Hanmi makes US partner an affiliate to step up advances in global markets

Hanmi Pharmaceutical said it has incorporated Spectrum, its U.S. partner, into an affiliate company ahead of commercializing its new drugs globally.

Hanmi invested about 24 billion won ($19.1 million) in Spectrum earlier this year to expand its stake in the latter to 8.6 percent. Although the stake did not meet the criteria for classification as an affiliate, the company classified its U.S. partner as an affiliate as Hanmi Pharmaceutical’s CEO, Lim Ju-hyun, joined Spectrum’s board of directors in March.

Under Korean regulations, even if an investment company has less than 20 percent of the voting rights of the target firm, it can incorporate the latter into an affiliate if it can exercise significant influence, such as participating in a decision-making body or providing essential technical information.

By incorporating Spectrum into an affiliate, the two companies plan to solidify their cooperation for commercializing two innovative anticancer drugs, Rolontis and Poziotinib, market watchers said.

The two drugs undergo a regulatory approval process by the .S. Food and Drug Administration (FDA).

Hanmi signed a technology transfer contract with Spectrum for Rolontis, a treatment for neutropenia that uses LAPSCOVERY based on the development of long-acting biologics, in 2012.

In March, spectrum recently submitted a biologics license application (BLA) for Rolontis after receiving a complete response letter (CRL) from the FDA last year. The FDA will inspect Hanmi’s Pyeongtaek Bio Plant, which produces raw materials for Rolontis, until September.

Spectrum also submitted a new drug approval (NDA) for Poziotinib for treating locally advanced and metastatic non-small cell lung cancer (NSCLC) patients with a HER2 Exon 20 insertion mutation in December.

“We and our new U.S. affiliate are working for a common goal of FDA approval and successful commercialization of Rolontis and Poziotinib,” a Hanmi official said. “Cooperation with Spectrum will be one of the key drivers of Hanmi’s growth.”