Helsinn and Mundipharma have entered an exclusive license and distribution agreement for China, Hong Kong and Macao, for Helsinn’s netupitant-palonosetron fixed dose combination (NEPA), currently in Phase III development for the treatment of chemotherapy-induced nausea and vomiting. The agreement consolidates the previously established alliance granting rights to the same combination product in Middle East and North African countries and selected South-Eastern Asian countries.
NEPA is a fixed-dose combination of netupitant and palonosetron and is currently marketed worldwide under the trade names Aloxi, Onicit and Paloxi. The NDA has recently accepted for review by the FDA and Helsinn is preparing a MAA submission to the EMA. Helsinn will retain all regulatory and clinical development activities related to China, as well as the supply of NEPA for commercial use in all territories. Mundipharma will be responsible for registering the product in all other countries.
"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, growing at a double-digit rate, and NEPA may represent a significant advance in the management of CINV," said Riccardo Braglia, Helsinn Group chief executive officer. "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."
Raman Singh, regional managing director of Mundipharma Asia, Latin America, Middle East and North Africa, said, "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."