FDA Issues Approvable Letter for Lilly's Cymbalta for Treatment of Depression; From the Makers of Prozac, Cymbalta Will Offer New Hope for Those With Depression, When Approved

Business Wire, Sept 16, 2002

Business & Health/Medical Editors

INDIANAPOLIS--(BUSINESS WIRE)--Sept. 16, 2002

Eli Lilly and Company (NYSE:LLY) has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Cymbalta(TM) (duloxetine hydrochloride), a dual reuptake inhibitor that works through two key neurotransmitters -- serotonin and norepinephrine -- involved in depression.

Approval is contingent upon labeling discussions and resolution of the company's outstanding manufacturing issues.

"Depression affects as many as 340 million people around the world -- and over 18 million Americans -- each year. Despite the advances in antidepressant therapy that began with the introduction of Prozac in 1988, often patients fail to benefit from existing therapy. As many as two-thirds of treated patients fail to achieve complete resolution of their symptoms, or remission," said Dr. John Lechleiter, executive vice president of pharmaceutical products and corporate development at Lilly. "The introduction of Cymbalta will offer physicians and patients new hope for this devastating disease."

Lilly submitted its New Drug Application (NDA) for Cymbalta in November 2001 with data from five placebo-controlled depression studies and a one-year open label safety study. Thus far, more than 3,000 patients have taken Cymbalta in clinical trials. Data suggest Cymbalta 60 mg once daily relieves symptoms of depression, such as low mood, anxiety and physical symptoms like aches and pains, as measured by a commonly used depression rating scale(1). Study patients who took Cymbalta were up to three times more likely to have complete resolution of their symptoms as patients on placebo.

Cymbalta enhances the levels of two neurotransmitters -- serotonin and norepinephrine -- while the most commonly used antidepressants, such as Prozac, only affect serotonin. An imbalance of these two neurotransmitters may explain the emotional and physical symptoms depressed patients often endure.

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.

This news release contains forward-looking statements that reflect management's current beliefs about the potential for duloxetine in the treatment of depression. However, as with any pharmaceutical under development, there are significant risks and uncertainties in the process of development and regulatory review. There are no guarantees that the product will receive regulatory approvals or prove to be commercially successful. There is also no assurance of the timing of final FDA action on the compound. For additional information about the factors that affect the company's business, please see Exhibit 99 to the company's latest Form 10-Q. The company undertakes no duty to update forward-looking statements.

(1) Hamilton Depression Rating Scale