Merck, Medarex and MBL enter antibody deal

Worldwide licensing agreement will target C. difficile infection

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WHITEHOUSE STATION N.J.—Medarex and Massachusetts Biologic Laboratories (MBL) have signed an exclusive licensing agreement with global research-driven pharmaceutical Merck & Co. for an investigational monoclonal antibody combination that targets Clostridium difficile infection, the primary cause of infectious diarrhea in hospitalized elderly patients. The deal, announced April 21, is worth more than $225 million.

The licensing agreement centers on 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 C. difficile toxins A and B, for the treatment of C. difficile infection. CDA-1 and CDB-1 were co-developed by Medarex and MBL.

The agreement gives Merck the worldwide rights to market and further develop the CDA-1 and CDB-1 antibody combination in return for paying Medarex and MBL $60 million up front.  A further $165 million will be paid upon the completion of certain milestones.

Medarex, a biopharmaceutical company focused on the discovery, development and commercialization of fully human antibody-based therapeutics, and MBL, manufacturer of vaccines and other biologic products in the United States, will receive double-digit royalties and milestones if certain sales levels are met. Pursuant to a prior co-development agreement, Medarex and MBL will divide all payments equally.

"Discovering and developing an effective new treatment for a significant public health threat is the mission of MBL," says Dr. Donna Ambrosino, executive director of MBL and professor of pediatrics at the University of Massachusetts Medical School (UMMS). "We are delighted that through this license agreement this candidate will advance towards final clinical studies and thus, will potentially be available to patients in the shortest possible time.

"MBL's responsibilities are to provide information, expertise and support, as needed, as Merck carries the development program forward." Ambrosino adds. "MBL and Medarex have a long-standing relationship and have worked on other development projects, including MABs targeted at Severe Acute Respiratory Syndrome (SARS)."

The partners have expertise at various stages along the drug development chain, from concept, to lab bench discovery work, to early product development, to the ability for large-scale clinical research and production, Ambrosino says.

The incidence of C. difficile infection in the U.S. is rapidly increasing, with rates doubling from 2000 to 2005. The Centers for Disease Control and Prevention (CDC) has projected that there will be as many as 750,000 cases of C. difficile infection per year by 2010.

Howard H. Pien, chairman and CEO of Medarex, said in a company release, "This agreement exemplifies our ability to execute our corporate strategy combining creative science with an industry-leading platform to successfully enter into partnerships that are financially attractive and value-enhancing."

Medarex will continue to invest in its growing pipeline of innovative product candidates to address significant unmet medical needs, advance them to proof-of-concept and explore strategic options, Pien said.

Top-line results from a Phase II multicenter, randomized, double-blind, placebo-controlled trial evaluating CDA-1/CDB-1 provided evidence of a statistically significant reduction in the rate of recurrence of CDI compared with placebo. In the study, 200 patients symptomatic with an acute episode of CDI receiving standard of care antibiotics (metronidazole or vancomycin) were randomized to receive intravenous CDA-1/CDB-1 or intravenous placebo.

Ian R. McConnell, Merck director of corporate communications, says Merck's role primarily will be to spearhead future clinical development.

"Medarex and MBL have developed a novel combination therapy that holds the potential to address the serious unmet medical need of C. difficile infection," McConnell says. "This agreement underscores Merck's ongoing commitment to infectious disease and our strategy of licensing promising candidates with the potential to address serious unmet medical needs."

C. difficile infection is likely caused by several factors including the spread of new, potentially more virulent strains, the presence in hospitals of older, debilitated adults with a severe range of underlying diseases and increased use of wide-spectrum antibiotics to which C. difficile has developed resistance, McConnell said.

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 disease most often develops in the presence of antibiotics administered for other infections, in which the complex microbial makeup of the GI tract is altered, and C. difficile spores may germinate, grow, and produce toxins A and B. The toxins cause damage to the GI tract lining in the colon, resulting in severe diarrhea, and may lead to perforation of the colon and/or death.

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