Dacogen(TM) (Decitabine) Injection Complete Response Accepted for Review by U.S. FDA
15 Diciembre 2005 - 3:37PM
PR Newswire (US)
MINNEAPOLIS and DUBLIN, Calif., Dec. 15 /PRNewswire-FirstCall/ --
MGI PHARMA, INC. (NASDAQ:MOGN) and SuperGen, Inc. (NASDAQ:SUPG)
today announced that the U.S. Food and Drug Administration (FDA)
has accepted the Companies' resubmission as of November 15, 2005 as
a complete response to the Approvable Letter for Dacogen(TM)
(decitabine) injection for myelodysplastic syndromes (MDS). The
resubmission has been classified by the FDA as a Class 2 response,
and the FDA has established a user fee goal to review this response
by May 15, 2006. About Dacogen(TM) (Decitabine) Injection Dacogen
injection is a product candidate that belongs to a class of drugs
called hypomethylating agents that is currently being evaluated in
a broad clinical development program in patients with MDS, acute
myeloid leukemia (AML), chronic myelogenous leukemia (CML), and
solid tumors. Dacogen injection is not 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. The Dacogen injection New
Drug Application (NDA) is under review by the FDA for the MDS
indication. A phase 3 EORTC-sponsored trial is currently ongoing in
Europe to evaluate Dacogen injection in patients with MDS. MGI
PHARMA is conducting a pivotal program to evaluate Dacogen
injection in patients with AML. Additional clinical studies are
also underway in patients with MDS to evaluate alternative dosing
regimens for Dacogen injection. 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 being evaluated for the treatment
of pancreatic cancer; Nipent(R) (pentostatin for injection),
approved for the treatment of hairy- cell leukemia; Mitomycin, for
use in the therapy of disseminated adenocarcinoma of the stomach or
pancreas in proven combinations with other approved
chemotherapeutic agents and as a palliative treatment when other
modalities have failed; and SurfaceSafe(R) cleaner. For more
information about SuperGen, please visit http://www.supergen.com/.
About MGI PHARMA MGI PHARMA, INC. is an oncology and acute care
focused biopharmaceutical company that acquires, researches,
develops and commercializes proprietary products that address the
unmet needs of patients. MGI PHARMA markets Aloxi(R) (palonosetron
hydrochloride) injection and Gliadel(R) 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 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. 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 the Companies' results to differ materially from
those expressed or implied by such forward-looking statements
include, but are not limited to, the ability of MGI PHARMA's and
SuperGen's product candidates to be proven safe and effective in
humans, to receive marketing authorization from regulatory
authorities, and to ultimately compete successfully with other
therapies; continued sales of MGI PHARMA's and SuperGen's marketed
products; development or acquisition of additional products;
reliance on contract manufacturing; changes in strategic alliances;
continued access to capital; and other risks and uncertainties
detailed from time to time in the Companies' 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. CONTACT: For further information about MGI
PHARMA, please contact: Jennifer M. Davis Robert Stanislaro MGI
PHARMA, INC. Noonan Russo Tel: (212) 332-4381 Tel: (212) 845-4268
E-mail: E-mail: For further information about SuperGen, please
contact: Timothy L. Enns Sharon Weinstein SuperGen, Inc. Noonan
Russo Tel: (925) 560-0100 x111 Tel: (212) 845-4271 E-mail: E-mail:
DATASOURCE: SuperGen, Inc. CONTACT: Jennifer M. Davis of MGI
PHARMA, INC., +1-212-332-4381, ; or Robert Stanislaro of Noonan
Russo, +1-212-845-4268, , for MGI PHARMA, INC.; or Timothy L. Enns
of SuperGen, Inc., +1-925-560-0100 x111, ; or Sharon Weinstein of
Noonan Russo, +1-212-845-4271, , for SuperGen, Inc. Web site:
http://www.supergen.com/ http://www.mgipharma.com/
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