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Helsinn Healthcare SA

Cancer supportive care: Oral Palonosetron approved in EU

Lugano (ots)

The second generation 5-HT3 receptor antagonist
palonosetron, already approved as an intravenous solution formulation
in more than 60 countries worldwide including US, EU and Japan, 
obtains the European Marketing Authorization for 0.5 mg oral capsules
Palonosetron 0.5 mg soft gelatine capsule oral formulation has 
been approved by the EMA (European Medicine Agency) for the 
prevention of nausea and vomiting associated with moderately 
emetogenic cancer chemotherapy (MEC) in adults. The European 
Marketing Authorization for the oral formulation of palonosetron, the
second generation 5-HT3 receptor antagonist licensed worldwide by the
Swiss pharmaceutical group Helsinn, follows the approval obtained in 
August 2008 in the USA.
"As proven by our product pipeline, Helsinn is highly committed to
Cancer Supportive Care and we are delighted that cancer patients 
suffering from nausea and vomiting can now benefit from oral Aloxi 
beside the injectable form." Riccardo Braglia, Helsinn's Group Chief 
Executive Officer, said. "We expect this will allow palonosetron to 
strengthen its leading position in the chemotherapy-induced nausea 
and vomiting (CINV) prevention", he concluded.
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*. Palonosetron is contraindicated in
patients known to have hypersensitivity to the drug or any of its 
components. The most commonly reported adverse reactions 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
worldwide. 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 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 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's 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 440 employees in 
Switzerland, Ireland and USA, reported a 2009 turnover of over C HF 
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:

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

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