Merck Discontinues Development of Osteoporosis Drug
September 02 2016 - 8:40AM
Dow Jones News
Merck & Co. said Friday it would discontinue developing the
osteoporosis drug odanacatib and not seek regulatory approval for
the treatment because it carries a higher risk of stroke.
New Jersey-based Merck said it decided to stop development after
an independent analysis confirmed an increased risk of stroke with
use of the drug. The data from the analysis will be presented this
month at the American Society for Bone Mineral Research.
"We are disappointed that the overall benefit-risk profile for
odanacatib does not support filing or further development," said
Dr. Roger Perlmutter, president of Merck Research Laboratories.
Merck, in its annual report in February, said it had planned to
seek regulatory approval for the drug in the U.S. and Japan
following the independent analysis.
Osteoporosis reduces bone density and strength, leading to an
increased risk of bone fractures. Dr. Perlmutter said that while
the treatment showed the ability to reduce the risk of osteoporotic
fractures, the increased risk of stroke "does not support further
development."
Merck's problems with odanacatib predates the hiring of Dr.
Perlmutter. In February 2013, the drugmaker signaled delays in
seeking approval for the drug. A month later, Merck hired Dr.
Perlmutter, the former research chief at Amgen Inc., to lead and
restructure its own research-and-development operation.
Merck shares, inactive premarket, have risen 19% so far this
year.
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
September 02, 2016 08:25 ET (12:25 GMT)
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