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Dacogen NDA Accepted for Filing by FDA
MINNEAPOLIS & DUBLIN, Calif.--(BUSINESS WIRE)--Jan. 3, 2005--MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) today announced that the New Drug Application (NDA) for Dacogen(TM) (decitabine) for injection was accepted for filing by the United States Food and Drug Administration (FDA).
The NDA for Dacogen injection was submitted to the FDA on November 1, 2004. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Dacogen injection. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by September 1, 2005. During October 2004 the Marketing Authorization Application (MAA) for Dacogen injection was submitted and is currently under review by the European Medicines Agency (EMEA).
As previously reported, the NDA included clinical data from one phase 3 clinical trial of Dacogen injection in MDS patients in addition to two phase 2 studies. The co-primary endpoints of the phase 3 study were response rate and time to AML transformation or death. The phase 3 trial achieved the co-primary endpoint of overall response rate. Patients in the Dacogen arm had a response rate of 17% as determined by intent to treat (ITT) analysis, compared to a 0% response rate for patients who received supportive care (p less than 0.001). Responses were durable and lasted a median of nine months, and all patients who responded to Dacogen therapy remained or became transfusion independent. Median time to progression to AML or death was 340 days for patients treated with Dacogen injection, compared to a median of 219 days for patients in the supportive care arm, which was not statistically significant.
"This NDA filing represents the achievement of another key regulatory milestone for both MGI PHARMA and SuperGen in our quest for marketing approval of Dacogen injection," said Lonnie Moulder, president and chief executive officer of MGI PHARMA. "We remain committed to bringing this important product to patients as quickly as possible and to exploring the breadth of its clinical potential. We look forward to initiating a phase 3 study of Dacogen injection in AML patients in early 2005."
"We are very pleased that the Dacogen NDA has been accepted for review," said Dr. James Manuso, president and chief executive officer of SuperGen. "We believe that Dacogen injection will become an important treatment option for hematologic cancer patients."
About Dacogen(TM) Injection
Dacogen injection is an investigational drug that belongs to a class of drugs called DNA methyltransferase inhibitors. DNA methylation is a process in which methyl (CH3) groups are added to DNA to inactivate or "silence" genes. 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. In clinical trials, Dacogen injection has been shown to have a broad spectrum of activity in several hematological malignancies as well as solid tumors.
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 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 sulfate) 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 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 either Company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, whether Dacogen injection will be approved in a timely manner, if at all; 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 supply; 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 Form 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: MGI PHARMA
Jennifer Davis, 212-697-1976
IR@mgipharma.com
or
SuperGen, Inc.
Timothy L. Enns, 925-560-0100 ext. 111
tenns@SuperGen.com
or
Euro RSCG Life NRP
Sharon Weinstein, 212-845-4271
sharon.weinstein@eurorscg.com
SOURCE: MGI PHARMA
Dacogen -Decitabine- for Injection Data Presented at American Society of Hematology -ASH- Annual Meeting
SAN DIEGO--(BUSINESS WIRE)--Dec. 6, 2004--MGI PHARMA, INC. (Nasdaq:MOGN):
-- Final Phase 3 data in MDS presented
-- Activity in other hematologic cancers reported
MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) today provided a summary of the Dacogen(TM) (decitabine) for Injection presentations made during the American Society of Hematology (ASH) 46th Annual Meeting and Exposition. Dacogen injection was the subject of four oral presentations, five poster presentations, and two published abstracts at the meeting. Final results of a Phase 3 study of Dacogen injection in patients with myelodysplastic syndrome (MDS) and of a trial of three different dosing regimens for Dacogen injection were among the data presented, in addition to data from clinical studies in acute myelogenous leukemia (AML) and chronic myelogenous leukemia (CML).
Final Phase 3 Data Demonstrates Activity in MDS
Final results of a randomized, double blind, Phase 3 study of Dacogen injection were presented in an oral presentation on Sunday, December 5. The co-primary endpoints of this study were overall response rate (as defined by International Working Group (IWG) criteria) and time to AML progression or death. Patients in this study were randomized to receive Dacogen injection plus supportive care or supportive care alone. Dacogen injection was administered intravenously over three hours at a dose of 15 mg/m2 every eight hours for three consecutive days. Secondary endpoints included duration of response, cytogenetic response rate, transfusion requirements, quality of life, survival, and safety.
The overall response rate (complete responses plus partial responses) for patients treated with Dacogen injection, inclusive of independent and blinded review, was 17% with a median response duration of 266 days, compared to 0% in the supportive care arm (p less than 0.001). For all patients in the Dacogen arm, median time to progression or death was 340 days vs. 219 days for patients who received only supportive care. The response rates for patients classified as high risk, intermediate-2, or intermediate-1 were 13%, 21% and 14%, respectively. All patients who responded to Dacogen treatment were transfusion independent and had higher quality of life scores for several parameters, including improvement of global health status, physical functioning, fatigue, and dyspnea. The primary toxicity associated with Dacogen treatment was myelosuppression, including neutropenia, thrombocytopenia, and anemia.
"Dacogen injection demonstrated significant activity in the treatment of MDS patients," stated Dr. Jean-Pierre Issa of the University of Texas MD Anderson Cancer Center. "Patients who responded to Dacogen therapy showed sustained improvements in several aspects of physical health, including transfusion independence, and quality of life measures such as physical functioning and fatigue."
Three-Arm Study Demonstrates Activity of Several Dosing Options in MDS
Interim results of a study designed to compare three different dosing regimens for Dacogen injection were presented in a poster session on Saturday, December 4. MDS patients in this study were randomized to receive one of three Dacogen regimens every four to six weeks: 1) a 20 mg/m2 intravenous one hour infusion once per day for five days; 2) a 10 mg/m2 one hour intravenous infusion once per day for 10 days; or 3) a 10 mg/m2 subcutaneous dose of Dacogen injection twice per day for five days. Of the 51 evaluable patients, the overall response rate was 43%; including a 35% complete response rate and an 8% partial response rate by IWG criteria. In the 21 patients treated with a 20 mg/m2 intravenous Dacogen infusion once per day for five days, the complete response rate was 48%. For those patients who received a 10 mg/m2 one hour intravenous Dacogen infusion once per day for 10 days, the complete response rate was 24%. The complete response rate for patients who were treated with a 10 mg/m2 subcutaneous dose of Dacogen injection twice per day for five days was 28%. Adverse events were primarily a result of myelosuppression and included fever (7%) and infection (12%). These data support the hypothesis that these alternative Dacogen regimens are active in treating MDS patients and may offer dose scheduling flexibility.
MDS Re-Dosing Study Describes Dacogen Activity Following Relapse
Interim results from a re-dosing study were presented in a poster session on Saturday, December 4 and included data from 22 MDS patients who responded to Dacogen therapy (12 CRs, 6 PRs, and 4 HIs) and were later re-treated with Dacogen injection after MDS relapse. Re-treatment of these patients began a median of 11 months after their last course of Dacogen therapy. During retreatment, patients received a median of 3 courses of Dacogen therapy which resulted in a 45% overall response rate.
Additional Clinical Activity Observed in CML
Preliminary results of a Phase 2 study of Dacogen injection in Gleevec(R) (imatinib) refractory or intolerant patients with CML were presented on Monday, December 6. Dacogen injection was administered to 35 patients intravenously at a dose of 15 mg/m2 once per day, five days per week for two weeks. The overall hematologic response rate was 65%, including 12 patients who had complete hematologic responses, 7 who had hematologic responses, and 4 who experienced hematologic improvement. The overall cytogenetic response rate, including both major and minor responses, was 46%. The most common grade 3 and 4 toxicities were related to myelosuppression.
"In addition to showing activity in patients with MDS, Dacogen injection has shown clinical activity in a broad range of other hematologic malignancies, including AML and CML and certain solid tumors," said Lonnie Moulder, president and CEO of MGI PHARMA. "We look forward to beginning a Phase 3 trial of Dacogen injection in AML in early 2005."
Below is the list of all Dacogen injection abstracts presented at the 2004 ASH annual meeting:
Oral Presentations
------------------
Abstract Number: 67
First Report of the Phase III North American Trial of Decitabine in
Advanced Myelodysplastic Syndrome (MDS).
Sunday, December 5, 2004, 4:30 PM
Abstract Number: 263
Results of a Phase I/II Study of the Combination of
5-aza-2'-deoxycytidine (DAC) and Valproic Acid (VPA) in Patients (pts)
with Leukemia.
Monday, December 6, 2004, 11:00 AM
Abstract Number: 378
The Effect of Decitabine on Covalent Histone Modifications of
Chromatin Associated with Globin Gene Promoters in the Baboon (P.
anubis).
Monday, December 6, 2004, 11:00 AM
Abstract Number: 204
Identification of Putative New Tumor Suppressor Genes in Highly
Purified CD34+ Bone Marrow Cells from Patients with Myelodysplastic
Syndromes.
Monday, December 6, 2004, 7:30 AM
Poster Presentations
--------------------
Abstract Number: 1437
Decitabine Low-Dose Schedule (100 mg/m2/course) in Myelodysplastic
Syndrome (MDS). Comparison of 3 Different Dose Schedules.
Saturday, December 4, 2004, 6:00 PM
Abstract Number: 2956
Hypomethylation Dynamics Following Decitabine Therapy in Chronic
Myelogenous Leukemia.
Monday, December 6, 2004, 5:30 PM
Abstract Number: 1447
Re-Treatment with Low-Dose 5-Aza-2'-Deoxycytidine (Decitabine) Results
in Second Remissions of Previously Responsive MDS Patients.
Saturday, December 4, 2004, 6:00 PM
Abstract Number: 1165
AML1/ETO Expresssion in Myeloid Leukemia Cells Is Associated with
Enhanced Growth-Inhibitory and P15/INK4b Demethylating Effects of
5-aza-2'-deoxycytidine.
Saturday, December 4, 2004, 6:00 PM
Abstract Number: 1166
5'-AZA-2'-Deoxycytidine Induces p21/WAF Expression by Demethylation of
p73 Leading to p53-Independent Apoptosis in Myeloid Leukemia.
Saturday, December 4, 2004, 6:00 PM
Publication Only
----------------
Abstract Number: 4528
Decitabine-Induced Differentiation Syndrome in a Patient with Acute
Myeloid Leukemia: A Case Report.
Abstract Number: 4707
Effect of 5-Aza-2'-Deoxycytidine in High-Risk Myelodysplasia Cells In
Vitro.
About Dacogen Injection
Dacogen injection is an investigational drug that 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 to inactivate or "silence" genes. It 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. In clinical trials, Dacogen injection has been shown to have a broad spectrum of activity in several hematological malignancies as well as solid tumors.
The new drug application (NDA) for Dacogen injection was submitted to the United States Food and Drug Administration during the fourth quarter of 2004. The Marketing Authorization Application (MAA) for Dacogen injection has been accepted for review by the European Medicines Agency (EMEA).
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 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 sulfate) 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 to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.
Gleevec(R) is a trademark of Novartis Pharmaceuticals Corporation.
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 either Company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, whether Dacogen injection will be approved in a timely manner, if at all; 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 supply; 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 Form 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: MGI PHARMA
Investors:
Jennifer Davis, 212-697-1976
IR@mgipharma.com
or
MGI PHARMA
Media:
David Melin, 952-346-4749
media@mgipharma.com
or
SuperGen, Inc.
Timothy L. Enns, 925-560-0100 x111
tenns@SuperGen.com
or
For SuperGen:
Euro RSCG Life NRP
Sharon Weinstein, 212-845-4271
sharon.weinstein@eurorscg.com
SOURCE: MGI PHARMA, INC.
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