Hitchin, UK, 14 June 2006 York Pharma plc, the AIM-listed (AIM:YRK) strategic acquirer, developer and marketer of pharmaceutical products in the field of dermatology, announces the commencement of a new programme, YP005, to develop a novel treatment for acne. The programme will be supported by a major German Grant of approximately €1,000,000 awarded to the Company from the “NanoforLife” (Nanotechnologies for Life Sciences and Health) programme of the Federal Ministry for Education and Research, BMBF (Bundesministerium für Bildung und Forschung), Germany. 

·                Under the YP005 programme, York Pharma is conducting the development of sphingosine-1-phosphate (S1P), applied topically to the skin, as a novel therapeutic treatment for acne.

·                S1P will be presented within a nano-particulate cream formulation. The novel nano-drug delivery system will be designed to enhance the access of the drug through the skin to the acne lesions.

·                "NanoforLife" grants are competitive and are awarded to those projects that make a substantial contribution to the health of society. Under the direction of York Pharma GmbH, several University facilities in Germany (including Freie Universität Berlin, Charité Universitätsmedizin, Berlin and Fachhochschule Gießen) will collaborate with other industrial partners - CPM ContractPharma GmbH (Feldkirchen), LPT Laboratory of Pharmacology and Toxicology (Hamburg) and Chiracon GmbH (Luckenwalde) to optimise the nano-particle formulation and complete pre-clinical testing.

·                York Pharma will retain all commercial rights to the product and the grant award provides approximately €1,000,000 towards the costs of the programme.

·                S1P-related patents, know-how and global commercialisation rights were acquired by York Pharma in July 2005 from the inventors, headed by Professor Monika Schäfer-Korting of the Freie Universität Berlin.   

The YP005 Programme

The YP005 programme is aimed at developing a novel, effective treatment for acne by exploiting the inherent pharmacological activity of S1P. This will be achieved in collaboration with academic institutes and service providers. The four-year collaboration begins in June 2006 with the development of a synthetic route for the commercial scale manufacture of sphingosine-1-phosphate. In the first project year, Prof. Lademann’s department at the Charite Berlin will investigate the penetration of the nanoparticles into hair follicles. In parallel, FU Berlin will develop a customised delivery system, developing nano-particles loaded with S1P. This work, including analytical testing of S1P, is expected to be completed in the second year of the programme. The nanoparticles will be incorporated into a suitable cream formulation at FH Giessen. This work is expected to be completed by the end of the third year of the programme. Penetration tests with the finished cream will continue until the end of the programme.  

Toxicological investigation of the substance, S1P, and the nano-particle cream formulation will be undertaken in the third year, together with cutaneous absorption, skin metabolism and tolerability studies. Measurements of the physical stability of the S1P-loaded nanoparticles will also be performed during this time.  

In the final year of the programme, the S1P cream formulation, based on nanoparticles, will enter a Phase II clinical ‘proof of concept’ trial for demonstration of efficacy and tolerability in patients with mild to moderate acne vulgaris.  

Terry Sadler, York Pharma’s CEO, commented: ‘We are delighted to have received this major grant award to incorporate S1P into leading edge technology. This treatment will herald a totally new approach to the treatment of acne, a common condition, the incidence of which is continuing to increase. We are also fortunate to be working with highly skilled partners who will contribute their expertise to this exciting project’.  

-ENDS- 

For further 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
Rowan Minnion, Justine Lamond r.minnion@northbankcommunications.com

Notes to editors: 

About Acne and S1P

Acne is caused by the hyperproliferation of cells (keratinocytes) at the entrance to the hair follicle, which can then become blocked. There is also an overproduction of sebum in acne, which builds up behind the blockage at the entrance to the hair follicle. The sebum becomes stagnant and bacteria multiply within it. The bacteria break down the sebum, which then causes an inflammatory reaction and an accumulation of pus. Reversing the hyperproliferation of the keratinocytes at the entrance to the hair follicle is therefore a very important part of the treatment of acne. S1P will target this primary cause of the problem by limiting proliferation of the cells in the hair follicle, a major advantage for the treatment of acne.  

As a result of its characteristics, researchers have suggested that S1P may have potential in the treatment of hyperproliferative skin diseases.^2. Interestingly, the anti-proliferative effects of S1P have been found not to rely on cell toxicity or altering programmed cell death, referred to as apoptosis.  In fact, S1P has been found to protect cells from programmed cell death further illustrating its unique anti-proliferative properties. Additionally, S1P demonstrates antimicrobial activity both in vitro and in vivo³, conferring a major advantage in the treatment of acne vulgaris where there is an infection of propionibacteria. 

¹ Paradoxical Effects of Sphingosine-1-Phosphate. Bollag WB (2003) Journal of Investigative Dermatology Vol 120 No 4 (April), p xiii -ix

² Sphingosine-1-Phosphate and Its Potentially Paradoxical Effects on Critical Parameters of Cutaneous Wound Healing Vogler et al (2003) Journal of Investigative Dermatology Vol 120 No 4 (April), pp 693- 699

³Garg et al The Journal of Infectious diseases 2004; 189, 2129-2138 

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 more than 75% of the global $10.4bn dermatology market.  

The acne market, which is the focus of YP005, is valued at approximately $2.3bn, making up 22% of the overall dermatology market.  Approximately 85% of people between the ages of 12-24 experience acne and have a high desire for innovative and improved therapies.   

York Pharma’s innovative product portfolio also includes its lead product, Abasol™ for the treatment of fungal infections of the skin, which has been filed for European marketing approval, whilst its psoriasis (Vampex™) and eczema and dermatitis (Sabarep™) products have progressed to Phase II clinical development. For further information, please go to www.yorkpharma.com