MGI PHARMA And SuperGen Provide Regulatory Status Updates For Dacogen(TM) (Decitabine) Injection For MDS; Approvable Letter Resp
15 Noviembre 2005 - 8:27AM
Business Wire
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withdrawn the Marketing Authorization Application for Dacogen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
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.
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