FDA Grants Priority Review for Schering-Plough's Peginterferon Alfa-2b for the Adjuvant Treatment of Patients With Stage II...( KENILWORTH N.J. Jan. 31 /- Scheri...)

KENILWORTH, N.J., Jan. 31 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Peg-IFN (peginterferon alfa-2b) supplemental Biologics License Application (sBLA) for review and has granted Priority Review status for the adjuvant treatment of patients with Stage III melanoma. Schering-Plough submitted its application to the agency in the fall of 2007.

The Priority Review designation is intended to expedite the review process for therapies that provide a significant improvement in the treatment of serious or life-threatening diseases. Based on this Priority Review status, the FDA reviews the application with the goal of taking action within six months of the sponsor's submission of the sBLA. The application will be discussed by the FDA Oncology Drugs Advisory Committee on March 12, 2008.

Peg-IFN was also filed with the EMEA in Europe in the fall of 2007.

About Malignant Melanoma

Approximately 60,000 people worldwide die each year from skin cancer caused in particular by excessive sun exposure according to the World Health Organization (WHO). According to the American Cancer Society, there will be almost 108,000 new cases of melanoma in the United States in 2007, and approximately 8,000 people will die from this disease.

Melanoma is the deadliest form of skin cancer and the primary cause of ultraviolet (UV) radiation related disease in the Americas, Europe, Australia, and New Zealand. However, when detected in its earliest stages, melanoma is highly curable.

About Peg-IFN

Interferon is a protein produced naturally by white blood cells to help the immune system fight viral infections and certain cancer
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