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Switzerland-based Curatis Holding AG and Neupharma, a Japanese pharmaceutical company specialising in oncology, immunology, pulmonology and cardiology disorders, have announced an exclusive license and development agreement for corticorelin (C-PTBE-01) in Japan.
Under the terms of the agreement, Neupharma will receive exclusive rights to develop and commercialise corticorelin for the treatment of peritumoral brain edema (PTBE) in Japan. PTBE is a tumour-associated condition for which no approved targeted therapies currently exist.
Neupharma will finance and conduct a pivotal clinical trial in Japan to support filing for approval in Japan. Curatis will receive upfront and milestone payments for the achievement of regulatory and commercial targets totaling up to CHF 83.5 million, as well as royalties on future sales in Japan of up to 20%.
The agreement stipulates that corticorelin is planned to be introduced in Japan initially for children and adolescents. A meeting with the Japanese drug regulatory authority PMDA to discuss the registration enabling study is planned for summer 2026, and the clinical study is expected to start in 2027.
At the same time, preparatory work for the pivotal Phase 3 study for approval in the US and Europe as well as global partnering activities are proceeding as planned.
Curatis’ lead product candidate, C-PTBE-01 (corticorelin), is being developed to treat peritumoral brain edema (PTBE). PTBE occurs in association with many primary and metastatic (secondary) brain tumors, often in connection with metastases caused by lung cancer, breast cancer, melanoma and colorectal cancer. PTBE results in impairment of brain function due to the accumulation of extracellular fluid around the tumuor.
