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Helsinn Healthcare SA

Supportive care in cancer: palonosetron recommended 5-HT3 antagonist for emesis prevention by MASCC/ESMO

Lugano (ots)

Anticipated at the Rome 2009 MASCC International
Symposium the outcome of the 2009 joint MASCC (Multinational 
Association for Supportive Care in Cancer)/ESMO (European Society of 
Medical Oncology) antiemetic guideline update meeting
New important acknowledgment for palonosetron, the second 
generation 5-HT3 receptor antagonist for prevention of chemotherapy 
induced nausea and vomiting (CINV). In April, the National 
Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in 
Oncology on Antiemesis included palonosetron, as the "preferred" 
5-HT3 antagonist in the combined regimen recommended for emesis 
prevention in patients undergoing highly emetogenic chemotherapy 
(HEC). Last week, MASCC (Multinational Association for Supportive 
Care in Cancer) and ESMO (European Society of Medical Oncology) 
decided to recommend palonosetron for the prevention of CINV induced 
by moderately emetogenic chemotherapy (MEC). The main outcome of 
MASCC/ESMO antiemesis guidelines, that will be published in July, has
been released at the recent MASCC 2009 International Symposium held 
in Rome. MASCC/ESMO announced that the combined regimen palonosetron 
and multiday dexamethasone is recommended to prevent acute and 
delayed vomiting and nausea following the chemotherapy of moderate 
risk.
About Palonosetron (Aloxi®, Onicit®, Paloxi®)
Palonosetron (palonosetron hydrochloride) is a selective 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 is 
a second generation 5-HT3 receptor antagonist, and 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 chemotherapies. A single intravenous dose of 
palonosetron (0.25 mg) provides better protection from CINV than 
first-generation 5-HT3 receptor antagonists throughout a 5-day post- 
chemotherapy period. This means that a single administration of 
palonosetron also grants protection during the delayed phase of CINV 
in MEC.
Palonosetron 0.075 mg IV is also approved by FDA as a single 
intravenous dose administered immediately before the induction of 
anaesthesia for the prevention of postoperative nausea and vomiting 
(PONV) for up to 24 hours following surgery.
Palonosetron is contraindicated in patients known to have 
hypersensitivity to the drug or any of its components. The most 
commonly reported adverse reactions (incidence approximately less than 2 percent) in CINV 
trials with palonosetron were headache (9 percent) and constipation 
(5 percent), and they were similar to the comparators. In PONV 
trials, the most commonly reported adverse reactions were QT 
prolongation (5 percent), bradycardia (4 percent), headache (3 
percent), and constipation (2 percent), similar to placebo.
Palonosetron has been developed by Helsinn Group of Switzerland 
and today it is marketed as Aloxi®, Onicit®, and Paloxi® in more than
40 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 further information 
concerning its efficacy and safety please see the Marketing 
Authorization documents in each Country, typically the Summary of 
Product Characteristics. For more information about palonosetron, 
please visit the website: www.aloxi.com
About Helsinn Group Helsinn is a privately owned pharmaceutical 
group with headquarters in Lugano, Switzerland, and subsidiaries in 
Ireland and USA. Helsinn is the worldwide licensor of palonosetron.
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. For more 
information about Helsinn Group, please visit the website: 
www.helsinn.com

Contact:

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

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