Monoclonal Antibody, MORAb-009, Receives FDA Orphan Drug Designation for the Indication of Pancreatic Cancer
November 7, 2006, Morphotek Inc
EXTON, PA -- November 7, 2006 -- 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, PhD, 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.
Morphotek Announces IND Submission for MORAb-009, a Monoclonal Antibody for the Treatment of Mesothelin-Expressing Cancers
January 9, 2006, Morphotek Inc
EXTON, Pa., Jan. 9 /PRNewswire/ -- Morphotek® Inc. announced today the submission of an investigational new drug application (IND) to the U.S. Food & Drug Administration for MORAb-009, a monoclonal antibody targeting mesothelin. Preclinical data indicate that mesothelin is highly over-expressed in tumors of patients with pancreatic adenocarcinoma and other prevalent cancers including non-small lung carcinoma, ovarian carcinoma and mesothelioma and may be associated with disease activity. Research has shown MORAb-009 to inhibit tumor growth by inhibiting mesothelin binding to extracellular substrate and also through antibody dependent cellular cytotoxicity. Morphotek obtained exclusive rights to develop and commercialize this antibody worldwide from the National Cancer Institute where the mesothelin protein and its expression association with various cancer types were discovered.
"This IND submission reflects Morphotek's commitment to the rapid and efficient development of novel therapeutic agents to treat unmet medical needs in the areas of oncology, inflammation and infectious diseases," said Martin Phillips, Senior Vice President of Clinical Development at Morphotek.
"The entry of this antibody into the clinic demonstrates our ability to successfully discover and develop antibodies for clinical benefit. The MORAb- 009 IND is the second we have submitted for an antibody product developed using our proprietary technology and we plan to advance additional antibodies over the next several quarters," said Nicholas C. Nicolaides, President and Chief Executive Officer of Morphotek.