|
| |

Research update on York
Pharma's Sabarep - YP001
Hitchin, UK, 31 July 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 novel treatment for eczema and
related diseases of the skin. The progress achieved has created the opportunity
for the Company to extend further its intellectual property in the field of skin
protease inhibition and has advanced Sabarep™ sufficiently for the Company to
request a meeting with the UK medicines regulator (MHRA), to discuss its future
development plans for the product and to clarify the requirements for the
remainder of its development programme prior to regulatory submission.
Clinical progress achieved to date and the proposed route to commercialisation
for Sabarep™ will be made public following the filing of a new patent and the
aforementioned regulatory meeting.
Terry Sadler, York Pharma’s CEO commented:
“I am extremely pleased by Sabarep’s™ progress to date. The three forthcoming
events, the filing of a new patent, the planned meeting with the regulatory
authorities and the release of new clinical data all bode well for positive news
flow in the final quarter of this year.
York Pharma is fast establishing itself as a leader in the fundamental
understanding of the skin barrier and the role that a dysfunctional barrier
plays in a cascade that appears to be associated with a wide range of allergic
reactions and diseases; the prevention of which will have a positive impact on
patient well-being and costs to health service providers."
Further information
The Company confirms that it has successfully incorporated a skin protease
inhibitor into an emollient vehicle for the treatment of eczema (Sabarep™) and
that the formulation is progressing well through a clinical evaluation of its
activity leading to the final dosage concentration. During the course of this
evaluation, prior to which the Company has engaged the services of world class
authorities on formulation development, additional novelty has emerged which the
Company has been advised creates an opportunity to enhance further its
intellectual property position in the area of skin protease inhibition.
Recent progress has accelerated to the extent that the Company has requested a
meeting with the UK regulator (MHRA) to discuss the pre-clinical and clinical
results generated to date with Sabarep™ and to clarify the requirements for the
remainder of its development programme prior to regulatory submission.
Background & Recent News
A UK government report released to the media last week drew attention to the
spiralling incidence of allergy-related conditions that will affect up to 30% of
the population, or 18 million people in Britain sometime in their lives. This
dramatic rise in allergic reactions, including eczema, has been linked to
‘oversensitive immune systems’.
Eczema is associated with the loss of structural integrity within the skin which
increases the risk of exposure to environmental allergens and ‘super-allergens’
through a dysfunctional skin barrier. Exposure to these allergens gives rise to
the flares associated with atopic diseases such as eczema, asthma and allergic
rhinitis (hay fever).
This loss of structural integrity within the skin is brought about by the
premature breakdown of adhesion proteins which result in a thinning of the skin
barrier, thus easing the penetration of environmental irritants and allergens
through the skin barrier which can trigger flares of eczema. Sabarep™ is aimed
at preventing this chain of events by inhibiting the premature breakdown of the
adhesion proteins thereby repairing the skin barrier and restoring its normal
protective function.
--END--
For further information please contact:
York Pharma plc
Terry Sadler, Chief Executive Officer
Tel: +44 (0) 870 066 4453
www.yorkpharma.com
Northbank Communications
Rowan Minnion
Tel: +44 (0) 207 886 8150
r.minnion@northbankcommunications.com
Notes to editors:
About Atopic eczema
Atopic eczema (synonym atopic dermatitis) is a disease that affects up to 25% of
children and can cause enormous suffering at a crucial time in their
development. The child’s skin becomes dry, red and itchy, causing relentless
scratching. It has been suggested that atopic eczema has a greater impact on a
child (and the family) than diabetes mellitus (Su et al, 2002).
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’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
can arise through 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 that
is being evaluated in a clinical study currently that will provide phase II dose
finding information and define the optimum combination of constituents. Sabarep™
is the first novel product arising from York Pharma’s skin barrier discovery
platform that inhibits skin protease activity thereby 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 embraces
skin diseases that make up approximately 75% of the global $10.4bn dermatology
market. The Company’s lead product Abasol™ is an entirely new drug for the
treatment of fungal infections of the skin, which was filed for marketing
approval in the UK in July 2005. For further information, please go to
www.yorkpharma.com
| |
|