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Helsinn Announces That Phase 2/3 Pivotal Trials For NEPA (Netupitant 300 Mg + Oral Palonosetron 0.50 Mg), Will Be Published In The Annals Of Oncology


7/10/2014 9:52:09 AM

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LUGANO, Switzerland, Jul 10, 2014 (PR Newswire Europe via COMTEX) -- LUGANO, Switzerland, July 10, 2014 /PRNewswire/ --

Helsinn Group, the company focused on building quality cancer care, today announces that the complete results of the three Phase 2/3 pivotal trials for the investigational oral fixed-dose combination capsule of netupitant 300 mg + oral palonosetron 0.50 mg (NEPA), which is licensed to Eisai Inc. in the United States, have been published, together with an accompanying editorial, in the July issue of Annals of Oncology.

The first study (Hesketh, et al) was a pivotal, Phase 2, randomized, double-blind, dose-ranging study in 694 patients undergoing cisplatin-based, highly emetogenic chemotherapy. Three different doses of oral netupitant (100, 200 and 300 mg) in combination with oral palonosetron (0.50 mg) plus dexamethasone were compared with oral palonosetron (0.50 mg) plus dexamethasone. All NEPA doses showed significantly higher overall (0-120 hour) complete response rates (no emesis, no rescue medication), the primary endpoint, compared with oral palonosetron, with the highest NEPA (300 mg) dose studied showing an incremental benefit over lower NEPA doses for all efficacy endpoints. On the basis of these results, this dose combination was selected for continued development.

The second study (Aapro, et al) was a multinational, randomized, double-blind, parallel-group Phase 3 study in 1455 chemotherapy-naive patients receiving anthracycline-cyclophosphamide moderately emetogenic chemotherapy. Patients were randomized to receive either oral NEPA plus dexamethasone or oral palonosetron plus dexamethasone, all administered only on Day 1 prior to chemotherapy. The percentage of patients who met the primary endpoint of complete response in the delayed (25-120 hours) phase was significantly higher in the NEPA group compared with the oral palonosetron group, which was also seen in the acute (0-24 hours) and overall (0-120 hours) phases post chemotherapy.

The third multinational, double-blind, Phase 3 study (Gralla, et al) in 413 patients was designed primarily to demonstrate the safety of NEPA over multiple cycles of either highly (24% of patients) or moderately emetogenic chemotherapy (76% of patients). Patients were randomly assigned (at a 3:1 ratio) to receive NEPA plus dexamethasone or aprepitant plus oral palonosetron and dexamethasone. Patients completed 1961 total chemotherapy cycles with 75% of patients completing greater than or equal to4 cycles. The adverse event profile was consistent with that expected for patients

undergoing cytotoxic chemotherapy, with the most frequently reported treatment-related events being headache and constipation.

As a strong advocate for adherence to evidence-based antiemetic guidelines such as those issued by the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO) and the Multinational Association of Supportive Care in Cancer (MASCC), Dr. Aapro suggested that this fixed-dose NEPA combination provides an opportunity to overcome some of the barriers interfering with guideline adherence and in doing so offers potential for improving prevention of CINV for patients. He added that these papers in Annals of Oncology have raised such interest that the authors were pleased to be invited to contribute to a "research highlight" summary which is in the July issue of Nature Reviews Clinical Oncology.

Helsinn's Chief Executive Officer, Riccardo Braglia, commented: "We are delighted to see that Phase II/III pivotal trials for NEPA, licensed to Eisai in the United States, will be published in the Annals of Oncology. The two efficacy studies met their primary end points showing that oral NEPA has significantly higher complete response rates compared with oral palonosetron, whilst the safety study confirmed the safety profile for NEPA. Overall, the studies suggest NEPA will be a useful addition for patients to prevent CINV. This underscores Helsinn's commitment to excellence in cancer supportive care."

About Netupitant 300 mg + Oral Palonosetron 0.50 mg (NEPA)

NEPA is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NEPA is an investigational single-day, oral, fixed-dose combination of a selective NK1 receptor antagonist, netupitant, and a 5-HT3 receptor antagonist, oral palonosetron, believed to target two critical signaling pathways associated with chemotherapy-induced nausea and vomiting (CINV).

About Helsinn and Eisai Inc.

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 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.

For more information, please contact:

Helsinn Group

Paola Bonvicini
Head of Communication & Press Office
Tel: +41-91-985-21-21
info-hhc@helsinn.com

For media/external inquiries

Consilium Strategic Communications
Mary-Jane Elliott / Jessica Hodgson / Matthew Neal / Melissa Jumbo
Tel: +44(0)203-709-5700
Helsinn@consilium-comms.com

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