Helsinn Announces That Phase 2/3 Pivotal Trials for NEPA (netupitant 300 mg + oral palonosetron 0.50 mg), Will be Published in

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

  PR Newswire

  LUGANO, Switzerland, 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-naïve 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 ≥4 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 NK [1] receptor
antagonist, netupitant, and a 5-HT [3] 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
 
Press spacebar to pause and continue. Press esc to stop.