Enbrel(R) Receives Positive European Recommendations for a New Plaque Psoriasis Treatment Regimen and New Pre-Filled Pen Delivery Device

Maidenhead, England (ots/PRNewswire) -

- CHMP Recommends Approval of a Continuous Dosing Regimen Option
for Enbrel In Plaque Psoriasis, and a New Pre-Filled Pen Delivery
Device

Today, Wyeth received positive recommendations from the European
Committee for Medicinal Products for Human Use (CHMP) for two recent
submissions relating to Enbrel(R) (etanercept), the tumour necrosis
factor alpha inhibitor treatment for plaque psoriasis, rheumatoid
arthritis and other related inflammatory conditions.

Enbrel is currently approved for intermittent treatment of adult
plaque psoriasis: if approved by the European Commission following
the Committee's recommendation, Enbrel will become the first and only
biologic treatment indicated for both continuous and intermittent
treatment of adult plaque psoriasis.

The CHMP provided its positive recommendation of a continuous
dosing regimen for Enbrel based on data from the CRYSTEL and other
trials. The CRYSTEL trial examined the efficacy and safety of Enbrel
using continuous or intermittent dosing regimens for up to 54 weeks.
If approved, the new indication will give physicians, together with
their patients, the opportunity and flexibility to tailor treatment
regimens in response to the severity of the patient's psoriasis and
their ongoing response to treatment.

The new dosage recommendations for adult plaque psoriasis reads:

"The recommended dose of Enbrel is 25 mg administered twice
weekly or 50 mg administered once weekly. Alternatively, 50 mg given
twice weekly may be used for up to 12 weeks followed, if necessary,
by a dose of 25 mg twice weekly or 50 mg once weekly. Treatment with
Enbrel should continue until remission is achieved, for up to 24
weeks. Continuous therapy beyond 24 weeks may be appropriate for some
adult patients. Treatment should be discontinued in patients who show
no response after 12 weeks. If re-treatment with Enbrel is indicated,
the same guidance on treatment duration should be followed. The dose
should be 25 mg twice weekly or 50 mg once weekly."

Results from the CRYSTEL study demonstrated that patients in the
continuous and intermittent treatment groups experienced significant
improvement in their conditions from baseline and both groups were
highly satisfied with the result of their treatment. There were no
new safety signals in either the continuous or intermittent treatment
groups.

In addition, the CHMP recommended the approval of a new 50mg
pre-filled pen (MYCLIC) for the delivery of Enbrel solution for
injection. If approved by the European Commission following the
positive recommendation, the new MYCLIC pen, may be particularly
useful for patients who have a fear of needles or who find using the
syringe difficult. Features of the pen include an innovative safety
system to prevent accidental misfires, a large inspection window to
allow patients to visually confirm drug delivery, and two audible
clicks to confirm the start and end of the injection.

Commenting on the new CHMP recommendation for the psoriasis
dosing regimen, Dr Michael Zaiac, Assistant Vice President,
Immunology, Wyeth Europa said: "This is a significant step towards
improving the management of what can be a disabling and potentially
stigmatising condition. It is hoped that the sustained efficacy
achieved with Enbrel in both the continuous and intermittent dosing
options will allow for greater individualised approach to psoriasis
patient care." With regard to the CHMP recommendation for the new
pre-filled pen, Dr Zaiac commented: "This will allow a more
convenient and simple administration of Enbrel, with the potential
for improved patient benefits."

In the European Union, Enbrel has been proven to be effective in,
and is Approved for, the treatment of rheumatoid arthritis, plaque
psoriasis, paediatric plaque psoriasis, polyarticular juvenile
idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis.

Please note a photograph of the MYCLIC device is available on
request

Notes to Editors

About Enbrel

Enbrel is a fully human soluble tumour necrosis factor (TNF)
receptor. Enbrel was first approved in the EU in 2000 for moderate to
severe rheumatoid arthritis and polyarticular juvenile idiopathic
arthritis, and has since been used in 505,000 patients worldwide
across indications.

Enbrel in the EU is approved for the following indications:

Rheumatoid Arthritis

Enbrel in combination with methotrexate is indicated for the
treatment of moderate to severe active rheumatoid arthritis in adults
when the response to disease-modifying antirheumatic drugs, including
methotrexate (unless contraindicated), has been inadequate.

Enbrel can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment with methotrexate is
inappropriate.

Enbrel is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in adults not previously treated
with methotrexate.

Enbrel, alone or in combination with methotrexate, has been shown
to reduce the rate of progression of joint damage as measured by
X-ray and to improve physical function.

Polyarticular juvenile idiopathic arthritis

Treatment of active polyarticular juvenile idiopathic arthritis
in children and adolescents from the age of 4 years who have had an
inadequate response to, or who have proved intolerant of,
methotrexate. Enbrel has not been studied in children aged less than
4 years.

Psoriatic Arthritis

Treatment of active and progressive psoriatic arthritis in adults
when the response to previous disease-modifying antirheumatic drug
therapy has been inadequate. Enbrel has been shown to improve
physical function in patients with psoriatic arthritis, and to reduce
the rate of progression of peripheral joint damage as measured by
X-ray in patients with polyarticular symmetrical subtypes of the
disease.

Ankylosing spondylitis

Treatment of adults with severe active ankylosing spondylitis who
have had an inadequate response to conventional therapy.

Plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis who
failed to respond to, or who have a contraindication to, or are
intolerant to other systemic therapy including ciclosporin,
methotrexate or PUVA.

Paediatric plaque psoriasis

Treatment of chronic severe plaque psoriasis in children and
adolescents from the age of 8 years who are inadequately controlled
by, or are intolerant to, other systemic therapies or phototherapies.

About Wyeth:

Wyeth is one of the world's largest research-based pharmaceutical
and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of prescription drugs and
over-the-counter medications. It is also a global leader in vaccines,
biotechnology and animal health care.

For further information, please contact:
Wyeth:
Gill Markham, Communications - Europe, Middle East and Africa
Direct Tel: +44(0)1628-692536
Mob: +44(0)777-082-7753
Email: markhagl@wyeth.com
Danielle Halstrom, Communications - Global
Mobile: +1-215-280-3898
Email: halstrd@wyeth.com
OgilvyHealthPR:
Mary Barrington-Ward
Tel: +44-207-108-6066
Email: mary.barrington-ward@ohpr.com

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information, please contact: Wyeth: Gill Markham,
Communications - Europe, Middle East and Africa, Direct Tel:
+44(0)1628-692536, Mob: +44(0)777-082-7753, Email: markhagl@wyeth.com