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Helsinn Healthcare SA

Helsinn Healthcare SA announces the launch of ALOXI® (palonosetron hcl) injection for the prevention of postoperative nausea and vomiting in the USA

Lugano (ots)

Helsinn's Top Management and its U.S. partner Eisai
Inc. today announced the availability in the USA of ALOXI®
(palonosetron hydrochloride) injection 0.075 mg for the prevention of
postoperative nausea and vomiting (PONV) for up to 24 hours following
surgery. The introduction of ALOXI® for PONV represents the first
launch of a new indication for an MGI product since Eisai acquired
the organization in January 2008.
Approved by the U.S. Food and Drug Administration (FDA) for PONV
on February 29, 2008, ALOXI® injection 0.075 mg is administered as
a single I.V. dose immediately before induction of anesthesia to
prevent PONV for up to 24 hours following surgery. Efficacy beyond 24
hours has not been demonstrated. ALOXI® has been available in the
United States since 2003, when it was approved by the FDA for the
prevention of chemotherapy-induced nausea and vomiting (CINV). A
supplemental New Drug Application for ALOXI® Capsules for oral
administration for CINV is currently under review by the FDA.
Postoperative nausea and vomiting are common consequences of
anesthesia and surgical procedures. Twenty to 30 percent of patients
undergoing surgery experience PONV at some point during their
recovery, and rates can approach 70 to 80 percent for patients with
multiple risk factors, such as female gender, non-smoker, history of
motion sickness or PONV, and use of postoperative opioids. Many
patients report that the prevention of PONV is more important than
the avoidance of postoperative pain.
An estimated 38 million general anesthesia procedures are
performed each year in the United States (2006 figures), and 39
percent of these - 15 million procedures - utilize anti-emetic
therapy for PONV. Of these 15 million procedures, 89 percent, or 13.4
million, use 5-hydroxytryptamine-3 (5-HT3) receptor antagonists, such
as ALOXI®.
About ALOXI® INJECTION
In addition to the new PONV indication (ALOXI® injection 0.075
mg), ALOXI® (palonosetron HCl) injection 0.25 mg is the first and
only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist to be
indicated for the prevention of acute and delayed nausea and vomiting
associated with initial and repeat courses of moderately emetogenic
chemotherapy, and for the prevention of acute nausea and vomiting
associated with initial and repeat courses of highly emetogenic
chemotherapy.
ALOXI® 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
ALOXI® CINV trials were headache (9 percent) and constipation (5
percent), and in the PONV trials, the most commonly reported adverse
reactions were QT prolongation (5 percent), bradycardia (4 percent),
headache (3 percent), and constipation (2 percent).
Please see the ALOXI® prescribing information, available at
www.ALOXI.com, for important additional details.
Eisai licensed the North American distribution and marketing
rights for ALOXI® from Helsinn Healthcare SA.
About EISAI INC.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd.,
a research-based human health care (hhc) company that discovers,
develops and markets products throughout the world. Eisai focuses its
efforts in three therapeutic areas: neurology, gastrointestinal
disorders and oncology/critical care. Established in 1995 and ranked
among the top-20 U.S. pharmaceutical companies (based on retail
sales), Eisai Inc. began marketing its first product in the United
States in 1997 and has rapidly grown to become an integrated
pharmaceutical business with fiscal year 2007 (year ended March 31,
2008) sales of approximately $3 billion, including the results of the
acquisition of MGI PHARMA, INC.
Eisai Inc. employs approximately 1,500 people at its headquarters
in Woodcliff Lake, NJ, at its state-of-the-art pharmaceutical
production and formulation research and development facility in
Research Triangle Park, NC, and in the field.  For more information
about Eisai, please visit www.eisai.com .
About HELSINN HEALTHCARE SA
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group
with headquarters in Switzerland and is the worldwide licensor of
palonosetron. HELSINN's core business is the licensing of
pharmaceuticals in therapeutic niche areas. The company's business
strategy is to in-license early stage new chemical entities and
complete their development from the performance of
pre-clinical/clinical studies and CMC development to the attainment
of market approvals in strategic markets (U.S. and Europe). HELSINN's
products are eventually out-licensed to its marketing partners for
distribution. The active pharmaceutical ingredients and the finished
dosage forms are manufactured at HELSINN's cGMP facilities and
supplied worldwide to its customers. For more information about
HELSINN, please visit the company's Web site at www.helsinn.com .

Contact:

HELSINN HEALTHCARE SA
Paolo Ferrari - Head of Marketing
Oncology & Supportive Care
Tel.: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com

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Plus de actualités: Helsinn Healthcare SA