Lotte Biologics, Rakuten Medical sign deal on producing new cancer treatment drug

Lotte Biologics signed a contract manufacturing organization (CMO) agreement with Rakuten Medical on Tuesday to produce and commercialize Rakuten’s photoimmunotherapy (PIT) drug, an antibody-dye conjugate used in the treatment of cancer.

From left, Rakuten Medical's Chief Operating Officer Abhijit Bhatia, President Minami Maeda, Lotte Biologics co-CEOs James Park and Shin Yoo-yeol pose for a commemorative photo after a signing ceremony to produce and commercialize Rakuten's drug pipeline at San Francisco on Jan. 12. [LOTTE BIOLOGICS]

Lotte Biologics said on Tuesday it had signed a contract manufacturing organization (CMO) agreement with Rakuten Medical to produce and commercialize Rakuten’s photoimmunotherapy (PIT) drug, an antibody-dye conjugate used in the treatment of head and neck cancer.

The investigational drug, which is marketed under the brand Akalux in Japan, has been approved for commercial use in Japan under the country’s conditional early approval system and has been used commercially. It is currently undergoing Phase 3 clinical trials in multiple countries, including the United States and Taiwan, with additional clinical studies to begin in Ukraine and Poland.

PIT modality is a new type of cancer treatment that combines a cancer-targeting antibody with a light-activated compound. After the drug binds to tumor cells, red light is applied to the tumor area, activating the drug and selectively destroying cancer cells while minimizing damage to the surrounding healthy tissue.

The deal was signed in San Francisco, where the 44th J.P. Morgan Health Care Conference is being held until Thursday. The size of the deal was undisclosed.

Lotte Biologics will produce the treatment drug through its Syracuse plant in New York.

Lotte Biologics is managing dual supply chains across the United States and Korea. In addition to the Syracuse facility for production, the company is building a new manufacturing facility at its Songdo Bio Campus in Incheon, scheduled for completion in August this year.

Executives from both companies attended the signing on Monday, including Lotte Biologics co-CEOs Shin Yoo-yeol and James Park, along with Rakuten Medical President Minami Maeda and Chief Operating Officer Abhijit Bhatia.

BY LEE JAE-LIM [lee.jaelim@joongang.co.kr]