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Wednesday 09 July, 2008

Helsinn Healthcare SA

Helsinn Healthcare SA Announces the Launch of A...

LUGANO, Switzerland, July 9 /PRNewswire/ --     Helsinn's Top Management and its
U.S. partner Eisai Inc. today
announced the availability in the USA of ALOXI(R) (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(R) 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(R) 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(R) 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(R)
Capsules for oral administration for CINV is currently under review by the

    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(R).

About Aloxi(R) Injection

    In addition to the new PONV indication (ALOXI(R) injection
0.075 mg), ALOXI(R) (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(R) 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 percent) in 
ALOXI(R) 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(R) prescribing information, available at, for important additional details.

    Eisai licensed the North American distribution and marketing
rights for ALOXI(R) 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


    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


    Paolo Ferrari - Head of Marketing
    Oncology & Supportive Care
    Tel.: +41-91-985-21-21
    E-Mail: [email protected]


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