Eli Lilly & Co. said Tuesday it will not seek Food and Drug Administration approval for its developing postmenopausal osteoporosis drug because of certain study results and safety concerns.
The company said the drug met its late-stage study goals of reducing the risk of vertebral fracture and invasive breast cancer, but failed to meet a variety of secondary goals, such as cognitive function and non-vertebral fractures.
Meanwhile, there were some serious safety concerns over increased risk of blood clots and gynecological-related events.
The five-year study involved 9,354 postmenopausal women.
"The results of arzoxifene's Generations study serve as a reminder of the high risks associated with pharmaceutical innovation," said Eli Lilly Chairman and CEO John Lechleiter, in a statement.
The Indianapolis company expects to book a third-quarter charge of about 3 to 4 cents per share associated with costs for shutting down the program. Still, the company expects full-year profit between $4.20 and $4.30 per share, excluding charges.
Analysts on average expect a profit of $1.01 per share for the third quarter and $4.28 per share for the full year.
Shares of Eli Lilly fell 34 cents to $32.50 in after-hours trading. The stock ended the regular session up 13 cents at $32.84.
Copyright 2009  AP Features
