News Release


 

Announcement; Launch of 5-HT3 Receptor Antagonist Aloxi® I.V. infusion bag 0.75mg (30/11/2012)

Taiho Pharmaceutical Co., Ltd (HQ : Tokyo ; President : Masayuki Kobayashi) announced today, the NHI Price listing of Aloxi® I.V. infusion bag 0.75mg, an additional formulation of Aloxi® I.V. injection 0.75mg(generic name: Palonosetron Hydrochloride), as of November 30. Product Launch is planned for December 5.

Aloxi® I.V. infusion bag 0.75mg is a formulation where 50mL of drug solution is put inside a 100mL soft bag, with advantages such as reduction in preparation time, reduction in contamination or bacterial contamination risk, and reduction in medical waste. Furthermore, with consideration to prevent malpractice, improved distinguishability is obtained by a red-orange color port and by drug name description directly on the bag.

Taiho will hereafter continue to put its efforts to contribute in the area of cancer supportive care.

About Aloxi®

With a single administration before chemotherapy (cisplatin, etc), Aloxi® has shown its efficacy not only in acute nausea and vomiting, but in delayed nausea and vomiting where previously available agents were not able to show adequate efficacy. Aloxi has a prolonged plasma half life of approximately 40 hours, and possess high binding affinity and selectivity toward the 5-HT3 receptors. Domestic development of Aloxi® was conducted by Taiho based on the license agreement with Helsinn Healthcare SA, and Marketing Approval was obtained for Aloxi® I.V. injection 0.75mg (vial formulation 5mL) on January 20, 2010, and for Aloxi® I.V. infusion bag 0.75mg (Bag formulation 50mL) on August 16, 2012. Aloxi has been approved in 69 countries worldwide, and its sales have reached 680 million USD in 2011.

About Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland and the United States. 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 http://www.helsinn.com.

Product Summary

Product Name Aloxi® I.V. infusion bag 0.75mg
Generic Name Palonosetron Hydrochloride
Indication and Usage Digestive symptoms (nausea or vomiting)(Including delayed phase) resulting from the administration of antineoplastic agents (cisplatin, etc)
Dosage and Administration For intravenous and drip infusion use, the usual adult dosage of palonosetron is 0.75mgperbody once daily.
Marketing Approval date August 16, 2012
NHI Pricing date November 30, 2012
Planned Launch date December 5, 2012
Package Aloxi® I.V. infusion bag 0.75mg : 50mL×5 bags
Drug Price Aloxi® I.V. infusion bag 0.75mg : 14,632yen
Marketing authorization holder Taiho Pharmaceutical Co., Ltd.

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