Merck Secures Rights to Two Novel Monoclonal Antibodies

Merck & Co., Inc. (Whitehouse Station, NJ), Medarex, Inc. (Princeton, NJ), and Massachusetts Biologic Laboratories (MBL, Jamaica Plain, MA) of the University of Massachusetts Medical School (UMMS) have signed an exclusive worldwide license agreement for CDA-1 and CDB-1 (also known as MDX-066/MDX-1388 and MBL-CDA1/MBL-CDB1), an investigational fully human monoclonal antibody combination developed to target and neutralize Clostridium difficile toxins A and B, for the treatment of C. difficile infection (CDI).

CDA-1 and CDB-1 were co-developed by Medarex and MBL.CDA-1 and CDB-1 are novel, fully human antibodies that were developed to target and neutralize the effects of toxin A and toxin B, respectively, produced by the bacterium C. difficile, which are associated with a serious and sometimes deadly form of diarrhea called C. difficile associated diarrhea.

Under the terms of the agreement, Merck gains worldwide rights to develop and commercialize CDA-1 and CDB-1. Medarex and MBL will receive an upfront payment of $60 million and are potentially eligible to receive additional cash payments up to $165 million after achieving certain milestones associated with the development and approval of a drug candidate covered by this agreement. On commercialization, Medarex and MBL also will be eligible to receive double-digit royalties on product sales and milestones if certain sales targets are met.