Shire Pharmaceuticals Group plc
Hampshire International Business Park,
Chineham, Basingstoke RG24 8EP UK
Tel +44 1256 894000 Fax +44 1256 894708
http://www.shire.com
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For immediate release
Shire's Adderall XRTM receives FDA approval
Basingstoke, UK - 12 October 2001 - Shire Pharmaceuticals Group plc (LSE: SHP.L,
NASDAQ: SHPGY, TSE: SQ) announces today that the US Food and Drug Administration
(FDA) have approved Adderall XR(TM), the new once a day treatment for attention
deficit/hyperactivity disorder (ADHD). Adderall XR was developed by Shire
Laboratories Inc., using their proprietary Microtrol(R)technology and will be
launched imminently in the US.
Adderall XR, a novel formulation of Shire's US ADHD brand leader
Adderall(R)1,2,3, is designed to provide an all day treatment with one morning
dose. This is considered to be an increasingly important benefit for children
with ADHD and their caregivers, both at home and at school.
The FDA based its approval of Adderall XR on results of two studies, involving
over 600 patients at more than 50 sites. These studies determined that Adderall
XR substantially improved patients' ability to work, focus and learn by tackling
the most common ADHD symptoms, namely poor concentration, hyperactivity and
impulsivity. The effects of ADDERALL XR were shown to have a prompt onset of
action and to last throughout the day and into the late afternoon, a time when
many children participate in after-school activities, including homework.
With most other ADHD medications an additional dose must be taken during the
school day, or immediately after school, making teachers or the child
responsible for the midday dose. Many schools do not employ nurses, which often
means that people
with no medical background, such as school secretaries and teachers are
compelled to dispense the medication. Dr. Joseph Biederman, Professor of
Psychiatry at Harvard Medical School, commented: "By eliminating the need for
children to bring their medication to school, the convenient dosing regimen of
Adderall XR decreases social stigma issues, as well as the risk of medication
misuse."
Each Adderall XR capsule contains both immediate release and delayed release
Microtrol beads in a 50:50 ratio, resulting in 50 percent of the active
ingredient being released immediately, followed by the remaining 50 percent
mid-day.
Dr Biederman adds: "Once-a-day medications, such as Adderall XR, are an
important new option for parents and patients and represent the future of ADHD
therapy. ADHD is an all-day disorder, affecting children as they study, play and
participate in sports and other extracurricular activities. Adderall XR provides
the long-acting treatment children with ADHD need, helping them achieve their
full potential inside and outside the classroom. "
Dr Wilson Totten, Shire's Group R&D Director said: "Shire is very excited at the
prospect of further improving our service to patients, parents and healthcare
providers with the once a day formulation, Adderall XR. Adderall is an effective
medicine that has radically transformed tens of thousands of children's lives.
Rolf Stahel, Shire's Chief Executive added: "Over the last 12 months
approximately 33% of US prescriptions for the treatment of ADHD were written by
Doctors for Adderall and by introducing Adderall XR we can compete in a market
which, appears to be showing a strong preference for once a day formulations. "
For further information please contact:
Europe
Clea Rosenfeld - Investor Relations +44 1256 894 000
Jessica Mann - Media +44 1256 894 000
US & Canada
Gordon Ngan - Investor Relations +1 450 978 7938
Michele Roy - Media +1 450 978 7938
Notes to editors
About ADHD
ADHD is considered the most commonly diagnosed psychiatric disorder among
children.4 Children with ADHD often are inattentive, impulsive, and hyperactive
- difficulties serious enough to interfere with their ability to function
normally in academic or social settings. Up to 66 percent of children with ADHD
will continue to show symptoms into adulthood.5 Although there is no "cure" for
ADHD, physicians, parents, teachers, nurses, and advocates are finding ways to
help people with the condition learn to adapt to their academic, social, and
work settings. ADHD usually can be successfully managed with a combination of
treatments, including educational approaches, psychological and behavioral
therapies, and medication. A recent government-sponsored clinical trial found
that therapies that include carefully monitored medication are more effective
than those that do not, such as behavioral therapy alone.6 Medication should be
considered part of an overall multimodal treatment plan for ADHD.
References
1. Manos MJ, Short EJ, Findling RL. Differential Effectiveness of
Methylphenidate and ADDERRALL(R)in School-Age Youths with Attention
Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry.
1999;38(7):1-7.
2. Pelham WE, Aronoff HR, Midlam JK, et al. A Comparison of Ritalin and
Adderall: Efficacy and Time-course in Children with
Attention-deficit/Hyperactivity Disorder. Pediatrics. 1999;103:1-14.
3. Swanson JM, Wigal S, Greenhill LL, Browne R, et al. Analog Classroom
Assessment of ADDERRALL in Children with ADHD. J Am Acad Child Adolesc
Psychiatry. 1998;37:519-526.
4. Cantwell DP. Attention Deficit Disorder: A Review of the Past 10 Years. J
Am Acad Child Adolesc Psychiatry. 1996;35:978-987.
5. Weiss G, Hechtman L, Milroy T, Perlman T. Psychiatric Status of
Hyperactives as Adults: A Controlled Prospective 15-Year Follow-up of 63
Hyperactive Children. J Am Acad Child Adolesc Psychiatry. 1985;24:211-220.
6. The MTA Cooperative Group. A 14-Month Trial of Treatment Strategies for
Attention-Deficit/Hyperactivity Disorder. Arch Gen Psychiatry.
1999;56:1073-1086.
Shire Pharmaceuticals Group plc
Shire is a rapidly growing international specialty pharmaceutical company with a
strategic focus on three therapeutic areas - central nervous system disorders
(CNS), oncology and anti-infectives. For further information on Shire
Pharmaceuticals, please visit the company's website: www.shire.com
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forward-looking statements that involve risks and uncertainties, including but
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development and commercialisation, the impact of competitive
products, patents, and other risks and uncertainties, including those detailed
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10K by Shire with the Securities and Exchange Commission.