Innovative Treatment Approach Offers New Hope for Eczema Sufferers With Moderate to Severe Disease PROTOPIC(R)

Prague (ots/PRNewswire) -

- Ointment (Tacrolimus Monohydrate) in a New Twice-Weekly Regimen
can Help Prevent Eczema Flares

Today sees the European launch of the first topical calcineurin
inhibitor to be approved for the maintenance treatment of eczema to
prevent flares and prolong flare-free intervals. PROTOPIC ointment
(tacrolimus monohydrate) is already licensed to treat moderate and
severe eczema (atopic dermatitis), often involving the treatment of
flares as and when they occur.(*) It is now also approved for
twice-weekly application to previously affected skin to prevent these
exacerbations and prolong flare-free periods in PROTOPIC-responsive
patients.(**) Clinical studies have shown that this new approach
brings significant benefits with over 40% of patients with moderate
to severe eczema remaining flare-free for at least a year.(1) Flares
are known to place an enormous burden on patients. The International
Study of Life with Atopic Eczema (ISOLATE) found that about 55% of
these patients worried about the onset of their next exacerbation and
that they spent on average over a third of the year (136 days) with
their eczema in flare.(2)

"Helping patients to reduce the number of flares they experience
will lift many of the burdens patients face on a day to day basis,"
said Dr Sakari Reitamo, Hospital for Skin and Allergic Diseases,
Helsinki University Central Hospital, Finland. He added: "We are
giving patients the opportunity to get on with their lives without
the worry of a flare hanging over them."

The standard approach to managing eczema has been to treat flares
as and when they occur with topical anti-inflammatory agents.
However, a deeper understanding of the pathology of this disease has
revealed that sub-clinical inflammation persists, even after the
clinical signs of flare have resolved.(3),(4) This new twice-weekly
treatment regimen with PROTOPIC ointment will allow physicians to
actively manage the sub-clinical inflammation between flares in
appropriate patients with moderate to severe disease, in order to
prevent flare recurrence and prolong the time that patients are free
from flares.

Approval of the twice-weekly regimen of PROTOPIC was based on
sub-analysis of the results from two phase III studies (CONTROL)
conducted in 524 adults and children in 13 European countries, which
found that once patients had responded to twice-daily treatment of
their flares with PROTOPIC ointment, continuing treatment to
previously affected areas with a twice-weekly regimen significantly
reduced the number of flares compared to a flare treatment-only
regimen.(5),(6) Patients in the twice-weekly PROTOPIC ointment group
also noticed a significant delay in the time they experienced their
first flare (from 14 to 123 days in adults and 17 to 146 days in
children), compared to those treated with the standard PROTOPIC
treatment regimen. (1)

Eczema is on the increase - affecting up to 30% of children and
10% of adults in developed countries.(7) It is a chronic problem,
with patients typically experiencing recurrent flares which can have
a significant impact on quality of life. The ISOLATE study, involving
over 2,000 eczema patients, showed that on average, patients with
moderate to severe disease experienced nine flares per year, each
lasting for over two weeks.2 75% of patients reported that greater
control of their disease would be the single most important
improvement to their quality of life.(2)

Dr Reitamo concluded: "Until now, more severe eczema often
controlled the lives of patients. Now, maybe for the first time, this
has reversed - patients control their eczema."

Notes for Editors

About PROTOPIC

PROTOPIC ointment (tacrolimus monohydrate) has been marketed in
Europe for the treatment of moderate to severe atopic dermatitis in
adults and children aged two and over since its launch in 2001. This
new indication is for maintenance treatment of moderate to severe
atopic dermatitis for the prevention of flares and the prolongation
of flare-free intervals in patients experiencing a high frequency of
disease exacerbations (i.e. occurring four or more times per year)
who have had an initial response to a maximum of six weeks treatment
of twice-daily tacrolimus ointment (lesions cleared, almost cleared
or mildly affected). Discovered and developed by Astellas Pharma
Inc., PROTOPIC has been marketed in 45 countries worldwide, including
Japan, the US, and countries in Europe, Asia and Latin America.

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is a European
subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceutical products. The organisation is committed to becoming a
global company by combining outstanding R&D and marketing
capabilities and continuing to grow in the world pharmaceutical
market. Astellas Pharma Europe Ltd. is responsible for 20 affiliate
offices located across Europe, the Middle East and Africa, an R&D
site and three manufacturing plants with approximately 3,400 staff.

References

(*) in adults and children (more than or equal to 2 years) who
are unresponsive or intolerant to conventional therapies such as
topical corticosteroids

(**) in patients who experienced at least four flares per year,
who respond to a maximum of six weeks of twice-daily treatment with
PROTOPIC

---------------------------------

(1) PROTOPIC Summary of Product Characteristics. 2009

(2) Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives
on the management of atopic dermatitis. J Allergy Clin Immunol
2006;11:226-232

(3) Leung DY, Boguniewicz M, Howell MD, et al. New insights into
atopic dermatitis. J Clin Invest 2004;113:651-7

(4) Wollenberg A and Bieber T. Proactive therapy of atopic
dermatitis - an emerging concept. Allergy 2009;64:276-278

(5) Wollenburg A, Reitamo S, Atzori F, et al. Proactive treatment
of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy
2008;63:742-750

(6) Thaçi D, Reitamo S, Gonzalez Ensenat MA, et al. Proactive
disease management with 0.03% tacrolimus ointment for children with
atopic dermatitis: results of a randomized, multicentre, comparative
study. Brit J Dermatol 2008;159:1348-56

(7) Bieber T. Mechanisms of disease: atopic dermatitis. N Engl J
Med 2008;358:1483-1494

PROTOPIC is a trade mark of Astellas Pharma Inc. and its related
entities.

ots Originaltext: Astellas Pharma Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contacts for enquiry or additional information: Astellas Pharma
Europe, Mindy Dooa, Tel: +44(0)1784-419-408, Email:
mindy.dooa@eu.astellas.com; Ketchum, Caroline Magee, Direct line:
+44(0)20-7611-3562, Mobile: +44(0)7974-643-763, Email:
caroline.magee@ketchum.com; Helen Crow, Tel: +44(0)20-7611-3654,
Mobile : +44(0)7787-533-023, Email: helen.crow@ketchum.com