Helsinn announces European Medicines Agency acceptance of regulatory submission for netupitant-palonosetron fixed dose combination (NEPA)

Lugano, Switzerland (ots) -

NEPA is currently under development for the treatment of
chemotherapy-induced nausea and vomiting

The Swiss pharmaceutical Helsinn Group announced today that on
January 22nd the European Medicines Agency (EMA) determined
netupitant-palonosetron fixed dose combination (NEPA) Marketing
Authorisation Application (MAA) to be valid. "With the EMA
submission, and the recently submitted New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA), we are close to bringing
a new potentially effective treatment for improving the quality of
life of many patients with cancer worldwide. Our
netupitant-palonosetron fixed dose combination is designed to prevent
one of the most dreaded effects of emetogenic chemotherapy and is
part of our pipeline of pharmaceutical and nutritional supplement
products dedicated to cancer supportive care, still an area of
significant unmet medical needs", said Riccardo Braglia, CEO of the
Helsinn Group.

About netupitant-palonosetron fixed dose combination (NEPA)

NEPA is a novel single-day fixed-dose combination of a highly
selective NK1 receptor antagonist, netupitant, and a
pharmacologically and clinically distinct 5-HT3 receptor antagonist,
palonosetron targeting two critical pathways associated with
chemotherapy induced nausea and vomiting (CINV).

The phase III investigational clinical program has recently been
concluded. In November 2013 and in January 2014, respectively, the
FDA and the EMA have accepted for substantive review the
applications. The proposed indication is prevention of acute and
delayed CINV in highly and moderately emetogenic cancer chemotherapy.

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, 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
www.helsinn.com.

Contact Person:
Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
PH +41 91-985-21-21
info-hhc@helsinn.com