MORPHOTEK, INC. ANNOUNCES THAT TWO INVESTIGATIONAL DRUGSHAVE RECEIVED ORPHAN DRUG DESIGNATIONS

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 ofpancreatic 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. In Europe, orphan designation is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 people in the EU.
“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/tumour endothelial marker-1 (TEM-1), which is a protein that is expressed in many human malignancies, and which plays a role in tumour development. MORAb-004 binds to TEM-1, and has demonstrated antitumour 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. In Europe, the estimated incidence of adult soft tissue sarcoma averages 4/100,000/year.
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 tumour types, including pancreatic cancer. A study published in 2007 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 demonstrated that an antibody to tissue factor inhibits the growth of human pancreatic cancer cells in a xenograft model. Pancreatic cancer is the fourth commonest cause of cancer-related mortality across the world, with incidence equaling mortality. In Europe, in the year 2000, there were 60,139 new patients with 64,801 deaths.