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Helsinn Healthcare SA

Helsinn Healthcare and MGI PHARMA announce submission of supplemental new drug application for Aloxi® oral capsules

Lugano (ots)

Oral Formulations of 5-HT3 receptor Antagonists
Represent Approximately 10% of the Day-of-Chemotherapy Market -
Helsinn Healthcare SA, a privately owned Swiss pharmaceutical
group, and its partner MGI PHARMA, INC., (Nasdaq: MOGN), a
biopharmaceutical company focused in oncology and acute care, today
announced that a supplemental New Drug Application (sNDA) for Aloxi®
(palonosetron hydrochloride) Capsules for oral administration has
been submitted to the U.S. Food and Drug Administration (FDA). Aloxi
Injection 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
submission includes results from a multicenter, double-blind, dose
ranging trial in 651 patients receiving moderately emetogenic
chemotherapy (MEC). Patients were stratified by gender and history of
chemotherapy and were randomly assigned to receive one of three doses
of oral Aloxi (0.25 mg, 0.50 mg, or 0.75 mg) or a single intravenous
(IV) 0.25 mg dose of Aloxi. The primary objective of the study was to
determine an oral dose which was non-inferior to the IV 0.25 mg dose
of Aloxi. Endpoints of the trial included complete response (CR; no
emesis, no rescue therapy) at multiple time intervals.
Overall, results of the study indicate that the 0.50 mg oral dose
of Aloxi was non-inferior to the 0.25 mg IV dose at inducing a CR
during both the early (0-24 hr) and delayed phases (0-48, 0-72, 0-120
hr) following administration of MEC. Specifically, CR rates for the
0.50 mg dose of oral Aloxi were 76.3% and 58.8% for the 0-24 hours
and 0-120 hours time periods versus 70.4% and 59.3% for the 0.25 mg
IV dose of Aloxi, respectively.
Adverse events were similar in nature and rate for the oral and IV
Aloxi groups and typical for this class of drug (headache and
constipation). Results from this trial were presented on September
26, 2007, at the 14th European Cancer Conference.
"Helsinn is extremely pleased with this submission as it
represents an important step in broadening the Aloxi franchise", said
Dr. Sergio Cantoreggi, Senior Director, Research & Development of
HELSINN HEALTHCARE SA. "We believe an oral formulation of Aloxi may
offer important benefits to the medical community and cancer
patients".
"The submission of the sNDA for an oral formulation of Aloxi
represents another key milestone in the efforts of Helsinn Healthcare
and MGI to seek indications that expand the Aloxi label and
accelerate the growth of the Aloxi franchise" said Mary Lynne Hedley,
Executive Vice President and Chief Scientific Officer of MGI PHARMA.
"We believe Aloxi's unique pharmacodynamic profile and long-lasting
activity would be desirable in clinical settings where an oral
formulation may be preferred"
About Aloxi® (palonosetron hydrochloride) 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 for the
prevention of delayed 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. Please see the Aloxi package insert, available at
www.mgipharma.com and www.aloxi.com, for important additional
details.
About MGI PHARMA
MGI PHARMA, INC. is a biopharmaceutical company focused in
oncology and acute care that acquires, researches, develops, and
commercializes proprietary products that address the unmet needs of
patients. MGI PHARMA markets Aloxi® (palonosetron hydrochloride)
Injection, Dacogen® (decitabine) for Injection, and Gliadel® Wafer
(polifeprosan 20 with carmustine implant) in the United States. The
Company directly markets its products in the U.S. and collaborates
with partners to reach international markets. For more information
about MGI PHARMA, please visit www.mgipharma.com.
About HELSINN HEALTHCARE
Helsinn HEALTHCARE SA, a privately owned pharmaceutical group with
headquarters in Switzerland, 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 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 and Supportive Care
Phone: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com

MGI PHARMA
Timothy J. Smith
Phone: +1/952/406'31'00
E-Mail: IR@mgipharma.com

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