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Friday 05 June, 2009

Helsinn Healthcare SA

Single Dose Palonosetron Prevents Emesis Induce...

BERLIN, Germany, June 5 /PRNewswire/ --

    - Single Dose Palonosetron is Effective and Safe in Preventing
Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients With Aggressive
Non-Hodgkin's Lymphomas who Undergo Moderately Emetogenic Chemotherapy

    - Data Presented Today at the European Haematology Association Congress 
in Berlin, Germany

    New data presented today at the EHA (European
Haematology Association) Congress in Berlin show that a single dose of
palonosetron, a second generation 5-HT3 receptor antagonist, is effective and
safe in preventing chemotherapy-induced nausea and vomiting (CINV) in
patients with aggressive non Hodgkin's lymphoma (NHL), treated with cytotoxic

    The result comes from a study conducted in Italy on behalf of the Italian
Group of Study on Lymphomas (GISL) by a multicentric team coordinated by Dr.
Nicola Di Renzo of the Vito Fazzi Hospital of Lecce. "The standard approach
in the antiemetic therapy in NHL is represented by antiserotoninergic drugs.
Palonosetron is a selective and potent serotonin antagonist that associated
to the chemotherapy of solid tumours has demonstrated improved efficacy
compared to older 5-HT3 receptor antagonists. The objective of our study was
to evaluate the efficacy and safety of a single dose of palonosetron in
preventing CINV induced by moderately emetogenic chemotherapy (MEC) agents
used for the treatment of aggressive NHL", explained Dr. Di Renzo.

    "Palonosetron, given as antiemetic treatment, is effective and safe in
preventing CINV in patients with aggressive NHL", he concluded. The GISL
study was an open-label, multicenter phase II study assessing the efficacy of
a single dose of palonosetron (0.25 mg) prior to the administration of
chemotherapy in the first day of treatment, in ten Italian hospitals. The
study included 86 patients, affected by aggressive NHL. The primary endpoint
was the overall rate of patients achieving a complete response (CR - defined
as no emetic episode and no use of rescue medication) during the whole study
period (0-120 h). Relevant secondary endpoints included: CR in the acute
(0-24h) and delayed (24-120) phases, no emesis and no nausea rates.

    The primary endpoint was achieved with a CR rate of 86%. The CR in the
acute and delayed phases was 90.7% and 88.4% respectively. No emesis rates
were 91.9% (0-24h), 89.5% (24-120h) and 88.4% (0-120h). Importantly, nausea,
that is still considered an unmet need despite the anti emetic treatments,
was very well controlled by a single palonosetron dose with no nausea rates
of 84.9%, 75.6% and 74.4% in the acute, delayed and overall periods
respectively. No serious drug related adverse events were reported. "These
results are of special interest for both physicians and patients", pointed
out Prof. Mauro Bianchi, Medical Development Director at Helsinn, the Swiss
pharmaceutical group developer and worldwide licensor of palonosetron.
"Generally, NHL patients undergoing moderately emetogenic chemotherapy based
on CHOP or CHOP-R protocols, including daily dose of 100 mg of prednisone
orally from day 1 to day 5 - show CINV rates around 40-50%. In this study,
palonosetron reduced this percentage to 14%", he concluded.

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 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. 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 more 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). 
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 

    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

    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:

    *These sentences refer to Moderately Emetogenic Chemotherapy (MEC)

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


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