Progress Update with Development of a New Treatment for Psoriasis (YP003)

Hitchin, UK, 30 January 2006 York Pharma plc, the AIM-listed strategic acquirer, developer and marketer of pharmaceutical products in the field of dermatology, announces progress with the development of YP003, disclosure of its lead compound from a new class of drugs termed Vitamin A Metabolic Pathway (VAMP) inhibitors and positive data from an initial Phase II study.  

York Pharma has progressed development of a new class of drugs for the topical treatment of psoriasis, Vitamin A Metabolic Pathway (VAMP) inhibitors.  Carbenoxolone has been selected as the lead compound.  To date, in vitro and in vivo study results supporting the use of carbenoxolone in psoriasis have all been positive.   

The Company now has Phase II results that further support carbenoxolone as a new treatment for psoriasis.  The Phase II study tested the activity of the compound in 12 patients with mild to moderate psoriasis.  For each patient, three medications were applied to selected psoriasis plaques daily for four weeks: 2% carbenoxolone gel (test medication), 0.05% calcipotriol (reference product) and placebo.   

Even though the carbenoxolone gel was not optimised, in terms either of formulation or concentration, the treatment showed favourable signs of clinical effect.  Its activity profile (scoring reduction in redness, scaling and thickness of plaques) demonstrated clinical activity according to the guideline set by the European Medicines Agency (EMEA) (an improvement in the scoring during treatment of at least 50%).  Histological examination further supported these positive results.  There were no adverse reactions to carbenoxolone. 

York intends to carry out further Phase II trials with an optimised formulation of carbenoxolone, including dose-ranging studies, before progressing to Phase III studies.  

Commenting on the announcement, Terry Sadler, Chief Executive of York Pharma, said:  “Psoriasis is a chronic condition affecting about 2% of the population, with current treatments often associated with systemic toxicity and topical irritation. York is pleased that these preliminary Phase II data indicate the potential of carbenoxolone for the treatment of this condition, and that the Company’s dermatology pipeline is continuing to make significant progress”. 

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For more information please contact: 

York Pharma plc	Tel: +44 (0) 870 066 4453
Terry Sadler, Chief Executive Officer

 

Northbank Communications	Tel: +44 (0) 207 886 8150
Emma Palmer Rowan Minnion

 Notes to editors: 

About VAMP inhibitors 

The VAMP inhibitor programme is directed at the regulation of cellular proliferation, a phenomenon that is overactive in psoriatic lesions compared with normal skin.  The programme has targeted certain key enzymes of the vitamin A metabolic pathway thought to be involved in the balance of cellular proliferation and differentiation of keratinocytes (skin cells).  

The effect of VAMP inhibitors in hyperproliferative diseases, such as psoriasis, encourages susceptible cell types to switch from proliferation to differentiation, returning them to a ‘non-disease’ state by inhibition of the vitamin A metabolic pathway.  This novel approach contrasts with current therapies which seek to achieve the same effect by increasing the activity of the vitamin A pathway through administration of retinoid drugs.  Increased vitamin A activity is associated with a variety of adverse effects. Topical retinoid therapy commonly leads to irritation of the skin which limits its use. 

About carbenoxolone (YP003)

The Company has identified a class of Vitamin A Metabolic Pathway (VAMP) inhibitors from which the well established cytoprotectant drug, carbenoxolone, was selected as the lead candidate for clinical development as a novel treatment for psoriasis.  To date, the Company has progressed the project through the following stages and carbenoxolone has shown favourable activity in each of the following:  

·         in vitro, a marked reduction of the proliferation of psoriatic keratinocytes in cell culture (data on file);

·         in vivo, a reduction of cellular hyperproliferation and scaling comparable to that of the reference drug, tacalcitol, a vitamin D analogue in current clinical use for the treatment of psoriasis (data on file);

·         Demonstrable clinical activity in a phase II study in accordance with the EMEA guidelines for psoriasis.  

About  Psoriasis 

Psoriasis affects about 2% of the world’s population (ranging from 0.5% in Japan up to 2.5 % in Scandinavia).  The condition can arise at any age but appears most often between the ages of 15 to 40.  The market is valued presently at approximately $630m but expected to grow to $2bn by 2008.  Therapy of mild to moderate psoriasis is dominated at present by topically applied Vitamin D analogues, all of which are prescription therapies.  The objective of therapy is to clear all the psoriatic plaques but achievement of that objective by Vitamin D analogues is limited by their propensity to cause skin irritation, a safety profile that limits the amount that can be applied and a tendency to lose efficacy with continuous use.   

A study conducted by the National Psoriasis Foundation in the USA found that twenty three percent of Americans having the disease were very dissatisfied with their overall treatment.  Seventy eight percent of respondents with moderate to severe psoriasis stated that they did not use the more aggressive therapies to treat their disease due to associated side effects or lack of efficacy.  Therefore, psoriasis represents a large dermatology market for which there is an attractive opportunity for products that provide more effective and better tolerated therapeutic options than those available presently. 

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 $10.4 bn dermatology market, and its lead product, Abasol for the treatment of fungal infections of the skin was filed for its first marketing approval in July 2005.  For further information, please go to www.yorkpharma.com