Morphotek Inc. Announces That Two Investigational Drugs Have Received Orphan Drug Designations

EXTON, Pa., June 8, 2011 /PRNewswire/ -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designations to two of its investigational cancer drugs, MORAb-004 for the treatment of soft tissue sarcoma and MORAb-066 for the treatment of pancreatic cancer.

The FDA grants this designation to drugs with the potential to treat a rare disease or condition that affects fewer than 200,000 people in the United States. According to data from the National Cancer Institute, in the United States in 2010 the prevalence figure for soft tissue sarcoma was 101,982 and for pancreatic cancer was 32,993 (www.seer.cancer.gov).

“We are very pleased to receive orphan drug designations for not only one, but two investigational compounds for the potential treatment of cancer: MORAb-004 for the treatment of soft tissue sarcoma and MORAb-066 for the treatment of pancreatic cancer,” said Nicholas C. Nicolaides, Ph.D., President and CEO of Morphotek. “We believe that working toward treating disease, 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 increasing the benefits that health care provides. Ultimately, these compounds could significantly improve our ability to provide enhanced treatment options for patients suffering from two very serious diseases.”

MORAb-004 is a humanized monoclonal antibody to endosialin/tumor endothelial marker-1 (TEM-1), which is a protein that is expressed in many human malignancies, and which plays a role in tumor development. MORAb-004 binds to TEM-1, and has demonstrated antitumor activity in a variety of nonclinical models. A phase I ascending dose study with MORAb-004 is currently being performed in subjects with a variety of cancers, including soft tissue sarcoma. According to the American Cancer Society, in 2010 about 3,920 people died of soft tissue sarcoma and about 10,520 people were diagnosed with the disease (www.cancer.org).

MORAb-066 is a humanized monoclonal antibody to tissue factor, which is a protein that plays an important role in blood coagulation. Tissue factor has also been shown to be present in a wide variety of tumor types, including pancreatic cancer. A study published in 2007 (Clin. Cancer Res 13(10): 2870-2875) indicated that tissue factor expression could be observed in a majority of pancreatic cancer tissue samples, but not in normal pancreatic tissue. A separate study (J. Immunother 2004: 27, S11) demonstrated that an antibody to tissue factor inhibits the growth of human pancreatic cancer cells in a xenograft model. According to the American Cancer Society, in 2010 about 36,800 people died of pancreatic cancer and about 43,140 people were diagnosed with the disease (www.cancer.org).

As a result of obtaining orphan drug designations, Morphotek receives certain tax credits to support the development of these compounds, a waiver of the FDA user fee if a marketing application is submitted, and a period of marketing exclusivity if the compounds are ultimately approved. These incentives are intended to encourage pharmaceutical companies to develop orphan drugs; however, an orphan drug designation does not alter the standard regulatory requirements and process for obtaining marketing approval for the drug.

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 is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. 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.

SOURCE Morphotek, Inc.