Helsinn Healthcare SA

The 5-HT3 Receptor Antagonist Aloxi® launched in Japan

Lugano, Switzerland / Tokyo, Japan (ots) - Helsinn Healthcare SA, Switzerland, and Taiho Pharmaceutical Co., Ltd., Japanese licensee of Helsinn's second generation 5-HT3 receptor antagonist palonosetron, announce the launch of Aloxi® injection today. Aloxi was developed in Japan by Taiho in close cooperation with Helsinn, based on the license agreement between Taiho and Helsinn of January 2004, and its marketing approval was obtained on 20 January 2010. Chemotherapy-induced nausea and vomiting can be classified into 'acute nausea and vomiting' which appears within 24 hours after chemotherapy administration, or into 'delayed nausea and vomiting' which appears after 24 hours from chemotherapy administration up to 120 hours. In Japan, only limited efficacy for delayed nausea and vomiting has been shown with currently available agents. With a single administration before chemotherapy (cisplatin, etc), Aloxi showed to be effective not only in acute nausea and vomiting, but also in delayed nausea and vomiting, in which currently available agents were not able to show adequate efficacy. Aloxi has a prolonged plasma half-life of approximately 40 hours, and possesses high binding affinity and selectivity towards the 5-HT3 receptors. Furthermore, use of Aloxi is recommended for the prevention of chemotherapy induced nausea and vomiting following Moderately Emetogenic Chemotherapy (non AC/EC) in the 2009 International Antiemetic Guideline of the European Society for Medical Oncology (ESMO)/ Multinational Association of Supportive Care in Cancer (MASCC). Aloxi is approved in 63 countries worldwide, reaching global sales of more than 400M USD (approx. 36B yen) last year. About Palonosetron (Aloxi®, Onicit®, Paloxi®) 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, with a long half-life of 40 hours and at least 30 times higher receptor binding affinity than currently available compounds. Palonosetron demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV. A single intravenous dose of palonosetron provides better protection from CINV than first-generation 5-HT3 receptor antagonists. Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions (incidence > 2 percent) in CINV trials with palonosetron were headache (9 percent) and constipation (5 percent), and they were similar to the comparators. Palonosetron has been developed by the Helsinn Group in Switzerland and today it is marketed as Aloxi®, Onicit®, and Paloxi® in more than 50 countries world-wide. Palonosetron, marketed as Aloxi®, is the leading brand in the USA within the CINV Day of Chemo segment, and it is steadily growing in the European markets. For more information about palonosetron, please visit the website: www.aloxi.com About Taiho Pharmaceutical Taiho Pharmaceutical Co., Ltd. (Taiho) is a company engaged in discovery, development, manufacturing and marketing of pharmaceutical products, with its headquarters in Tokyo, Japan. Taiho is the leading company of oncology field in Japan. For more information about Taiho, please visit the company's Web site at: www.taiho.co.jp/english/index.html About Helsinn Group Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland and subsidiaries in Ireland and USA. Helsinn's business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early to late stage new chemical entities, completes their development from the performance of preclinical/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 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, a second generation 5-HT3 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer and of post-operative nausea and vomiting (PONV), and of the original nimesulide, a non-steroidal anti-inflammatory drug (NSAID) distributed in more than 50 countries worldwide. Helsinn, with a workforce of around 450 employees in Switzerland, Ireland and USA, reported a 2009 turnover of over CHF 305 million (about EUR 200 million), covering 85 countries worldwide, with over 20% of this turnover invested in R&D. For more information about Helsinn Group, please visit the website: www.helsinn.com ots Originaltext: Helsinn Healthcare SA Internet: www.presseportal.ch Contact: Contact person at Helsinn Healthcare SA: Paolo Ferrari Head of International Marketing Helsinn Healthcare SA Phone: +41/91/985'21'21 E-Mail: info-hhc@helsinn.com Contact person at Taiho Pharmaceutical: Mitsutoshi Utatsu Public Relations Dep. TAIHO Pharmaceutical Co., Ltd. Phone: +81-3-3293-2878

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