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Tuesday 30 June, 2009

Helsinn Healthcare SA

Supportive Care in Cancer: Palonosetron Recomme...

LUGANO, Switzerland, June 30 /PRNewswire/ --

    - 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

About Palonosetron (Aloxi(R), Onicit(R), Paloxi(R))

    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 greater than 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. 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(R), Onicit(R), and Paloxi(R) in more than 40
countries world-wide. Palonosetron, marketed as Aloxi(R), 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:

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:

    Helsinn Healthcare SA
    Paolo Ferrari
    Head of International Marketing
    Tel.: +41/91/985-21-21
    E-Mail: [email protected]


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