WHITEHOUSE STATION, N.J. -- Merck & Co. plans to file five products currently in Phase III human trials -- including three vaccines -- for approval with the Food and Drug Administration by the end of 2006.
The most well-known of these is the drug maker's potential human papillomavirus vaccine that could in effect be a preventative for cervical cancer, which is caused by HPV.
In a widely published study last month, about 2,400 women age 16 to 23 who had had five or fewer sexual partners received a version of the vaccine, while others got a placebo. Seventeen months later, 41 women who received placebos had become infected with a strain of HPV that can lead to cervical cancer. None of those who got the vaccine were infected.
The company is currently using a version of the vaccine that targets four different strains of the virus, though two of them cause 70% of cervical cancer.
Data suggests that around 25% of female adolescents are infected by HPV by their first year in college, and half of women between ages 23 to 27 years old have the virus, Merck said.
Merck is also studying a vaccine for shingles -- a virus that occurs in adults when the chickenpox virus reactivates.
"There are no vaccines or therapies that are effective," said Peter Kim, the young biologist who's in the midst of taking over as head of research at Merck. "There's tremendous unmet medical need."
Shingles affect up to one million adults each year in the U.S., Merck said.
Merck's in the midst of a 38,000-person Phase III study, a late-stage clinical trial, for the shingles vaccine.
The company is also studying a potential vaccine for rotavirus, which causes severe diarrhea in babies and currently causes 800,000 infant deaths a year in the developing world.
Merck estimates that the direct and indirect costs associated with rotavirus is more than $1 billion a year in the U.S. alone.
In the treatment realm, Merck is in late trials for two drugs with three different applications.
The first, called its "substance p program," may lead to a depression drug and another to help prevent nausea and vomiting in chemotherapy patients. The chemotherapy application, called EMEND, is undergoing priority review at the FDA. The company is also studying the same molecule to treat depression.
Merck is also studying a potential new diabetes drug that in Phase II trials showed a large decrease in triglycerides, a large increase in helpful HDL cholesterol and "favorable effects" on LDL cholesterol. The drug, currently called MK-0767, was so far generally safe and well-tolerated, Merck said. A Phase III program is under way.
-Hollister H. Hovey, Dow Jones Newswires, 201-938-5287; hollister.hovey@ dowjones.com |
