Helsinn, a Swiss-based privately owned pharmaceutical group, and Mundipharma have signed a new, exclusive license and distribution agreement, covering China, Hong Kong and Macao, for netupitantpalonosetron 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 US 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 2 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 Raman Singh, regional managing director of Mundipharma Asia, Latin America, Middle East and North Africa.
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 programmr has recently been concluded.
The US 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).
Helsinn, a privately owned pharmaceutical group, focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas.
Mundipharma’s independent associated companies are privately owned entities covering the world's pharmaceutical markets.