SuperGen Initiates Phase II Combination Trial of Orathecin™ and Gemcitabine in Chemotherapy Naive Pancreatic Cancer Patients

SuperGen Initiates Phase II Combination Trial of Orathecin(TM) and Gemcitabine in Chemotherapy Naive Pancreatic Cancer Patients DUBLIN, Calif., March 3 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG) today announced that the first patient has been dosed in a Phase II clinical trial studying Orathecin ® (rubitecan) Capsules and gemcitabine as a first -line combination therapy for advanced pancreatic cancer patients who have not undergone chemotherapy. Orathecin is an orally active camptothecin that is being developed for the treatment of pancreatic cancer. The study will enroll 30 chemotherapy naive patients at up to 15 centers in the United States. Patients will receive combination therapy of gemcitabine and Orathecin capsules, in a dosing regimen of 1,000 mg/m2 gemcitabine weekly for three weeks plus 1 mg/m2 Orathecin capsules taken once daily for five days, with two days off during gemcitabine treatment. The primary efficacy endpoint is overall survival. "We are very pleased to have initiated this study which will help determine whether chemonaive patients will benefit from a combination of Orathecin and gemcitabine," commented Dr. James Manuso, President and Chief Executive Officer of SuperGen. "Given the extremely high mortality rates for pancreatic cancer, the limited treatment options currently available and the encouraging data in refractory patients, we believe Orathecin combinations could have utility as first -line therapy." About Orathecin Orathecin™ (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor that is being developed for the treatment of pancreatic cancer. Orathecin has Orphan Drug status in both the U.S. and EU. The Orathecin European filing, or Marketing Authorization Application, contains data from a Phase III clinical program believed to be the largest program in pancreatic cancer ever initiated worldwide, with more than 1,000 patients. A decision from the EMEA on the approval of Orathecin is expected later this year. About Pancreatic Cancer According to American Cancer Society Cancer Facts and Figures 2004, 31,860 people will be diagnosed with pancreatic cancer this year in the United States and 31,270 people will die. Pancreatic cancer is the fourth highest cancer killer in the United States amongst both men and women. The 99 percent mortality rate for pancreatic cancer is the highest of any cancer. 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 Nipent® (pentostatin for injection); Mitomycin (generic brand of Mutamycin ®); and SurfaceSafe ® cleaner. For more information about SuperGen, please visit http://www.supergen.com. This news release contains certain "forward -looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions, and include statements regarding the progress of SuperGen's European filing of Orathecin for pancreatic cancer patients failing one or more therapies and the utility of Orathecin and gemcitabine as a combination first-line therapy. These forward -looking statements are not guarantees of 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. For example, actions by European regulators or numerous other factors could delay or halt progress on the European filing. Other factors that might cause results to differ materially from those expressed or implied by such forward - looking statements include, but are not limited to, whether the drug will be timely approved, if at all in any country where a filing has been made; whether the drug, if approved will be successfully commercialized; and other risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission including the report on Form 10 -Q for the quarter ended September 30, 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: Timothy L. Enns SuperGen, Inc. Tel: (925) 560 -0100 x111 E-mail: [email protected] Sharon Weinstein Noonan/Russo Tel: (212) 845 -4271 E-mail: [email protected] SOURCE SuperGen 03/03/2005

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