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Eli Lilly and Company

Non-Stimulant Strattera More Widely Available for Attention-Deficit/Hyperactivity Disorder Patients in Europe

Indianapolis (ots/PRNewswire)

- Europe's only approved non-stimulant ADHD medication offers a
new treatment choice
Eli Lilly and Company's Strattera(R), the only approved
non-stimulant medication proven clinically effective(1) at treating
the potentially serious symptoms of attention-deficit/hyperactivity
disorder (ADHD), is now more widely available in Europe, following
marketing authorizations granted by regulatory authorities in
Germany, The Netherlands and Norway. Strattera is approved for the
treatment of ADHD in children and adolescents. Adolescents who have
shown a clear benefit may also continue treatment into adulthood.
A selective norepinephrine reuptake inhibitor, Strattera
represents the first new class of ADHD medications in the 50 years
since stimulant medications first began being used. Strattera became
available in Germany in March 2005 and became available in The
Netherlands and Norway in April. Within Europe, Strattera was
previously approved for use in the United Kingdom by the UK's
Medicines and Healthcare Products Regulatory Agency in May 2004.
In clinical trials(1), Strattera demonstrated effective,
continuous relief of core ADHD symptoms, including inattention and/or
hyperactivity and impulsivity, from morning until late evening.
Strattera treats ADHD without causing insomnia in most children and
adolescents and has been shown to effectively treat ADHD in children
who have other, co-existing conditions such as tics and anxiety.
"Strattera provides physicians and families with something they've
never had before -- a proven effective, non-stimulant option for the
treatment of ADHD," said Dr. Jesus Hernandez, executive director of
clinical research and regulatory affairs in European Operations at
Eli Lilly and Company. "Through this new class of ADHD treatment, we
are living up to Lilly's commitment to provide patients innovative
new medications. We are very pleased that more doctors in Europe will
be able to consider Strattera as a part of a comprehensive ADHD
treatment program."
About ADHD
ADHD affects 3-7 percent of school-age children and manifests
itself in levels of attention, concentration, activity,
distractibility and impulsivity that are inappropriate to the child's
age.(2)
A biological, brain-based condition, ADHD is thought to be caused
by an imbalance of some of the brain's neurotransmitters, which are
the substances used to signal between nerve cells.(2) The condition
is characterized by hyperactive/impulsive behaviors and/or
attention-deficit problems that cannot be explained by any other
psychiatric condition and are not in keeping with the child's
intellectual ability or stage of development.(3)
Studies have shown that more than 50 percent of children with
untreated ADHD have poor peer relationships and that families of
children with ADHD experience greater stress.(4) If the disorder is
not appropriately treated, these children are much less likely to
finish college, and are more likely to develop drug use disorders
(20-32 percent) and to hold less skilled jobs in adulthood.(4)
About Strattera
Strattera is the only non-stimulant medication approved for the
treatment of ADHD and has received regulatory approval in the United
States, Europe (United Kingdom, Germany, Norway and The Netherlands),
Canada, Australia and additional countries. More than 2.5 million
patients have taken Strattera worldwide since its first approval in
the United States in November 2002.
Strattera, a selective norepinephrine reuptake inhibitor, works
differently than other approved treatments for the disorder, all of
which are stimulants. It is not known precisely how Strattera reduces
ADHD symptoms, but scientists believe it works by blocking or slowing
reabsorption of norepinephrine, a chemical in the brain considered
important in regulating attention, impulsivity and activity levels.
This keeps more norepinephrine at work in the spaces between neurons
in the brain. Improved efficiency in the norepinephrine system is
associated with improvement in symptoms of ADHD (Pliska, 1996).
Strattera should not be taken at the same time as, or within two
weeks of taking, a monoamine oxidase inhibitor, or by patients with
narrow angle glaucoma. Patients with a history of high or low blood
pressure, increased heart rate, or any heart or blood vessel disease
should tell their doctor before taking Strattera. Strattera has not
been tested in children less than six years of age or in geriatric
patients. Some children may lose weight when starting treatment with
Strattera. As with all ADHD medications, growth should be monitored
during treatment. Strattera can cause liver damage in very rare
cases. Patients should tell their doctor if they have itching, dark
urine, yellow skin/eyes, upper right-sided abdominal tenderness, or
unexplained "flu-like" symptoms.
Most people in clinical studies who experienced side effects were
not bothered enough to stop using Strattera. The most common side
effects in children and adolescents in medical studies were upset
stomach, decreased appetite, nausea and vomiting, dizziness,
tiredness and mood swings.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and 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. P-LLY
This press release contains forward-looking statements about the
potential of Strattera for the treatment of ADHD and reflects Lilly's
current beliefs. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of
commercialization. For further discussion of these and other risks
and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.
(1) Strattera Summary of Product Characteristics (SPC):
http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=14482
(2) American Psychiatric Association: Diagnostic and Statistical
Manual of Mental Disorders, fourth edition, text revision,
Washington, DC, American Psychiatric Association, 2000.
(3) Green C, Chee K. Understanding ADHD - The Definitive Guide to
Attention Deficit Hyperactivity Disorder. The Random House Ballantine
Publishing Group 1998.
(4) Barkley RA. Attention-Deficit Hyperactivity Disorder: A
Handbook for Diagnosis and Treatment. 1998, Guildford Publications,
New York.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

Contact:

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

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