EISAI ENTERS INTO U.S. LICENSE AGREEMENT WITH HELSINN HEALTHCARE S.A. FOR NEW COMBINATION ANTIEMETIC AGENT
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that U.S. subsidiary Eisai Inc. has signed a license agreement with Helsinn Healthcare S.A. (Headquarters: Lugano, Switzerland, CEO: Riccardo Braglia) for the commercialization of 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 combination antiemetic agent (in both oral and intravenous forms) containing netupitant (generic name), a neurokinin-1 (NK1) receptor antagonist, and palonosetron (generic name, brand name: Aloxi®), a serotonin-3 (5-HT3) receptor antagonist.
Under the terms of the agreement, Helsinn Healthcare S.A. will be responsible for conducting clinical trials, obtaining regulatory approvals, and holding the New Drug Application in the United States. If approved, the new products will be co-promoted by Eisai Inc. and Helsinn Therapeutics (U.S.) Inc. Additionally, Helsinns manufacturing affiliate in Ireland, Helsinn Birex Pharmaceuticals Ltd., will be responsible for the manufacture and supply of finished products for clinical and commercial use in the United States. Eisai Inc. will book sales of the products in the United States.
Helsinn Healthcare SA is entering Phase III clinical trials of the oral product as a potential therapy for the prevention of acute and delayed nausea and vomiting associated with the use of highly or moderately emetogenic chemotherapeutic agents.
Currently, Eisai Inc. has exclusive North American distribution and marketing rights from Helsinn Healthcare S.A. for Aloxi® (generic name: palonosetron hydrochloride) injection 0.25mg, an antiemetic agent indicated for the prevention of chemotherapy-induced nausea and vomiting. The expanded relationship with Helsinn will help Eisai strengthen its presence in the area of anti-emesis therapy in the Unites States.
Eisai defines oncology as a therapeutic area of focus and is committed to the development of new anticancer agents and treatments for supportive care. Through these efforts, Eisai will make further contributions to addressing the diversified needs of and increasing the benefits to patients and their families as well as healthcare professionals.
[Please refer to the following notes for further information on Helsinn Healthcare SA]
Public Relations Department,
Eisai Co., Ltd.
< Notes to editors >
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and subsidiaries in Ireland and the United States. Helsinns business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early to late stage new chemical entities, completes their development from the performance of pre-clinical/clinical studies and Chemistry, Manufacturing and Control (CMC), development to the filing for and attainment of their market approval worldwide. Helsinns products are sold directly through the Groups subsidiaries or out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice. The active pharmaceutical ingredients and the finished dosage forms are manufactured at Helsinns cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers.
For more information about the Helsinn Group, please visit the website: www.helsinn.com