Oral chemotherapy agent Orathecin™ (rubitecan) capsules accepted by FDA for filing

SuperGen Inc. announced today that the Food and Drug Administration (FDA) has officially accepted the Orathecin™ (rubitecan) capsules’ New Drug Application (NDA) for filing. Orathecin, an investigational anticancer compound, is an oral chemotherapy agent that has been investigated as a treatment for pancreatic cancer patients who have failed at least one prior chemotherapy.

The FDA indicated that the user fee goal date for the Orathecin NDA is November 26, 2004. This date is the target date for the completion of the FDA’s review and resulting action letter for the filed NDA. The filing contained data on more than 1,000 pancreatic cancer patients who failed at least one prior chemotherapy. Of this population, more than 600 patients received Orathecin and the remainder were given control therapies. SuperGen's Phase III clinical program is believed to be the largest clinical development program in pancreatic cancer ever initiated worldwide.

“Our clinical and regulatory teams worked tirelessly to submit a through and complete NDA and we are gratified that it has been accepted by the FDA,” said Dr. James Manuso, Chairman, President and Chief Executive Officer of SuperGen. “Although Orathecin is not a cure, we adamantly believe that it can be of benefit to some patients with pancreatic cancer. We are committed to working with the FDA to bringing this drug to market so that it can help the very patients who need it most.”

According to the Pancreatic Cancer Action Network (PanCAN), pancreatic cancer has the highest fatality rate of all cancers. 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.

Contact: Tim Enns, Vice President, Investor Relations & Business Development, SuperGen Inc., 800-353-1075, ext. 111

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.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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