Yentreve(TM)* Receives Approval Across the European Union for the Treatment of Stress Urinary Incontinence in Women
August 13 2004 - 7:00AM
PR Newswire (US)
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. (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 CONTACT: Tammy Hull of
Lilly, +1-317-651-9116, ; or Marybeth McGuire of Boehringer
Ingelheim, +1-203-798-4801, Web site: http://www.lilly.com/
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