Printer Friendly
The Free Library
19,607,059 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Dacogen NDA Accepted for Filing by FDA.


MINNEAPOLIS & DUBLIN, Calif. -- MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) today announced that the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Dacogen(TM) (decitabine) for injection was accepted for filing by the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
).

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 PDUFA Prescription Drug User Fee Act of 1992 (USA)  (Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. ) 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 MAA
abbr.
macroaggregated albumin
) for Dacogen injection was submitted and is currently under review by the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.

Roughly parallel to the U.S.
 (EMEA).

As previously reported, the NDA included clinical data from one phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study.  of Dacogen injection in MDS MDS,
n See temporomandibular pain-dysfunction syndrome.

MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there
 patients in addition to two phase 2 studies. The co-primary endpoints of the phase 3 study were response rate and time to AML AML - A Manufacturing Language  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 hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 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 DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 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 mitomycin /mi·to·my·cin/ (mi?to-mi´sin)
1. any of a group of antitumor antibiotics (e.g., mitomycin A, B, C) produced by Streptomyces caespitosus.

2. mitomycin C; used as a palliative antineoplastic.
; 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 pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae).  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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Jan 3, 2005
Words:957
Previous Article:CoreValve Receives German Government's Approval to Initiate Clinical Trial Using Its ReValving System to Percutaneously Replace Diseased Aortic Heart...
Next Article:Tenet Completes Sale of Five Hospitals in California, Louisiana and Massachusetts.
Topics:



Related Articles
Bone Care International, Inc. Announces FDA Filing of NDA for Hectorol Injection.
FDA SPEEDS REVIEW OF NEW DRUG APPLICATIONS WITH ADOBE ACROBAT AND PDF.
Andrx's Metformin XT NDA Accepted for Filing by FDA.
MGI PHARMA and SuperGen Announce Signing of a Worldwide License Agreement for Dacogen.
SuperGen and MGI PHARMA Announce Acceptance of Dacogen MAA for Review by EMEA.
SuperGen and MGI PHARMA Announce Submission of Dacogen NDA to U.S. FDA.
Approvable Letter Received from the FDA for Dacogen(TM) (Decitabine) Injection for the Treatment of MDS; Conference Call To Be Held At 5:15 PM ET...
MGI PHARMA Completes Acquisition of Guilford Pharmaceuticals.
MGI PHARMA And SuperGen Provide Regulatory Status Updates For Dacogen(TM) (Decitabine) Injection For MDS; Approvable Letter Response Submitted to...
Dacogen(TM) (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles