New Biologic Ustekinumab Receives Positive Opinion From European Regulatory Authority for the Treatment of Moderate to Severe Plaque Psoriasis

Beerse, Belgium, November 21 (ots/PRNewswire) - Janssen-Cilag
announced today that ustekinumab, the first in a new class of
biologics, has received a positive opinion for the treatment of
moderate to severe plaque psoriasis from the European Committee for
Medical Products for Human Use (CHMP). This positive opinion takes
patients living with the physical and mental burdens of psoriasis a
step closer towards a convenient new therapeutic option. The CHMP's
positive opinion is now referred for final action to the European
Commission.

The CHMP recommended approval of ustekinumab is for adults who
have failed to respond to, have a contraindication to, or are
intolerant to other systemic therapies including ciclosporin,
methotrexate and PUVA (a light sensitising medication, combined with
exposure to ultraviolet light A).

This positive opinion is based on data from two large pivotal
Phase 3 (PHOENIX 1 & 2), multi-centre, randomised, double blind,
placebo controlled trials involving nearly 2,000 patients in whom the
efficacy and tolerability of ustekinumab in the treatment of moderate
to severe plaque psoriasis was evaluated.(1,2) More than two-thirds
of patients achieved the primary endpoint of each pivotal study, at
least 75% reduction in psoriasis using the Psoriasis and Severity
Index (PASI 75) at week 12, after just two doses at weeks 0 and 4.
Significant maintenance of PASI 75 response through at least one year
in patients receiving maintenance therapy every 12 weeks was also
demonstrated using a randomised withdrawal design in the first
pivotal study (PHOENIX 1). Rates of serious adverse events, including
serious infections, malignancies and cardiovascular events, were low
and consistent with the expected background rates. The most common
adverse events in Phase 3 clinical trials were arthralgia, cough,
headache, injection site erythema, nasopharyngitis and upper
respiratory tract infection.

About Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory disease,
which results from the over-production of skin cells resulting in
their accumulation on the surface of the skin, which causes red,
scaly plaques that may itch and bleed. It is estimated that three
percent of the world's population has psoriasis.(3) Twenty to thirty
percent of people with psoriasis have cases that are considered
severe.(4)

About Ustekinumab

Ustekinumab is a new, human monoclonal antibody with a novel
mechanism of action that targets the p40 sub-unit of 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 some immune-mediated
inflammatory disorders, including plaque psoriasis. Ustekinumab is
under regulatory review in the United States.

Centocor, Inc. developed ustekinumab and has exclusive marketing
rights to the product in the United States. Janssen-Cilag companies
have exclusive marketing rights in all countries outside of the
United States.

References

(1) 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). The Lancet.
2008;371:1665-74

(2) 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). The Lancet.
2008;371:1675-84.

(3) International Federation of Psoriasis Associations. Profile
of Psoriasis. Available at: http://www.ifpa-pso.org/t2.aspx?p=107478
Accessed on 10 November 2008

(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.

ots Originaltext: Janssen-Cilag
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information, please contact: Jennifer Tear,
Janssen-Cilag, Turnhoutsweg 30, Beerse 2340, Belgium, Tel:
+32-14-60-26-38, Mobile: +32-473-55-94-60, Email: JTear1@its.jnj.com