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Medarex and Massachusetts Biologic Laboratories Announce Primary Objective Achieved in Phase 2 Trial of Monoclonal Antibody Combination for the Treatment of Clostridium difficile Associated Diarrhea (CDAD)
Date:11/3/2008

with estimates of over 500,000 cases in the United States, and approximately 15,000 deaths caused or contributed by C. difficile.(2) The emergence of a highly virulent epidemic strain that produces much higher levels of toxins A and B has also been associated with morbidity and mortality in younger, healthier, and non-hospitalized patients.(3)

"We are delighted with these dramatic results. CDAD is a growing and serious epidemic, with twenty to fifty percent of hospitalized patients relapsing after receiving antibiotic treatment," said Donna Ambrosino, MD, Executive Director of the MBL and Professor of Pediatrics at UMMS. "The demonstration of significant protection from relapse indicates that treatment with monoclonal antibodies against the toxins could reduce this significant and costly public health problem."

"These results highlight the exquisite specificity of monoclonal antibodies and their important role to save lives," said Howard H. Pien, President and CEO of Medarex. "We believe that the strength of our antibody technology platform for generating potentially important treatment options, such as the C. difficile program antibodies, will continue to shape the future of medicine. Furthermore, Medarex's strategy of proving the utility of potentially promising candidates for development by well-designed and well- executed studies is amply demonstrated."

About Clostridium difficile Acquired Diarrhea (CDAD)

C. difficile is a spore forming bacterium that is common in the environment and can colonize the gastrointestinal (GI) tract. It can be easily spread among hospitalized patients and residents of long term care facilities, but also can be found in otherwise healthy individuals in the community. The origin of disease is believed to develop in the presence of antibiotics administered for other infections, in which the complex microbial make up of the GI tract is altered, and C. difficile spores may germinate, grow, and produce toxins A
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