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York Pharma PLC (YRK) Release: New Abasol™ Formulation for Onychomycosis can Effectively and Rapidly Penetrate the Nail Barrier


10/31/2007 4:33:29 PM

Hitchin, UK, 30 October 2007 York Pharma plc, the AIM-listed (AIM: YRK) specialist dermatology company, announces that it has made new discoveries and filed a patent application for a novel topical formulation of Abasol™ (abafungin) for treating fungal infections of the nail (onychomycosis).

Abasol™ Cream is currently awaiting approval from the MHRA in the UK for the treatment of fungal infections of the skin (dermatomycoses). Concurrently, York Pharma has made progress in developing a novel gel formulation of Abasol™ for the treatment of onychomycosis, which is a US$1.7 billion per annum global market. The Company has filed for patent coverage of this new invention.

The Abasol™ gel formulation appears to offer many advantages over currently available treatments. Not least is the ability to deliver the antifungal drug into and through the nail. Past attempts by pharmaceutical companies to develop effective topical treatments for fungal infections of the nail have long been hindered by the failure of their formulations to deliver therapeutically effective drug concentrations through the nail.

In laboratory tests, the new Abasol™ gel formulation quickly delivered drug concentrations of abafungin into the nail which greatly exceeded the levels sufficient to kill the causative organisms of onychomycosis.

The new gel formulation has a unique delivery mechanism; through both the nail and the skin. It is quick and easy to use whilst also providing cosmetic advantages. The gel is intended for application directly to the nail. There is no need for filing to roughen the surface to prepare it for gel application – unlike the currently marketed lacquers, for which the nail surface has to be filed to remove the previous layer of lacquer and prepare it for the next. Also, in contrast to these lacquers, the new Abasol™ gel formulation does not leave a hard gloss film on drying, either on the nail or on the surrounding skin.

Terry Sadler, Chief Executive of York Pharma, commented

“We are delighted to have invented a novel and innovative formulation of Abasol™ to deliver our unique antifungal drug to treat fungal infections of the nail; one of the most problematic and intractable of topical infections. The new gel formulation of Abasol™ extends York Pharma’s exclusive position in a valuable and unsatisfied market with a formulation the Company is now looking to take forward into clinical development.”

For further information please contact: York Pharma plc Tel: +44 (0)870 067 2563

Terry Sadler, Chief Executive Officer Financial Dynamics Tel: +44 (0)207 831 3113 David Yates Ben Brewerton Emma Thompson

Notes to editors:

About Onychomycosis Onychomycosis, fungal infection in, under and around fingernails and toenails, is most frequently caused by dermatophytes (skin fungus) such as Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton flocossum, but can also be caused by other fungi including moulds and yeasts. Many infections are mixed infections and current treatment methods are poor. Onychomycosis causes roughness, splitting and discoloration of the nail and can result in nail loss.

Fungal nail infection is more frequently seen in toenails than in fingernails. A published study reported that onychomycosis affects 2 to 3% of the general population in the USA whereas a study conducted in Finland reported a rate of 13% [Elewski et al, 1997 and Heikkila et al, 1995]. The prevalence of the condition increases with age and both of the studies referred to above reported prevalence of approximately 25% in elderly patients. Furthermore, the prevalence amongst individuals with diabetes is approximately 26% and almost three times more prevalent than age matched non-diabetic controls [Gupta et al, 1998].

According to IMS data, the estimated drug spend on onychomycosis in the 7 largest markets was approximately US$1.7 BN (£925 million) in the 12 months leading to September 2005. The treatment of onychomycosis is challenging, with existing treatments applied topically reporting cure rates of as low as 10% after six to twelve months of continuous use. Whilst greater success is reported for systemic treatments administered orally, they have safety concerns that limit their utility for routine treatment of a condition such as onychomycosis.

References:

Elewski, B. E., and M. A. Charif. 1997. Arch Dermatol. 133:1172-3

Heikkila, H., and S. Stubb. 1995. Br J Dermatol. 133:699-703

Gupta, A. K., N. Konnikov, P. MacDonald, P. Rich, N. W. Rodger, M. W.

Edmonds, R. McManus, and R. C. Summerbell. 1998. Br J Dermatol. 139:665-71

About Abasol™ The active ingredient in Abasol™ is abafungin, a patented and first drug belonging to an entirely new chemical class of antimicrobial agents which has broad-spectrum and potent antifungal activity with a novel mechanism of action. Abafungin has been shown to have fungicidal effects on a wide variety of pathogens, including dermatophytes, yeasts (Candida) and moulds. The drug acts on the infecting organisms in two ways: by preventing cell growth of the infecting organism and also through disrupting its cell membrane causing its death even if it is in a resting state. Clinical studies conducted to date using a cream formulation for treating skin infections have demonstrated the product to have a remarkably well tolerated safety profile and to not be absorbed significantly into the blood circulation. These features are unique to abafungin and make it a particularly interesting new drug for the treatment of onychomycosis.

A cream formulation of Abasol™ is awaiting marketing approval in its first international market, the UK, for the treatment of fungal infections of the skin.

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 87% of the global $10.6bn dermatology market. For further information, please go to www.yorkpharma.com.



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