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Palonosetron more effective than granisetron in controlling nausea according to the protect study

Lugano (ots)

New data presented at the ESMO Milan 2010 Congress
show a better control of nausea and vomiting with palonosetron versus
granisetron in patients undergoing cisplatin or anthracycline plus 
cyclophosphamide based regimens. Palonosetron superior efficacy is 
statistically significant in nausea control, following Highly 
Emetogenic Chemotherapy, in the delayed phase in total study 
population and also in subgroups by age, female gender and 
chemotherapy.
Palonosetron is effective in preventing CINV (Chemotherapy Induced
Nausea and Vomiting) induced by Highly Emetogenic Chemotherapy (HEC) 
compared to granisetron, according to the data of the PROTECT Study 
presented by Dr. Kaoru Kubota, from the National Cancer Center 
Hospital Division of Internal Medicine and Thoracic Oncology, Tokyo, 
Japan, at the ESMO (European Society of Medical Oncology) Milan 2010 
Congress. Dr. Kubota belongs to the PROTECT Study Group that involved
several oncology Centers in Japan as the National Cancer Center 
Hospital, Tokyo, the Juntendo University School of Medicine, Tokyo, 
and other Japanese Institutions.
Dr. Kubota's presentation, focused on the analysis of the PROTECT 
study data, showed the higher efficacy of palonosetron in nausea 
induced by HEC compared to granisetron, in  the 1.114 patients study 
population, and especially in young and female patients, which are 
the high risk factors for nausea and vomiting.
A statistically significant higher percentage of 'nausea free 
patients' has been shown for the total study population, in the 
palonosetron plus dexamethasone group versus granisetron plus 
dexamethasone, during the delayed (24-120 hrs) and overall (0-120 
hrs) phases as well as in each day of the delayed phase (daily 
setting).
Furthermore, statistically significant better results have been 
shown in the analysis by subgroups, for age, gender and chemotherapy.
Nausea free rate of palonosetron was similar to that of 
granisetron in day 1, however it was significantly higher after day 2
both in younger (<55) and older (>=55) patients, in total study 
patients who received either cisplatin or anthracycline plus 
cyclophosphamide based study regimens, and in the female patients 
subgroup.
About Chemotherapy-induced nausea and vomiting (CINV)
Chemotherapy-induced nausea and vomiting is among the most dreaded
side effects following therapy in patients with cancer. Despite 
prophylaxis, on the day of chemotherapy, up to 30-45 percent of 
patients experience nausea or vomiting or require rescue therapy 
following administration of certain types of emetogenic chemotherapy.
The 5-HT3 receptor plays a pivotal role in the process of emesis, and
agents that antagonise these receptor subtypes are the basis for 
control of this effect. Following the development of the first 
generation 5-HT3 receptor antagonists, such as ondansetron and 
granisetron, in the late '80s and early '90s, in recent years new 
compounds have been made available for preventing CINV, including 
palonosetron.
About Palonosetron
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
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 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 450 
employees in Switzerland, Ireland and USA, reported a 2009 turnover 
of over CHF 305 million (about EUR 232.0 million at the current 
conversion exchange rate), 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
Phone: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com

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