Merck's Diarrhea Drug Could be First in 30 Years
Infection Costs $1.3 Billion A Year
C. difficile infections have become more common and more severe in recent years. It is the leading cause of hospital-acquired diarrhea, making its spread a growing concern, The Boston Globe notes. More than 7,000 patients are treated for the infection every day at an annual cost of more than $1.3 billion, the U.S. CDC says, creating longer hospital stays.
So far, bacteria infections have generally been treated with antibiotics. But just recently, the American Academy of Microbiology published a report warning about antibiotic resistance becoming an "international pandemic that compromises the treatment of all infectious diseases." The report echoed warnings on antibiotic research from the London School of Economics and Political Science.
With the emergence of antibiotic-resistant strains of infections, new approaches such as Merck's drug were needed. It consists of two human monoclonal antibodies. These are specifically grown infection-fighting proteins. The medicine is designed to neutralize toxins released by C. difficile that damage the intestines.
Larger-Stage Studies Needed
Monoclonal antibodies have also been developed against some cancers, rheumatoid arthritis and multiple sclerosis. Only one other infectious disease used this type of treatment, respiratory syncytial virus in infants.
The drug was developed by the University of Massachusetts's non-profit MassBiologics arm and Medarex, a subsidiary of Bristol-Myers Squibb (BMY) and rights have been licensed to Merck. The onus is now on Merck to perform the larger late-stage studies needed for regulatory approval.
But while Merck may be on to something here, it also said Wednesday it won't seek U.S. regulatory approval for an experimental HIV treatment, vicriviroc, at this time because the drug didn't meet its primary goal in two late-stage studies.
Merck inherited vicriviroc when it acquired Schering-Plough last year. Schering executive had predicted the drug would have peak annual sales of $500 million to $750 million. Luckily for Merck, Street analysts weren't as optimistic and the shares, while down today with the overall market, haven't suffered much.