SuperGen Provides Additional Analysis of Response Data from Phase III Study of Dacogen in MDS

SuperGen Provides Additional Analysis of Response Data from Phase III Study of Dacogen in MDS DUBLIN, Calif., May 24 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG) today presented an update on results from the Company's randomized Phase III study of Dacogen™ (decitabine) for injection, its investigational treatment for myelodysplastic syndromes (MDS), at the UBS Specialty Pharmaceuticals Conference in New York. The presentation, which included new additional subset analysis of investigators' evaluation of clinical responses, indicated an average patient objective response rate (partial and complete) of 25 percent. In the 170-patient study, 89 patients were randomized to Dacogen plus supportive care and 81 patients were randomized to supportive care only. The additional analysis (chart below) shows that the overall patients' response to Dacogen therapy was 25 percent. Further subset analysis showed that treatment with Dacogen achieved the following positive responses in all specific subtypes of MDS: 17 percent of patients with chronic myelomonocytic leukemia (CMML); 25 per cent of patients with refractory anemia (RA); 26 percent of patients with RA with excess blasts (RAEB); 29 percent of patients with RAEB in transformation (RAEB-T); and 14% of those with RA with ringed sideroblasts (RARS). "We are pleased to be able to provide this additional analysis of our phase III study," stated Dr. James Manuso, President and Chief Executive Officer of SuperGen. "Data for this analysis has now been locked and will be part of the rolling NDA submission that will start this quarter and is projected to be completed in the third quarter." DACOGEN TREATMENT GROUP SUPPORTIVE CARE GROUP All CR/PR # Patients Response CR/PR # Patients Response Patients Rate % Rate % CMML 1 6 17% 0 8 0% RA 3 12 25% 0 12 0% RAEB 12 47 26% 0 43 0% RAEB-T 5 17 29% 0 14 0% RARS 1 7 14% 0 4 0% TOTAL 22 89 25% 0 81 0% Adverse events were observed in patients receiving Dacogen more frequently than patients randomized to receive supportive care alone. The most frequent adverse events were observed to be nausea, constipation, diarrhea, vomiting, pneumonia, arthralgia, headache and insomnia. Severe adverse events observed more frequently in patients randomized to Dacogen, categorized as Grade 3 or 4, were leucopenia and febrile neutropenia. The rates of Grade 3 -4 sepsis were similar (8 percent in the Dacogen arm versus 6 percent in the supportive care only arm). Overall adverse events for Dacogen treated patients were similar to previously reported phase II studies in MDS. 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 an NDA application to the FDA before the end of 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. Timothy L. Enns 925-560-0100 x111 [email protected] Euro RSCG Life NRP Sharon L. Weinstein 212-845-4271 [email protected] SOURCE SuperGen, Inc.

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