Helsinn Group and Eisai Announce FDA Acceptance of NDA
Helsinn Group and Eisai Announce FDA Acceptance of New Drug Application for Investigational Compound Netupitant 300 mg + Palonosetron 0.50 mg (NEPA)
LUGANO, Switzerland and WOODCLIFF LAKE, New Jersey, December 9, 2013 /PRNewswire/ --
Seeking indication for prevention of chemotherapy-induced nausea and vomiting
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 NK1 receptor antagonist, netupitant, and a 5-HT3 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-HT3 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-HT3 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: 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 programs.
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
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Posted: December 2013