Sinclair Pharma plc Announces Positive Results of Atopiclair(TM) Pediatric Study in US Results Demonstrate Safety, Efficacy and Steroid Sparing Effect

Wednesday, 20. September 2006 08:30



20 September 2006, Godalming. Sinclair Pharma plc (SPH.L), the
specialty pharmaceutical company, today announced positive results of
a new US pediatric study for its atopic dermatitis product,
Atopiclair(TM).

The multicentre, double-blind, randomized, vehicle-controlled,
142-patient clinical trial demonstrated significant improvement of
mild to moderate atopic dermatitis (eczema), for infants and children
(between the ages of 6 months and 12 years) treated with
Atopiclair(TM) cream versus an emollient vehicle cream. It also
showed that patients using Atopiclair(TM) needed less steroid rescue
treatment during the study compared to the emollient group.

The results support the use of Atopiclair(TM) in younger patients,
where clinicians are more reluctant to prescribe topical steroids and
need products to provide fast relief from the itch associated with
atopic dermatitis. Approximately a third of atopic dermatitis
prescriptions are for pediatric patients[i] and this data will
provide support to Sinclair's US marketing partner, Chester Valley
Pharmaceuticals, Inc, the company's own sales force in Italy, and
other global partners, to build sales for Atopiclair(TM).

Study results
The primary endpoint of the study was 'treatment success', defined by
whether the patient was either 'clear' or 'almost clear' of atopic
dermatitis after 22 days. 77% (53 out of 69) patients using
Atopiclair(TM) were considered 'treatment successes' and at the same
time point there were no treatment successes in the control group
(p<0.0001).

Secondary outcomes included measurement of itch and the need for
rescue medication with a topical corticosteroid, in the event of a
flare-up during the study period. Atopiclair(TM) achieved a
significant reduction in itch when compared to the control group, and
this difference was seen as early as day 3 (p<0.0001). In the
Atopiclair(TM) group, 9% (6 out of 69) patients needed rescue
medication with a steroid cream, compared to 40% (20 out of 70) in
the control group.

Dr Mark Boguniewicz of the National Jewish Medical and Research
Center, Denver, Colorado, was the lead investigator of the study:
"This study shows that Atopiclair improves the symptoms and
appearance of eczema in children and infants. The fast improvement
in itch will be particularly important to patients and their
families. When we are treating children, we try to avoid the use of
topical corticosteroids, and so we were pleased that patients using
Atopiclair in this study had significantly less need for steroid
creams."

Study design
142 patients between the ages of 6 months and 12 years were
randomized to either Atopiclair(TM) or control (a 'vehicle' emollient
cream, similar to Atopiclair(TM) but without its key ingredients).
After an initial washout period for existing medications, patients
received the study cream for 43 days.

Outcome measurements included the Investigator's Global Assessment
(IGA), pruritus (itch), Eczema Area and Severity Index (EASI), speed
and duration of effect on itch, clinical signs (appearance of skin)
and the need for rescue medication. Seven centres in the US
participated in the study.

Atopiclair(TM)
Atopiclair(TM) is a key product in Sinclair's international
dermatology range. It is available in the US and EU and indicated
for the treatment of atopic dermatitis and contact dermatitis in
adults and pediatrics.

Dr Michael Flynn, CEO of Sinclair Pharma, commented: "This is a very
important clinical trial result for Sinclair and our partners.
Previous large-scale US data shows how effective Atopiclair is in
adult patients. This new US study follows smaller scale European
studies, showing Atopiclair to be safe and effective in infants and
children. About one third of eczema prescriptions are for infants or
children. Unfortunately when the usual emollients are not effective
the next choices are topical steroids or immune modulating products.
Atopiclair offers the possibility to avoid these products in some
children. We believe that these results will help to strengthen
the position of Atopiclair in the dermatitis market and be welcomed
by both parents and physicians."

Bob Moccia, CEO of Chester Valley Pharmaceuticals, said: "The
positive results of this paediatric study reinforce the safety and
efficacy of Atopiclair in children and signifies its ability to
control the symptoms of atopic dermatitis and eczema."

Atopiclair(TM) is free from corticosteroids and immunomodulators. No
serious adverse events relating to Atopiclair(TM) were recorded in
this study.

Notes to editors:

Atopiclair(TM)
Atopiclair(TM) is a non-steroidal cream, marketed as a medical
device in the US and EU, for the management of symptoms of atopic
dermatitis and contact dermatitis. It is sold through Sinclair's
sales and marketing team in Italy, and is also sold in the US, Spain,
Portugal, Turkey, Indonesia, Israel and Jordan. For further product
information please visit www.atopiclair.com.

Atopic dermatitis (also known as eczema) is one of the most common
dermatological complaints and accounts for a large number of
physician consultations. It is known to affect approximately 20% of
school aged children[ii], [iii], [iv].
The prevalence in adults is estimated at 1-3%[v],[vi].

Other atopic dermatitis treatments
The current cornerstone of atopic dermatitis therapy is topical
corticosteroids. However this group of drugs may have unfavourable
side effects, especially when used long-term or on sensitive areas of
skin such as the face, hands, or in children. These effects vary
from mild and reversible thinning, to irreversible telangiectasiae
(fine blood vessels becoming visible at the surface of the skin) and
striae distensae (marks similar in appearance to 'stretch marks').
Steroids' effectiveness may also become less effective with
continued use, which may lead to the escalation to a more potent
steroid[vii]. There may also be a risk of adrenal suppression in
children with the use of topical steroids[viii]. Atopiclair(TM) does
not contain corticosteroids.

Another group of drugs, the topical immunomodulators (TIMs), are also
used in atopic dermatitis. In January 2006, the US Food and Drug
Administration (FDA) approved updated labeling for two TIMs,
pimecrolimus and tacrolimus. The new labeling includes a boxed
warning about a possible risk of cancer and a Medication Guide
(FDA-approved patient labeling). The Medication Guide is to be
distributed with each prescription to help ensure that patients using
these prescription medicines are aware of this concern. The new
labeling also clarifies that these drugs are recommended for use as
second-line treatments. This means that other prescription topical
medicines should be tried first. Use of these drugs in children under
2 years of age is not recommended by the FDA.

Sinclair Pharma plc
Sinclair Pharma plc is an international specialty pharmaceutical
company. It has a growing sales and marketing operation that is
already present in France, Spain, Italy and Portgual, and a
complementary marketing partner network that spans 60 countries.
Sinclair focuses in niche/specialty therapeutic areas and its current
portfolio focuses on products for dermatological conditions and oral
health.

Chester Valley Pharmaceuticals Inc
Chester Valley Pharmaceuticals, based in Malvern, Pennsylvania, is a
specialty dermatology company focused on acquiring, in-licensing and
developing branded prescription dermatological products to be
marketed and sold through their professional sales force within the
United States.

Enquiries:

Financial Dynamics Tel: 020 7831 3113
Ben Atwell/John Gilbert
Sinclair Pharma plc Tel: +44 1483 410600
Zoe McDougall
John Barrington-Carver


[i] Din Link UK 2006, patients under 17 were given 28.5% of eczema
prescriptions
[ii] Yura A, Shimizu T. . Trends in the prevalence of atopic
dermatitis in school children: longitudinal study in Osaka
Prefecture, Japan, from 1985 to 1997 Br J Dermatol 2001; 145 (6):
966-73
[iii] Tay YK, Kong KH, Khoo L et al. The prevalence and descriptive
epidemiology of atopic dermatitis in Singapore school children. Br J
Dermatol 2002; 146 (1): 101-6
[iv] Mortz CG, Lauritsen JM, Bindslev-Jensen C, Prevalence of atopic
dermatitis, asthma, allergic rhinitis, and hand and contact
dermatitis in adolescents. Br J Dermatol 2001; 144 (3): 523-32
[v] Schultz-Larsen F, Hanifin JM. Epidemiology of Atopic
Dermatitis. Immunol Allergy Clin North Am 2002; 22: 1-24
[vi] Ellis CN, Drake LA, Prendergast MM. Cost of Atopic Dermatitis
and eczema in the United States. J Am Acad Dermatol 2002; 46 (3):
361-70
[vii] Atherton DJ, BMJ. Topical Corticosteroids in atopic
dermatitis. 2003;327:942-943
[viii] Siklar Z, Bostanci I, Atli O, Dallar Y. Pediatr Dermatol.
2004 Sep-Oct;21(5):561-3


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