SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen™

SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen(TM) DUBLIN, Calif., June 1 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG) today announced that it has submitted the Chemistry, Manufacturing and Controls (CMC) section as the first component of its New Drug Application (NDA) for Dacogen ™ (decitabine) for injection to the United States Food and Drug Administration (FDA). SuperGen was granted "rolling submission" status for its NDA in April of this year. Dacogen is the company's investigational agent for the treatment of myelodysplastic syndromes (MDS), a cancer of the bone marrow that can be fatal. The Company intends to complete the NDA submission within the third quarter of 2004, during which the remaining sections of the NDA will be submitted. "Completing submission of the NDA for Dacogen is one of our top priorities, and this event marks a major milestone in this process," stated Dr. Audrey Jakubowski, Senior Vice President Regulatory Affairs and Quality Assurance. "I am confident that our application will be completed within the third quarter. We are working very closely with the Oncology Division of the FDA to manage the review of two applications in the same calendar year: Dacogen for MDS and Orathecin ™ (rubitecan) capsules, for pancreatic cancer which was submitted on January 26th." A rolling NDA is a process used by the FDA to expedite the review of a drug intended for the treatment of a serious or life threatening condition. This allows the FDA to more efficiently utilize its resources to complete a timely review. SuperGen obtained FDA agreement to submit this rolling NDA based on "Fast Track" status granted in April, 2003. About SuperGen Based in Dublin, Calif., SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders. The company's website can be reached at http://www.supergen.com . This press release contains "forward -looking" statements within the meaning of section 21A of the Securities Act of 1933, as amended, and section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created thereby. Such forward -looking statements include statements related to our expectations regarding Dacogen. The success of such product could differ materially from those discussed in the forward -looking statements as a result of known and unknown risk factors and uncertainties. Such factors include, but are not limited to: risks and uncertainties related to whether the Company will submit a complete NDA application to the FDA within the third quarter, or at all, whether the FDA will accept the NDA filing for substantive review, whether additional clinical data will be needed before the FDA will approve the drug for commercialization or whether Dacogen will receive regulatory approval for any indication. References made to the discussion of the risk factors are detailed in the Company's filing with the Securities and Exchange Commission including the report on Form 10-Q for the quarter ended March 31, 2004. These forward -looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward -looking statements, whether as a result of new information, future events or otherwise. Contacts: SuperGen, Inc. Euro RSCG Life NRP Timothy L. Enns Sharon Weinstein (925) 560-0100 x111 (212) 845-4271 [email protected] [email protected] SOURCE SuperGen, Inc. 06/01/2004 Web site: http://www.supergen.com

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