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

Aug 13, 2004, 01:00 ET from Eli Lilly and Company from ,Boehringer Ingelheim

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

SOURCE Eli Lilly and Company; Boehringer Ingelheim