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Tuesday 10 July, 2007

HELSINN Healthcare SA

HELSINN Announces Aloxi sNDA for PONV Accepted ...





LUGANO, Switzerland, July 10 /PRNewswire/ --

- PDUFA date of 4th March, 2008 established

    HELSINN's Top Management today announced that the supplemental New Drug
Application (sNDA) for Aloxi(R) (palonosetron hydrochloride) Injection for
the prevention of post-operative nausea and vomiting was accepted for filing
by the United States Food and Drug Administration (FDA). Aloxi is approved by
the 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.



    The sNDA for Aloxi Injection was submitted to the FDA on May 7, 2007. The
acceptance for review of the NDA represents the FDA's determination that the
application is sufficiently complete to permit a substantive review of the
data. The filing of the application by the FDA does not represent any opinion
regarding the safety, efficacy or approvability of Aloxi Injection. Under
PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and
act on the NDA by March 4, 2008.



    The sNDA included data from two randomized, multi-center, phase 3 trials
conducted to evaluate the safety and efficacy of three doses of Aloxi
compared to placebo for the prevention of PONV. In these two trials, a total
of 1,219 patients undergoing elective outpatient abdominal or gynecological
laparoscopic surgery (Study PALO-04-06) or elective inpatient gynecological
or breast surgery (Study PALO-04-07) were randomized to receive one of three
single intravenous doses of Aloxi or placebo prior to administration of
anesthesia. Data were collected to examine the effectiveness and safety of
Aloxi during the time course of patient risk for nausea and vomiting,
regardless of inpatient or outpatient site of postoperative care on the day
of surgery and for two more days (0-72 hrs). Both clinical trials
successfully met the primary efficacy endpoint of complete response, defined
as no emesis or use of rescue medication, for the 0-24 hour time period and
the key secondary efficacy endpoint of complete response for the entire 0-72
hour time period following surgery, for the proposed dose of 0.075 mg. The
incidence, pattern, and intensity of adverse events were similar among all
treatment groups including placebo, and the most frequently observed side
effects were headache and constipation.



About Post-Operative Nausea and Vomiting (PONV)

    Post-operative nausea and vomiting are common consequences of anesthetic
and surgical procedures, frequently occurring immediately following the
procedure and up to 72 hours post procedure. 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(R) Injection

    Aloxi is currently being evaluated in a clinical program designed to
evaluate its safety and efficacy in post-operative nausea and vomiting, but
it is not approved for this indication. 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 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%). Please see the
Aloxi package insert, available www.mgipharma.com and www.aloxi.com, for
important additional details.



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.



    
    HELSINN Healthcare Contact: 
    Rachid BenHamza, Ph.D., 
    Commercial Operations
    Tel: +41-91-9852121
    E-mail: [email protected] 






                                        

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