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Swiss-based Helsinn Group And Mundipharma Sign For Rights To Phase III Netupitant-Palonosetron Fixed Dose Combination For China

LUGANO, Switzerland, December 19, 2013 /PRNewswire/ --

The two companies sign a distribution and license agreement for an investigational therapy for the prevention of chemotherapy-induced nausea and vomiting covering China, Hong Kong and Macao

Helsinn and Mundipharma announce the signature of a new, exclusive license and distribution agreement, covering China, Hong Kong and Macao, for netupitant-palonosetron fixed dose combination (NEPA), a Helsinn product under development for the treatment of chemotherapy-induced nausea and vomiting. This Agreement consolidates the alliance between the companies which was established with the granting of rights to the same combination product sealed earlier this year in Middle East and North African countries and in late 2012 in selected South-Eastern Asian countries. Besides China, Hong Kong and Macao, the Mundipharma Group of companies therefore plans to distribute the product in further key markets in Asia-Pacific, the Middle East and North Africa.

NEPA is a fixed dose combination of netupitant, a novel NK 1 receptor antagonist and palonosetron, a second generation 5-HT 3 receptor antagonist already present in the main markets world-wide under the trade names Aloxi®, Onicit® and Paloxi®.

Positive results of the phase III pivotal trials have been announced last spring and data have been presented during this year's Annual Meeting of the American Society of Clinical Oncology (ASCO) and at the European CanCer Organization (ECCO) Congress.

The U.S. Food and Drug Administration (FDA) has recently accepted for review the submission of the NEPA New Drug Application (NDA). The proposed indication is for the prevention of acute and delayed CINV in both highly and moderately emotegenic chemotherapy. Helsinn is preparing submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA).

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