SUPERGEN'S DECITABINE GRANTED "ORPHAN DRUG" STATUS IN EUROPE.

SuperGen Inc. (NASDAQ: SUPG), Dublin, Calif., has announced that, following the favorable opinion of the European Agency for the Evaluation of Medicinal Products (EMEA - adopted by the committee of Orphan Medical Products), the European Commission has granted its European affiliate, EuroGen Pharmaceuticals Ltd. (EuroGen), an "Orphan Medicinal Product" designation for the anticancer drug decitabine as a treatment for myelodysplastic syndrome (MDS).

The EMEA's "orphan" designation promotes development of drugs to treat rare diseases or conditions by: providing marketing exclusivity for 10 years; including protocol assistance by EMEA to optimize drug development in preparing a dossier that will meet regulatory requirements; facilitating access to the Centralized Procedure for the application for marketing approval; reducing fees associated with applying for marketing approval and protocol assistance; and, securing a European Union research funding grant.

Decitabine is currently in the latter stages of Phase III clinical testing in the United States for MDS. The multicenter study, which is being conducted at 22 clinical sites nationwide, has enrolled 152 of 160 patients. In addition, previous Phase II studies, conducted in Europe on 125 patients with advanced MDS, demonstrated positive results: Of 121 evaluable patients, a response rate of 49 percent was observed, and an additional sixteen percent of the patients experienced stable disease. The average duration of remission was 9 months with a median survival rate of 22 months.

"Receiving EMEA orphan drug designation for decitabine may accelerate the approval process in Europe by allowing us to combine the results of our Phase III program in the United States with previous European studies that have produced positive results," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "All data has been thoroughly analyzed to meet the rigorous standards of the Food and Drug Administration and the EMEA.

"We are gratified to have received rapid approval for this designation, which complements the orphan drug designation that decitabine received in the U.S. for MDS in 1999," added Dr. Rubinfeld. "In addition, with a decade of market exclusivity in Europe, the orphan drug designation protects our intellectual property position on decitabine for the next ten years."

MDS is a disorder that is a pre-cursor to leukemia and is often fatal. According to the American Cancer Society, about 14,000 new cases of MDS are diagnosed in the United States each year, and the number of new cases diagnosed each year is steadily increasing. The average life expectancy for patients diagnosed with MDS is anywhere between 6 months and 5 years, depending on the severity of the disease.

The primary mechanism of action for decitabine is thought to be the correction of DNA hypermethylation, a major mechanism for regulating gene expression. In some cancer cells a condition known as `hypermethylation' blocks the activity of several `tumor suppressor genes' that regulate cell division and differentiation to prevent unregulated malignant transformation. When suppressor genes are silenced, cell division becomes unregulated, often leading to the formation of cancer cells. Decitabine's unique mechanism of action - inhibition of DNA hypermethylation - specifically targets the series of events that lead to the formation of malignant cells. Silencing suppressor genes via hypermethylation is an early key event in the development of cancer.

Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer.

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