Helsinn Healthcare S.A. and Eisai Inc. 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 (US) 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 (US) Inc. has signed a Detail Service Agreement with Eisai Inc. to co-promote the existing brand Aloxi (palonosetron hydrochloride) in the US market. As a result, Helsinn Therapeutics (US) 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 US for Aloxi is now extending to a co-promotion of Aloxi 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."
Netupitant is a highly selective NK1 receptor antagonist, an antiemetic that works by blocking the action of Substance P, an endogenous neurotransmitter contained in high concentrations in the vomiting centre of the brainstem that can stimulate the vomiting reflex. The fixed-dose combination of netupitant and palonosetron is entering phase III for the prevention of acute and delayed nausea and vomiting following both highly and moderately emetogenic chemotherapy.
Aloxi is used in adults to help prevent nausea and vomiting on the day of chemotherapy that is highly likely to cause nausea and vomiting or up to five days following chemotherapy that is moderately likely to cause nausea and vomiting.
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland and USA. Helsinn's business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas.
Eisai Inc. was established in 1995 and is ranked among the top-20 US pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion.