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FDA Issues Approvable Letter for Duloxetine for Stress Urinary Incontinence -SUI-; Lilly Expects Regulatory Update on Cymbalta Later This Year.

Business Editors/Health/Medical Writers


Eli Lilly and Company has received an approvable letter from the U.S. Food and Drug Administration's Division of Reproductive and Urologic Drug Products (DRUDP) for duloxetine for the treatment of stress urinary incontinence (SUI). Final FDA approval is contingent upon successful completion of additional acute pre-clinical and clinical pharmacology studies; satisfactory resolution of manufacturing issues at Lilly's Indianapolis manufacturing facilities, including the satisfactory completion of a pre-approval site inspection; and completion of label negotiations.

Lilly plans to conduct discussions with the FDA concerning the company's plans to provide the information the agency has requested. The results of these discussions will allow the company to provide a better estimate of the potential U.S. approval date. Currently, pending more precise information, Lilly anticipates a U.S. approval of duloxetine for SUI in late 2004 or the first half of 2005.

Duloxetine for depression, known as Cymbalta(TM), is also currently under review by the FDA's Division of Neuropharmacologic Drug Products. Lilly received an approvable letter from the FDA for Cymbalta in September 2002. As of this date, the Division of Neuropharmacologic Drug Products has not communicated to Lilly the extent to which the requests made by DRUDP, in the approvable letter for duloxetine for SUI, will affect the review and approval of Cymbalta. Lilly expects to have more clarity on the timing of the approval of Cymbalta by the action date prior to the end of this year.

"We are committed to bringing our innovative late stage products as quickly as possible to the patients who need them," said Sidney Taurel, chairman, president and chief executive officer, Eli Lilly and Company. "To that end, we will work rapidly to provide the additional data requested by the agency and to resolve our outstanding manufacturing issues."

On Friday Sept. 5, Lilly is convening its annual investment community meeting where senior management will discuss these products as well as others in the company's late stage pipeline. The meeting, held from 8:30 a.m. to 1:30 p.m. Eastern Time, will be webcast live at and will be available for replay through September 19, 2003.

In November 2002, Lilly 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 United States, the collaboration is for SUI only.

About SUI and duloxetine

Stress urinary incontinence is a medical condition primarily affecting women, attributed to insufficient closure of the urethral sphincter muscle (at the bladder outlet). For SUI sufferers, accidental urine leakage results when there is an increase in pressure in the abdomen - such as when laughing, coughing, sneezing, lifting or exercising. SUI symptoms affect an estimated 1 in 3 women in the United States.(1) Unfortunately many women do not seek treatment because they are embarrassed, fear surgery, or believe SUI is a normal part of aging and that nothing can be done about it. Primary causes and risk factors of SUI are nerve damage, muscle damage or weakness, childbirth, obesity, chronic coughing and constipation. Once approved, duloxetine would become the first pharmaceutical indicated to treat SUI.

Duloxetine is a dual reuptake inhibitor of the neurotransmitters serotonin and norepinephrine, which are believed to play key roles in the normal closure of muscle at the base of the bladder. Increased neurotransmitter concentration in turn stimulates increased activity of the nerve that stimulates the urethral sphincter. This stimulation is believed to increase the tone of the urethral sphincter at the exit of the bladder, thereby helping prevent accidental urine leakage due to physical activity.

Eli Lilly and Company

Lilly, a leading innovation-driven corporation is developing a growing portfolio of 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

Boehringer Ingelheim

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 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

This press release contains forward-looking statements about the potential of duloxetine in treating stress urinary incontinence and depression that reflect management's current beliefs. However, as with any pharmaceutical under development, there are risks and uncertainties in the process of development and regulatory review. There are no guarantees that the products will receive regulatory approvals within the expected timeframes or at all or that they 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.

(1)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
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Geographic Code:1USA
Date:Sep 3, 2003
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