Eli Lilly, Boehringer Ingelheim change agreements for Yentreve/AriClaim

By E. Janene Geiss

Philadelphia, Feb. 15 - Eli Lilly and Co. and Boehringer Ingelheim announced Wednesday that the alliance will change the nature of its contractual agreements for Yentreve/AriClaim (duloxetine hydrochloride), a pharmaceutical treatment for stress urinary incontinence, which is approved for marketing in 38 countries outside of the United States.

Lilly will repurchase sole worldwide commercialization rights to Yentreve/AriClaim (duloxetine for stress urinary incontinence and future related urinary incontinence indications) and will continue marketing this indication outside the United States, according to a company news release.

The Lilly-Boehringer Ingelheim agreement to market duloxetine outside the United States for major depressive disorder, diabetic peripheral neuropathic pain and other potential indications (under the trademarks Cymbalta/Xeristar) remains unaffected by the change, officials said.

"Based on our collective experiences to date in the marketplace, both companies believe that the Yentreve/AriClaim opportunity is best suited and can be best commercialized in markets outside the U.S. with the support of one company," John Lechleiter, president and chief operating officer of Lilly, said in the release.

"This is about 'right sizing' our investments to address our greatest opportunities and the greatest patient needs," he added.

The companies also said the alliance has determined it will not seek marketing authorization for Yentreve in the United States following its decision to rescind the initial New Drug Application in January 2005.

"The decision not to pursue approval for Yentreve in the U.S. was a difficult one given the belief both companies share about the importance of stress urinary incontinence as a medical condition and Yentreve's proven ability to address a significant unmet medical need," Lechleiter said in the release.

"Collectively, these business decisions will ensure focused resources in markets where Yentreve is already approved and aggressive investments in newer areas of duloxetine's development and commercialization that relate to depression and pain. We are very optimistic about our ability to build on the achievements we have experienced in our alliance with Boehringer Ingelheim," he added.

Both companies said they are finalizing the terms of the agreement and will work closely together in 2006 to ensure a smooth transition of all related activities to Lilly.

Lilly said it plans to take over full commercialization of Yentreve/AriClaim in markets outside the United States by the end of 2006.

Lilly and Boehringer Ingelheim said they will continue to market Cymbalta/Xeristar outside the United States for major depressive disorder and diabetic peripheral neuropathic pain, and to develop potential new indications including generalized anxiety disorder and fibromyalgia.

Lilly said it owns the rights to commercialize Cymbalta in the United States.

In Greece, Italy and Spain, the contractual agreement for duloxetine for stress urinary incontinence allowed the product to be available under the trade names Yentreve (marketed by Lilly) and AriClaim (marketed by Boehringer Ingelheim). Similarly, duloxetine for depression and diabetic peripheral neuropathic pain in Greece, Italy and Spain will continue to be available as Cymbalta (marketed by Lilly) and Xeristar (marketed by Boehringer Ingelheim), officials said.

Lilly is a research-driven pharmaceutical company based in Indianapolis.

Boehringer is an Ingelheim, Germany, pharmaceutical company that develops, manufactures and markets new products for human and veterinary medicine.

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