NeoPharm and Nippon Kayaku sign brain tumor agreement

According to terms of the agreement, NeoPharm received an initial up-front license fee of $2 million. Nippon Kayaku is responsible for all development costs in Japan. NeoPharm will receive an additional $2 million payment upon filing for approval of cintredekin besudotox (IL13-PE38QQR) in Japan, and a $4 million payment upon publication of cintredekin besudotox in the NHI pricing guide by the Japanese ministry of Health, Labor, and Welfare.

NeoPharm will also be entitled to receive royalty payments once commercial sales have commenced, as well as milestone payments tied to cumulative net sales levels post-launch.

“We are very pleased to sign this license agreement with Nippon Kayaku,” said Gregory Young, NeoPharm’s president and CEO. “Both NeoPharm and Nippon Kayaku have spent a great deal of time and energy to bring this deal to fruition. We expect Nippon Kayaku to be a great partner as we attempt to bring the potential benefits of cintredekin besudotox to patients in Japan suffering from glioblastoma multiforme (GBM).”

Cintredekin besudotox is a recombinant protein consisting of a single molecule composed of two parts: a tumor-targeting molecule (interleukin-13) and a cytotoxic agent (Pseudomonas Exotoxin, or PE). IL13-PE38QQR has received orphan drug designation in Europe and the US, and fast track drug development program status from the FDA.

NeoPharm’s IL13-PE38QQR development program was also selected to participate in the FDA continuous marketing application (CMA) Pilot 2 program. Currently, IL13-PE38QQR is being tested in an ongoing phase III clinical trial in patients with first recurrent GBM.