Yentreve(TM)* Receives Approval Across the European Union for the Treatment of Stress Urinary Incontinence in Women

Yentreve(TM)* Receives Approval Across the European Union for the
Treatment of Stress Urinary Incontinence in Women 


INDIANAPOLIS and RIDGEFIELD, Conn., Aug. 13  /PRNewswire-FirstCall/ -- Eli
Lilly and Company and Boehringer Ingelheim announced today that Yentreve(TM)*
(duloxetine hydrochloride) has been granted marketing authorization across the
European Union (EU) for the treatment of moderate to severe stress urinary
incontinence (SUI) in women.

SUI is the accidental leakage of urine during physical activities such as
sneezing, coughing, laughing, lifting or exercising, and it affects nearly 15
million American adult women(1,2,3).  With nearly twice the prevalence as urge
incontinence, SUI is the most common form of urinary incontinence among
women(1,4).

Although common, SUI is a medical condition that is not normal at any age;
unfortunately, many women do not seek treatment because they are embarrassed,
fear surgery, or believe it is a normal part of aging and that nothing can be
done about it.  The primary causes of SUI are weakness of the urethral
sphincter and/or diminished pelvic support of the bladder and urethra.  Risk
factors include obesity, childbirth, chronic coughing and constipation(5).

Yentreve(TM)* is a balanced dual reuptake inhibitor of the neurotransmitters
serotonin and norepinephrine(6) and is currently being evaluated by the U.S.
Food and Drug Administration (FDA) for the treatment of SUI.  The FDA issued an
approvable letter for Yentreve(TM)* in August 2003. Lilly and Boehringer
Ingelheim have recently submitted a complete response to the FDA and anticipate
approval from the agency for Yentreve in the first half of 2005.

"With the EU approval of Yentreve(TM)*, Lilly and Boehringer Ingelheim are
excited to soon be offering patients in Europe the first medication indicated
for the specific symptoms of SUI -- a distressing and embarrassing medical
disorder that affects millions of women worldwide," said Dr. Tim Garnett, group
medical director, Eli Lilly and Company.

"The proven reduction of incontinence episodes demonstrated in clinical studies
and the statistically significant improvement in quality of life shown in women
treated with Yentreve(TM)* make this new oral medication an effective and well
tolerated treatment option for the many women living with SUI," said Manfred
Haehl, M.D., corporate medical director, Boehringer Ingelheim.  "We are very
pleased that The European Agency for the Evaluation of Medicinal Products has
acknowledged the importance of this novel medication, which we can now offer to
SUI patients throughout Europe."

About Yentreve(TM)*

Yentreve(TM)* (duloxetine hydrochloride) is a balanced dual reuptake inhibitor
of the neurotransmitters serotonin and norepinephrine based on preclinical
studies(6).  Yentreve(TM)* is believed to affect SUI by blocking the reuptake
of serotonin and norepinephrine in the spinal cord, and the increase in the
neurotransmitters in turn stimulates increased activity of the pudendal nerve
that controls the external urethral sphincter(7).  This stimulation is believed
to increase contraction of the external urethral sphincter, thereby helping
prevent accidental urine leakage with physical activity.

Clinical studies of Yentreve(TM)* have shown the most commonly reported adverse
events (incidence of > 5 percent and at least twice the placebo rate) reported
by patients receiving duloxetine have been nausea, dry mouth, fatigue,
insomnia, constipation, headache, dizziness, somnolence (drowsiness) and
diarrhea(8).

About Eli Lilly and Boehringer Ingelheim

In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a
global long-term agreement to jointly develop and commercialize duloxetine
hydrochloride for the treatment of stress urinary incontinence (SUI),
depression and diabetic neuropathic pain.  This partnership covers most
countries worldwide with few exceptions.  In the U.S., the collaboration
focuses on SUI.

Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and 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, IN, 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/ .

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the
largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT)
and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim Corporation is one of the world's 20 leading
pharmaceutical companies.  Headquartered in Ingelheim, Germany, it operates
globally with 152 affiliates in 45 countries and more than 34,000 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 2003, Boehringer Ingelheim posted net U.S. sales of $8.37 billion (7.4
billion euro) while spending more than one fifth of net sales in its largest
business segment -- prescription medicines -- on research and development.

For more information please visit http://www.boehringer-ingelheim.com/

This press release contains forward-looking statements about the potential of
duloxetine for the treatment of stress urinary incontinence and reflects
Lilly's current beliefs.  However, as with any pharmaceutical product under
development, there are substantial risks and uncertainties in the process of
development and/regulatory review.  There is no guarantee that the product will
receive regulatory approvals and any indication for which it is approved will
be determined at the discretion of the Food and Drug Administration. There is
also no guarantee that the product will prove to be commercially successful. 
For further discussion of these and other risks and uncertainties, see Lilly's
filings with the United States Securities and Exchange Commission.  Lilly
undertakes no duty to update forward-looking statements.

*  Yentreve is a trademark of Eli Lilly and Company.  This trademark is pending
approval by the FDA as a proprietary drug name for the established name,
duloxetine hydrochloride.

1.  Hampel C, Wienhold D, Benken N, Eggersmann C, Thuroff T.  Definition of
overactive bladder and epidemiology of urinary incontinence.  Urology.
1997;50(suppl 6A):4-14.

2.  Diokno A, Burgio K, Fultz N, Kinchen K, Obenchain R, and Bump R. Medical
and self-care practices reported by women with urinary incontinence. Am J
Managed Care.  2004;10:69-78.  The estimate of STRESS URINARY INCONTINENCE
prevalence was derived from Diokno et al and based on STRESS URINARY
INCONTINENCE prevalence as determined by Hampel et al and by Diokno et al.

3.  US Census 2000 Briefs (Age & Gender), US Department of Commerce website.

4.  Fultz NH, Burgio K, Diokno A, Kinchen K, Obenchain R and Bump R. Burden of
stress urinary incontinence for community-dwelling women.  Am J Obstet Gynecol.
 2003; 189: 1275-1282.

5.  Bump R, Norton P. Epidemiology and natural history of pelvic floor
dysfunction.  Obstet Gynecol Clin North Am. 1998; 25(04): 723 - 746.

6.  Bymaster F, Dreshfield-Ahmad L, Threlkeld P, Shaw J, Thompson B, Nelson D,
et. al.  Comparative affinity of duloxetine and venlafaxine for serotonin and
norepinephrine transporters in vitro and in vivo, Human serotonin receptor
subtypes, and other neuronal receptors. Neuropsychopharmacology. 2001;
25(6):871-880.

7.  Thor K, Katofiasc M. Effects of duloxetine, a combined serotonin and
norepinephrine reuptake inhibitor, on central neural control of lower urinary
tract function in the chloralose-anesthetized female cat.  J Pharmacol Exp
Ther. 1995; 274:1014-1024.

8.  Hurley D, Turner C, Baygani S, Yalcin I and Viktrup L.  Duloxetine for
stress urinary incontinence: A meta-analysis of safety.  Poster presented at
the International Federation of Gynaecology and Obstetrics (FIGO) World
Congress, Santiago, Chile. 2-7 November 2003.

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DATASOURCE: Eli Lilly and Company; Boehringer Ingelheim



CONTACT:  Tammy Hull of Lilly, [phone],  ; or

Marybeth McGuire of Boehringer Ingelheim, [phone],

 



Web site:  http://www.lilly.com/ 

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