Release issued 4th October 2007

4 October 2007, Godalming, UK: Sinclair Pharma plc ("Sinclair", SPH:L), the international specialty pharmaceutical company, today presents data at the World Congress of Dermatology, to support its novel pipeline product for acne, SPHD420.

SPHD420 is designed to treat acne in a novel way; it works by breaking down the resilient layer of bacteria that form a ‘biofilm' on the skin and then reducing levels of acne-causing bacteria by promoting the activity of β-defensin, a key element in the body's defence against acne.

To achieve this mode of action, SPHD420 includes delmopinol, which interferes with the ability of bacteria to adhere to each other and to adhere to surfaces, resulting in breakdown of biofilm. An additional complex of ingredients including LMW-HA, is designed to stimulate production of β-defensin 2 in the skin.

Data presented today shows that human keratinocytes (the type of cell most commonly found in the epidermis of the skin) treated with LMW-HA show increased secretion of β-defensin 2. Although skin cells were treated for 18 hours, the increase in β-defensin 2 in the treated cells was seen from 30 minutes.

These data support Sinclair's novel pipeline product for acne. Sinclair plans to file for product registration for SPHD420 in FY09. Preliminary results showing clinical efficacy were presented at the company's R&D day in June 2007, and results from further clinical trials are anticipated in 2008. The market size for acne is currently approximately $2.5 billion, representing nearly a quarter of the dermatology market.

Corrective dermatology

Sinclair also presents data to support SPH911, its pipeline product that is designed to address skin ageing. Data presented today shows that telmesteine, a key ingredient of SPH911, inhibits metalloproteases and hyaluronidase. This is desirable as these substances contribute to the natural breakdown of skin proteins collagen and elastin.
Data presented by Sinclair in June 2007 showed that application of SPH911 resulted in a statistically significant decrease in skin wrinkles, and significantly increased elasticity, hydration and thickness. Target date for filing for registration is FY09. Sinclair expects commercialisation through one or more marketing partners. The anti-ageing market worldwide is estimated at $6.9 billion, with a growing emphasis on products that have scientific proof of efficacy.

Radiation dermatitis

Sinclair presents clinical data today to support Xclair, its on-market product for radiation dermatitis (skin reactions seen during radiotherapy). The interim analysis of a clinical study including 22 patients showed that patients using Xclair had significantly less erythema (reddening) of the skin, burning, and significantly improved quality of life when compared to a control group using a vehicle cream.

Psoriasis

Sinclair presented data to support its pipeline psoriasis product SPHD400. Data showed that the key ingredient of SPHPD400 inhibits Human Leucocyte Elastase (HLE) and collagenases, both substances associated with hyperproliferation in keratinocytes. Skin hyperproliferation is a key feature of psoriasis and its reduction is a desirable outcome when treating the condition.

Atopic dermatitis

A poster was presented at the congress to highlight data from a recent multicentre study to evaluate Atopiclair in the management of mild to moderate atopic dermatitis in adults. The study demonstrates that Atopiclair is a safe and effective treatment, delivering significantly superior control of signs and symptoms than patients using a vehicle cream. Patients using Atopiclair were significantly less likely to need rescue medication with a topical steroid during the study period.

Intellectual property

Sinclair has patents or patents pending for its pipeline products and technologies.

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