Palonosetron More Effective Than Granisetron in Controlling Nausea According to the Protect Study

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

MILAN, October 11, 2010 - 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(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:
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

Contact: Paolo Ferrari, Head of International Marketing, HELSINN Healthcare SA, Phone: +41-91-985-21-21, E-Mail: info-hhc at helsinn.com