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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

July 10, 2014

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

SOURCE Helsinn Group


Source: PR Newswire



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