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Helsinn Healthcare SA

Palonosetron "preferred" 5-HT3 antagonist for emesis prevention in oncology patients receiving highly emetogenic chometherapy

Lugano, Switzerland (ots)

A new release of the NCCN (National
Comprehensive Cancer Network) Clinical Practice Guidelines in
Oncology on Antiemesis recommends palonosetron as the "preferred"
5-HT3 antagonist in combination with aprepitant and dexamethasone for
prevention of emesis in highly emetic risk chemotherapy
Based on the important multicenter study published in The Lancet
Oncology by the equipe of Dr. Mitsue Saito, last February (Saito M.,
Aogi K., Sekine I. et al.; Lancet Oncology  2009 Feb; 10(2):115-24.
Epub 2009 Jan 8), the National Comprehensive Cancer Network (NCCN, a
not-for-profit alliance of 21 of the world's leading cancer centres),
antiemesis panel members have reached consensus to include only
palonosetron, the second generation 5-HT3 receptor antagonist, as the
"preferred" 5-HT3 antagonist, in the combined regimen recommended for
emesis prevention in patients undergoing highly emetogenic
chemotherapy. According to the NCCN, the newly recommended regimen
comprises: palonosetron (0.25 mg IV on day 1) plus aprepitant (125 mg
PO on day 1, and 80 mg PO daily on days 2 and 3; on day 1, aprepitant
may be substituted by fosaprepitant 115 mg IV) plus dexamethasone (12
mg PO or IV on days 1 to 4).
The decision follows the data recently published by Saito, who
showed, in a phase III comparator trial conducted in Japanese
patients undergoing highly emetogenic chemotherapy including
antracycline and cyclophosphamide containing regimens (AC/EC) that
palonosetron is better than granisetron, a first generation drug of
the same class, in preventing chemotherapy-induced nausea and
vomiting (CINV) during the delayed phase, defined as 24-120 hours
after the initiation of anti-cancer treatment. In the acute phase,
defined as the first 24 hours of the start of chemotherapy,
palonosetron is as effective as granisetron with a comparable safety
profile.
"The NCCN recommendation is an important recognition of
palonosetron's therapeutic value and a new milestone achievement for
the product", commented Andrea Meoli, Chief Commercial Officer at
Helsinn, the Swiss pharmaceutical group developer and worldwide
licensor of palonosetron.
About NCCN (National Comprehensive Cancer Network)
The National Comprehensive Cancer Network, a not-for-profit
alliance of 21 of the world's leading cancer centers, is dedicated to
improving the quality and effectiveness of care provided to patients
with cancer. Through the leadership and expertise of clinical
professionals at NCCN Member Institutions, NCCN develops resources
that present valuable information to the numerous stakeholders in the
health care delivery system. As the arbiter of high-quality cancer
care, NCCN promotes the importance of continuous quality improvement
and recognizes the significance of creating clinical practice
guidelines, including the guidelines on "Antiemesis", appropriate for
use by patients, clinicians, and other health care decision-makers.
The primary goal of all NCCN initiatives is to improve the quality,
effectiveness, and efficiency of oncology practice so patients can
live better lives. For more information about NCCN, please visit the
website: www.nccn.org
About Palonosetron (Aloxi®, Onicit®, Paloxi®)
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 * 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®, Onicit®, and Paloxi®. Palonosetron,
marketed as Aloxi®, 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
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 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:

Paolo Ferrari
Head of International Marketing
Tel.: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com

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