Helsinn Group and Eisai Inc. announced today that the FDA
has agreed to the safety and efficacy protocols for Phase III trials with an
investigational oral fixed-dose combination of netupitant and palonosetron in
the prevention of chemotherapy-induced nausea and vomiting (CINV).
Netupitant, a highly selective NK1 receptor antagonist, is
thought to work by blocking the action of substance P, an endogenous neurotransmitter
contained in high concentrations in the vomiting center of the brainstem that
can stimulate the vomiting reflex.
Palonosetron is a serotonin-3 (5-HT3) receptor antagonist.
The 5-HT3 receptor has been demonstrated to selectively participate in the emetic
response.
Riccardo Braglia, CEO of Helsinn Group, said: "We are
very excited that the netupitant-palonosetron FDC is entering Phase III, as
this is an important milestone towards our goal of giving cancer patients additional
options for the prevention of CINV in the future." Recently Helsinn signed
a licensing agreement with Eisai Inc., granting the company rights for the new
FDC product in the United States.
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 Inc., the U.S.
franchise of the Swiss group, established with the
acquisition of Sapphire Therapeutics Inc. in 2009.
Lonnel Coats, President and CEO of Eisai Inc., said:
"We are pleased that the FDA has agreed to the Special Protocol
Assessment, and look forward to the possibility of further expanding our
oncology portfolio in an effort to make a difference in patients' lives."