York Pharma provides regulatory update on lead product Abasol

Regulatory Update - Abasol™


Hitchin, UK, 2 October 2006; York Pharma, the AIM-listed (AIM:YRK) strategic acquirer, developer and marketer of pharmaceutical products in the field of dermatology, is pleased to announce that it has received a response from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), regarding its application for Marketing Authorisation of Abasol™ (abafungin 1% topical cream) for the treatment of dermatomycoses (fungal infections of the skin). In view of this response, the Company has begun to prepare for the launch of Abasol™ in H1 2007.

Preparations for launch include production planning, assembling of commercial materials and, in consultation with the Company’s Scientific Advisory Panel, the conduct of additional non-registration studies to build on the knowledge base of Abasol™.

As expected, prior to the grant of a Marketing Authorisation, the Company has been requested to supply certain additional data to the MHRA and the Company has commenced assembling its response from data held on file or generated since its application was filed originally. The Company is confident that the response will be submitted shortly and of achieving its commercial launch in H1 2007.

Following registration of Abasol™ in the UK, the Company will seek approvals in other European markets through the mutual recognition procedure.

The submission to the MHRA was the first worldwide regulatory filing for Abasol™ which is both a new chemical entity and the first in a new class of novel antifungal agents; in view of this, its regulatory review has been undertaken by the MHRA and referred to the Commission on Human Medicines (CHM).

Terry Sadler, CEO of York Pharma, commented: “We are pleased that Abasol™, our lead product, has now been reviewed thoroughly by the UK regulator and we are looking forward to bringing this novel product to its first European market for its initial indication, the treatment of dermatomycoses. We believe that Abasol™ will provide both high efficacy and distinct competitive benefits.

In parallel, we have been finalising our regulatory strategy for Japan and the USA and, with the benefit of a detailed response to our first worldwide regulatory filing, we also plan to meet with the regulators in these two major territories to confirm their data requirements for the granting of marketing approvals.

Importantly, the clarity arising from the MHRA review, combined with the substantial amount of new data generated since our filing in July 2005, also enables the Company to progress our discussions with certain commercial partners and to plan the global commercialisation of Abasol™.

The remainder of our innovative and growing dermatology pipeline is developing rapidly with two projects progressing through clinical development and all other projects ‘on-track’. The Company intends to have important products in all major disease areas within the $10.4 billion prescription dermatology market.”

York Pharma announces its intention to hold a Company update and R&D portfolio review on the 31st October 2006 in central London; details on venue and timings will be provided in due course.

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For more information please contact:

York Pharma plc

Terry Sadler, Chief Executive Officer
Tel: +44 (0) 870 067 2563

E-mail: info@yorkpharma.com

Northbank Communications


Annabel Entress /Justine Lamond/ Adam Michael
Tel: +44 (0) 20 3008 7550

Email: yorkpharma@northbankcomminications.com 

Notes to editors:

About Abasol™ (abafungin)

Abasol™ is a topical cream formulation of abafungin, a patented broad-spectrum antifungal agent with a novel mechanism of action. Abafungin has been shown to have fungicidal and fungistatic effects on a wide variety of pathogens, including dermatophytes, yeasts (Candida) and moulds. The drug acts on the infecting organisms in two ways: by interfering with the formation of a vital sterol in the fungal cell membrane, thereby preventing cell growth, and also by direct interaction with another membrane component resulting in membrane disruption, leakage of cellular contents and death of the cell and independent of whether it is in a non-metabolising (‘resting’) phase of development or actively growing. These features of abafungin, combined with the attainment of microbicidal concentrations in the skin from a 1% preparation, its long residence at the site of dermal application and the lack of significant systemic absorption, mean that Abasol™ is particularly attractive for the topical treatment of dermatomycoses, which is the first indication under review for marketing approval.

Furthermore, abafungin has antibacterial properties which could give therapeutic potential in cases of mixed fungal and bacterial infections. Also, its ability to penetrate the nail bed, together with its fungicidal action on both growing and ‘resting’ cells are significant features necessary to the successful topical treatment of onychomycosis (fungal disease of the nails).

Global sales of products for the treatment of topical dermatomycoses reached approximately $1bn in 2005, according to IMS data. The second indication for Abasol is expected to be onychomycosis, which affects in the region of 35 million people in the US alone, the market for which was valued at $1.25bn in 2005 (IMS) and also remains underserved with existing products. Abasol may also have potential in several other areas, such as acne and gynaecological infections.

About York Pharma plc

York Pharma is an AIM-listed (AIM:YRK) strategic acquirer, developer and marketer of pharmaceutical products in the field of dermatology. Its portfolio embraces skin diseases that make up approximately 75% of the global $10.4bn dermatology market.

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