Helsinn Healthcare SA, announced that the U.S. Food and Drug Administration (FDA) granted the marketing approval for their new drug palonosetron for:-- the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, -- and the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
"The new indications for palonosetron advance the standards of therapy for delayed emesis due to moderately emetogenic chemotherapy," said Steven M. Grunberg, lead consultant on the palonosetron pivotal program and professor of Medicine and Pharmacology, Fletcher Allen Healthcare, University of Vermont. "Palonosetron is the first 5-HT3 receptor antagonist to be granted approval for prevention of delayed emesis with a single dose in this patient population."
The drug shall be commercialized under its new trademark Aloxi in United States by Helsinn's licensee MGI Pharma, an oncology focused biopharmaceutical company.
Aloxi (palonosetron hydrochloride) injection is a selective 5-HT3 receptor antagonist with strong binding affinity and an extended plasma half-life of approximately 40 hours, which demonstrated efficacy in preventing chemotherapy-induced nausea and vomiting in phase 3 clinical trials when compared to currently used 5-HT3 receptor antagonists. These trials were recently presented during the American Society of Clinical Oncology (ASCO) and the Multinational Association of Supportive Care in Cancer (MASCC) conferences held respectively in Chicago and in Berlin.
"We are delighted with the FDA approval which marks an important achievement for our company and confirms again the success of our business model as a licensing company, capable of in-licensing new drugs at various stages of development, successfully completing their development and registration and then commercializing them through our licensees," said Dr. Enrico Braglia, managing director of Helsinn Healthcare SA. "Palonosetron has a differentiated profile within the class of 5-HT3 receptor antagonists and we are glad to make it available to the oncology community to help their cancer patients better deal with chemotherapy side effects."
Helsinn acquired the world-wide rights to palonosetron from Syntex in 1998 while the drug was in phase 2 development and established a complete development program in the US and in Europe involving over 1800 patients. The palonosetron NDA was submitted in September 2002. Helsinn granted the US and Canadian distribution and licensing rights to MGI Pharma in April 2001.