SuperGen and MGI PHARMA Announce Submission of Dacogen(TM) NDA to U.S. FDA
01 Noviembre 2004 - 7:02AM
PR Newswire (US)
SuperGen and MGI PHARMA Announce Submission of Dacogen(TM) NDA to
U.S. FDA DUBLIN, Calif. and MINNEAPOLIS, Nov. 1
/PRNewswire-FirstCall/ -- SuperGen, Inc. (NASDAQ:SUPG) and MGI
PHARMA, INC. (NASDAQ:MOGN), today announced that the full New Drug
Application (NDA) seeking approval of Dacogen(TM) (decitabine) for
injection has been submitted to the U.S. Food and Drug
Administration (FDA) for its review. Dacogen is an investigational
anti-cancer therapeutic for the treatment of patients with
myelodysplastic syndromes or MDS. MGI PHARMA has exclusive
worldwide rights to the development, manufacture, commercialization
and distribution of Dacogen. "SuperGen is delighted to achieve this
key U.S. regulatory milestone for Dacogen," said Dr. James Manuso,
President and Chief Executive Officer of SuperGen. "Thanks to the
valuable assistance from our partner MGI PHARMA and the diligent
efforts of the entire SuperGen team, we completed our submission of
the Dacogen NDA early in the fourth quarter. We look forward to
FDA's response, and we remain committed to bringing Dacogen to
patients as quickly as possible." "Given today's announcement and
the recently announced acceptance for review of the Marketing
Authorization Application (MAA) for Dacogen by the European
Medicines Agency (EMEA), we look forward to working closely with
SuperGen and the regulatory authorities in both the U.S. and Europe
throughout the review processes," said Lonnie Moulder, President
and Chief Executive Officer of MGI PHARMA. SuperGen completed Phase
III clinical trials of Dacogen in patients with MDS in March 2004.
SuperGen and MGI PHARMA are collaborating on the regulatory
development process for Dacogen in MDS. MGI PHARMA plans to
initiate a Phase III trial of Dacogen for the treatment of acute
myelogenous leukemia (AML) in early 2005 and plans to evaluate
Dacogen for further development in other hematologic malignancies.
Alternative dosing schedules for Dacogen, including subcutaneous
administration and other intravenous infusion regimens, are
currently being evaluated in clinical studies. About Dacogen
Dacogen is an investigational drug. It has not yet been approved
for marketing in the U.S. or by other regulatory agencies in their
respective countries; therefore, safety and efficacy have not yet
been established in any patient population. In clinical trials,
Dacogen has been shown to have a broad spectrum of activity in
several hematological malignancies as well as solid tumors. Dacogen
belongs to a class of drugs called hypomethylating agents, with a
unique mechanism of action. Methylation is a process in which
methyl (CH3) groups are added to DNA, which may inactivate or
"silence" tumor suppressor genes. About MDS MDS is a cancer of the
bone marrow that is often fatal. Some cases of MDS progress to
leukemia. According to the Aplastic Anemia and MDS International
Foundation (http://aamds.org/), 20,000 to 30,000 new cases of MDS
are diagnosed annually in the United States. The number of new
cases diagnosed each year is increasing. The average life
expectancy for patients diagnosed with MDS is 6 months to 5 years,
depending on the severity of the disease. About SuperGen Based in
Dublin, California, SuperGen is a pharmaceutical company dedicated
to the acquisition, rapid development and commercialization of
therapies for solid tumors, hematological malignancies and blood
disorders. SuperGen's product portfolio includes Orathecin(TM)
(rubitecan) capsules, an investigational drug intended for the
treatment of pancreatic cancer; Nipent(R) (pentostatin for
injection); Mitomycin; and SurfaceSafe(R) cleaner. For more
information about SuperGen, please visit http://www.supergen.com/.
About MGI PHARMA MGI PHARMA, INC. is an oncology-focused
biopharmaceutical company that acquires, develops and
commercializes proprietary products that address the unmet needs of
cancer patients. MGI PHARMA has a portfolio of proprietary
pharmaceuticals, and intends to become a leader in oncology. MGI
PHARMA markets Aloxi(R) (palonosetron hydrochloride) injection,
KADIAN(R) (sustained release morphine capsules), Salagen(R) Tablets
(pilocarpine hydrochloride) and Hexalen(R) (altretamine) capsules
in the United States. The Company directly markets its products in
the U.S. and collaborates with partners in international markets.
For more information about MGI PHARMA, please visit
http://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, and include statements regarding the timing of the
submission of an NDA for Dacogen to the U.S. Food and Drug
Administration. These forward-looking statements are not guarantees
of MGI PHARMA's or SuperGen'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 either company's results to differ
materially from those expressed or implied by such forward-looking
statements include, but are not limited to, whether acceptance of
the NDA submission for regulatory approval for Dacogen will be made
in the U.S. in a timely fashion, if at all; whether the drug will
be timely approved, if at all in any country where a submission is
made; whether the drug, if approved will be successfully
commercialized; continued sales of MGI PHARMA's or SuperGen's other
marketed products; development or acquisition of additional
products; reliance on contract manufacturing and third party
suppliers; changes in strategic alliances; and other risks and
uncertainties detailed from time to time in either company's
filings with the Securities and Exchange Commission, including
their most recently filed Forms 10-Q or 10-K. MGI PHARMA and
SuperGen undertake no duty to update any of these forward- looking
statements to conform them to actual results. CONTACTS: For further
information about MGI PHARMA, please contact: Jennifer Davis David
Melin MGI PHARMA - Investors MGI PHARMA - Media Tel: (212) 697-1976
Tel: (952) 346-4749 E-mail: E-mail: For further information about
SuperGen, please contact: Timothy L. Enns Sharon Weinstein
SuperGen, Inc. Euro RSCG Life NRP Tel: (925) 560-0100 x111 Tel:
(212) 845-4271 E-mail: E-mail: DATASOURCE: SuperGen, Inc.; MGI
PHARMA, INC. CONTACT: Investors - Jennifer Davis, +1-212-697-1976,
, or Media - David Melin, +1-952-346-4749, , both for MGI PHARMA;
or Timothy L. Enns of SuperGen, Inc., +1-925-560-0100, ext. 111, ;
or Sharon Weinstein of Euro RSCG Life NRP, +1-212-845-4271, , for
SuperGen, Inc. Web site: http://aamds.org/
http://www.mgipharma.com/ http://www.supergen.com/
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