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York Pharma (AIM:YRK): Product Update, Sabarep
Hitchin, UK, 30 October 2006 - York Pharma plc, the AIM-listed (AIM: YRK)
strategic acquirer, developer and marketer of pharmaceutical products in the
field of dermatology, announces progress in the development of Sabarep™, York
Pharma’s patented treatment for atopic eczema and related diseases of the skin.
The Company is pleased to report results from human subjects, identifying the
optimal composition of this multi-component product. The Company has also
discovered additional novelty during the course of these studies and has filed a
new patent to enhance further its strong intellectual property position in the
area of skin protease inhibition.
The functional mechanistic studies of Phase II design (vehicle and placebo
controlled) generated data from 114 human subjects, involving 149 tests on these
subjects, with 760 skin sites tested. The skin was damaged in a clinically
controlled manner to model the defective barrier in eczema. Subsequent repair
was monitored during treatment. These investigations were designed to optimise
the composition of Sabarep™.
Using biophysical and clinical assessments following four-day treatment periods,
initial preparations containing single ingredients improved skin barrier
function by 22%, compared to baseline. Subsequent development has led to an
optimised, multi-component Sabarep™ formulation achieving a 67% improvement over
baseline. These developments have produced new discoveries leading to an
additional patent filing, further strengthening the Company’s position in this
field.
Furthermore, earlier this month, the Company held a meeting with the UK
medicines regulator (MHRA) to review the results generated to date with Sabarep™
and to agree the requirements for the remainder of its development programme
prior to the regulatory submission for a Marketing Authorisation. The Company is
pleased with the outcome of this meeting, which has clarified the remaining
stages of development of this new class of therapy.
Terry Sadler, York Pharma’s CEO commented:
“The progress the Company has achieved to date with Sabarep™ is impressive and
the three events: the progress towards the final formulation; the filing of a
new patent and the meeting with the regulator, now allow the Company to move
into the remainder of the clinical development programme with clarity and
confidence. York Pharma is now a world leader in the fundamental understanding
of the skin barrier. A dysfunctional barrier plays a primary role in a cascade
that results in a wide range of allergic reactions and diseases such as atopic
eczema. The restoration of skin barrier function is expected to have a major
impact on patient well-being and a cost-benefit to health service providers."
— ENDS —
For further information please contact:
York Pharma plc
Tel: +44 (0) 870 066 4453
Terry Sadler, Chief Executive Officer
info@yorkpharma.com
Northbank Communications
Tel: +44 (0) 203 008 7550
Annabel Entress
yorkpharma@northbankcommunications.com
Notes to editors:
About Atopic eczema
Atopic eczema (synonym atopic dermatitis) is a disease that primarily affects
children and can cause enormous suffering at a crucial time in their
development. The skin becomes dry, red and itchy, causing relentless scratching.
It has been demonstrated that atopic eczema has a greater impact on a child (and
the family) than diabetes mellitus (Su et al, 2002). The prevalence of atopic
eczema has increased significantly from 4% of children in the 1940’s to 25%
today.
There has been increasing scientific data, published over the past five years,
indicating that breakdown of the skin barrier is a primary event in the
development of atopic eczema. York Pharma’s clinical and scientific team has
demonstrated that a major contributor to the development of atopic eczema is a
genetic predisposition to a defective skin barrier. The defective skin barrier
arises because of increased production or activity of proteolytic enzymes,
proteases, in the skin. These proteases break down the skin barrier, allowing
the penetration of irritants and allergens that trigger a flare of eczema.
The major current medical need is for a new (non-steroidal) class of product to
restore the normal skin barrier and to reduce the incidence of flares of eczema.
Sabarep™, York Pharma’s Skin Protease Inhibitor formulation is intended to
fulfill this need and is potentially a major advance in the treatment of
diseases such as atopic eczema.
About Sabarep™
Sabarep™ is a new treatment for eczema and related diseases of the skin. Sabarep™
is the first product arising from York Pharma’s skin barrier discovery platform
and is a novel, patented formulation that is able to inhibit skin protease
activity, repairing and maintaining a healthy skin barrier.
About York Pharma plc
York Pharma is an AIM-listed strategic acquirer, developer and marketer of
pharmaceutical products in the field of dermatology. Its portfolio now targets
skin diseases that make up approximately 75% of the global $10.4bn dermatology
market. The Company’s lead product Abasol™, an entirely new drug for the
treatment of fungal infections of the skin, is anticipated to be commercialised
from H1 07. For further information, please go to
www.yorkpharma.com .
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