SuperGen Reports Results from Dacogen™ Phase III Study in Myelodysplastic Syndromes (MDS)

SuperGen Reports Results from Dacogen(TM) Phase III Study in Myelodysplastic Syndromes (MDS) Company anticipates completing 'rolling' NDA submission by end of third quarter DUBLIN, Calif., March 31 /PRNewswire-FirstCall/ -- SuperGen Inc. (Nasdaq: SUPG - ) today reported results from the Company's randomized Phase III study of Dacogen™ (decitabine) for injection as a treatment for myelodysplastic syndromes (MDS). The study enrolled 170 patients at 22 North American sites, with 89 randomized to Dacogen plus supportive care and 81 randomized to supportive care only. Supportive care included antibiotics, growth factors and/or transfusions. The data analysis was performed after 92 patients reached the primary endpoint of either progression to acute myelogenous leukemia (AML) or death. Patients randomized to the Dacogen arm had an increased time to progression to AML or death (p=0.042 Wilcoxon test, p=0.198 log-rank test), compared to patients randomized to supportive care only. Median time to progression to AML or death in Dacogen patients was 338 days versus 263 days in supportive care patients. The overall response rate for patients randomized to Dacogen was 22 percent (9 complete responses and 11 partial responses) compared to 0 percent in patients on supportive care only (p<0.001 Fisher exact test). All analyses were specified by the protocol. The Company and its clinical advisors believe that these data are clinically significant and will form the basis of a New Drug Application. More adverse events were reported for patients randomized to the Dacogen arm. Leucopenia and febrile neutropenia were observed more frequently in patients given Dacogen, as were 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). The mortality rate for patients on study is 12 percent for Dacogen and 9 percent for supportive care. This difference in mortality rates was not statistically significant. "We are very pleased with the outcome of this study," said Dr. James Manuso, President and Chief Executive Officer of SuperGen. "We anticipate completing the submission of a 'rolling' New Drug Application to the FDA in the third quarter of this year." 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. Additional data from the clinical study is included at the end of this news release. 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. 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 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-K as amended 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. Contact: Tim Enns, Vice President, Investor Relations & Business Development, SuperGen Inc., 800-353-1075, ext. 111 Selected data from the clinical study to follow ... Investigator's Assessments of Patients' Reponses on Intent to Treat Dacogen Supportive Care P-Values (N=89) (N=81) Best response on study Complete response 9 (10%) 0 <0.001(1) Partial response 11 (12%) 0** Hematological improvement 10 (11%) 0 Stable disease 33 (37%) 34 (42%) Progressive disease 15 (17%) 20 (25%) Not assessed for response* 11 (12%) 25 (31%) *Patients that withdrew from study prior to any response evaluation **Two patients had a partial response to Dacogen after progressing on supportive care (1)from 2-sided Fisher exact test for equal overall response rate (CR+PR) Investigator's Assessments of Patients' Reponses Evaluable for Response Dacogen Supportive Care P-Values (N=78) (N=56) Best response* Complete response 9 (12%) 0 <0.001(1) Partial response 11 (14%) 0** Hematological improvement 10 (13%) 0 Stable disease 33 (42%) 34 (61%) Progressive disease 15 (19%) 20 (36%) *Patients that withdrew from study prior to any response evaluation **Two patients had a partial response to Dacogen after progressing on supportive care (1)from 2-sided Fisher exact test for equal overall response rate (CR+PR) Times to AML or Death ● (Patients withdrawing consent, not receiving randomized treatment or crossing over are censored) Population Dacogen Supportive Care P-Value (N=89) (N=81) All Patients 89 81 0.042(1) Number of Events (%) 46 (52%) 46 (57%) 0.198(2) Median (days) 338 263 High Risk IPSS Patients 23 21 0.001(1) Number of Events (%) 14 (61%) 17 (81%) 0.004(2) Median (days) 275 79 Intermediate-2 IPSS 38 36 0.227(1) Patients 20 (53%) 20 (56%) 0.417(2) Number of Events (%) 340 275 Median (days) Int-2 & High Risk IPSS Patients 61 57 0.005(1) Number of Events (%) 34 (56%) 37 (65%) 0.040(2) Median (days) 334 189 Intermediate-1 IPSS Patients 28 24 0.624(1) Number of Events (%) 12 (43%) 9 (38%) 0.508(2) Median (days) 370 417 Previously Treated MDS Patients 27 19 0.340(1) Number of Events (%) 17 (63%) 9 (47%) 0.193(2) Median (days) 300 417 Treatment Naive MDS Patients 62 62 0.004(1) Number of Events (%) 29 (47%) 37 (60%) 0.030(2) Median (days) 354 189 (1)2-sided Wilcoxon Test for homogeneity of survival distributions (2)2-sided log-rank Test for homogeneity of survival distributions Baseline Characteristics Dacogen Supportive Care P-Values(1) (N=89) (N=81) Age (years) Median 70 70 0.113 IPSS Stage Intermediate-1 28 (31%) 24 (30%) 0.980 Intermediate-2 38 (43%) 36 (44%) High Risk 23 (26%) 21 (26%) Weeks Since MDS Diagnosis Median 29 35 0.990 Gender Male 59 (66%) 57 (70%) 0.622 Female 30 (34%) 24 (30%) Type of MDS De Novo 77 (87%) 70 (86%) 1.00 Secondary 12 (13%) 11 (14%) Previous MDS Therapy Yes 27 (30%) 19 (23%) 0.388 No 62 (70%) 62 (77%) (1)from 2-sided Fisher exact test

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