New Treatment for Schizophrenia Licensed in the UK


SAUNDERTON, England, July 3 /PRNewswire/ --

- ATTN: UK Editors Only

Today, Janssen-Cilag Ltd has announced the authorisation of
INVEGA(R) (paliperidone), a new treatment for schizophrenia.(1) Schizophrenia
can have a major detrimental effect on people's personal, social and
occupational lives leading to difficulty in daily living.(2) In clinical
trials, people treated with paliperidone experienced reductions in the
positive and negative symptoms of schizophrenia, as well as improvements in
day-to-day personal and social functioning.(3)-(5)

Paliperidone (prolonged-release tablets) is the first and only
atypical antipsychotic treatment for schizophrenia to use the innovative OROS
prolonged-release technology that provides a steady release of medicine over
a 24-hour period.(6) The smooth release of medicine reduces fluctuations of
drug levels in the blood(5) experienced with some other existing treatments
for schizophrenia.

The once a day oral tablet which delivers smooth and constant medication
release over 24 hours(6), offers a new treatment option for the one in 100
people in the UK who experience schizophrenia.(7),(8)

National mental health advocacy organisations recognise the
importance of new treatments for schizophrenia. "We are pleased that
innovative delivery technologies are being applied to new treatments for
schizophrenia," said Marjorie Wallace, Chief Executive at the mental health
charity Sane "New treatment options such as Paliperidone are a significant
opportunity for more people with schizophrenia to effectively manage their
disease, working with their medical team to live more fulfilling and
productive lives."

The authorisation of paliperidone (prolonged-release tablets)
is based on results of an extensive clinical development programme enrolling
over 1,200 patients in 23 countries around the world as part of three pivotal
studies.(3)-(5)

Janssen-Cilag has been at the forefront of new advancements in
mental health for over 50 years having launched Haldol in 1958, Risperdal
Oral in the early 1980s and more recently, Risperdal Consta, a long-acting
injectable antipsychotic.

"Paliperidone is a new atypical antipsychotic with an
innovative delivery system that can offer a more consistent release of
medication," explained Dr. Helen Millar, Consultant Psychiatrist at the
Carseview Centre, Dundee, Scotland. "Clinical trials have shown that
paliperidone is effective and generally well tolerated. Effective treatments
for people with schizophrenia are important in helping to improve everyday
functioning."

Worldwide, it is estimated that one person in every 100
develops schizophrenia, a serious type of mental illness, which can effect
men and women equally, often appearing between the ages of 15-25 and 25-35,
for men and women respectively.(7),(8) The disease may effect individual
patients throughout their lives, with relapses being marked by positive
symptoms (hallucinations, delusions and disorganised thinking) and negative
symptoms (depression, blunted emotions and social withdrawal).(8)

The costs of schizophrenia include direct costs (such as the
costs of hospitalisation, drug costs, wages of healthcare professionals), and
indirect costs (such as social security benefits and other social costs
involved in supporting patients). The total direct treatment costs of
schizophrenia in England and Wales are estimated to be in excess of GBP1
billion, or around 3% of the total NHS expenditure. Hospitalisations account
for the majority of this expenditure (and for approximately 5% of total NHS
inpatient expenditure), while drug costs account for 5% only of the direct
costs of schizophrenia. Indirect costs of schizophrenia in the UK are
estimated to be at least GBP1.7 billion.(9)

Notes to Editor:

INVEGA prolonged release tablets were developed by Johnson &
Johnson Pharmaceutical Research and Development (J&JPRD). INVEGA prolonged
release tablets have been authorised by the Food and Drug Administration
since December 2006 and is marketed by Janssen, L.P. in the United States.
Upon authorisation by the European Commission, INVEGA prolonged release
tablets will be marketed in Europe by the Janssen-Cilag companies.

Janssen-Cilag Ltd (www.janssen-cilag.co.uk), manufacturer of
Risperdal(R) Consta(TM), Risperdal(R) (risperidone) and Risperdal(R)
Quicklet(TM) is part of the Johnson & Johnson family of companies, a leading
research-based pharmaceutical company, with more than 110,000 employees
worldwide and establishments in approximately 50 countries.

References:

(1). Summary of Product Characteristics of INVEGA (paliperidone)
prolonged-release tablets, May 2007.

(2). The National Institute of Clinical Excellence. Schizophrenia - Full
national clinical guideline on core interventions in primary and secondary
care. 2003

(3). Marder S, et al. A 6-week US-based placebo-controlled study on the
efficacy and tolerability of two fixed dosages of oral paliperidone
extended-release tablets in the treatment of acute schizophrenia. Poster
presented at APA May 2006; Toronto, Canada, 20-25.

(4). Davidson M. et al. Efficacy, safety and early response of
paliperidone extended-release tablets (paliperidone ER): Results of a 6-week,
randomized, placebo-controlled study. Schizophrenia Research. 2007: 93; 117
130.

(5). Kane J, et al. Treatment of schizophrenia with paliperidone
extended-release tablets: A 6-week placebo-controlled trial, Schizophrenia
Research. 2006: 90; 147-161.

(6). Karlsson P, et al. Pharmacokinetics, and dopamine D2 and serotonin
5-HT2A receptor occupancy and safety profile of paliperidone extended-release
in healthy subjects. Poster presented at WWS; Davos, Switzerland, (5)-11
February 2006.

(7). http://www.patient.co.uk/showdoc/23069111/: (last updated November
2006)

(8). Lehman AF, et al. American Psychiatric Association. Practice
guidelines for the treatment of patients with schizophrenia, second edition.
Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56.

(9). The National Institute of Clinical Excellence. Guidance of the use
of newer (atypical) antipsychotic drugs for the treatment of schizophrenia.
June 2002.

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