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Helsinn Healthcare SA

HELSINN announces positive Phase 3 results for ALOXI® (Palonosetron Hydrochloride) injection for the prevention of post operative nausea & Vomiting

Lugano (ots)

HELSINN HEALTHCARE SA, a privately owned Swiss
pharmaceutical group, today announced the successful completion of
two phase 3 trials of Aloxi® (palonosetron hydrochloride) Injection
for the prevention of post-operative nausea and vomiting (PONV). Both
clinical trials successfully met the primary efficacy endpoint of
complete response for the 0-24 hour time period following surgery for
the selected dose of 0.075 mg.  In addition, both trials achieved the
secondary endpoints of complete response for the 0-48 and 0-72 hour
time periods.  The incidence, pattern, and intensity of adverse
events were similar among treatment groups, and the most frequently
observed side effects were headache and constipation.
Two randomized, multi-center phase 3 clinical trials were
conducted to evaluate the safety and efficacy of three doses of Aloxi
compared to placebo for the prevention of PONV.  Based on these
results, HELSINN and its US partner MGI PHARMA plan for the
submission of a Supplemental New Drug Application (sNDA) to the U.S.
Food and Drug Administration during the first half of 2007.
"HELSINN is pleased with the completion of the phase 3 trials and
we look forward to full presentation of these data at future medical
meetings," said Enrico Braglia, Managing Director of HELSINN. "We are
enthusiastic about working together with our partner MGI PHARMA to
bring this new indication to the medical community and to patients".
About Post-Operative Nausea and Vomiting (PONV)
Post-operative nausea and vomiting, or PONV, is a common
consequence of anesthetic and surgical procedures.  In the United
States, nearly 30 million doses of 5-HT3 receptor antagonists are
used annually for the management of PONV.  Patients undergoing
abdominal, gynecological, ear/nose/throat, or optical procedures are
at highest risk for PONV.  Additional factors that can increase the
risk for PONV include female gender, non-smoking status, prior
history of PONV or motion sickness, length of surgery and the use of
volatile anesthetics and opioids.  If not prevented, PONV can result
in hospital re-admissions and increased healthcare costs in
approximately 58% of patients who undergo surgery.
About Aloxi® Injection
Aloxi is approved by the U.S. FDA for the prevention of acute
nausea and vomiting associated with initial and repeat courses of
moderately and highly emetogenic cancer chemotherapy and for the
prevention of delayed nausea and vomiting associated with initial and
repeat courses of moderately emetogenic cancer chemotherapy.  Aloxi
is the first and only 5-HT3 receptor antagonist to be indicated in
USA for the prevention of delayed chemotherapy-induced nausea and
vomiting (CINV) caused by moderately emetogenic cancer chemotherapy.
The most common adverse reactions related to Aloxi were headache (9%)
and constipation (5%).  Aloxi is contraindicated in patients known to
have hypersensitivity to the drug or any of its components.  For more
information please visit www.aloxi.com.
About HELSINN HEALTHCARE
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:

Rachid BenHamza, Ph.D.,
Head Business Unit 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