Eli Lilly and Company and Boehringer Ingelheim Announce Changes to Their Contractual Agreements for Yentreve(R)/AriClaim(R)
15 February 2006 - 10:00PM
PR Newswire (US)
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 http://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 http://www.boehringer-ingelheim.com/. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO ) First Call
Analyst: FCMN Contact: terrafox@lilly.com
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO DATASOURCE: Eli
Lilly and Company; Boehringer Ingelheim CONTACT: Dan Collins of Eli
Lilly and Company, +1-317-277-2688; Julia Meyer-Kleinmann of
Boehringer Ingelheim GmbH, +49-6132-77-82-71
Copyright