said Wednesday it would abandon trying to sell a stress urinary incontinence drug in the U.S. even though the drug is available in 38 foreign markets.
Lilly withdrew its Yentreve application from the Food and Drug Administration in January 2005, saying then that discussions with the FDA indicated "the agency is not prepared at this time to grant approval ... based on the data package submitted." Lilly said clinical trials would continue.
Now Lilly says it won't pursue Yentreve for the U.S. market. The company is also changing its agreement with the German drugmaker
for marketing Yentreve, which is known as AriClaim in some foreign markets. Lilly will purchase sole worldwide rights to the drug and will continue marketing it outside the U.S.
Yentreve contains duloxetine, the ingredient in Lilly's depression treatment Cymbalta. Lilly continues to expand its duloxetine franchise. Cymbalta is also approved for treating nerve pain associated with diabetes, and Lilly is testing it for generalized anxiety disorder and fibromyalgia.
The marketing agreement between Lilly and Boehringer Ingelheim for duloxetine's other uses or potential future uses aren't affected.
"Based on our collective experiences to date in the marketplace, both companies believe that the Yentreve/AriClaim opportunity ... can be best commercialized in markets outside the U.S. with the support of one company," said John Lechleiter, president and chief operating officer of Lilly, in a prepared statement. "This is about 'right-sizing' our investments to address our greatest opportunities and the greatest patient needs."
Dropping Yentreve was a difficult decision, Leichleiter said, given "the importance of stress urinary incontinence as a medical condition and Yentreve's proven ability to address a significant unmet medical need."
Lilly says nearly 15 million adult women in the U.S. experience stress urinary incontinence, which is the accidental leakage of urine during physical activities such as sneezing, coughing, laughing, lifting or exercising. Risk factors include obesity, childbirth, chronic coughing and constipation.