Helsinn Announces European Medicines Agency Acceptance of Regulatory Submission for Netupitant-palonosetron Fixed Dose Combination (NEPA)

LUGANO, Switzerland, January 29, 2014 /PRNewswire/ --

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

The Swiss pharmaceutical Helsinn Group announced today that on January 22^nd 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 http://www.helsinn.com.

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