Athenex, the U.S. partner that aimed to commercialize Hanmi Pharm’s anticancer drug Oraxol, has recently initiated the asset-selling procedure subsequent to its filing for bankruptcy.

According to industry watchers, Athenex recently filed for voluntary bankruptcy protection in the U.S. Bankruptcy Court in the Southern District of Texas.

It has reached an agreement with its lenders to expedite the sale of the company's assets.

Oraxol is an oral dosage form of the widely used intravenous administered tubulin-stabilizing chemotherapeutic agent paclitaxel that applied Hanmi's Labscovery technology. Hanmi Pharm licensed it out to Athenex in 2011.

It received orphan drug designation from the U.S. Food and Drug Administration (FDA) in 2018 for angiosarcoma and from the European Medicines Agency (EMA) in 2019 for soft tissue sarcoma.

Athenex applied to the FDA for marketing authorization of Oraxol for the treatment of metastatic breast cancer in 2021.

However, Athenex faced a setback as the FDA issued a complete response letter (CRL).

In the CRL, the FDA indicated its concern about patients' safety risk regarding an increase in neutropenia-related sequelae in the oral paclitaxel group compared with the IV paclitaxel group.

The U.S. regulator also expressed worries regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR).

The FDA stated that the BICR reconciliation and re-read process might have introduced unmeasured bias and influence on the BICR.

Accordingly, the FDA advised Athenex to conduct appropriate new clinical trials in patients with metastatic breast cancer in the U.S. to evaluate additional safety data and the need for additional strategies to improve safety, such as optimizing dosage.

"Unfortunately, our oral paclitaxel product candidate received a response letter from the U.S. FDA, which, coupled with the challenging economic environment, has put pressure on our ability to raise funds," Athenex CEO Johnson Lau said. "We have explored several options, but at this time, an asset sale is the best option."

As Athenex begins the process of selling its assets, industry watchers are closely watching if Athenex will also sell off rights to Oraxol.

Meanwhile, Hanmi was unavailable for immediate comments regarding the matter.