Helsinn and Vifor Pharma sign Licensing and Distribution agreement for Netupitant-Palonosetron fixed dose combination
Jeudi 16 mai 2013, ↓ accès direct au téléchargement
Lugano and Glattbrugg, Switzerland, 16 May, 2013 – Helsinn Healthcare SA and Vifor Pharma, announced that the companies have entered into an exclusive license and distribution agreement for netupitant-palonosetron fixed dose combination, a Helsinn product currently in the development stage for the treatment of chemotherapy-induced nausea and vomiting (CINV). Under the agreement, Vifor Pharma will have rights to distribute the product in Switzerland, France, Spain, Portugal, the Netherlands, Belgium and Luxembourg. Vifor Pharma will also assume responsibility for registering the product in Switzerland.
The agreement refers to the fixed dose combination of netupitant, a novel NK1-receptor antagonist, and palonosetron, a 5-HT3-receptor antagonist that is already marketed in the main markets worldwide under the trade names Aloxi®, Onicit® and Paloxi®,, through Helsinn’s network of partners, including Vifor Pharma in Switzerland, Benelux and France. Netupitant-palonosetron fixed dose combination is still in the development phase, with the oral form expected to have phase III clinical results available soon.
“Chemotherapy-induced nausea and vomiting is a frequent and severe side effect of most cancer treatments. While various treatments already exist, nausea remains an area with a major unmet need that netupitant-palonosetron fixed dose combination will effectively address,” said Riccardo Braglia, CEO of the Helsinn Group. “Vifor Pharma is a long-standing partner for Helsinn and we are glad this agreement will further extend our collaboration,” Dr Braglia added.
“Helsinn is a leader in managing cancer supportive care. Together we will provide patients and doctors with an innovative product that improves quality of life significantly,” commented Thierry Volle, Head of International Business Operations, Vifor Pharma.
Vifor Pharma, une entreprise du Groupe Galenica, est l’un des leaders mondiaux en matière de découverte, développement, fabrication et commercialisation de produits pharmaceutiques utilisés dans le traitement de la carence en fer. La société propose également un portefeuille diversifié de produits de prescription et de produits délivrés sans ordonnance (OTC). Vifor Pharma, dont le siège est à Zurich (Suisse), étend sans cesse sa présence mondiale et dispose d’un vaste réseau de filiales et de partenaires dans le monde.
About netupitant-palonosetron fixed dose combination (NEPA): 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 program has recently been concluded.
NEPA is currently in the pre-submission status to the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA) for the prevention of acute and delayed CINV following both highly and moderately emetogenic chemotherapy.
About Helsinn Group: Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland, the United States and China. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas. Helsinn is an important player in cancer supportive care. Helsinn Group in-licenses early-to-late stage new chemical entities, completes their development through the performance of pre-clinical /clinical studies and Chemistry, Manufacturing, and Control (CMC) development, and files and attains their market approvals worldwide. Helsinn’s products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how whom Helsinn assists and supports by providing a full range of product and scientific management services, including commercial, regulatory, financial, legal, and medical marketing advice. The active pharmaceutical ingredients and the finished products are manufactured according to the highest quality, safety, and environmental standards at Helsinn’s GMP facilities in Switzerland and Ireland and supplied worldwide to its customers.
Further information on Helsinn Group is available at www.helsinn.com
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Head of Global Communications & Public Affairs