MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen(TM) (decitabine) Injection for MDS
15 Noviembre 2005 - 8:28AM
PR Newswire (US)
- Approvable Letter Response Submitted to FDA; Confirms Phase 3
Results - MINNEAPOLIS and DUBLIN, Calif., Nov. 15
/PRNewswire-FirstCall/ -- MGI PHARMA, INC. (NASDAQ:MOGN) and
SuperGen, Inc. (NASDAQ:SUPG) today provided an update on the
regulatory status for Dacogen(TM) (decitabine) injection in both
the United States and Europe. Approvable Letter Response Submitted
To FDA MGI PHARMA and SuperGen have submitted their response to the
Approvable Letter received for Dacogen injection to the U.S. Food
and Drug Administration (FDA). The Approvable Letter for Dacogen
injection, which was received on September 1, 2005, provided that
Dacogen injection is approvable pending the FDA's review of a
requested analysis of the transfusion requirements of patients
enrolled in the completed phase 3 trial, submission of certain
other information, and completion of labeling discussions. The
Companies believe that their response addresses all items noted in
the Approvable Letter. The response provided to the FDA by MGI
PHARMA and SuperGen confirms that the phase 3 trial of Dacogen
injection met its co-primary endpoint of overall response rate
(ORR) in patients with myelodysplastic syndromes (MDS). MGI PHARMA
and SuperGen intend to provide an update to investors regarding the
review timeline for Dacogen injection following receipt of feedback
from the FDA. European Regulatory Strategy Revised MGI PHARMA and
SuperGen have determined that additional clinical data will be
required to continue the review of Dacogen injection in Europe.
Therefore, the Companies have withdrawn the Marketing Authorization
Application for Dacogen injection. This revision in the European
regulatory strategy for Dacogen injection does not affect
regulatory strategies being pursued in the U.S. MGI PHARMA and
SuperGen will continue to work with European regulatory authorities
to determine the information required to support a resubmission of
the application, and anticipate resubmitting the application at a
later date. MGI PHARMA anticipates that next steps in the European
regulatory strategy may be finalized in collaboration with a
partner. About MDS Myelodysplastic syndromes, or MDS, are a group
of diseases that affects the bone marrow with the majority of cases
seen in patients over 60 years of age. Depending on the stage of
the disease, the life expectancy for patients diagnosed with MDS is
6 months to 5 years. In MDS, the bone marrow stops making healthy
blood cells and instead produces poorly functioning and immature
blood cells. People with MDS may experience a variety of symptoms
and complications, including anemia, bleeding, infection, fatigue
and weakness. Over time, MDS can progress to acute leukemia. The
Aplastic Anemia and MDS International Foundation currently
estimates that 20,000 to 30,000 new cases of MDS are diagnosed
annually in the U.S. Those patients with high-risk MDS may
experience bone marrow failure, which may lead to death from
bleeding and infection. 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, or
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. A phase 3
EORTC-sponsored trial is currently ongoing in Europe to evaluate
Dacogen injection in patients with MDS. In addition, MGI PHARMA is
currently conducting a pivotal program to evaluate Dacogen
injection in patients with AML. The New Drug Application (NDA) is
currently under review by the FDA in the U.S. 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, for MGI PHARMA, INC., +1-212-845-4268, ; or Timothy L. Enns,
of SuperGen, Inc., +1-925-560-0100 x111, ; or Sharon Weinstein, of
Noonan Russo, for SuperGen, Inc., +1-212-845-4271, Web site:
http://www.supergen.com/ http://www.mgipharma.com/
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