Cancer Supportive Care: Oral Palonosetron Approved in EU

By Helsinn Healthcare Sa, PRNE
Sunday, May 9, 2010

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

LUGANO, Switzerland, May 10, 2010 - 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(R), Onicit(R), Paloxi(R))

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(R), Onicit(R), and Paloxi(R) in
more than 50 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 more information about palonosetron, please visit the website:

*This sentence refers to Moderately Emetogenic Chemotherapy (MEC)

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 CHF 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:

    Paolo Ferrari
    Head of International Marketing
    HELSINN Healthcare SA
    Tel: +41-91-985-21-21

Paolo Ferrari, Head of International Marketing, HELSINN Healthcare SA, Tel: +41-91-985-21-21, E-Mail: info-hhc at

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