WOODCLIFF LAKE, New Jersey, and LUGANO, Switzerland, June 26, 2014 /PRNewswire/ --
Eisai Inc. and Helsinn Group announced today that several abstracts highlighting data analyses of NEPA, an investigational oral fixed-dose combination of netupitant and palonosetron being evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV), will be presented at the International Symposium on Supportive Care in Cancer. The Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) will host this year's Symposium in Miami, Florida.
"There is a need to study a new option for chemotherapy-induced nausea and vomiting prevention, despite the progress that has been made thus far," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc. "Further exemplifying our human health care mission, Eisai is committed to the continued study of NEPA in order to better understand its potential benefit for patients who experience these common side effects of chemotherapy."
Riccardo Braglia, Helsinn's Group Chief Executive Officer, commented: "Chemotherapy-induced nausea and vomiting is one of the most common side effects following cancer treatments. Helsinn is committed to addressing these symptoms and looks forward to presenting, alongside Eisai, the latest clinical data on NEPA."
In addition to the NEPA abstracts, three abstracts from Eisai's Health Economics and Outcomes Research group will also be presented, for a total of seven oral presentations and one poster presentation.
The following abstracts have been accepted for presentation at this year's MASCC/ISOO Symposium:
Abstract Name/Description Session NEPA Abstracts Multiple Cycle CINV Control and Safety of NEPA, a Capsule PL03 Plenary Session Containing Netupitant and Palonosetron Administered Once M. Aapro per Cycle of Moderately Emetogenic Chemotherapy (MEC) The aim of this prospective analysis was to assess maintenance of efficacy and safety across continued cycles in this randomized, double-blind Phase 3 study of NEPA versus oral palonosetron in chemotherapy-naïve patients receiving multiple cycles of anthracycline-cyclophosphamide. NEPA, a Fixed-Dose Antiemetic Combination of Netupitant PS03 Parallel Session and Palonosetron: Results of Effectiveness in 407 Patients P. J. Hesketh Receiving Cisplatin Plus Chemotherapy of Various Emetic Risk This retrospective study analyzed results of a completed, double-blind NEPA study to determine if emetic prevention differed by the chemotherapy added to cisplatin. Do NK1 Receptor Antagonists (RA) Contribute to Nausea PS03 Parallel Session Control? Evaluation of the Novel NEPA Fixed-Dose L. Schwartzberg Combination of NK1 RA + 5-HT3 RA from Pivotal Trials This pooled analysis evaluated patients from two randomized, multinational studies to evaluate nausea control in patients receiving NEPA plus dexamethasone compared with single-agent oral palonosetron plus dexamethasone. Is the Addition of an NK1 Receptor Antagonist Beneficial PS03 Parallel Session in Patients Receiving Carboplatin? Supplementary Data with K. Jordan NEPA, a Fixed-Dose Combination of Netupitant and Palonosetron This post-hoc analysis from a prospective Phase 3 trial evaluated the effectiveness of a single oral dose of NEPA plus dexamethasone in chemotherapy-naïve patients receiving repeated carboplatin cycles. Safety of NEPA, an Oral Fixed-Dose Combination of PO18 Poster Session Netupitant and Palonosetron: Pooled Data from the Phase Poster Number: 142 2/3 Clinical Program M. Aapro This pooled analysis evaluated adverse event data for 3,280 patients who participated in four randomized, double-blind, multinational NEPA clinical trials. Eisai Oncology Health Economics and Outcomes Abstracts Comparing the Incidence of Chemotherapy Induced Nausea and PS03 Parallel Session Vomiting Following 5HT3RA and NK1 Antiemetic Prophylaxis R. Knoth This retrospective cohort analysis compared the incidence of CINV in patients undergoing chemotherapy and treated prophylactically with either intravenous (IV) palonosetron alone or other 5HT3RAs in combination with an IV or oral neurokinin 1 receptor antagonist (NK1). Comparing the Cost of Chemotherapy Induced Nausea and PS07 Parallel Session Vomiting Following 5HT3RA and NK1 Antiemetic Prophylaxis R. Knoth This study compared CINV-related costs in patients undergoing chemotherapy and treated prophylactically with either IV palonosetron alone vs. other 5HT3RAs in combination with an IV or oral neurokinin 1 receptor antagonist (NK1). Resource Utilization and Costs Associated with Nausea in PS07 Parallel Session Patients Experiencing Chemotherapy-Induced Nausea and C. Faria Vomiting The goal of this retrospective analysis of insurance claims from 2005-2011 was to evaluate the implications of nausea alone on resource utilization and costs.
The information discussed in this release presents an investigational agent that is not Food and Drug Administration (FDA)-approved. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that this investigational agent will successfully gain FDA approval.
About Netupitant 300 mg + Palonosetron 0.50 mg (NEPA)
NEPA is an investigational oral, fixed-dose combination of a NK1 receptor antagonist, netupitant, and a 5-HT3 receptor antagonist, palonosetron, believed to target two critical signaling pathways associated with chemotherapy-induced nausea and vomiting (CINV).
On December 9, 2013, the U.S. Food and Drug Administration (FDA) accepted for review the submission of Helsinn's New Drug Application (NDA) for NEPA. Acceptance of the NDA indicates that the FDA has found the submission to be sufficiently complete to review.
On January 22, 2014, the European Medicines Agency (EMA) accepted for review the submission of Helsinn's Marketing Authorisation Application for the prevention of acute and delayed CINV. Acceptance of the MAA indicates that the EMA has found the submission to be valid for review.
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. subsidiary of Helsinn.
About the Helsinn Group
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a Representative Office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.
Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn's products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at http://www.helsinn.com.
About Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that may make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to help increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, vaccines, and biologic agents across various types of cancer. For more information about Eisai, please visit http://www.eisai.com/US.
About Eisai Inc.
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., we have a passionate commitment to patient care that 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.
1. Roscoe JA, Morrow GR, Hickok JT, Stern RM. Nausea and vomiting remain a significant clinical problem: Trends over time in controlling chemotherapy-induced nausea and vomiting in 1413 patients treated in community clinical practices. J Pain and Symptom Management. 2000;20(2):113-121.
2. Aapro M et al. Multiple cycle CINV control and safety of NEPA, a capsule containing netupitant and palonosetron administered once per cycle of moderately emetogenic chemotherapy (MEC). MASCC/ISOO 2014 Abstract. June 2014.
3. Hesketh PJ et al. NEPA, a fixed-dose antiemetic combination of netupitant and palonosetron: Results of effectiveness in 407 patients receiving cisplatin plus chemotherapy of various emetic risk. MASCC/ISOO 2014 Abstract. June 2014.
4. Schwartzberg L et al. Do NK1 receptor antagonists (RA) contribute to nausea control? Evaluation of the novel NEPA fixed-dose combination of NK1 RA + 5-HT3 RA from pivotal trials. MASCC/ISOO 2014 Abstract. June 2014.
5. Jordan K et al. Is the addition of an NK1 receptor antagonist beneficial in patients receiving carboplatin? Supplementary data with NEPA, a fixed-dose combination of netupitant and palonosetron. MASCC/ISOO 2014 Abstract. June 2014.
6. Aapro M et al. Safety of NEPA, an oral fixed-dose combination of netupitant and palonosetron: Pooled data from the Phase 2/3 clinical program. MASCC/ISOO 2014 Abstract. June 2014.
7. Faria C et al. Resource utilization and costs associated with nausea in patients experiencing chemotherapy induced nausea and vomiting. MASCC/ISOO 2014 Abstract. June 2014.
8. Gralla R et al. A Phase 3 study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy. Annals of Oncology. Accessed March 24, 2014: http://annonc.oxfordjournals.org/content/early/2014/03/14/annonc.mdu096.full.pdf+html.
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