Eli Lilly (NEO:LLY)
Historical Stock Chart
From Jul 2019 to Jul 2024
![Click Here for more Eli Lilly Charts. Click Here for more Eli Lilly Charts.](/p.php?pid=staticchart&s=NEO%5ELLY&p=8&t=15)
Large-Scale Study in the British Journal of Urology Shows More Than One Out of
Three Women With Urinary Incontinence Suffer From Stress Urinary Incontinence
Journal Also Reports Duloxetine Significantly Reduces the Frequency of SUI
Episodes and ImprovesQuality of Life for Women Globally
INDIANAPOLIS and INGELHEIM, Germany, Feb. 9 /PRNewswire/ -- Two separate
studies appear now on the British Journal of Urology International Web site: one
addressing the prevalence of stress urinary incontinence (SUI) and the other
highlighting data on duloxetine, an investigational agent for this medical
disorder currently under regulatory review. The first is a large cross-country
prevalence survey showing that 35 percent of the 17,080 women analyzed reported
having urinary incontinence (UI). Thirty-seven percent of these incontinent
women reported having SUI, the most prevalent form of UI(1). The second study, a
global Phase III clinical trial comparing duloxetine versus placebo in the
treatment of SUI, shows that duloxetine significantly decreased incontinence
episodes frequency (IEF) with comparable significant Incontinence Quality of
Life (I-QOL) in those women studied who suffer from SUI(2). Both studies will
be published in the February print edition of the British Journal of Urology
International.
Prevalence Survey: SUI Most Common Form of Urinary Incontinence Among
Women
The study gathered data using a postal survey to randomly selected women ages 18
years and older in France, Germany, Spain and the United Kingdom. The
prevalence of UI by type found in this study shows that SUI was the most common
type of UI overall. The findings also revealed that over one-third of all women
surveyed reported having experienced UI. However, two-thirds of those affected
had never consulted a health care professional for treatment.
"Many misperceptions and social embarrassment surround SUI, making this common
disorder one which unfortunately is coped with in silence. Low consultation
rates signal there is a great need to raise awareness of this bothersome
condition affecting millions of women worldwide," said Professor Steinar
Hunskaar, Section for General Practice, Department of Public Health and Primary
Health Care, University of Bergen, Norway.
Global Duloxetine Phase III Study: Reduced Frequency of Episodes of SUI
The global Phase III clinical trial results of duloxetine, conducted in 38 study
centers, randomized 458 women ages 27 to 79 from seven countries: Argentina,
Australia, Brazil, Finland, Poland, South Africa and Spain. The results showed
that patients treated with 80 mg of duloxetine experienced a median reduction of
54 percent in the frequency of incontinence episodes (IEF), a primary measure of
efficacy, compared to a median reduction of 40 percent in the placebo group.
This difference accounted to be both statistically and clinically significant
with 59.5 percent of duloxetine- treated women experiencing a 50 to 100 percent
decrease in their IEF(2). Only 43.2 percent of subjects in the placebo group
experienced a decrease in their IEF(2).
"The safety and efficacy data from this late-stage study provide evidence for
the value of duloxetine as potentially the first drug that will be widely
available to women suffering from stress urinary incontinence," said Dr. Richard
J. Millard, Associate Professor of Urology, The Prince of Wales Hospital,
Sydney, Australia, and lead investigator in the study.
Duloxetine Treated Patients Showed Significant Improvements
in Quality of Life Measurements in Clinical Trial
Subjects in the duloxetine group also showed significant improvements in their
I-QOL scores compared to those in the placebo group. The I-QOL is a targeted
condition-specific questionnaire that assesses the impact and distress of
symptoms of incontinence in women who suffer from this medical disorder. I-QOL
evaluates the disorder in three relevant domains: avoidance and limiting
behavior, social embarrassment, and psychosocial impact.
Duloxetine's improvements in incontinence frequency episodes and quality of life
in this study confirm those observed in two other recently completed phase III
trials in Europe and North America(2).
Safety and Efficacy Profile
In the study, the side effect profile of duloxetine was consistent with that
seen with other drugs that have an impact on serotonin and norepinephrine. The
most commonly reported adverse event (incidence of greater than or equal to 10.0
percent and at least twice placebo) was nausea, although it was usually mild to
moderate and resolved within one week to one month in most patients
participating in the trial. Other common adverse events included headache,
insomnia, constipation, dry mouth, dizziness and fatigue(2), which tended to be
non-progressive and mild to moderate in almost all subjects.
About duloxetine
Duloxetine is a balanced potent dual reuptake inhibitor of the neurotransmitters
serotonin and norepinephrine based on pre-clinical studies. Duloxetine 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 nerve that stimulates the urethral sphincter. This
stimulation is believed to increasecontraction of the urethral sphincter at the
opening of the bladder, thereby helping prevent accidental urine leakage with
physical activity.
The U.S. Food and Drug Administration recently issued an approvable letter for
duloxetine for SUI.
About Stress Urinary Incontinence
SUI, with nearly twice the prevalence as urge incontinence, is the most common
form of urinary incontinence among women. In the United States alone it affects
approximately 30 million women over the age of 18(i). Although common, SUI is a
medical condition that is not normal at any age, but 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. Primary causes of
SUI are nerve damage, muscle damage or weakness, and damage to the support of
the bladder and urethra. Risk factors include childbirth, obesity, chronic
coughing and constipation.
About Eli Lilly and Boehringer Ingelheim
In November 2002, Eli Lillyand Company and Boehringer Ingelheim signed a
long-term agreement to jointly develop and commercialize duloxetine
hydrochloride. Duloxetine is currently being developed for the treatment of
stress urinary incontinence (SUI) and depression. This partnership covers most
countries worldwide with few exceptions. In the USA, 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, 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/ .
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the
largestU.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and
a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group of companies ranks among the 20 leading
pharmaceutical corporations in the world. Headquartered in Ingelheim, Germany,
it operates globally with 156 affiliates in 44 countries and a total of about
32,000 employees.
Since it was founded in 1885, the family-owned company has been committed to
researching, manufacturing and marketing novel products of high therapeutic
value for human and veterinary medicine. In 2002, Boehringer Ingelheim posted
net sales of $7.2 billion (7.6 billion euro) while spending about one fifth of
net sales in its largest business segment Prescription Medicines on research and
development.
For more information on Boehringer Ingelheim, please see the international
Internet website http://www.boehringer-ingelheim.com/ .
(1) Hunskaar S, Lose G, Sykes D, Voss S. The prevalence of urinary incontinence
in women in four European countries. British Journal of Urology International.
2004 Feb: 324-330: http://www.blackwell-/
synergy.com/servlet/useragent?func=synergy&synergyAction=showTOC&journalCode=b
ju&volume=93&issue=2&year=2004&part=null
(2) Millard M J, Moore K, Rencken R, Yalcin I, Bump R C. Duloxetine vs. placebo
in the treatment of stress urinary incontinence: A four continent randomized
clinical trial. British Journal of Urology International, 2004 Feb: 311-318
http://www.blackwell-/
synergy.com/servlet/useragent?func=synergy&synergyAction=showTOC&journalCode=b
ju&volume=93&issue=2&year=2004&part=null
(3) Abrams P, Cardozo L, Fall M, Griffiths, D, Rosier P, Ulmsten U, et al. The
standardization of terminology of lower urinary tract function: report from the
standardization sub-committee of the International Continence Society.
Neurourol Urodyn, 2002;21(2):167-178
(4) Viktrup L, Female stress and urge incontinence in family practice: insight
into the lower urinary tract, International Journal of Clinical Practice, 2002
Nov;56 (9)694-700
(5) Bymaster F.P, Dreshfield-Ahmad L.J, Threlkeld P.G, 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
(i) Estimated that 29.5 million women have SUI in pure or mixed forms, based on
2000 US census bureau figures and incontinence prevalence rate of 35% as cited
in Hampel C, Wienhold D, Benken N, Eggersmann C, Thuroff. Definition of
overactive bladder and epidemiology of urinary incontinence. Urol
1997:50(S6A):4-14
This press release contains forward-looking statements about the potential of
duloxetine for the treatmentof 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040122/BILOGO )
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 Pharmaceuticals, Inc.
CONTACT: Tammy Hull of Lilly, +1-317-651-9116, ; or Pam
DeMala of Boehringer Ingelheim, +1-203-798-4700,