ºÚÁÏÍø

ºÚÁÏÍø., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “ºÚÁÏÍø”) announced today that its U.S. subsidiary ºÚÁÏÍø Inc. has agreed to revise the joint promotion agreement with Helsinn Healthcare S.A. (Headquarters: Lugano, Switzerland, Group Vice Chairman and CEO: Riccardo Braglia, “Helsinn”) for their chemotherapy-induced nausea and vomiting (CINV) franchise.

Under the new arrangement, from April 1, 2016, Helsinn Therapeutics Inc., the U.S. affiliate of Helsinn (“Helsinn U.S.”), will obtain exclusive rights to promote and sell AKYNZEO (netupitant/palonsetron), its oral fixed dose combination product for the prevention of CINV. AKYNZEO had previously been co-promoted in the United States by both Helsinn U.S. and ºÚÁÏÍø Inc. As part of the revised agreement, ºÚÁÏÍø and Helsinn U.S. will continue to co-promote ALOXI® (palonosetron HCl) injection in the United States for CINV.

Moving forward, ºÚÁÏÍø Inc. will focus on further contributing to patients with ALOXI through this revised joint promotion agreement with Helsinn U.S., along with ºÚÁÏÍø’s in-house anticancer agents Halaven® and Lenvima®.

AKYNZEO is a new oral fixed combination that targets two critical signaling pathways associated with CINV, by combining netupitant, an NK₁ receptor antagonist, with palonosetron, a 5-HT₃ receptor antagonist. Marketing authorization applications for AKYNZEO are currently being submitted in countries throughout the world.

Helsinn is a privately owned cancer supportive care pharmaceutical group with an extensive portfolio of marketed products and a broad development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality, through a unique integrated licensing business model working with long standing partners in pharmaceuticals, medical devices and nutritional supplement products. Helsinn is headquartered in Lugano, Switzerland, with operating subsidiaries in Ireland and the US, a representative office in China, as well as a product presence in about 90 countries globally.
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Helsinn Healthcare S.A. signed a licensing agreement with ºÚÁÏÍø Inc. granting ºÚÁÏÍø commercial rights for ALOXI® in the United States. 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). ALOXI is co-promoted in the United States by ºÚÁÏÍø Inc. and Helsinn Therapeutics U.S. Inc., and sales of the product are booked by ºÚÁÏÍø Inc.