Sinclair is committed to exploiting
fully the products and technologies that we acquire. The company
is currently considering or developing products in the areas of
dermatology, oral health and eyecare. Here is a summary of
our main near term pipeline products:
SPHD420 for the treatment of acne
An important feature of acne is that the bacteria which cause the condition create biofilms – structures which impair the penetration of antibiotics and also reduce the efficacy of natural antibiotics (defensins) resulting in the need for prolonged treatment to achieve success. SPHD420 combines the technology behind Decapinol that breaks down the biofilm, with additional components that stimulate the production of beta-defensin 2 in the skin. This is a key element in the body's defence against acne. The product is designed to improve
acne through this mechanism and also to enhance the response to antibiotics. Clinical study results showing efficacy for this product were presented at Sinclair’s R&D day in June 2007 and further data are currently being generated. The market size for acne is currently approximately $2.5 billion, representing nearly a quarter of the dermatology market. Target for filing for registration is FY09.
SPHP700 for the treatment of dry eye syndrome
SPHP700 uses a long-chain polysaccharide combined with a polymer to provide prolonged wetting and lubrication to the eye. Impairment of the quality or quantity of tear production leads to dry eye syndrome, which affects about 3.2m women over the age of 50 in the US. The current market leader in prescription dry eye products in the US achieves sales of $280m. The key feature is a constant feeling of “grittiness” in the eyes. It is commonly treated with artificial tears but there is a need for a rapid onset, long acting product for this condition. A clinical study to evaluate this product was completed this year. Results of the study showed that SPHP700 improved the common symptoms of dry eye syndrome, including redness, dryness, irritation and a sandy/gritty sensation. For each symptom, improvements were reported in more than 75% of patients. Further studies have shown that SPHP700 is compatible with contact lens use. SPHP700 is approved in the EU and has been filed for registration in the US; Sinclair expects commercialisation through one or more marketing partners.
SPHR913 in Corrective Dermatology
This year, Sinclair unveiled a new development project in corrective dermatology, a rapidly-growing market. The anti-ageing market worldwide is estimated at $6.9 billion, with a growing emphasis on products that have scientific proof of efficacy. SPHR913 is designed to restore the quality of the skin by reducing the breakdown of collagen and elastin. Experimental data show that the key ingredient of SPHR913 has a significant effect in inhibiting the enzyme elastase, which breaks down elastin, which in turn maintains the elasticity of the skin, and metalloproteases, which are responsible for collagen breakdown. Clinical data were presented this year showing that application of SPHR913 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.
Decapinol line extensions
Decapinol represents a novel treatment for gum disease, and Sinclair is maximising this opportunity through line extensions and additional products. EU approval has been received for fluoride-containing toothpaste, a gel for use after teeth-cleaning at the dental office, and a spray. Also in development is a gel that can be applied directly to the gum margin and is intended to relive pain after dental procedures. A single-use applicator is in development for application of Decapinol into deeper gum pockets that are seen with more severe gingivitis or periodontitis.
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