STELARA(TM) (ustekinumab) Shows Greater Efficacy Than Etanercept for Treatment of Moderate to Severe Plaque Psoriasis

HIGH WYCOMBE, England, January 14 - For Medical Media Only

- Results From First Phase III Comparator Study of Biologic
Agents in Psoriasis Published Today in New England Journal of Medicine

Findings from a new Phase III study comparing the efficacy and safety of
STELARA(TM)(ustekinumab) with etanercept in the treatment of moderate to
severe plaque psoriasis, show a significantly higher clinical response with
STELARA over a 12-week period compared to high-dose etanercept (50mg
twice-weekly). The results of the study, published today in The New England
Journal of Medicine, also demonstrate the clinical benefit of STELARA among
patients who failed to respond to etanercept.(1)

"This study provides important comparative efficacy information about the
treatment of moderate to severe plaque psoriasis with two biologic agents,"
said Professor Chris Griffiths of the University of Manchester, and lead
trial investigator. "We observed a substantial proportion of patients
achieving high levels of skin clearance with ustekinumab, both through the
study's primary endpoint at week 12 and following crossover from etanercept,
including in those patients who showed a lack of response to etanercept
during the study."

In the comparator study of 903 patients, 68% and 74% of patients
receiving subcutaneous injections of STELARA (45 mg or 90 mg respectively) at
weeks 0 and 4 achieved at least a 75 per cent improvement in their psoriasis
symptoms as measured by the Psoriasis Area and Severity Index (PASI 75) at
week 12, the primary endpoint. This was significantly higher compared to the
57% of patients who achieved PASI 75 receiving the maximum recommended dose
for etanercept; subcutaneous injections of 50 mg twice per week for 12 weeks
(P = 0.01 for STELARA 45 mg; P < 0.001 for STELARA 90 mg, each compared with
etanercept). Onset of clinical response occurred more rapidly among
STELARA-treated patients, with higher numbers of patients achieving PASI 75
by week 8 compared with patients receiving etanercept.(1)

Investigators also reported that a greater proportion of patients
receiving STELARA achieved a marked improvement in psoriasis as assessed by
PASI 90 response, or nearly complete clearance of psoriasis. At week 12, 36%
of patients receiving STELARA 45 mg and 45% of patients receiving STELARA 90
mg achieved PASI 90 compared with 23% of patients receiving etanercept (P <
0.001 for each comparison versus etanercept). Moreover, a greater proportion
of patients in the STELARA 45 mg and 90 mg treatment groups achieved a
Physician Global Assessment (PGA) score of "cleared" or "minimal" (65% and
71% of patients, respectively) compared with patients in the etanercept
treatment group (49%; p < 0.001 for each comparison versus etanercept).(1)

Patients who had an inadequate response to etanercept, as measured by PGA
score (classified as moderate, marked or severe psoriasis at week 12),
received an injection of STELARA 90 mg at weeks 16 and 20. At week 28,
investigators reported that nearly half of patients (49%) who failed to
respond to etanercept and who crossed over to STELARA achieved PASI 75.(1)

Through week 12 of the study, the percentage of study participants
experiencing at least one adverse event (AE) was comparable between the
STELARA 45 mg group (66%), the STELARA 90 mg group (69%) and the etanercept
50 mg group (70%). The proportion of patients experiencing at least one
serious AE through week 12 were as follows: 1.9% and 1.2% of patients
receiving STELARA 45 mg or 90 mg, respectively, compared with 1.2% of
patients receiving etanercept. Rates of specific AEs were generally
comparable between treatment groups with the exception of injection site
reactions, which were reported in 25% of patients treated with etanercept
versus 4.3% and 3.7% with STELARA 45 mg and 90 mg, respectively. This
disparity, however, may have been influenced by the greater number of
etanercept injections administered (at least 24 in the 12-week portion of the
study) compared with two STELARA injections.(1)

Through week 64, the rates and types of AEs were generally comparable
between patients in the 45 mg (87%) and 90 mg (89%) STELARA groups, and also
before and after crossover from etanercept to STELARA (79% vs 65%). This was
also the case for serious adverse events (3.5% vs 3.4%).(1)

About the ACCEPT Trial

The Phase 3, Multicenter, Randomized Study Evaluating the Efficacy and
Safety of Ustekinumab Compared to Etanercept in the Treatment of Subjects
with Moderate to Severe Plaque Psoriasis (ACCEPT) included 903 patients with
chronic plaque psoriasis (etanercept=347, STELARA 45 mg=209, STELARA 90
mg=347). Patients were randomised to receive subcutaneously administered
STELARA or etanercept. Patients randomised to receive STELARA received 45 mg
or 90 mg doses at weeks 0 and 4. Patients in the etanercept group received
twice-weekly doses of 50 mg for 12 weeks. The primary endpoint of the study
was the proportion of patients who achieved PASI 75 at week 12. At week 12,
patients in the etanercept group who were classified as non-responders (i.e.,
had moderate, marked or severe psoriasis) received 90 mg of STELARA at weeks
16 and 20. STELARA non-responders received one additional dose of STELARA at
week 16. Treatment was interrupted for all patients who had cleared, minimal
or mild psoriasis at the end of week 12, and all patients were re-treated
with 45 or 90 mg STELARA when their disease worsened to moderate or worse.
The study was sponsored by Centocor Ortho Biotech Inc.

About Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory disease resulting in
the over-production of skin cells which accumulate on the surface of the
skin, leading to raised, red, scaly plaques that may itch and bleed. It is
estimated that 1.5 million people in the UK have psoriasis.(2,3) Twenty to
thirty percent of those with psoriasis have severe disease.(4) In addition to
the significant impact that psoriasis can have on quality of life,(5) many
patients report feeling dissatisfied and frustrated with some existing
treatment options which can be inconvenient and time consuming to use.(5)

About STELARA (ustekinumab)

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

STELARA is licensed for the treatment of moderate to severe plaque
psoriasis in adults who failed to respond to, or have a contraindication to,
or are intolerant to other systemic therapies including ciclosporin,
methotrexate and PUVA (psoralen plus ultraviolet A light).The recommended
dose for STELARA in patients weighing up to 100kg is 45mg at week 0, week 4
and then every 12 weeks thereafter. In patients weighing more than 100kg the
dose is 90mg at week 0, week 4 and then every 12 weeks thereafter.(6)

Centocor Ortho Biotech Inc. developed STELARA and has exclusive marketing
rights to the product in the United States. Janssen-Cilag has exclusive
marketing rights in all countries outside of the United States. Centocor
Ortho Biotech and Janssen-Cilag are members of the Johnson & Johnson family
of companies.

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, and during, 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.

References

1. Griffiths C, Strober B, van de Kerkhof P et al. Comparison of
Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis. N Engl J Med.
2010;362:118-28

2. National Statistics Online. Population size. Available at:
www.statistics.gov.uk/CCI/nugget.asp?ID=273. Accessed on January 07,
2010.

3. The Psoriasis Association. What is psoriasis? Available
at:www.psoriasis-association.org.uk/what-is.html. Accessed January 07,
2010.

4. Smith CH, Anstey AV, Barker JN, et al. British Association of
Dermatologists guidelines for use of biological interventions in psoriasis
2005. Br J Dermatol. 2005;153(3):486-497.

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. Janssen-Cilag Ltd. STELARA 45mg solution for injection. Summary of
Product Characteristics (SPC). 16 January 2009.

For further information, please contact: Alex Butler, Janssen-Cilag, Tel: +44-(0)1494-567-504, Email: AButler2 at its.jnj.com. Liz Wyatt, Resolute Communications, Tel: +44-(0)20-7357-8187, Email: liz.wyatt at resolutecommunications.com