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Helsinn Healthcare SA

Oncology: Palonosetron approved in Japan, second pharmaceutical market wordwide

Lugano/Tokyo, Japan (ots)

The second generation 5-HT3 receptor
antagonist palonosetron available in more than 50 countries 
worldwide, including US, EU and Japan
Today, Taiho Pharmaceutical Co., Ltd., Japanese licensee of 
Helsinn's second generation 5-HT3 receptor antagonist palonosetron, 
gained marketing approval in Japan for this drug indicated for the 
prevention of chemotherapy-induced nausea and vomiting (CINV) 
(including delayed phase) in patients with cancer.
Palonosetron will be marketed as 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 versus granisetron in 
the delayed phase. Palonosetron has been developed by the Helsinn 
Group in Switzerland, worldwide licensor of the drug. Today the 
product is approved in 62 countries, including US (since 2003) and EU
(approved in 2005).
Aloxi® (palonosetron) is the leading brand in the USA within the 
CINV Day of Chemo segment, and it is steadily growing in the major 
European markets. The worldwide sales of palonosetron totalled more 
than 400 million US dollars 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", Riccardo Braglia, Helsinn's Group Chief Executive Officer, 
said. "This is the first ever approval we have gained in Japan, and 
we must acknowledge the essential role played by our partner Taiho, 
leading oncology firm in this country", he concluded.
"To contribute to the improvement of cancer treatment, Taiho is 
putting its effort in research and development of not only anticancer
agents but also agents to alleviate adverse reactions induced by 
cancer chemotherapy," commented Toru Usami, President of Taiho 
Pharmaceutical. "With the marketing approval of Aloxi®, we hope to 
provide a new treatment option to patients who are suffering from 
cancer chemotherapy induced nausea and vomiting."
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. 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 NCCN (National 
Comprehensive Cancer Network) 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).
Palonosetron is contraindicated in patients known to have 
hypersensitivity to the drug or any of its components. The most 
commonly reported adverse reactions (incidence more or equal to 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
*This sentence refers to Moderately Emetogenic Chemotherapy (MEC) 
setting
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with 
headquarters in Lugano, Switzerland, and subsidiaries in Ireland and 
USA. 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. Helsinn, with a workforce of around 450 
employees in Switzerland, Ireland and USA, reported a 2008 turnover 
of over CHF 280.3 million (about EUR 178 million), covering 75 
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
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

Contact:

Paolo Ferrari
Head of International Marketing
HELSINN Healthcare SA
Tel: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com

Mitsutoshi Utatsu
Public Relations Dep.
TAIHO Pharmaceuticals Co., Ltd.
Tel.: +81-3-3293-2878

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