Non-Stimulant Strattera More Widely Available for ADHD Patients in Europe

Europe's only approved non-stimulant ADHD medication offers a newtreatment choice

INDIANAPOLIS, May 18 (PRNewswire)

Eli Lilly and Company's Strattera(R), the only approved non-stimulantmedication proven clinically effective(1) at treating the potentially serioussymptoms of attention-deficit/hyperactivity disorder (ADHD), is now morewidely available in Europe, following marketing authorizations granted byregulatory authorities in Germany, The Netherlands and Norway. Strattera isapproved for the treatment of ADHD in children and adolescents. Adolescentswho have shown a clear benefit may also continue treatment into adulthood.

A selective norepinephrine reuptake inhibitor, Strattera represents thefirst new class of ADHD medications in the 50 years since stimulantmedications first began being used. Strattera became available in Germany inMarch 2005 and became available in The Netherlands and Norway in April.

Within Europe, Strattera was previously approved for use in the UnitedKingdom by the UK's Medicines and Healthcare Products Regulatory Agency inMay 2004.

In clinical trials(1), Strattera demonstrated effective, continuousrelief of core ADHD symptoms, including inattention and/or hyperactivity andimpulsivity, from morning until late evening. Strattera treats ADHD withoutcausing insomnia in most children and adolescents and has been shown toeffectively treat ADHD in children who have other, co-existing conditionssuch as tics and anxiety.

"Strattera provides physicians and families with something they've neverhad before -- a proven effective, non-stimulant option for the treatment ofADHD," said Dr. Jesus Hernandez, executive director of clinical research andregulatory affairs in European Operations at Eli Lilly and Company. "Throughthis new class of ADHD treatment, we are living up to Lilly's commitment toprovide patients innovative new medications. We are very pleased that moredoctors in Europe will be able to consider Strattera as a part of acomprehensive ADHD treatment program."

About ADHD

ADHD affects 3-7 percent of school-age children and manifests itself inlevels of attention, concentration, activity, distractibility and impulsivitythat are inappropriate to the child's age.(2)

A biological, brain-based condition, ADHD is thought to be caused by animbalance of some of the brain's neurotransmitters, which are thesubstances used to signal between nerve cells.(2) The condition ischaracterized by hyperactive/impulsive behaviors and/or attention-deficitproblems that cannot be explained by any other psychiatric condition and arenot in keeping with the child's intellectual ability or stage ofdevelopment.(3)

Studies have shown that more than 50 percent of children with untreatedADHD have poor peer relationships and that families of children with ADHDexperience greater stress.(4) If the disorder is not appropriately treated,these children are much less likely to finish college, and are more likely todevelop drug use disorders (20-32 percent) and to hold less skilled jobs inadulthood.(4)

About Strattera

Strattera is the only non-stimulant medication approved for the treatmentof ADHD and has received regulatory approval in the United States, Europe(United Kingdom, Germany, Norway and The Netherlands), Canada, Australia andadditional countries. More than 2.5 million patients have taken Stratteraworldwide since its first approval in the United States in November 2002.

Strattera, a selective norepinephrine reuptake inhibitor, worksdifferently than other approved treatments for the disorder, all of which arestimulants. It is not known precisely how Strattera reduces ADHD symptoms,but scientists believe it works by blocking or slowing reabsorption ofnorepinephrine, a chemical in the brain considered important in regulatingattention, impulsivity and activity levels. This keeps morenorepinephrine at work in the spaces between neurons in the brain.

Improved efficiency in the norepinephrine system is associated withimprovement in symptoms of ADHD (Pliska, 1996).

Strattera should not be taken at the same time as, or within two weeks oftaking, a monoamine oxidase inhibitor, or by patients with narrow angleglaucoma. Patients with a history of high or low blood pressure, increasedheart rate, or any heart or blood vessel disease should tell their doctorbefore taking Strattera. Strattera has not been tested in children less thansix years of age or in geriatric patients. Some children may lose weight whenstarting treatment with Strattera. As with all ADHD medications, growthshould be monitored during treatment. Strattera can cause liver damage invery rare cases. Patients should tell their doctor if they have itching, darkurine, yellow skin/eyes, upper right-sided abdominal tenderness, orunexplained "flu-like" symptoms.

Most people in clinical studies who experienced side effects were notbothered enough to stop using Strattera. The most common side effects inchildren and adolescents in medical studies were upset stomach, decreasedappetite, nausea and vomiting, dizziness, tiredness and mood swings.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growingportfolio of first-in-class and best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories and fromcollaborations with eminent scientific organizations. Headquartered inIndianapolis, Ind., Lilly provides answers -- through medicines andinformation -- for some of the world's most urgent medical needs.

P-LLY

This press release contains forward-looking statements about thepotential of Strattera for the treatment of ADHD and reflects Lilly's currentbeliefs. However, as with any pharmaceutical product, there are substantialrisks and uncertainties in the process of commercialization. For furtherdiscussion of these and other risks and uncertainties, see Lilly's filingswith the United States Securities and Exchange Commission. Lilly undertakesno duty to update forward-looking statements.

(1) Strattera Summary of Product Characteristics (SPC):http://emc.medicines.org.uk/emc/assets/c...

(2) American Psychiatric Association: Diagnostic and Statistical Manualof Mental Disorders, fourth edition, text revision, Washington, DC, AmericanPsychiatric Association, 2000.

(3) Green C, Chee K. Understanding ADHD - The Definitive Guide toAttention Deficit Hyperactivity Disorder. The Random House BallantinePublishing Group 1998.

(4) Barkley RA. Attention-Deficit Hyperactivity Disorder: A Handbook forDiagnosis and Treatment. 1998, Guildford Publications, New York.

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Source: Eli Lilly and Company

Valerie Tully of Eli Lilly and Company, +1-317-655-2993; or Lucy Whitehead of Cohn & Wolfe, +44-(0)-7799553510Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO PRN Photo Desk, photodesk@prnewswire.com

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