Mgi Pharma (MM) (NASDAQ:MOGN)
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MGI PHARMA, INC. (Nasdaq:MOGN), a biopharmaceutical company focused in
oncology and acute care, and its partner HELSINN HEALTHCARE SA, a
privately owned Swiss pharmaceutical group, today announced that a
supplemental New Drug Application (sNDA) for Aloxi®
(palonosetron hydrochloride) Capsules for oral administration was
accepted for filing by 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 for Aloxi Capsules was submitted to the FDA on October 24,
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 Capsules for oral administration. Under PDUFA
(Prescription Drug User Fee Act) III, the FDA's goal is to review and
act on the NDA by August 22, 2008.
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 HELSINN HEALTHCARE
HELSINN is a privately owned pharmaceutical group with headquarters in
Switzerland. Helsinn’s core business is the
licensing of pharmaceuticals in therapeutic areas (oncology, cancer
supportive care, pain and inflammation, gastrointestinal). The company's
business strategy is to in-license early-stage new chemical entities and
to 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 worldwide consolidated
network of partners for distribution. Helsinn’s
key products in the US are Aloxi®
(palonosetron), distributed by MGI Pharma and Gelclair®.
The active pharmaceutical ingredients and the drug products are
manufactured at Helsinn’s cGMP facilities and
supplied worldwide to its customers. Helsinn’s
chemical business focuses on the pharmaceutical chemical process
development and manufacturing of advanced intermediates, Active
Pharmaceutical Ingredients (APIs) and High Potency Active Ingredients
(HPAIs) for both the Helsinn group and its outsourcing partners. For
more information about Helsinn, please visit www.helsinn.com
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.
This news release contains certain “forward-looking”
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements are typically preceded by
words such as “believes,”
“expects,” “anticipates,”
“intends,” “will,”
“may,” “should,”
or similar expressions. These forward-looking statements are not
guarantees of MGI PHARMA’s future performance
and involve a number of risks and uncertainties that may cause actual
results to differ materially from the results discussed in these
statements. Factors that might cause MGI PHARMA's results to
differ materially from those expressed or implied by such
forward-looking statements include, but are not limited to, the
determinations by FDA regarding the safety or efficacy of Aloxi
Injection and other risks and uncertainties detailed from time to time
in MGI PHARMA’s filings with the
Securities and Exchange Commission including its most recently filed
Form 10-K and Form 10-Q. MGI PHARMA undertakes no duty to update
any of these forward-looking statements.