FDA Issues Approvable Letter for Strattera for ADHD; Strattera Would Give Patients, Families and Physicians a New Treatment Opti

     
BW20020814002125  20020814T122852Z UTC


( BW)(ELI-LILLY)(BC43) FDA Issues Approvable Letter for Strattera for
ADHD; Strattera Would Give Patients, Families and Physicians a New
Treatment Option

    Business Editors
    UK REGULATORY NEWS

    INDIANAPOLIS--(BUSINESS WIRE)--Aug. 14, 2002--

Eli Lilly and Company (NYSE:LLY) has received an approvable letter
from the U.S. Food and Drug Administration (FDA) for Strattera(TM)
(atomoxetine hydrochloride), a treatment for
Attention-Deficit/Hyperactivity Disorder (ADHD) in children,
adolescents and adults.

Approval is contingent upon labeling discussions, and submission of
additional data or analyses from either existing studies or a
potential new study. While Lilly continues to plan for final FDA
approval in the spring of 2003, approval timing is contingent upon
further discussions with the FDA regarding the additional data
requested.

"We are delighted to reach this important milestone in the development
of Strattera, and we are working closely with the FDA to complete this
process as quickly as possible," said John Lechleiter, executive vice
president of pharmaceutical products and corporate development at Eli
Lilly and Company. "We're eager to bring this new treatment option to
patients, families and health care professionals."

Lilly submitted its New Drug Application (NDA) for Strattera in
October 2001. It included data from six placebo-controlled studies,
involving children, adolescents and adults. So far, more than 4,000
patients have taken Strattera in clinical trials.

ADHD affects 3-7 percent of school age children(1) and manifests
itself in levels of attention, concentration, activity,
distractibility, and impulsivity that are inappropriate to the child's
age group.(2) Experts estimate 60 percent of children with the
disorder carry their symptoms into adulthood.(3)

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 atomoxetine in
the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
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) American Academy of Pediatrics. Clinical practice guidelines:
diagnosis and evaluation of the child with
attention-deficit/hyperactivity disorder. Pediatrics. 2000;
105:1158-1170.

(2) American Psychiatric Association: Diagnostic and Statistical
Manual of Mental Disorders, fourth edition. Washington, DC, American
Psychiatric Association, 1994.

(3) American Psychiatric Association: DSM-IV-TR.2000.85-93 Schweitzer
JB, et al. Attention-deficit/hyperactivity disorder. Med Clin of North
Am. 2001; 85(3):757-777.

   Short Name: Lilly (Eli) & Co
   Category Code: MSC
   Sequence Number: 00000628
   Time of Receipt (offset from UTC): 20020813T192905+0100

    --30--db/in*

    CONTACT: Eli Lilly and Company
             David Shaffer, 317/651-3710

    KEYWORD: INDIANA UNITED KINGDOM INTERNATIONAL EUROPE
    INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCT
    SOURCE: Lilly (Eli) & Co

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