The Helsinn Group of Switzerland and Taiho Pharmaceutical Co., Ltd., Japanese licensee of Helsinn’s second-generation 5-HT3 receptor antagonist palonosetron, announced it has signed a new licensing agreement. It grants Taiho development and commercialization rights in Japan for a new product which may prevent chemotherapy-induced nausea and vomiting (CINV). The arrangement 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.
The agreement specifies that Helsinn will be responsible for the CMC development. Helsinn’s chemical plant in Switzerland will provide both APIs, and will manufacture the product in the group’s plant in Ireland. Helsinn will also be responsible to supply the product for clinical and commercial use in Japan.
And in strict collaboration with Helsinn, Taiho will be responsible for conducting preclinical and clinical development, for obtaining regulatory approvals in Japan, and holding the New Drug Application on the basis of studies already performed by — and in collaboration with — Helsinn.
The CEO of Helsinn group, Mr Riccardo Braglia, said: “We are very proud of the existing successful collaboration with Taiho Pharmaceutical in Japan. At the beginning of last year our Japanese partner launched palonosetron on the national market and, within less than one year, our drug became the market leader in its class. Now our collaboration is extending to the netupitant-palonosetron fixed dose combination and we are sure that the success will reiterate.”
“We are delighted to extend our relationship with Helsinn with this license agreement in addition to our strong collaboration with palonosetron.” Mr Toru Usami, President and Representative Director of Taiho Pharmaceutical Co., Ltd. Said, “with netupitant – palonosetron fixed dose combination product, we hope to further contribute in the area of supportive care in oncology.”
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