HELSINN GROUP SIGNS EXCLUSIVE AGREEMENT WITH MUNDIPHARMA FOR DISTRIBUTION AND LICENSING OF NETUPITANT/PALONOSETRON (NEPA) IN BRAZIL
The exclusive agreement builds on our existing partnerships in the area of cancer supportive care across multiple global territories
Lugano, Switzerland and Singapore, 9 February, 2015: Helsinn, the Swiss Group focused on building quality cancer care, and Mundipharma today announce that they 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.”
Mr. 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.
About Helsinn Group
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the USA and a representative office in China. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.
Helsinn in-licenses early-to-late stage new chemical entities, completing their development by performing pre-clinical/clinical studies as well as associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn’s products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. Helsinn has built a large product portfolio of cancer care products with the alliance of over 65 global partners. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn’s GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com
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. 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 and to substantially improve their quality of life.
For more information, please visit: www.mundipharma.com.sg
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