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Lilly and Boehringer Ingelheim Jointly Announce the Recision of
U.S. FDA Application for Duloxetine for Treatment of Stress Urinary
Incontinence
Companies Confident in SUI Data and Are Evaluating Options
INDIANAPOLIS, Ind. and RIDGEFIELD, Conn., Jan. 28
/PRNewswire-FirstCall/ -- Eli Lilly and Company and Boehringer Ingelheim
Pharmaceuticals, Inc. today jointly announced that Lilly has withdrawn from the
U.S. FDA's Division of Reproductive and Urologic Drug Products its New Drug
Application for duloxetine hydrochloride for the treatment of stress urinary
incontinence (SUI). This decision was based on discussions with the FDA
suggesting the agency is not prepared at this time to grant approval for
duloxetine for the treatment of the SUI patient population based on the data
package submitted. The companies will evaluate all options for next steps once
they have had time to fully understand the FDA's perspective. Ongoing clinical
trials for duloxetine SUI will continue.
This action does not affect the marketing status of duloxetine for the
indications of depression and diabetic peripheral neuropathic pain (DPNP) in
the United States or the SUI and depression indications outside of the United
States.
"Despite this decision, we continue to have confidence in duloxetine, which is
currently available for the treatment of stress urinary incontinence in many
other countries," said Sidney Taurel, chairman, president and chief executive
officer, Eli Lilly and Company.
"We are certainly disappointed with this outcome but are committed to exploring
our options for duloxetine, as millions of American women who suffer from SUI
do not currently have a pharmaceutical option to help manage their condition,"
stated Dr. Alessandro Banchi, chairman of the Board of Managing Directors of
Boehringer Ingelheim.
Duloxetine for the treatment of SUI, marketed as Yentreve(R) and AriClaim(R)
outside of the United States, has been deemed safe and effective by regulatory
authorities that have granted its approval in 27 countries throughout the
world.
Duloxetine for the treatment of major depressive disorder and DPNP has already
been approved by the U.S. FDA as a safe and effective treatment under the brand
name Cymbalta(R). The European Commission has approved duloxetine under the
trade names of Cymbalta(R) and Xeristar(R) for major depressive episodes.
Throughout the world, the drug is approved in 30 countries for major
depression.
About SUI
SUI is the accidental leakage of urine during physical activities such as
sneezing, coughing, laughing, lifting or exercising. It is an embarrassing and
bothersome medical condition that affects nearly 15 million adult women in the
United States(1,2) and can have a significant impact on quality of life. With
nearly twice the prevalence of urge incontinence, SUI is the most common form
of urinary incontinence among women.(3) Although common, it 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 that 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.(4)
About Duloxetine
Based on preclinical studies, duloxetine for SUI is a dual reuptake inhibitor
and is believed to affect SUI by blocking the reuptake of serotonin and
norepinephrine in the spinal cord.(3) The increase in the neurotransmitters in
turn stimulates increased activity of the pudendal nerve that controls the
external urethral sphincter. This stimulation is believed to increase
contraction of the external urethral sphincter, thereby helping prevent
accidental urine leakage with physical activity.
Clinical studies of duloxetine for the treatment of SUI have shown the most
commonly reported adverse events (incidence of greater than or equal to 5
percent and significantly more common than placebo) reported by patients
receiving duloxetine have been nausea, dry mouth, fatigue, insomnia,
constipation, headache, dizziness, somnolence (drowsiness) and diarrhea.(5)
About Cymbalta
Cymbalta (sim-BAWL'-tuh) is indicated in the United States for the treatment of
major depression and the management of diabetic peripheral neuropathic pain,
both in adults. As Cymbalta has not been studied in children, Lilly discourages
its use in those under 18.
Cymbalta should not be confused with Symbyax(TM) (pronounced SIMM-bee-ax), a
medicine for bipolar depression also marketed by Lilly. Symbyax is a
combination of olanzapine, the active ingredient in Zyprexa(R), and fluoxetine,
the active ingredient in Prozac(R). Symbyax is available in capsules of 6 mg/25
mg (olanzapine/fluoxetine), 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg. Cymbalta
is available in 20 mg, 30 mg and 60 mg capsules.
Important Safety Information
In clinical studies, antidepressants increased the risk of suicidal thinking
and behavior in children and adolescents with depression and other psychiatric
disorders. Anyone considering the use of Cymbalta or any other antidepressant
in a child or adolescent must balance the risk with the clinical need.
Patients who are starting therapy should be observed closely. Families and
caregivers should discuss with the doctor any observations of worsening
depression symptoms, suicidal thinking and behavior, or unusual changes in
behavior. Cymbalta is not approved for use in patients under the age of 18.
Patients on antidepressants and their families or caregivers should watch for
worsening depression symptoms, unusual changes in behavior and thoughts of
suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping,
irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme
hyperactivity. Call the doctor if you have thoughts of suicide or if any of
these are severe or occur suddenly. Be especially observant at the beginning
of treatment or whenever there is a change in dose.
Prescription Cymbalta is not for everyone. People who are allergic to
duloxetine hydrochloride or the other ingredients in Cymbalta should not take
it. If you have recently taken a type of antidepressant called a monoamine
oxidase inhibitor (MAOI), are taking thioridazine or have uncontrolled narrow-
angle glaucoma, you should not take Cymbalta. Talk with your doctor before
taking Cymbalta if you have liver or kidney problems, glaucoma or consume large
quantities of alcohol. Women who are pregnant should talk with their doctor
before taking Cymbalta. Breast feeding while taking Cymbalta is not
recommended.
In clinical studies of Cymbalta for depression, the most common side effects
were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness,
and increased sweating. Cymbalta also is approved for the management of
neuropathic pain associated with diabetic peripheral neuropathy. In clinical
studies of Cymbalta in these patients, the most common side effects were
nausea, sleepiness, dizziness, constipation, dry mouth, increased sweating,
decreased appetite, and muscle weakness. In all clinical trials, most people
were not bothered enough by side effects to stop taking Cymbalta. Your doctor
may periodically check your blood pressure. Don't stop taking Cymbalta without
talking to your doctor.
For full prescribing information, visit http://www.cymbalta.com/.
About 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 peripheral neuropathic pain (DPNP). This partnership
covers most countries worldwide with few exceptions. In the U.S., the
collaboration focuses on SUI and excludes depression and DPNP.
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, Conn., is the
largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, Conn.)
and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group of companies 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 Prescribing Information, please visit
http://www.boehringer-ingelheim.com/.
* Note to Editors:
Duloxetine for major depressive episodes will be marketed by Lilly and
Boehringer Ingelheim in all countries included in the partnership under the
brand name Cymbalta(R), except for Greece, Italy and Spain. In Greece, Italy
and Spain Lilly will market the product as Cymbalta and Boehringer Ingelheim
will market the product as Xeristar(R). In the USA the collaboration does not
include Cymbalta. In the USA, the collaboration excludes neuroscience
indications.
Duloxetine for stress urinary incontinence will be marketed by Lilly and
Boehringer Ingelheim in all countries included in the partnership under the
brand name Yentreve(R), except for Greece, Italy and Spain. In Greece, Italy
and Spain Lilly will market the product as Yentreve and Boehringer Ingelheim
will market the product as AriClaim(R).
P-LLY
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/or 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.
REFERENCES
1. 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.
2. US Census 2000 Briefs (Age & Gender), US Department of Commerce Web site.
3. 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.
4. Fultz NH, Burgio, K, Diokno A, Kinchen K, Obenchain R, and BumpR. Burden of
stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol.
2003; 189: 1275-1282.
5. 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 Pharmaceuticals, Inc.
CONTACT: Tammy Hull of Lilly, +1-317-651-9116, ; or
Marybeth McGuire of Boehringer Ingelheim, +1-203-798-4801,