SuperGen and MGI PHARMA Announce Acceptance of Dacogen(TM) MAA for Review by EMEA
25 Octubre 2004 - 8:02AM
PR Newswire (US)
SuperGen and MGI PHARMA Announce Acceptance of Dacogen(TM) MAA for
Review by EMEA DUBLIN, Calif., and MINNEAPOLIS, Oct. 25
/PRNewswire-FirstCall/ -- SuperGen, Inc. (NASDAQ:SUPG) and MGI
PHARMA, INC. (NASDAQ:MOGN) today announced that the European
Medicines Agency (EMEA) has accepted for review the Marketing
Authorization Application (MAA) for Dacogen(TM) (decitabine) for
injection. 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. "We are
pleased by the EMEA's response to our application for review of
Dacogen, and we look forward to working closely with the EMEA and
MGI PHARMA throughout the review process," stated Dr. James S.
Manuso, President and Chief Executive Officer of SuperGen.
"SuperGen remains committed to bringing Dacogen through the
regulatory approval process as quickly as possible, and we look
forward to completing the NDA submission to the U.S. Food and Drug
Administration." "The acceptance of the MAA for Dacogen is a key
step towards bringing this important product candidate to cancer
patients," commented Lonnie Moulder, President and Chief Executive
Officer of MGI PHARMA. "We look forward to the submission of the
NDA as the next key regulatory milestone for Dacogen." 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, and expect to
complete the NDA submission to the FDA during the fourth quarter of
2004. 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 a 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
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: 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: DATASOURCE: SuperGen, Inc.; MGI PHARMA,
INC. CONTACT: 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; or Jennifer Davis of MGI PHARMA -
Investors, +1-212-697-1976, , or David Melin of MGI PHARMA - Media,
+1-952-346-4749, Web site: http://www.supergen.com/
http://www.mgipharma.com/ http://aamds.org/
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