Helsinn Group and Eisai Inc. announced today that Helsinn has commenced a multi-centered Phase III clinical study program investigating the Netupitant/Palonosetron (300mg/0.50mg) oral fixed-dose combination for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The Phase III program, reviewed by the FDA and EMA, consists of three studies which are expected to enroll 2,600 oncology patients receiving highly or moderately emetogenic chemotherapy in approximately 250 study sites in 18 countries.
"The commencement of this Phase III program is an important milestone in the development of this investigational compound, our commitment of giving cancer patients additional options for the prevention of CINV and for providing supportive care therapies for patients in their fight against cancer," said Dr. Riccardo Braglia, Chief Executive Officer of Helsinn Group.
Helsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for the fixed-dose combination product in the United States (if approved). Under the terms of the agreement, Helsinn 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). If approved by the FDA, the fixed-dose combination product will be co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. company of the Swiss group.
Lonnel Coats, President and CEO of Eisai Inc., said: "We are pleased that the Phase III clinical program is underway and look forward to the possibility that, if approved, this investigational compound may one day bring benefit to patients who experience CINV."
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