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news.Taiho Pharmaceutical, the Japanese licensee of Helsinn's second generation 5-HT(3) receptor antagonist, palonosetron, has gained marketing approval in Japan for the same. The drug is indicated for the prevention of chemotherapy-induced nausea and vomiting (including delayed phase) in patients with cancer. Palonosetron will be marketed as Aloxi.
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The approval of Aloxi is based on the compelling results of a large multicenter randomized double-blind clinical trial (Protect study) conducted in Japan, which demonstrated the superiority of palonosetron versus granisetron in the delayed phase. Palonosetron has been developed by the Helsinn Group in Switzerland, world-wide licensor of the drug. The product is approved in 62 countries, including the US and the EU.
Riccardo Braglia, group chief executive officer of Helsinn, said: “The marketing approval granted to palonosetron in Japan, the second largest pharma market worldwide, is a key achievement for our company. This is the first ever approval we have gained in Japan, and we must acknowledge the essential role played by our partner Taiho, leading oncology firm in this country.”
Toru Usami, president of Taiho Pharmaceutical, said: “To contribute to the improvement of cancer treatment, Taiho is putting its effort in research and development of not only anticancer agents but also agents to alleviate adverse reactions induced by cancer chemotherapy. With the marketing approval of Aloxi, we hope to provide a new treatment option to patients who are suffering from cancer chemotherapy induced nausea and vomiting.”