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Massbiologics Receives Milestone Payment From Merck for Advancement of Monoclonal Antibody Candidate Into Phase III Study

Therapeutic candidate aims to reduce recurrence of debilitating diarrhea caused by C difficile

BOSTON, Mass. December 13, 2011 — MassBiologics of the University of Massachusetts Medical School (UMMS) today announced the receipt of a milestone payment from Merck following the initiation of a Phase III clinical trial by Merck to evaluate an investigational fully human monoclonal antibody combination to target and neutralize Clostridium difficile toxins A and B, for the treatment of C. difficile infection (CDI). The antibody combination was developed by MassBiologics in collaboration with Medarex and licensed to Merck by MassBiologics and Medarex in an agreement announced in April 2009.

“As the proportion of cases of C. difficile infection has increased and with the changing epidemiology of more disease being caused by hypervirulent strains, it’s clear that C. difficile infection is a public health problem that is not going away,” said Deborah C. Molrine, MD, deputy director of clinical and regulatory affairs at MassBiologics.

Results from a phase 2 multicenter, randomized, double-blind, placebo-controlled trial evaluating the candidate antibody combination in 200 patients provided evidence of a statistically significant reduction in the rate of recurrence of CDI compared with placebo. These results were reported in the New England Journal of Medicine in January 2010 (NEJM 2010;362:197-205).

C. difficile infection is a major medical problem in the United States, with an estimated 400,000 cases occurring annually. The emergence of an epidemic strain of C. difficile that produces larger amounts of C. difficile toxins A and B has been implicated in several outbreaks worldwide. More than 25 percent of patients who are treated for CDI will experience a recurrence, and patients having one recurrence of CDI have up to a 60 percent chance of further recurrences.

About the University of Massachusetts Medical School

The University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $307 million in research funding annually, 80 percent of which comes from federal funding sources. The mission of the Medical School is to advance the health and well-being of the people of the commonwealth and the world through pioneering education, research, public service and health care delivery with its clinical partner, UMass Memorial Health Care. For more information, visit www.umassmed.edu..

About MassBiologics

MassBiologics at the University of Massachusetts Medical School is the only publicly owned, non-profit FDA-licensed manufacturer of vaccines and other biologic products in the United States. The laboratory was established in 1894 by the state Board of Health to produce diphtheria antitoxin. Since that time, the focus at MassBiologics has been to improve public health through applied research, development and production of biologic products.

In 1997, the Commonwealth of Massachusetts transferred MassBiologics operations from the Department of Public Health to UMass Medical School to “maintain their public purpose, preserving their ability to compete in an increasingly competitive marketplace and to maximize their value to the Commonwealth.”

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