U.S. FDA APPROVES ANTIEMETIC AGENT AKYNZEO® FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV)World’s First Oral Fixed Combination Targeting Two Critical Pathways Involved in CINV

AKYNZEO is a new oral fixed combination that targets two critical signaling pathways associated with CINV, by combining netupitant, an NK₁receptor antagonist, with palonosetron, a 5-HT₃receptor antagonist. Marketing authorization applications for AKYNZEO are currently being submitted in countries throughout the world. In January 2014, the European Medicines Agency began assessment of the marketing authorization application submitted by Helsinn Healthcare S.A. for a treatment combining netupitant and palonosetron for the prevention of acute and delayed nausea and vomiting associated with CINV. In addition, Eisai and Helsinn are currently developing an injectable formulation in order to further maximize the value of AKYNZEO to patients.

Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.

Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics U.S. Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers.

Further information on Helsinn Group is available at: www.helsinn.com/

Helsinn Healthcare S.A. signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for AKYNZEO in the U.S. Under the terms of the agreement, Helsinn Therapeutics S.A. is responsible for conducting all development activities (Chemistry and Manufacturing Controls [CMC]), preclinical and clinical), obtaining regulatory approvals and holding the New Drug Application (NDA). AKYNZEO will be co-promoted in the U.S. by Eisai Inc. and Helsinn Therapeutics U.S. Inc. Eisai Inc. will book sales of the product in the U.S.