April 26, 2024

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[THE INVESTOR] Hanmi Pharmaceuticals said on Oct. 30 that its partner Athenex will initiate clinical trials next year on an oncology drug candidate that has utilized its platform.

The New York-based biopharma firm received approval for an Investigational New Drug application from the US Food and Drug Administration for phase 1 clinical trials of its oral version of Eribulin currently named Eribulin ORA, planned for the first half of 2019. 

Eribulin is a treatment for metastatic breast cancer and liposarcoma, marketed by Eisai under the trade name Halaven in intravenous form. It generated around US$360 million in sales last year.

The Orascovery platform, which Hanmi licensed out to Athenex in 2011, was the technology behind the change in formulation from intravenous to oral.

Through the license deal worth over US$34 million, Athenex secured overseas rights in all major markets except Korea. Hanmi declined to comment if it will receive milestone fees from the US partner for clearing the first drug review process, citing confidentiality reasons.

“Utilizing Athenex’s proprietary Orascovery platform with Eribulin, we were able to demonstrate that good oral absorption of Eribulin is possible, based on preclinical studies,” the US firm said in a statement.

The company added that the Eribulin active pharmaceutical ingredient has been developed internally using a novel synthetic approach.

“We believe these developments demonstrate the broad utility of the Orascovery platform and commitment of Athenex to become a major global oncology biopharma company.”

The lead compound in Athenex’s Orascovery program is Oraxol, oral form of paclitaxel used as treatment for breast, lung and ovarian cancer. Oraxol is currently in pivotal Phase 3 study.

By Park Han-na (hnpark@heraldcorp.com)