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News Release

FOR IMMEDIATE RELEASE
May 3, 2017

PATENT INFRINGEMENT LITIGATION FOR ANTIEMETIC AGENT ALOXI® IN THE UNITED STATES

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) has announced today that a panel of the United States Court of Appeals for the Federal Circuit, in the patent infringement lawsuit for antiemetic agent ALOXI® (palonosetron hydrochloride) injection brought by Helsinn Healthcare S.A. (Headquarters: Lugano, Switzerland, CEO: Riccardo Braglia, “Helsinn”) together with Roche Palo Alto LLC (Roche) against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (collectively “Teva”) in the United States, reversed the opinion of the District Court for the District of New Jersey and ruled that certain patent claims covering ALOXI are not valid and are not infringed by Teva's generic palonosetron product.

Teva will not be able to launch a generic version of ALOXI until additional steps are taken by the Federal Circuit, the New Jersey Court and the Food & Drug Administration (“FDA”) allowing such a launch. This process may take several months, and potentially longer if the Federal Circuit were to grant a petition for rehearing.

Helsinn Group and Eisai are disappointed with the court's ruling. Protecting intellectual property is vital to a company's ability to continue developing medicines that will make a difference in the lives of patients. Helsinn and Eisai maintain their position that the patents protecting ALOXI are valid and will pursue further legal options to protect and enforce such patents.


Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

< Notes to editors >

1.  About the Helsinn Group

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 United States 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/

2.  About Eisai and the Helsinn Group

Eisai Inc. gained exclusive marketing rights to ALOXI in the United States and Canada from Helsinn Healthcare S.A. through its acquisition of MGI Pharma, Inc. in 2008. Under the terms of the agreement, Helsinn Healthcare 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). ALOXI is co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., while sales of the product in the United States are booked by Eisai Inc.