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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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