Palonosetron Warrants Adequate Caloric Intake in Oncology Patients Receiving High Emetogenic Chemotherapy

ZURICH, Switzerland - A new, innovative study shows that a single dose of palonosetron, the
second generation 5-HT3 antagonist, plus dexamethasone not only prevents
chemotherapy-induced nausea and vomiting (CINV), but also allows adequate
caloric intake in oncology patients. Data presented today at the ESMO
Symposium on Cancer and Nutrition in Zurich, Switzerland

New data presented today at the ESMO (European Society of Medical
Oncology) Symposium on Cancer and Nutrition in Zurich shows that
palonosetron, a second generation 5-HT3 receptor antagonist, warrants
adequate caloric intake in oncology patients receiving high emetogenic
chemotherapy (HEC). The result comes from an innovative study conducted in
the Oncology Institute of Ospedale V. Fazzi of Lecce, Italy, by the research
team of Dr. Vito Lorusso. The findings confirmed the efficacy of a single
dose of palonosetron and dexamethasone to control chemotherapy-induced nausea
and vomiting (CINV) episodes in patients treated with HEC (cisplatin and/or
epirubicin and/or iphosphamide) for soft tissue sarcoma: 76% of the patients
achieved complete response (no vomiting, no use of rescue medication), 74%
complete control (complete response and no more than mild nausea), in the
7-day period following chemotherapy, after palonosetron treatment.

Moreover, the results demonstrated that patients with no vomiting and
without nausea had a median daily food intake of 1500 Kcal and 1600 Kcal in
the acute and delayed period respectively, which is an adequate caloric
consumption. “Palonosetron not only confirms its ability to control nausea,”
Dr. Lorusso commented. “But considering the relevance of a correct
nutritional status for cancer patients, it also demonstrates to allow an
adequate caloric consumption, in the 7 day period following chemotherapy.
Moreover this benefit prolonged over the monitored period, allowing patients
to avoid chemotherapy related weight loss.”

“These results are of special interest in light of ensuring an even more
effective supportive care to patients undergoing high emetogenic
chemotherapy. From this point of view, such an outcome is consistent with
Helsinn’s commitment in this particular setting,” stated Prof. Mauro Bianchi,
Medical Development Director at Helsinn.

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 (Aloxi(R), Onicit(R), Paloxi(R))

Palonosetron (palonosetron hydrochloride) is a selective 5-HT3 receptor
antagonist, developed for the prevention of 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. Since its availability in USA in September 2003, and since then in more
than 40 countries world-wide, there have been over 10 million administrations
of palonosetron. 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*.

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%) in CINV
trials with palonosetron were headache (9%) and constipation (5%), and they
were similar to the comparators. In PONV trials, the most commonly reported
adverse reactions were QT prolongation (5%), bradycardia (4%), headache (3%),
and constipation (2%), similar to placebo.

Palonosetron has been developed by Helsinn Healthcare SA of Switzerland
and today it is marketed as Aloxi(R), Onicit(R), and Paloxi(R). 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. Its
approval in Japan is expected during 2009.

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.

*These sentences refer to Moderately Emetogenic Chemotherapy (MEC)
setting

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

Source: Helsinn Healthcare SA

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