News Releases

April 21, 2010
Taiho Pharmaceutical Co., Ltd.

5-HT3 Receptor Antagonist, Aloxi® on April 22

Tokyo, April 21, 2010 - Taiho Pharmaceutical Co., Ltd., announced today that it will release the 5-HT3 (serotonin) receptor antagonist antiemetic agent Aloxi IV Injection® (palonosetron hydrochloride) on April 22, 2010. Aloxi® was developed for the Japanese market by Taiho based on a license agreement signed by Taiho and Helsinn* of Switzerland in January 2004, and approval to market the produce in Japan was obtained on January 20, 2010.

*Helsinn Healthcare SA

Chemotherapy induced nausea and vomiting can be classified into two types: "acute nausea and vomiting" which appears within 24 hours after chemotherapy administration; or "delayed nausea and vomiting" which appears from 24 hours to 120 hours after chemotherapy administration. In Japan, currently available treatments have shown only limited efficacy for delayed nausea and vomiting.
With a single administration before chemotherapy (cisplatin, etc.), Aloxi® showed efficacy not only for acute nausea and vomiting, but for delayed nausea and vomiting. Aloxi® boasts a prolonged plasma half life of approximately 40 hours, and demonstrates high 5-HT3 receptor binding affinity and selectivity. Use of Aloxi® is recommended for the prevention of chemotherapy induced nausea and vomiting in the International Antiemetic Guideline 2009 of the European Society for Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC).
Aloxi® has been approved for use in 63 countries worldwide, and global sales reached more than 400 million US dollars (approx. 36 billion Japanese yen) last year. Peak year sales of Aloxi® in Japan are expected to reach 6 billion yen.

Product Summary

Product name Aloxi® IV Injection 0.75mg
Generic name Palonosetron Hydrochloride
Indication Digestive symptoms (nausea and vomiting, including delayed phase) resulting from the administration of antineoplastic agents (cisplatin, etc.)
Dosage and administration For intravenous use, the usual adult dosage of palonosetron is 0.75mg per person once daily
Product Characteristics 1.A second-generation 5-HT3 receptor antagonist indicated for use in treating chemotherapy induced nausea and vomiting, both acute and delayed.
2.Shows a continuous antiemetic effect with a single administration before chemotherapy (cisplatin, etc.)
3.An elimination half life in human plasma of approximately 40 hours.
4.High 5-HT3 receptor affinity and selectivity (in vitro)
5.In the clinical trial, of the 1,343 participants administered the drug, 460 patients (34.3%) experienced adverse reactions of some kind. The major adverse reactions were: constipation in 222 patients (16.5%); headache in 52 patients (3.9%); and vascular pain in 42 patients (3.1%). The major abnormalities observed in laboratory test data were ALT elevation in 73 patients (5.4%), QT prolongation in 58 patients (4.3%), AST (GOT) elevation in 49 patients (3.6%), blood bilirubin increase in 31 patients (2.3%) and γ-GTP elevation in 28 patients (2.1%) (from data provided in approval application). Serious adverse reactions, including anaphylactic reactions (pruritus, flare, chest discomfort, difficulty breathing and a drop in blood pressure) may be observed (frequency unknown).
Package Aloxi® IV Injection 0.75mg 5mL 5 vials
NHI price Aloxi® IV Injection 0.75mg 5mL 1 vial — 14,522yen
Date of NHI listing April 16, 2010
Release date April 22, 2010

Information in this news release was current as of the original release date.