2014

Eli Lilly and Company and Boehringer Ingelheim Announce Changes to Their Contractual Agreements for Yentreve(R)/AriClaim(R)

    INDIANAPOLIS, and INGELHEIM, Germany, Feb. 15 /PRNewswire-FirstCall/ --
 Eli Lilly and Company and Boehringer Ingelheim announced today that the
 alliance will change the nature of its contractual agreements for
 Yentreve(R)/AriClaim(R) (duloxetine hydrochloride), a pharmaceutical treatment
 for stress urinary incontinence (SUI), which is currently approved for
 marketing in 38 countries outside of the United States.
     Lilly will repurchase sole worldwide commercialization rights to
 Yentreve/AriClaim (duloxetine for SUI and future related urinary incontinence
 indications) and will continue marketing this indication outside the U.S.  The
 Lilly-Boehringer Ingelheim agreement to market duloxetine outside the U.S. for
 major depressive disorder (MDD), diabetic peripheral neuropathic pain (DPNP)
 and other potential indications (under the trademarks Cymbalta(R)/Xeristar(R))
 remains unaffected by today's announcement.
     "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," said John Lechleiter, Ph.D., president and chief operating officer
 of Lilly.  "This is about 'right sizing' our investments to address our
 greatest opportunities and the greatest patient needs."
     "There has been an excellent spirit of collaboration in our alliance with
 Lilly.  Based on this, we are committed to the continued success in our
 partnership to commercialize duloxetine for indications other than SUI in
 markets outside the U.S.," said Dr. Alessandro Banchi, chairman of the Board
 of Managing Directors at Boehringer Ingelheim.
     Additionally, the alliance has determined it will not seek marketing
 authorization for Yentreve in the U.S. 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
 SUI as a medical condition and Yentreve's proven ability to address a
 significant unmet medical need," Lechleiter stated.
     "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 parties 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 plans to take over full commercialization of
 Yentreve/AriClaim in markets outside the U.S. by the end of 2006.
     Lilly and Boehringer Ingelheim will continue to market Cymbalta/Xeristar
 outside the U.S. for major depressive disorder and diabetic peripheral
 neuropathic pain, and to develop potential new indications including
 generalized anxiety disorder and fibromyalgia.  Lilly owns the rights to
 commercialize Cymbalta in the United States.
 
     About AriClaim and Xeristar
     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 (MDD and DPNP) in Greece, Italy and Spain will continue to be
 available as Cymbalta (marketed by Lilly) and Xeristar (marketed by Boehringer
 Ingelheim).
 
     About Eli Lilly and Company
     Lilly, a leading innovation-driven corporation, is developing a growing
 portfolio of best-in-class pharmaceutical products by applying the latest
 research from its own worldwide laboratories and from collaborations with
 eminent scientific organizations.  Headquartered in Indianapolis, Ind., Lilly
 provides answers -- through medicines and information -- for some of the
 world's most urgent medical needs.  Additional information about Lilly is
 available on www.lilly.com.  LLY-P
 
     About Boehringer Ingelheim
     The Boehringer Ingelheim group is one of the world's 20 leading
 pharmaceutical companies.  Headquartered in Ingelheim, Germany, it operates
 globally with 144 affiliates in 45 countries and nearly 36,000 employees.
 Since it was founded in 1885, the family-owned company has been committed to
 researching, developing, manufacturing and marketing novel products of high
 therapeutic value for human and veterinary medicine.
     In 2004, Boehringer Ingelheim posted net sales of 8.2 billion euro while
 spending nearly one fifth of net sales in its largest business segment
 Prescription Medicines on research and development.  Additional information
 about Boehringer Ingelheim is available on www.boehringer-ingelheim.com.
 
     (Logo:  http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
             http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO )
 
 

SOURCE Eli Lilly and Company; Boehringer Ingelheim
RELATED LINKS
http://www.lilly.com

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