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 NK₁ receptor antagonist and palonosetron, a second generation 5-HT₃ 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).

Under the terms of the Agreement, Helsinn will retain all regulatory and clinical development activities (CMC, preclinical and clinical) related to China, as well as the supply of NEPA for commercial use in all territories. Mundipharma will undertake responsibility for registering the product in all other countries included in the deals.

"We are extremely pleased of this new agreement signed with Mundipharma which adds China, Hong Kong and Macao to the existing territories of our alliance for NEPA. According to IMS, the Chinese market for 5-HT₃ antagonists is worth over 300 million USD, growing at a double-digit rate, and NEPA may represent a significant advance in the management of CINV," said Mr. Riccardo Braglia, Helsinn Group CEO. "Mundipharma brings to us an expertise built and consolidated through a 20-year presence in the country and a significant recognition of their reliability and proficiency by the Chinese oncological and supportive care universe," he added.

"We are committed to pursuing new and innovative treatments that markedly improve the quality of patients' lives in every market we are present. By launching NEPA in China, we hope to provide healthcare professionals access to a treatment option for cancer patients that optimizes prevention of chemotherapy-induced conditions. Our collaboration with Helsinn Group marks a new milestone, given their proven track record of innovation in cancer supportive care," said Mr Raman Singh, Regional Managing Director of Mundipharma Asia, Latin America, Middle East and North Africa.

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 program has recently been concluded.

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).

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.

About Mundipharma

Mundipharma's independent associated companies are privately owned entities covering the world's pharmaceutical markets. Mundipharma is a prime example of a company that consistently delivers high quality products while standing by the values that represent the company. Our mission is to alleviate the suffering of patients with cancer and non-cancer pain and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients with severe and debilitating diseases the benefit of novel treatment options in fields such as moderate-to-severe pain, oncology, respiratory disease, rheumatoid arthritis, antiseptics and laxatives.

For more information please visit: http://www.mundipharma.asia

Contact Person:

Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
PH +41-91-985-21-21
[email protected]

Mundipharma
Stephenie Vasko
Communications Director - Asia, Latin America & Middle East
PH +65-6303-9732
[email protected]

SOURCE Helsinn Healthcare SA