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FDA Grants Orphan Drug Status to FDA's Amatuximab (MORAb-009)


11/12/2012 9:50:39 AM

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 is associated with a range of cancers, including pancreatic ductal adenocarcinoma, mesothelioma, epithelial ovarian cancer, and lung adenocarcinoma. Researchers at the National Cancer Institute (NCI) and the Johns Hopkins University have independently validated mesothelin as a potential target of immuno-based therapies.

About Morphotek

Morphotek® Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology.  The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications.  The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease.  For more information, please visit www.morphotek.com.

About Eisai Inc.

Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai has rapidly grown to become a fully integrated pharmaceutical business.  Eisai's key areas of commercial focus are neurology and oncology.  The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. 

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina.  The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.  For more information about Eisai, please visit www.eisai.com/us.

1Mesothelioma Applied Research Foundation What is Mesothelioma. Available at
http://www.curemeso.org/site/c.kkLUJ7MPKtH/b.8050629/k.6568/What_is_Mesothelioma.htm
     A.      Pg. 1, col. 1, par. 4

2U.S Food and Drug Administration (FDA) Designating an Orphan Product: Drugs and Biologics. Available at
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm
     A.      Pg. 1, col. 1, par. 1

SOURCE Morphotek Inc.



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