Monoclonal Antibody, MORAb-009, Receives FDA Orphan Drug Designation For The Indication Of Pancreatic Cancer

Main Category: Pancreatic Cancer
Article Date: 08 Nov 2006 - 0:00 PDT

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Morphotek(R) Inc., a privately held biopharmaceutical company focused on the discovery and development of therapeutic monoclonal antibodies, announces that the United States Food and Drug Administration (FDA) has granted orphan drug status to MORAb-009, a monoclonal antibody, for the indication of pancreatic cancer.

To achieve orphan drug designation, the prevalence of the indication in the target United States population cannot exceed 200,000. Approximately 23,000 new cases of pancreatic cancer are diagnosed annually in the United States. Under orphan drug status, MORAb-009 is allowed certain tax and user fee benefits including grant funding to help support development as well as a period of marketing exclusivity upon FDA approval.

"We are very pleased to receive orphan drug designation for MORAb-009 in this indication," said Nicholas C. Nicolaides, Ph.D., president and CEO of Morphotek. "We are also very optimistic about the development and the prospects for MORAb-009 in the treatment of pancreatic cancer as well as other cancers."

MORAb-009 is an antibody that recognizes mesothelin, a cell surface glycoprotein over-expressed in a number of cancers. Researchers at the National Cancer Institute (NCI) and Johns Hopkins University have independently validated the association of this protein in cancer and the therapeutic potential of drugs that can specifically target it. Studies have demonstrated a high correlation of mesothelin expression with pancreatic, mesothelioma, ovarian, non-small cell lung carcinomas as well as several epithelial-based cancers.

According to the American Cancer Society, pancreatic cancer accounted for approximately 31,800 deaths nationwide in 2005. For 2006, that figure is expected to reach 32,300.

About Morphotek

Morphotek is a privately held biopharmaceutical company which discovers and develops monoclonal antibodies for oncology, inflammation and infectious diseases through the use of a proprietary human antibody technology called Human MORPHODOMA(R). Morphotek markets its Human MORPHODOMA platform in collaboration with third parties to yield high-quality human antibodies and attendant production lines that alleviate the burdensome royalty mandated by other antibody technologies. For further information, visit http://www.morphotek.com.

Morphotek(R) Inc.
http://www.morphotek.com

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