Lilly and Boehringer Ingelheim sign commercialization agreement for the potentially first globally available pharmaceutical for stress urinary incontinence

Partnership also includes joint commercialization of Cymbalta^TM for depression outside the U.S.

05  December 2002

Indianapolis/USA, Ingelheim/Germany, 5 December 2002 – Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim announced today that they have signed a long-term agreement to jointly commercialize duloxetine for the treatment of stress urinary incontinence on a worldwide basis (excluding Japan). Lilly filed its U.S. submission for duloxetine for stress urinary incontinence during the fourth quarter of 2002 and anticipates making a European submission early next year. In addition, the companies have agreed to jointly commercialize Cymbalta^TM (duloxetine hydrochloride) for the treatment of depression in countries outside the U.S. (excluding Japan). Lilly anticipates making a European depression submission for Cymbalta in 2003.

"We believe that the combined resources of this partnership will allow us to maximize the value of the molecule and will result in a greater return to Lilly`s shareholders than had we commercialized it on our own," said John C. Lechleiter, Ph.D., Lilly executive vice president of pharmaceutical products and corporate development. "With this collaboration, we gain a strong and experienced partner in the urology market who will help increase awareness of stress urinary incontinence and the significant benefits that duloxetine could provide as the potentially first globally available pharmaceutical treatment for women suffering from this chronic condition. In addition, this collaboration maximizes our sales and marketing support for Cymbalta outside the U.S. and complements our existing U.S. Cymbalta commercialization agreement with Quintiles."

"We see this close cooperation as a perfect match for our two companies," said Dr. Alessandro Banchi, member of the board of managing directors of Boehringer Ingelheim. "We are proud to work jointly together with Lilly in establishing a new effective drug treatment option for stress urinary incontinence, at present a highly underdiagnosed and undertreated condition that affects millions of women. This adds a promising long-term perspective to our existing urology franchise, which over the last years we built very successfully with tamsulosin (Flomax®, Pradif®, Alna®), today the most widely prescribed alpha blocker for treatment of lower-urinary-tract symptoms due to benign prostatic hyperplasia. We are also very active in drug treatment of disorders of the central nervous system, such as Parkinson`s disease. Cymbalta fits nicely into our marketing and sales experience."

Duloxetine for the treatment of SUI
Duloxetine is a potent, balanced dual reuptake inhibitor of both serotonin and norepinephrine that is being studied for the treatment of stress urinary incontinence and depression. In clinical trials for the treatment of stress urinary incontinence (SUI), duloxetine 80 mg, when taken as 40 mg twice a day, significantly reduced the frequency of incontinence episodes compared with placebo and was generally well tolerated. Urinary incontinence is a disease that affects as many as 30 percent to 40 percent of women worldwide, and SUI is the most common form. SUI is the involuntary leakage of urine brought on by stress or pressure upon the bladder as a result of physical activities, such as laughing, coughing, sneezing, lifting or exercising. The most common risk factors for SUI are vaginal childbirth, obesity, smoking, constipation and chronic physical stress. The current therapies for SUI include pelvic muscle exercises and surgery as there are no globally approved pharmaceutical treatments.

Duloxetine for the treatment of depression
In clinical trials for the treatment of depression, duloxetine 60 mg once daily (brand name Cymbalta^TM) relieved symptoms of depression, such as low mood, anxiety and physical symptoms associated with depression like aches and pains. In addition, study patients who took Cymbalta were more likely to have complete resolution of their symptoms than patients on placebo. There are significant unmet medical needs in the antidepressant market as more than two-thirds of patients using current therapies will not fully recover and at least one in three patients does not complete an appropriate course of therapy.

Financial terms of the agreement
Under the terms of the agreement, Boehringer Ingelheim will make upfront and potential milestone payments up to a maximum of $280 million to Lilly. Lilly will amortize the upfront payment to other income through anticipated product approval. The milestone payments are anticipated to be received during the next several years based upon successful attainment of certain regulatory approvals for depression, SUI and other potential urinary incontinence indications and other performance criteria and will be reflected primarily in other income by Lilly. In addition, in the fourth quarter of 2002 Lilly will receive a reimbursement of a portion of the expenses incurred by Lilly (primarily research and development) in support of duloxetine during 2002. The companies over time intend to share approximately equally in the ongoing development and marketing costs. Lilly will pay Boehringer Ingelheim a commission rate, which is competitive with other major pharmaceutical product collaborations, on net sales in the respective territories. Lilly expects the positive financial impact of this collaboration to Lilly in the fourth quarter of 2002 will be approximately $56 million pretax, or about 4 cents per share, which has been included in Lilly`s financial guidance.

The partners
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 at www.lilly.com.

The Boehringer Ingelheim group of companies, headquartered in Ingelheim, Germany, is one of the 20 leading pharmaceutical corporations in the world. It has some 140 affiliated companies in 42 countries worldwide and focuses on human pharmaceuticals and animal health. The human pharmaceuticals business, which accounts for 95% of sales, comprises prescription medicines, consumer health care products and chemicals and biopharmaceuticals for industrial customers. Research and development, production, and distribution facilities are located around the globe.

Related Link:
Eli Lilly and Company

Contact:
Eli Lilly and Company
Corporate Communications
Eli Lilly and Company
Indianapolis/USA
Phone: +1-317-276-5795
E-mail: terrafox@lilly.com

Boehringer Ingelheim GmbH
Judith von Gordon
Corporate Division Communications
Boehringer Ingelheim GmbH
55216 Ingelheim
Phone: +49-6132-77 3582
Fax: +49-6132-77 6601
E-mail: gordon@ing.boehringer-ingelheim.com

References:
Cymbalta™ (duloxetine hydrochloride, Lilly) Flomax®, Pradif®, Alna® are trademarks of tamsulosin hydrochloride, marketed by Boehringer Ingelheim under a license of Yamanouchi Pharmaceutical Co., Ltd, Japan