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XBiotech Initiates Program to Develop Antibody Against Clostridium Difficile

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XBiotech (NASDAQ: XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile (C. difficile) infection. Using its proprietary True Human technology, the Company has begun screening human blood samples from donors to identify and clone a therapeutic antibody candidate from individuals with natural immunity to C. difficile infection.

C. difficile is the causative organism of antibiotic-associated pseudomembranous colitis, a potentially devastating inflammatory condition of the colon. The incidence of C. difficile infection has risen sharply over the last two decades and today is a leading cause of morbidity and mortality in hospital-acquired infections in the U.S. According to the U.S. Centers for Disease Control and Prevention (CDC), C. difficile is estimated to have caused almost half a million infections in the U.S. in 2011, with 29,000 deaths, often occurring within 30 days of initial diagnosis. Eight out of 10 deaths related to C. difficile infection in the U.S. occur in patients 65 years of age or older, where recurrent infections are common, and estimated treatment cost per infection ranges from $6,000-$9,000.

John Simard, President and CEO of XBiotech, stated, "This program represents more than the addition of a new anti-infective product to our development pipeline. A successful True Human candidate could be the first oral monoclonal antibody against C. difficile, and a model for an oral antibody therapy approach. Recent outbreaks and increased virulence of C. difficile suggest the urgent need to identify novel approaches to treat the disease. We are eager to bring XBiotech's technology to develop a potential safe and effective therapy for this disease."

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