Orphan Drug Designation Granted for Treatment of Mesothelioma and Ovarian Cancer

NeoPharm Receives Orphan Drug Status for Its Novel Anti-Mesothelin Monoclonal Antibody Toxin SS1-PE38

NeoPharm, Inc.

NeoPharm, Inc. (Nasdaq: NEOL - news) announced today that it has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the company's novel anti- mesothelin monoclonal antibody toxin, SS1-PE38, for both the treatment of mesothelioma, a devastating form of lung cancer, and ovarian cancer. SS1-PE38 targets the mesothelin antigen on tumor cells and delivers the potent cytotoxin PE38 to destroy the tumor cell. NeoPharm has exclusively licensed SS1-PE38 from the National Cancer Institute (NCI) and is developing the compound under a Cooperative Research and Development Agreement (CRADA) with NCI.

"We are pleased to receive the FDA's orphan drug designation for SS1- PE38," said James Hussey, President and Chief Executive Officer of NeoPharm. "Orphan drug status will help us in our attempt to fulfill this critical unmet need for people who must live with these devastating and deadly diseases by providing us with the potential to accelerate clinical development of this product, in cooperation with the FDA. NeoPharm now has two compounds in clinical development, SS1-PE38 and IL13-PE38, that have received this designation."

To qualify for FDA's orphan drug designation, a proposed compound must be intended for use in the treatment of a condition that affects fewer than 200,000 people in the United States. The scientific rationale for use of the compound in treating the condition must also pass FDA review. Benefits provided from orphan drug status include two additional years of marketing exclusivity, tax credits for related clinical research expenses, a waiver of FDA user fees, and clinical development assistance from the FDA.

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