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MGI PHARMA and SuperGen Announce Signing of a Worldwide License Agreement for Dacogen.


MINNEAPOLIS & DUBLIN, Calif. -- MGI MGI Mouse Genome Informatics
MGI Modular Gateway Interface
MGI McKinsey Global Institute
MGI Military Geographic Information
MGI Marine Geological Institute
MGI Policy on the Management of Government Information (Canada) 
 PHARMA, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic.

Antonym: dec.
. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG SUPG Streamline Upwind Petrov Galerkin ) today announced that they have signed a definitive agreement granting MGI PHARMA exclusive worldwide rights to the development, manufacture, commercialization and distribution of Dacogen(TM) (decitabine), SuperGen's investigational anti-cancer therapeutic for the treatment of patients with myelodysplastic syndromes or MDS MDS,
n See temporomandibular pain-dysfunction syndrome.

MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there
.

Under the terms of this agreement, MGI PHARMA will make a $40 million equity investment in SuperGen at $10.00 per share and will pay SuperGen up to $45 million based upon achievement of specified regulatory and commercialization milestones. SuperGen will continue with its filing of the MDS applications for regulatory approval in the U.S. and Europe with assistance from MGI PHARMA. SuperGen will receive a royalty on worldwide net sales starting at 20% and escalating to a maximum of 30%. MGI PHARMA has also committed to fund further development costs associated with Dacogen, at a minimum of $15 million. The transaction is subject to customary closing conditions and regulatory approval. Additional financial terms and details of the agreement were not disclosed. UBS Investment Bank acted as exclusive advisor to MGI PHARMA in this transaction. The Kriegsman Group, A Division of QA3 Financial Corp, acted as exclusive advisor to SuperGen.

"We are very pleased to announce this agreement with SuperGen and to advance the development of this important product candidate, Dacogen," said Lonnie Moulder moul·der  
v. Chiefly British
Variant of molder.


moulder or US molder
Verb

to crumble or cause to crumble, as through decay:
, President and Chief Executive Officer of MGI PHARMA. "We believe that it may eventually offer patients with a variety of hematologic hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 cancers an important treatment option."

"MGI PHARMA is a strong commercialization partner for Dacogen, and we are very pleased to have reached this agreement," said Dr. James Manuso, President and Chief Executive Officer of SuperGen. "We believe Dacogen now has the resources and support of a premier oncology biopharmaceutical company with the expertise to facilitate it reaching the cancer patients who most need it as expeditiously as possible."

SuperGen completed Phase III clinical trials of Dacogen in patients with MDS in March 2004. SuperGen and MGI will collaborate on the regulatory development process for Dacogen in MDS, and SuperGen expects to complete the 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  filing within the fourth quarter of 2004. MGI PHARMA plans to evaluate Dacogen for further development in several additional indications, including acute myeloid leukemia (AML AML - A Manufacturing Language ), chronic myelogenous leukemia Chronic myelogenous leukemia (CML)
Also called chronic myelocytic leukemia, malignant disorder that involves abnormal accumulation of white cells in the marrow and bloodstream.

Mentioned in: Bone Marrow Transplantation
 (CML 1. CML - A query language.

["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986].
2. CML - Concurrent ML.
), and sickle cell anemia sickle cell anemia
n.
A chronic, usually fatal inherited form of anemia marked by crescent-shaped red blood cells, occurring almost exclusively in Blacks, and characterized by fever, leg ulcers, jaundice, and episodic pain in the joints.
, as well as its use in combination with other anticancer agents for the treatment of various solid tumors. Alternative dosing schedules for Dacogen, including subcutaneous administration and more rapid intravenous infusions, are currently being evaluated in clinical studies.

MGI PHARMA Conference Call And Webcast Details

MGI PHARMA will host a conference call today, September 1, 2004 at 9:30 a.m. Eastern Time to discuss the three news releases issued by the Company this morning and the Company's updated financial guidance, and to answer questions from investors and analysts. Lonnie Moulder, president and chief executive officer of MGI PHARMA, will host the call. All interested parties are welcome to access the webcast via the Company's Web site at www.mgipharma.com. This audio webcast will be archived on the Company's Web site for a limited period of time.

About Dacogen

Dacogen is an investigational drug. It has not yet been 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 has been shown to have a broad spectrum of activity in several hematological malignancies as well as solid tumors. Dacogen belongs to a class of drugs called hypomethylating agents, with a unique mechanism of action. Methylation methylation,
n a phase-II detoxification pathway in the liver; methyl groups combine with toxins to rid the body of various substances.

methylation
(meth´
 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 in·ac·ti·vate
v.
1. To render nonfunctional.

2. To make quiescent.



in·acti·va
 or "silence" genes.

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 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, 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 in international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.

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.
 (generic brand of Mitomycin(R)); and SurfaceSafe(R) cleaner. For more information about SuperGen, please visit www.supergen.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 a submission for regulatory approval for Dacogen will be made in either the U.S. or Europe, in a timely fashion, if at all; if a regulatory submission for Dacogen is made whether the drug will be timely approved, 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 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Geographic Code:1USA
Date:Sep 1, 2004
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