half-life without the use of polymers, encapsulation techniques or nanoparticles. The technology is based on a natural peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin. CTP technology is also used in OPKO’s hGH-CTP (somatrogon), a long-acting recombinant human growth hormone product that has successfully completed phase 3 clinical trials in children with deficiency. in growth hormone. hGH-CTP has been submitted for approval in the United States, Europe and Japan and is in partnership with Pfizer for global commercialization. Factor VIIa-CTP has achieved orphan drug designation in the United States and Europe.
In China, hemophilia was designated as a rare disease in 2018. LeaderMed plans to seek early regulatory approval for factor VIIa-CTP through a special national channel for rare diseases.
About the LeaderMed Group
The LeaderMed Group is a pharmaceutical development company with operations in Asia and a professional team in Greater China and Asia with extensive experience in new drug development and successful case stories.
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company seeking to establish industry leadership positions in large, rapidly growing markets by leveraging its expertise in discovery, development and commercialization and new and proprietary technologies. . For more information, visit www.opko.com.
Caution Regarding Forward-Looking Statements
This press release contains “forward-looking statements”, as defined by the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expect”, “plans”, “plans”, ” will ”,“ may ”,“ anticipates ”,“ believes ”,“ should ”,“ intention ”,“ believes ”and other words with the same 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 regarding the success of the collaboration and joint venture with LeaderMed, if the joint venture will develop successfully, obtain regulatory approval, launch or market either oxyntomodulin or factor VIIa-CTP, and the expected market for the products in Greater China e t in Asia. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in the 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 the risks inherent in funding, developing and obtaining regulatory approvals for new commercially viable products and treatments. In addition, forward-looking statements may also be affected by general market factors, competitive product development, product availability, federal and state regulations and laws, 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 assume no obligation to update any forward-looking statements. We intend that all forward-looking statements will be subject to the safe harbor provisions of the PSSRA.