News Releases

Lugano – Tokyo, 20 January 2010 — Taiho Pharmaceutical Co., Ltd., gained marketing approval in Japan today for palonosetron, a second-generation 5-HT₃ receptor antagonist it has licensed from the Helsinn Group of Switzerland. The drug is indicated for prevention of chemotherapy-induced nausea and vomiting (CINV) (including delayed phase) in patients with cancer. Palonosetron will be marketed in Japan under the brand name Aloxi®.

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 over granisetron in the delayed phase. Palonosetron was developed by the Helsinn Group, the worldwide licensor of the drug. The product has been approved in 62 countries, including the US (since 2003) and EU (approved in 2005).

Aloxi® (palonosetron) is the leading brand in the US within the CINV Day of Chemothrapy segment, and it is steadily growing in the major European markets. The worldwide sales of palonosetron totaled more than US$ 400 million in 2008 and continued to increase in 2009.

"The marketing approval granted to palonosetron in Japan, the second largest pharma market worldwide, is a key achievement for our company," said Riccardo Braglia, Helsinn's Group Chief Executive Officer. "This is the first ever approval we have gained in Japan, and we are delighted to acknowledge the essential role played by our partner Taiho, the leading oncology firm in the country," he concluded.

Toru Usami, President of Taiho Pharmaceutical, commented "Our goal is to improve cancer treatment, and we are working hard on research and development not only of anticancer agents but also of agents to alleviate the adverse reactions induced by cancer chemotherapy. With the marketing approval of Aloxi®, we can now provide an effective, new treatment option to patients who are suffering from cancer chemotherapy induced nausea and vomiting."

Palonosetron (palonosetron hydrochloride) is a second-generation 5-HT₃ receptor antagonist, developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer. It features a long half-life of 40 hours and has at least 30 times higher receptor binding affinity than the currently available products. Palonosetron demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV. The product has shown to be effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapy (MEC). A single intravenous dose of palonosetron provides better protection from CINV than first-generation 5-HT₃ receptor antagonists throughout a 5-day post-chemotherapy period*. According to the National Comprehensive Cancer Network (NCCN) Guidelines, palonosetron is the preferred 5-HT₃ receptor antagonist to be used in a combined regimen with an NK-1 antagonist and dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy (HEC).

For more information about palonosetron, please visit: www.aloxi.com

*In moderately emetogenic chemotherapy (MEC) settings

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and subsidiaries in Ireland and the United States.
Helsinn's unique business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early stage new chemical entities, completes their development from the performance of pre-clinical/clinical studies and chemistry, manufacturing and control (CMC) development, to the filing for and attainment of their market approval worldwide.
Helsinn's products are sold directly, through the Group subsidiaries, or eventually out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with 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 dosage forms are manufactured at Helsinn's cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers.
Helsinn is the worldwide licensor of palonosetron and of the original nimesulide, a non-steroidal anti-inflammatory drug (NSAID) distributed in more than 50 countries worldwide.
For more information about Helsinn Group, please visit: www.helsinn.com

Taiho Pharmaceutical Co., Ltd. (Taiho) is engaged in the discovery, development, manufacturing and marketing of pharmaceutical products, and is headquartered in Tokyo, Japan. Taiho is Japan's leading pharmaceutical company in the field of oncology. For more information about Taiho, please visit the company online at: www.taiho.co.jp/english/index.html.