Helsinn Healthcare S.A. and Eisai Inc. have announced the signing of a licensing agreement granting Eisai Inc. commercialization rights for a new product for potential use in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the United States. 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.
Under the terms of the agreement, Helsinn Healthcare S.A. will be responsible for conducting all development activities (CMC, preclinical and clinical), obtaining regulatory approvals, and holding the New Drug Application. If approved by the Food and Drug Administration, the fixed dose combination oral and IV products will be co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics (U.S.) Inc. Helsinn’s manufacturing affiliate in Ireland, Helsinn Birex Pharmaceuticals Ltd., will be responsible for the manufacture and supply of finished product for clinical and commercial use in the United States.
In addition, Helsinn Therapeutics (U.S.) Inc. has signed a Detail Service Agreement with Eisai Inc. to co-promote the existing brand Aloxi(R) (palonosetron hydrochloride) in the U.S. market. As a result, Helsinn Therapeutics (U.S.) Inc. will recruit and hire a dedicated sales force to visit primarily clinical oncologists in the United States.
Riccardo Braglia, CEO of Helsinn group, said: “We are very proud that the existing successful collaboration with Eisai Inc. in the U.S. for Aloxi(R) is now extending to a co-promotion of Aloxi(R) and, if approved, to Netupitant-Palonosetron FDC, and the strengths of our two companies will enable patients to have additional treatments for CINV now and in the future.”
“Eisai is committed to satisfying unmet medical needs and contributing to the health and well-being of people worldwide,” said Lonnel Coats, President and COO of Eisai Inc. “Our expanded relationship with Helsinn further demonstrates our focus on oncology and supportive care and will help to strengthen our presence in the area of anti-emesis therapy.”