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FDA Grants Orphan Drug Status To Morphotek's Amatuximab (MORAb-009)
Date:11/12/2012

EXTON, Pa., Nov. 12, 2012 /PRNewswire/ -- Morphotek® Inc., a subsidiary of Eisai Inc., announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to its investigational cancer drug, amatuximab (MORAb-009) for the treatment of malignant pleural mesothelioma, the most common form of mesothelioma, which accounts for around 2,500 cases a year in the United States. This disease affects the pleura, which is the thin balloon shaped lining of the lungs.1

The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which has the potential for the safe and effective treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.2  Under the ODA, orphan designation qualifies the sponsor of the product for certain incentives, such as tax credits, prescription drug user fee waivers for the development product, and a seven year period of marketing exclusivity from the date of approval.

"We are very pleased to receive orphan drug designation for amatuximab for the potential treatment of malignant pleural mesothelioma," said Julia Maltzman, M.D., Senior Director of Clinical Development at Morphotek.  "We believe that addressing unmet medical needs, no matter the size of the patient population, is essential to the achievement of our human health care mission, which is to give first thought to patients and their families and to helping increase the benefits that health care provides.  Ultimately, this antibody has the potential to provide an additional treatment option for patients suffering from an extremely serious disease." 

Amatuximab (MORAb-009) is an investigational chimeric IgG1 antibody that targets a cell surface glycoprotein, mesothelin, which is over-expressed in a number of cancers. Mesothelin is thought to be involved in cell adhesion. Its presence
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SOURCE Morphotek Inc.
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