NEPA is an oral fixed combination of a novel NK1receptor antagonist (netupitant) and the best-in-class 5-HT3receptor 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 other regulatory authorities in the territories included in the agreement between Helsinn and Stendhal, for the prevention of CINV.
One of the components of NEPA is palonosetron, the market-leading 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 new agreement, Helsinn retains all international regulatory and clinical development activities and the supply of NEPA for commercial use. Stendhal will be responsible for all distribution and marketing activities in the designated territories.
This commercial agreement builds on the previously signed agreement in the same territories for anamorelin, a novel, once-daily, ghrelin receptor agonist under investigation for the treatment of unintended weight loss in non small cell lung cancer (NSCLC) patients which recently announced promising Phase III trials results.
Riccardo Braglia,CEO of Helsinn Group, said: "Helsinn is delighted to sign this latest agreement with Stendhal, which enlarges the range of our joint work in cancer supportive care including now the chemotherapy-induced nausea and vomiting field.
"By having multiple agreements in place with the same partner, we are aiming to give to physicians a full range of available treatment options, to be provided by a single source for the benefit of the patients affected by the many side effects of cancer treatments. We look forward to working with Stendhal and building upon our already strong relationship."