Helsinn Group And Eisai Announce FDA Acceptance Of New Drug Application For
Investigational Compound Netupitant 300 mg + Palonosetron 0.50 mg (NEPA)
Seeking indication for prevention of chemotherapy-induced nausea and vomiting
LUGANO, Switzerland and WOODCLIFF LAKE, N.J., Dec. 9, 2013
LUGANO, Switzerland and WOODCLIFF LAKE, N.J., Dec.9, 2013 /PRNewswire/
--Helsinn Group and Eisai Inc. today announced that the U.S. Food and Drug
Administration (FDA) accepted for review the submission of the New Drug
Application (NDA) for the investigational oral fixed-dose combination capsule
of netupitant 300 mg + palonosetron 0.50 mg (NEPA) for prevention of acute and
delayed chemotherapy-induced nausea and vomiting (CINV) following both highly
and moderately emetogenic chemotherapy.
Acceptance of the NDA indicates that the FDA has found the submission to be
sufficiently complete to review. Helsinn's NDA is supported by data from
pivotal studies evaluating the efficacy and safety of NEPA for the prevention
of CINV following both highly and moderately emetogenic chemotherapy.
About Netupitant 300 mg + Palonosetron 0.50 mg (NEPA)
NEPA is an investigational single-day, fixed-dose combination of a selective
NK[1 ]receptor antagonist, netupitant, and a 5-HT receptor antagonist,
palonosetron, designed to target two critical pathways thought to be
associated with chemotherapy-induced nausea and vomiting (CINV).
About Chemotherapy-induced Nausea and Vomiting (CINV)
Chemotherapy-induced nausea and vomiting is among the most common side effects
following therapy in patients with cancer. Despite prophylaxis given on the
day of chemotherapy, up to 30-45 percent of patients experience nausea or
vomiting or require rescue therapy following administration of certain types
of emetogenic chemotherapy. 5-HT receptors are located on the nerve
terminals of the vagus in the periphery and centrally in the chemoreceptor
trigger zone of the area postrema. It is thought that chemotherapeutic agents
produce nausea and vomiting by releasing serotonin from the enterochromaffin
cells of the small intestine and that the released serotonin then activates
5-HT[3 ]receptors located on vagal afferents to initiate the vomiting reflex.
About Helsinn and Eisai
Helsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial
rights for NEPA 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, NEPA 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.
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 a
representative office in 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 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 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
Helsinn Healthcare SA Eisai Inc.
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