SMC Accepts Janssen-Cilag's Stelara(R) Black Triangle Drug for use in NHS Scotland for the Treatment of Moderate to Severe Plaque Psoriasis

For Medical Media Only

HIGH WYCOMBE, England, February 8 - STELARA (ustekinumab) has today been accepted by the Scottish Medicines
Consortium (SMC) for restricted use within NHS Scotland for the treatment of
moderate to severe plaque psoriasis.(1) STELARA is the first in a novel class
of biologics. The SMC guidance highlights that patients treated with STELARA
achieved a significantly higher clinical response over a 12-week period
compared to those treated with a different biologic treatment, etanercept
(50mg twice-weekly).(1,2)

The SMC advice takes into account the benefits of an innovative Patient
Access Scheme (PAS) proposed by Janssen-Cilag. After integrating the PAS into
the health economic analysis, the breakdown indicated that STELARA would
result in cost savings compared to continuous use of either etanercept 25mg
or 50mg.(1)

"The approval by the SMC for the use of STELARA in NHS Scotland provides
both physicians and patients with a new treatment option, which is important
because psoriasis can be a challenging disease to treat," says Dr. David
Burden, Consultant Dermatologists at the Western Infirmary, Glasgow. "One of
the benefits my patients appreciate is that the injection is only every three
months compared to every week for some alternative treatments."

Psoriasis is a chronic, painful autoimmune skin disease.(4) Up to 20-30%
of people with psoriasis have the severe form of the disease, which can have
both a physical and psychological impact on patients.(5,6) The impact on
quality of life in people with psoriasis is comparable to other chronic
illnesses such as heart disease, hypertension, diabetes and cancer.(7)

"Around 125,000 people in Scotland suffer from psoriasis, a common
condition which is not only painful and unsightly but has a huge impact on
how you feel about yourself - it affects your confidence and can sometimes
cause depression and anxiety. This is not helped by the fact that psoriasis
has a low profile and as such is often misunderstood," comments Janice
Johnson, Co-Founder and Trustee of the Psoriasis Scotland Arthritis Link
Volunteers (PSALV). "Some patients who have received STELARA have seen real
benefits, so the SMC's advice for its use in NHS Scotland is a welcome
decision."

In clinical studies, treatment with STELARA demonstrated a significant,
visible improvement in patient's psoriasis with convenient 12 weekly
maintenance dosing.(8,9) This has the potential to give patients with
psoriasis greater freedom to live their lives with a significantly reduced
burden of disease and without the inconvenience of frequent injections.

The SMC has accepted STELARA (ustekinumab) as a treatment option for
moderate to severe plaque psoriasis in adults who failed to respond to, or
who have a contraindication to, or are intolerant to other systemic therapies
including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA).
The guidance states that treatment with STELARA should be discontinued in
patients who do not achieve at least a 75% reduction in Psoriasis Area
Severity Index (PASI 75) by week 16.(1)

About STELARA(R) Black Triangle Drug (ustekinumab)

STELARA is a fully 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).(3)

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,
Inc. and Janssen-Cilag are members of the Johnson & Johnson family of
companies.

SMC Advice(1)

Ustekinumab (Stelara) is accepted for restricted use within NHS Scotland
for the treatment of moderate to severe plaque psoriasis in adults who failed
to respond to, or who have a contraindication to, or are intolerant to other
systemic therapies including ciclosporin, methotrexate and psoralen and UVA
treatment (PUVA).

Significantly more patients treated with ustekinumab achieved at least
75% improvement in their Psoriasis Area and Severity Index (PASI 75) at week
12, compared with those treated with a tumour necrosis factor alpha
antagonist.

Continued treatment should be restricted to patients who achieve a PASI
75 response within 16 weeks.

This SMC advice takes account of the benefits of a Patient Access Scheme
(PAS) that improves the cost-effectiveness of ustekinumab. This SMC advice is
dependent upon the continuing availability of the patient access scheme in
NHS Scotland.

About Psoriasis Scotland Arthritis Link Volunteers (PSALV)

PSALV/Psoriasis Scotland is a peer led Scottish charity for people with
skin psoriasis and/or psoriatic arthritis.

References:

1. Scottish Medicines Consortium. Ustekinumab, 45mg solutions for
injection (STELARA). No. 572/09. 2010.

2. 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

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

4. The Psoriasis Association. What is psoriasis? Accessed on 21 January
2010, from www.psoriasis-association.org.uk/what-is.html.

5. 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.

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

7. 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.

8. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of
ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with
psoriasis: 76-week results from a randomised, double-blind,
placebo-controlled trial (PHOENIX 1). Lancet. 2008;371:1665-74

9. Papp K, Langley RG, Lebwohl M, et al. Efficacy and safety of
ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with
psoriasis: 52-week results from a randomised, double-blind,
placebo-controlled trial (PHOENIX 2). Lancet. 2008;371:1675-84.

For further information about PSALV please contact Janice Johnson on +44-(0)131-556-4117 or janice.johnson5 at btinternet.com. 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