FDA Issues Approvable Letter for Lilly's Cymbalta for Treatment of Depression; From the Makers of Prozac, Cymbalta Will Offer Ne

     
BW20020916002401  20020916T160212Z UTC


( BW)(ELI-LILLY-&-CO)(BC43) 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 Editors
    UK REGULATORY NEWS

    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

   Short Name: Lilly (Eli) & Co
   Category Code: MSC
   Sequence Number: 00000787
   Time of Receipt (offset from UTC): 20020916T162553+0100

    --30--sm/uk*

    CONTACT: Eli Lilly and Company
             Anne Griffin (US), 317/276-3254
             Jennifer Yoder (Global), 317/433-3445 or 317/985-7720

    KEYWORD: INDIANA UNITED KINGDOM INTERNATIONAL EUROPE
    INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL PRODUCT
    SOURCE: Eli Lilly and Company

Today's News On The Net - Business Wire's full file on the Internet
                          with Hyperlinks to your home page.
                          URL: http://www.businesswire.com