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

Indianapolis, and Ingelheim, Germany (ots/PRNewswire)

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

Contact:

Dan Collins of Eli Lilly and Company, +1-317-277-2688; Julia
Meyer-Kleinmann of Boehringer Ingelheim GmbH, +49-6132-77-82-71,
First Call Analyst: Photo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO, PRN Photo Desk,
photodesk@prnewswire.com

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Plus de actualités: Eli Lilly and Company