Helsinn and Taiho Pharma to extend relationship with CINV drug accord

Privately-held Swiss company Helsinn Group and Taiho Pharmaceutical, a subsidiary of Otsuka (4768: JP) and its Japanese licensee of Helsinn's second generation 5-HT3 receptor antagonist palonosetron, have signed a licensing agreement granting Taiho the development and commercialization rights for a new product for potential use in the prevention of chemotherapy-induced nausea and vomiting (CINV) in Japan.

The arrangement, financial terms of which were not disclosed, covers the development of a fixed-dose combination product (in both oral and IV forms) containing netupitant, a neurokinin-1 (NK1) receptor antagonist, and palonosetron, a serotonin-3 (5-HT3) receptor antagonist.

Under the terms of the deal, Helsinn will be responsible for the CMC development. Helsinn's chemical plant in Switzerland will provide both APIs and Helsinn will manufacture the product in the group's plant located in Ireland and will also be responsible for the supply of the product for clinical and commercial use in Japan. Taiho will be responsible, in strict collaboration with Helsinn, for conducting preclinical and clinical development and for obtaining regulatory approvals in Japan, and holding the New Drug Application, on the basis of studies already performed by Helsinn and in collaboration with Helsinn.