Category: Uncategorized
March 10, 2004

News Release: SuperGen Releases Interim Data Clarification From Dacogen(TM) Phase III Clinical Study in Myelodysplastic Syndrome Following Analyst/Investigator Conference Call

SuperGen Inc. (Nasdaq: SUPG) today announced that the Company has released the Kaplan-Meyer curves from the primary interim analysis that was performed on the first forty-five events in the 170-patient Phase III clinical study of Dacogen(TM) (decitabine) injection in myelodysplastic syndrome (MDS). This data is being released at this time due to an unintentional disclosure of interpretive analysis related to the Kaplan-Meyer curves by a SuperGen Scientific Advisory Board member during a non-SuperGen conference call at approximately 4:30 p.m. (EST) yesterday, March 9th, between the advisory board member and a group of investors. The Company previously released an interim analysis of the Phase III clinical study and discussed its analysis of that data during its February 13th, 2004 conference call. The interim analysis of the data previously released by the Company and relating to the first forty-five events revealed that those receiving Dacogen had an increased time to acute myelogenous leukemia (AML) or death (median 105 days versus 92 days, P=0.036), which is the primary end point of the study. This analysis was based on data from 19 high-risk, 18 intermediate 2, and 8 intermediate 1 patients, as defined by the International Prognostic Scoring System (IPSS) that is used to classify MDS patients.

By contrast, the Kaplan-Meyer curves, available at www.supergen.com, are based on data derived from all 170 patients at the time point of the 45th event. The median calculations listed above, and previously disclosed by SuperGen, are based on only data derived from the 45 patients with events. The Kaplan-Meyer curves do not have a formal calculated median, but extrapolation from the 50 percent of patients alive without AML produces significantly different results than calculating the median of the first 45 patients and is not intended to be predictive of and may not be consistent with the final results on all 170 patients. Accordingly, the advisory board member based his analysis and conclusions on different data (i.e., the Kaplan-Meyer curves) than that used by the Company (the median of the first 45 events) in preparing its previously disclosed median calculations. Thus the advisory board member's median extrapolations are not consistent with SuperGen's interim data median calculations and neither set of conclusions is intended to be predictive of the final results of this study, which are planned for release later this month.

The Company also announced that it will hold a conference call to discuss these results later today, Wednesday, March 10th at 4:15 p.m. (EST) / 1:15 p.m. (PST). Dr. James Manuso, President and Chief Executive Officer, and Edward L Jacobs, Chief Operating Officer, will host the call with participation by Craig Rosenfeld, M.D., Karl Mettinger, M.D., Ph.D., Senior Vice President and Chief Medical Officer; and, Michael Molkentin, Chief Financial Officer. To participate in the call, please dial 888-371-8859 approximately ten minutes prior to the scheduled start time. Those who do not wish to participate may listen to the 'web cast'of the conference call by visiting www.supergen.com. An audio recording of the call will be available on the web site for 90 days.

'The interim analysis, regardless of how it is calculated or extrapolated, is based on limited preliminary data representing less than half of the currently available data and is not predictive of the final outcome of the trial. We are working diligently to complete final data analysis later this month,'said Dr. James Manuso, President and Chief Executive Officer of SuperGen.

Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapeutic anticancer products. The Company's website can be reached at 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 completing the Phase III clinical trial in patients with myelodysplastic syndrome, whether any of the interim analyses will be consistent with the final study results, whether Dacogen will demonstrate any clinical benefit in this Phase III trial or any future study in this patient population and whether the company will submit or receive regulatory approval for Dacogen 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-K for the year ended December 31, 2003. 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.

SOURCE SuperGen Inc.

Tim Enns, Vice President, Investor Relations &Business Development of SuperGen Inc., +1-800-353-1075, ext. 111

http://www.supergen.com

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