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ADD/ADHD News

June 13th 2005

Equasym XL Launched

Press Release

NEW TREATMENT MAY HELP OPEN THE DOOR TO LEARNING FOR CHILDREN WITH ADHD

London, UK, 22nd March 2005 - UCB Pharma today launched Equasym XLTM (methylphenidate hydrochloride), a new once-daily treatment specifically designed to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) over the school day.

New government initiatives call for all children be given the best start in life, regardless of their background or circumstance and the focus is increasingly on education^1,2,3. However, enjoying and achieving at school can be difficult for children with ADHD⁴.

ADHD is a neurological disorder that affects controls on attention, impulsiveness and activity⁵. The symptoms of ADHD impact on a child's ability to access learning, to interact with their peers and teachers⁴ and therefore to get the best start in life.

"Children with ADHD have a very difficult time at school because their condition undermines their attempts to learn and socialise effectively," says Professor Peter Hill, Child and Adolescent Psychiatrist, Honorary Consultant, Great Ormond Street Hospital. "A comprehensive management plan which may include drug treatment is critical to giving these children the best chance of getting on. I welcome this new treatment option to help children enjoy and achieve at school."

Equasym XL is a once-daily, novel methylphenidate medication which is to be taken by children in the morning before breakfast⁶. Equasym XL is designed to help relieve the symptoms of ADHD (hyperactivity, inattention and impulsivity) for a period of time consistent with the average school day⁶. It contains both immediate-release and extended-release methylphenidate, meaning it is effective within an hour and a half of morning dosing, and keeps working until the time when the child will usually return home from school⁶.

In contrast to some other medications available for ADHD, Equasym XL does not require that a midday dose is taken; research amongst parents of children with ADHD revealed that parents feared a midday dose at school may lead to embarrassment and loss of self-esteem⁷.

"Medication can help relieve children's ADHD symptoms at school so they can cope with their studies and make friends more easily. Parents want their child to feel like every other child in the classroom, but at home, parents may feel better equipped to manage ADHD behaviour," comments Andrea Bilbow, Founder and Chair of national parent support group ADDISS (The National Attention Deficit Disorder Information and Support Service). "Having additional choice of medication for ADHD is a big step forward - giving physicians and parents the flexibility to cope with this debilitating condition."

Recent research has revealed that over three quarters of parents of ADHD children feel that disruption to school is their main concern for their child⁸. Among specialist physicians improving school-time functioning is the most commonly noted treatment objective⁹. Children with persistent hyperkinetic disorders are 11 times more likely to be excluded from school compared to those without the disorder¹⁰.

UCB Pharma is part of the UCB Group, a global pharmaceutical and specialty chemical company with headquarters in Brussels, Belgium. UCB Pharma is a global biopharma leader, specialising in the fields of central nervous system disorders, allergy and respiratory disease, immune and inflammatory disorders and oncology. Worldwide UCB Pharma's key products are Keppra® (antiepileptic), Xyzal® and Zirtek® (antiallergics), Nootropil® (cerebral function regulator), Tussionex® (antitussive) and Equasym XL™ (attention deficit hyperactivity disorder). UCB Pharma employs over 8,300 people operating in over 100 countries and in 2004 achieved sales of €1,679 million.

Notes to Editors

o ADHD affects an estimated 5% of school aged children in the UK, but it is thought that many more children meet the diagnostic criteria and yet have not been diagnosed. Children who have ADHD might be at risk of serious long-term consequences to their health and welfare, with damage to self-esteem, the possibility of emotional and social problems and impairment of educational achievement⁵

o Each Equasym XL capsule contains 30% immediate-release methylphenidate and 70% extended-release methylphenidate in order to produce the duration of action consistent with the average school day, with no requirements for a midday dose⁶

o Equasym XL comes in three different dose strengths (10mg, 20mg, 30mg)⁶

o Equasym is already available in an immediate-release formulation allowing additional symptom control outside of school if it is required⁶

o ADHD can only be diagnosed by specially trained healthcare professionals (normally child and adolescent psychiatrists or paediatricians) and there are two medical guidelines which outline the criteria for diagnosis. These guidelines are the American Psychiatric Association DSM-IV (The Diagnostic and Statistical Manual of Mental Disorders) and the World Health Organisation ICD-10 (The International Statistical Classification of Diseases and Related Health Problems)¹⁰

o Recent government initiatives aimed at improving outcomes for children include: - Change for Children - Every Child Matters (2003); National Service Framework for Young People and Maternity Services (2004); Department for Education and Skills, Departmental Report (2004)^1,2,3.

- End -

For further information please contact:

Jake Davis, Philippa Mallaband or Emma Crozier at the Chandler Chicco Agency on 0207 318 8330 / 07843 448252, or via email at j.davis@cca-uk.com References: 1 Department for Education and Skills, Change for Children - Every Child Matters in schools, September 2003
2 Department of Health, National Service Framework for Young People and Maternity Services, 2004
3 Department for Education and Skills, Departmental Report, April 2004 / www.dfes.gov.uk/deptreport2004
4 Waslick, B., and Greenhill, L. Textbook of child and adolescent psychiatry (2nd ed., pp.389-410). Washington DC: American Academy of Child and Adolescent Psychiatry, American Psychiatric Press
5 NICE technology appraisal guidance - No. 13 Guidance on the Use of Methylphenidate (Ritalin, Equasym) for Attention Deficit/Hyperactivity Disorder (ADHD) in childhood
6 Summary of Product Characteristics: Equasym XL
7 Swanson JM. Compliance with stimulants for attention deficit/hyperactivity disorder: issues and approaches for improvement. CNS Drugs; 17 (2): 117-31, 2003
8 Research conducted by Holden Pearmain, April 2004
9 Research conducted by Holden Pearmain, December 2003
10 ADHD: Paying Enough Attention? A Research Report Investigating ADHD in the UK, published by ADDISS, 2003

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