Helsinn Group and Eisai Inc. Announce Top-Line Results for Pivotal Studies of
the Investigational Fixed-Dose Combination of Netupitant and Palonosetron for
Prevention of Chemotherapy-Induced Nausea and Vomiting
LUGANO, Switzerland and WOODCLIFF LAKE, New Jersey, May 16, 2013
LUGANO, Switzerland and WOODCLIFF LAKE, New Jersey, May 16, 2013 /PRNewswire/
Data to Be Presented at Annual Meeting of the American Society of Clinical
Helsinn Group and Eisai Inc. announced today top-line results from Helsinn's
pivotal clinical studies investigating the oral fixed-dose combination of
netupitant and palonosetron (NEPA) being evaluated for the proposed indication
of prevention of chemotherapy-induced nausea and vomiting (CINV). These data
will be presented as poster discussions on June 1, 2013 at the annual meeting
of the American Society of Clinical Oncology.
About the Pivotal Phase III Study
The Phase III study of a single oral dose of NEPA (netupitant 300 mg +
palonosetron 0.50 mg) versus a single oral 0.50 mg dose of palonosetron (PALO)
being evaluated for the prevention of CINV following moderately emetogenic
chemotherapy (MEC) showed that NEPA was superior to palonosetron in preventing
NEPA showed superior complete response rates (defined as no emesis and no use
of rescue medication) compared with palonosetron during the delayed phase
after chemotherapy administration (25 to 120 h), which was the primary
endpoint of the study.
The most frequently reported study drug-related adverse events (AEs) for NEPA
included headache (3.3 percent) and constipation (2.1 percent). The type and
frequency of AEs were comparable between NEPA and PALO.
The global, randomized, double-blind, parallel group superiority study was
designed to assess the efficacy and safety of a single oral dose of NEPA
(netupitant 300 mg + palonosetron 0.50 mg) versus a single oral 0.50 mg dose
of PALO in 1455 chemotherapy-naïve patients receiving anthracycline-based
chemotherapy. All patients received oral dexamethasone on day 1. The primary
efficacy endpoint was complete response during the delayed phase.
About the Pivotal Phase II Study
The Phase II study, which was designed to determine the proper dose of
netupitant to combine with palonosetron, examined the efficacy of three
different doses of NEPA for the prevention of chemotherapy-induced nausea and
vomiting following highly emetogenic chemotherapy (HEC). The study showed that
each NEPA dose resulted in a superior complete response rate compared with
PALO during the overall phase (the primary endpoint of the study).
AEs were comparable across groups with no dose-response. The percentage of
patients developing electrocardiogram changes was comparable across groups.
The Phase II trial was a 694-patient randomized, double-blind, parallel group
study in chemotherapy-naïve patients undergoing cisplatin-based HEC. Four
study arms compared three different oral doses of NEPA (netupitant 100, 200,
300mg + palonosetron 0.50 mg) with oral PALO 0.50 mg, all given on day 1. All
patients received oral dexamethasone on days 1-4. The primary efficacy
endpoint was complete response during the overall phase.
About Netupitant-Palonosetron Fixed-Dose Combination (NEPA)
NEPA is an investigational single-day, fixed-dose combination of a highly
selective NK  receptor antagonist, netupitant, and a 5-HT  receptor
antagonist, palonosetron, believed to target two critical pathways associated
with chemotherapy induced nausea and vomiting (CINV).
The Phase III investigational program recently concluded and Helsinn plans to
submit a New Drug Application for NEPA to the U.S. Food and Drug
Administration (FDA) and a Marketing Authorisation Application to the European
Medicines Agency (EMA) for the proposed indication of prevention of acute and
delayed CINV following both highly and moderately emetogenic chemotherapy.
About ALOXI® (palonosetron hydrochloride) Capsules for Oral Administration
ALOXI ® (palonosetron hydrochloride) Capsules 0.5 mg for oral administration
is indicated for the prevention of acute nausea and vomiting associated with
initial and repeat courses of moderately emetogenic chemotherapy. One ALOXI ®
0.5 mg capsule is administered approximately one hour prior to the start of
Important Safety Information
ALOXI ® is contraindicated in patients known to have hypersensitivity to the
drug or any of its components. There were no adverse reactions that occurred
greater than or equal to 5 percent for the 0.5 mg oral dose. The most commonly
reported adverse reactions were headache (3.7 percent) and constipation (0.6
For more information about ALOXI® capsules see full prescribing information at
ALOXI® capsules are not currently marketed in the United States.
About Helsinn and Eisai
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 investigational
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
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano,
Switzerland, and operating subsidiaries in Ireland, the United States and
China. Helsinn's business model is focused on the licensing of
pharmaceuticals, medical devices and nutritional supplement products in
therapeutic niche areas. Helsinn is an important player in cancer supportive
care. Helsinn Group in-licenses early-to-late stage new chemical entities,
completes their development through the performance of pre-clinical /clinical
studies and Chemistry, Manufacturing, and Control (CMC) development, and files
and attains their market approvals worldwide. Helsinn's products are
out-licensed to its network of local marketing and commercial partners,
selected for their deep in-market knowledge and know-how whom Helsinn assists
and supports by providing a full range of product and scientific management
services, including commercial, regulatory, financial, legal, and medical
marketing advice. The active pharmaceutical ingredients and the finished
products are manufactured according to the highest quality, safety, and
environmental standards at Helsinn's GMP facilities in Switzerland and Ireland
and supplied worldwide to its customers.
Further information on Helsinn Group is available at http://www.helsinn.com .
At Eisai Inc., human health care is our goal. We give our first thoughts to
patients and their families, and helping to increase the benefits health care
provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co.,
Ltd., our passionate commitment to patient care is the driving force behind
our efforts to help address unmet medical needs. We are a fully integrated
pharmaceutical business with discovery, clinical, manufacturing and marketing
capabilities. Our key areas of commercial focus include oncology and specialty
care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more
about Eisai Inc., please visit us at http://www.eisai.com/US .
Eisai Inc. has affiliates that are part of a global product creation
organization that includes R&D facilities in Massachusetts, New Jersey, North
Carolina and Pennsylvania, as well as a global demand chain organization that
includes manufacturing facilities in Maryland and North Carolina. Eisai's
global areas of R&D focus include neuroscience; oncology; metabolic disorders;
vascular, inflammatory and immunological reaction; and antibody-based
Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care ( hhc ) company that
discovers, develops and markets products across the world through a global
network of research facilities, manufacturing sites and marketing
subsidiaries. For more information about Eisai's global operations, please
visit http://www.eisai.com .
Helsinn Healthcare SA Media Inquiries Paola Bonvicini +41-91-985-21-21
Eisai Inc. Media Inquiries Laurie Landau +1-201-746-2510
Investor Inquiries Alex Scott +1-201-746-2177 firstname.lastname@example.org
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