Helsinn, the Swiss Group focused on building quality cancer care, and Mundipharma have signed an exclusive agreement for the distribution and licensing of NEPA, an investigational oral fixed combination of netupitant and palonosetron developed for the prevention of chemotherapy-induced nausea and vomiting (CINV), in Brazil.
NEPA is an oral fixed combination of a novel NK1 receptor antagonist (netupitant) and the best-in-class 5-HT3 receptor antagonist palonosetron, already approved in the USA with the trade name Akynzeo for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. NEPA is currently in the registration phase in Europe and will be soon submitted to the Brazilian regulatory authorities for the prevention of CINV.
One of the components of NEPA is palonosetron, the market-leading preventive treatment for CINV in patients with cancer. Palonosetron worldwide sales in 2014 were around USD 649 million (IMS data). The product is marketed and available in over 65 countries worldwide under the brand names of Aloxi, Onicit and Paloxi.
Under the terms of the agreement, Helsinn retains all international regulatory and clinical development activities and the supply of NEPA for commercial use. Mundipharma will have rights related to marketing, promotion and sales of NEPA in the designated territory.
By signing this agreement, Mundipharma adds to its commercialization rights in several key markets in Asia-Pacific, China, Hong Kong, Middle-East and North Africa the territory of Brazil.
Riccardo Braglia, chief executive officer of Helsinn Group, commented: "We are delighted that NEPA, once registered, will be on offer to patients in Brazil with Mundipharma as they are widely recognized for their reliability and proficiency from the oncological and supportive care community across. Mundipharma is a company we know well and we are pleased to have signed this latest agreement expanding our joint collaborations in cancer supportive care into the area of CINV."
Raman Singh, president, Mundipharma Asia, Latin America, Middle East and Africa added: "We are committed to pursuing new and innovative treatments that markedly improve the quality of patients' lives in every market we are present. With the availability of NEPAin Brazil, we hope to provide healthcare professionals access to a treatment option for cancer patients aimed at preventing chemotherapy-induced conditions. Our collaboration with Helsinn Group marks a new milestone, given their proven track record of innovation in cancer supportive care."
NEPA is a novel single-day oral fixed combination of a highly selective NK1 receptor antagonist, netupitant, and a pharmacologically and clinically distinct 5-HT3 receptor antagonist, palonosetron, targeting two signaling pathways associated with CINV.
Mundipharma's global network of companies are privately owned entities covering the world's pharmaceutical markets. Mundipharma provides patients across 6 continents with a growing portfolio of 19 products in 5 therapeutic areas, which include moderate-to-severe pain, consumer healthcare, oncology, respiratory disease, rheumatoid arthritis, antiseptics and laxatives.