August 19, 2009 / 3:45 AM / 11 years ago

UPDATE 2-Eli Lilly says to stop osteoporosis drug development

* Treatment arm shows higher rate of adverse events

* Arzoxifene does not meet late-stage secondary end points

* Says drug meets primary endpoint (Adds details on drug, expected sales)

Aug 18 (Reuters) - Eli Lilly and Co (LLY.N) said it would discontinue trials of its experimental osteoporosis drug and not seek U.S. approval of the product, due to side effects and its failure to achieve secondary goals in one large study.

It expects to take a 3 cent to 4 cent per share charge in the third quarter from its decision, but backed its earnings outlook for the full year.

“After reviewing the overall clinical profile of arzoxifene in light of currently available treatments, including Lilly’s own osteoporosis products, the company has decided not to submit the compound for regulatory review,” Eli Lilly said in a statement.

The company said preliminary data in the study showed a higher rate of adverse events, such as blood clots, hot flushes and gynecological-related events, in the treatment group.

The drug, arzoxifene, met the main goal of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women.

However, it did not show significant difference in key secondary efficacy endpoints, such as non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function, compared to a dummy drug.

Cowen and Co had forecast annual arzoxifene sales of $600 million by 2015.

Shares of Eli Lilly were down one percent at $32.50 in trading after the bell on Tuesday on the New York Stock Exchange.

Lilly had planned to seek U.S. approval for arzoxifene later this year, hoping to introduce it before the company’s Evista osteoporosis drug loses patent protection in coming years. (Reporting by Vidya L Nathan in Bangalore; Editing by Anthony Kurian and Anshuman Daga)

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