LeaderMed, OPKO to Develop Treatments in Asia

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Two pharmaceutical companies, LeaderMed Health Group and OPKO Health, are teaming up to develop, manufacture, and commercialize two experimental medications in China and other locations in Asia.

One of the investigational medicines, Factor VIIa-CTP, is being developed as a potential treatment for hemophilia.

“Through this joint venture, we have an opportunity to extend the global availability of two of our novel long-acting development products and to establish a presence in China in partnership with collaborators who have significant experience and deep knowledge of the Asian biopharmaceutical opportunity,” Phillip Frost, MD, chairman and CEO of OPKO, said in a press release.

Factor VIIa-CTP, originally developed by OPKO, is a recombinant (lab-made) version of a clotting protein, called factor VIIa, that has been chemically modified so it lasts longer in the bloodstream.

The specific chemical modification is based off of a peptide — a short chain of amino acids, which are the building blocks of proteins — called C-terminal peptide, or CTP. The CTP technology used in this therapy is similar to that used in another of OPKO’s products, somatrogon, which is up for approval as a treatment for growth hormone deficiency in the U.S., Europe, and Japan.

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In the U.S. and Europe, Factor VIIa-CTP has been given orphan drug designation. LeaderMed is planning to pursue fast regulatory approval for Factor VIIa-CTP in China through a special national rare disease pathway, which was made possible by hemophilia’s designation as a rare disease in the country in 2018.

Under the terms of the new agreement, OPKO will own 47% of the joint venture between the two companies, while LeaderMed will own the remaining 53%. LeaderMed will be responsible for funding the joint venture, including providing an initial $11 million investment. In turn, OPKO will grant the venture rights to develop, manufacture, and commercialize Factor VIIa-CTP in Greater China and eight other Asian territories. OPKO will retain the therapy’s full rights elsewhere.

In addition to Factor VIIa-CTP, the joint venture also is developing another of OPKO’s products, called OPK88003, a molecule similar to a hormone called oxyntomodulin that is made in the colon and helps to regulate appetite and metabolism. OPK88003 is being developed as a potential treatment for type 2 diabetes and obesity.

“We are excited about the opportunity to expeditiously deliver a novel and superior treatment for obesity and diabetes to hundreds of millions of patients in China and Asia, as well as a treatment for hemophilia, an orphan indication,” said Joanne Jiang, PhD, CEO of LeaderMed Group.