Data Demonstrate Treatment With STELARA(R) Results in Sustained Improvements in Psoriasis Severity and Quality of Life up to Three Years

BEERSE, Belgium, October 6, 2010 - Data presented today at the European Academy of Dermatology and
Venereology (EADV) Congress indicate the significant improvement in patients'
psoriasis and quality of life, demonstrated with STELARA (ustekinumab) at
week 12, is sustained in the majority of patients up to three years.(1,2)

Psoriasis is a chronic, non-contagious, autoimmune disease which results
in the over production of skin cells. It affects approximately 12.5
million(3,4) people in Europe and can have a significant physical and
psychological impact on people affected. In addition, many people living with
moderate to severe psoriasis report feeling dissatisfied and frustrated with
conventional treatment options, which can be inconvenient and time consuming
to apply to the skin.(5)

An analysis of 766 patients in the PHOENIX 1 Phase III trial showed for
the first time the long-term efficacy of maintenance therapy with ustekinumab
- a first in class biologic therapy for moderate to severe plaque psoriasis -
up to three years.(1) Treatment with every 12 week maintenance dosing,
following two starter doses at weeks 0 and 4, of ustekinumab resulted in
rapid skin clearance. Skin clearance peaked at week 24 when 76% and 85% of
patients receiving 45mg and 90mg ustekinumab, respectively, achieved a 75
percent improvement in their psoriasis, as measured by the Psoriasis Area and
Severity Index (PASI 75). Efficacy was generally sustained through to Year 3
with maintenance dosing when 64% and 76% of the 45mg and 90mg groups,
respectively, achieved PASI 75.(1)

It has been reported that people living with psoriasis may experience low
self-confidence, depression, anxiety and sexual problems(6-8), and for some
the impact on quality of life is comparable to other chronic illnesses such
as heart disease, hypertension, diabetes and cancer.(9) Further long-term
results presented at the Congress showed meaningful quality of life
improvements in patients receiving regular maintenance therapy with
ustekinumab, up to a period of three years.(2) Over 70% of patients who were
responders at week 40, and stayed on every 12 week dosing in the PHOENIX 1
trial, experienced significant improvements in skin disease specific quality
of life with a clinically meaningful score of greater than or equal to 5
improvement in Disease Life Quality Index (DLQI) at year 3.(2)

"During registration trials, ustekinumab showed great promise
delivering significant improvements in skin clearance and quality of life at
week 12. The three year data presented today gives a better understanding of
the role of ustekinumab in the long-term management of psoriasis," comments
Dr Pierre-Dominique Ghislain*, Consultant Dermatologist, St-Luc University
Hospital, UCL, Brussels and study investigator. "Bringing about and
sustaining relief from the physical and psychological impact of psoriasis is
of great importance to patients and their dermatologists. This data provides
the clinical evidence to support the valuable role that ustekinumab may play
in helping to achieve this in clinical practice."

In addition, separate findings from a pooled safety analysis of data for
ustekinumab evaluating 3,117 patients for periods up to three years, were
consistent with results from previous studies.(10) The data, compiled from
the phase II trial, the pivotal Phase III PHOENIX 1 and 2 trials, and the
ACCEPT trial, which compared the efficacy and safety of ustekinumab with
etanercept, showed that overall rates of adverse events and serious adverse
events per 100 patient years were comparable in the 45mg and 90mg ustekinumab
groups.(10)

"Living with a long-term disease like psoriasis can be extremely
difficult - it can have a huge impact on a person's confidence, self-esteem
and their overall quality of life," comments Ottfrid Hillmann*, President of
the European Umbrella Organisation for Psoriasis Movements (EUROPSO). "The
three year data supporting the long-term efficacy, safety and quality of life
improvements with ustekinumab offers hope to patients for a life free from
the burdens of psoriasis."

*Ottfrid Hillmann is President of EUROPSO, who have received a grant from
Janssen towards their core funding in 2010. Dr Ghislain has on occasion acted
as a paid advisor for Janssen.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease that results from the
overproduction of skin cells, resulting in their accumulation on the surface
of the skin, which causes red, scaly plaques that may bleed. It is estimated
that approximately 12.5 million Europeans and nearly three percent of the
world's population are living with psoriasis and nearly one-quarter of those
people have cases that are considered moderate to severe.

The Dermatology Life Quality Index (DLQI)

The DLQI is a skin disease-specific, patient-reported, 10-item
questionnaire assessing six different aspects of patients' quality of life -
symptoms and feelings, daily activities, leisure, work or school performance,
personal relationships, and treatment. DLQI scores range from 0 to 30, with
higher scores indicating poorer quality of life. A DLQI score of 0 or 1
indicates no negative effect on a patient's life, while DLQI scores >10
represent a very large impact of disease on quality of life.

About STELARA(R) (ustekinumab)

Ustekinumab is a human monoclonal antibody with a novel
mechanism of action that targets the p40 sub-unit of two cytokines,
interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring
proteins that are important in regulating immune responses and that are
thought to be associated with immune-mediated inflammatory disorders,
including plaque psoriasis.

The recommended dosing regimen for ustekinumab is an initial dose of 45
mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and
then every 12 weeks thereafter. For patients with a body weight of greater
than 100 kg the dose is 90 mg administered subcutaneously, followed by a 90
mg dose 4 weeks later, then every 12 weeks thereafter.

In patients weighing greater than 100 kg, 45 mg was also shown to be
efficacious. However, 90 mg resulted in greater efficacy in these patients.

Centocor Ortho Biotech Inc. discovered and developed ustekinumab and has
exclusive marketing rights to the product in the United States. Janssen
companies have exclusive marketing rights in all countries outside of the
United States.

Important Safety Information

Ustekinumab is a selective immunosuppressant and may have the
potential to increase the risk of infections and reactivate latent
infections. Serious infections have been observed in patients receiving
ustekinumab in clinical trials. Do not start ustekinumab during an active
infection. If a serious infection develops, monitor patients carefully and
stop ustekinumab until the infection resolves. Patients should be evaluated
for tuberculosis (TB) infection prior to initiating treatment with
ustekinumab.

Ustekinumab is a selective immunosuppressant.
Immunosuppressive agents have the potential to increase the risk of
malignancy. Malignancies have been observed in patients receiving ustekinumab
in clinical trials. Caution should be exercised when considering the use of
ustekinumab in patients with a history of malignancy or when considering
continuing treatment in patients who develop a malignancy.

Serious allergic reactions have been reported in the
post-marketing setting, in some cases several days after treatment.
Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious
allergic reaction occurs, administration of ustekinumab should be
discontinued immediately and appropriate therapy instituted.

About Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to
addressing and solving the most important unmet medical needs of our time,
including oncology (e.g. multiple myeloma and prostate cancer), immunology
(e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain),
infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and
cardiovascular and metabolic diseases (e.g. diabetes).

Driven by our commitment to patients, we develop sustainable, integrated
healthcare solutions by working side-by-side with healthcare stakeholders,
based on partnerships of trust and transparency. More information can be
found at www.janssen-emea.com/.

References:

1. Ghislain et al. Maintenance of long-term efficacy of ustekinumab
through year 3 for patients with moderate-to-severe psoriasis. Poster
presented at:19th Congress of the European Academy of Dermatology and
Venereology; 2010 October 06-10;Gothenburg, Sweden. Poster P589.

2. Leonardi et al. Sustained improvement in skin disease-specific quality
of life in patients with moderate to severe psoriasis receiving ustekinumab
maintenance therapy: Long term results from PHOENIX 1. Poster presented
at:19th Congress of the European Academy of Dermatology and Venereology; 2010
October 06-10;Gothenburg, Sweden. Poster P653.

3. Europa. How many people live in the EU? Available at:
europa.eu/abc/keyfigures/sizeandpopulation/index_en.htm Last accessed
on 19 August 2010.

4. Schäfer T. Epidemiology of Psoriasis; Review and the German
Perspective. Dermatology. 2006;212: 327-337.

5. Dubertret L, Mrowietz U, Ranki A, et al. European patient perspectives
on the impact of psoriasis: the EUROPSO patient membership survey. Br J
Dermatol. 2006;155(4):729-736.

6. National Psoriasis Foundation. Spring 2007 Survey Panel Snapshot.
Available at: www.psoriasis.org/NetCommunity/Document.Doc?id=382 Last
Accessed on 19 August 2010

7. National Psoriasis Foundation. Fall 2006 Survey Panel Snapshot.
Available at: www.psoriasis.org/NetCommunity/Document.Doc?id=379 Last
Accessed on 19 August 2010.

8. Kimball AB, Jacobson C, Weiss S, et al. The Psychosocial Burden of
Psoriasis. Am J Clin Dermatol. 2005;6 (6):383-392.

9. Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much
disability as other major medical diseases. J Am Acad Dermatol.
1999;41:401-7.

10. Gordon K et al. Ustekinumab Safety Update: Cummulative safety
experience from longer-term follow-up of patients treated in the ustekinumab
psoriasis clinical development program. Poster presented at: 19th Congress of
the European Academy of Dermatology and Venereology; 2010 October 06-10;
Gothenburg, Sweden. Poster P560.

For further information, including details about the clinical trials reported on in this release, please contact: Sue Silk, Janssen, Tel: +44-1494-553955, Email : ssilk at its.jnj.com. Liz Wyatt, Resolute Communications, Tel: +44-207-357-8187, Email: liz.wyatt at resolutecommunications.com