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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

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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