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Product Update

6th Oct 2005 07:00

Sinclair Pharma PLC06 October 2005 SINCLAIR ANNOUNCE NEW ATOPICLAIR(TM) & DECAPINOL(R) DISTRIBUTION DEALS FDA EXTEND DECAPINOL(R) LABEL Godalming UK, 6 October, 2005 Atopiclair(TM) Sinclair Pharma plc ('Sinclair' - SPH.L), the specialty pharmaceuticals company,announces that its wholly owned Italian subsidiary Sinclair Srl (formerlyEuroderm) has signed a one year co-promotion deal in Italy for Atopiclair(TM) with the Madaus Group's Italian subsidiary, Madaus Srl (Madaus) based in Padua. The Madaus Group, headquartered in Cologne, focuses on development, marketing and sales of pharmaceutical products. Sinclair Srl launched Atopiclair(TM) for atopic dermatitis (eczema) in Italy inSeptember 2005. This launch by Sinclair's own sales force follows Atopiclair(TM)'s US launch last June by CVP Inc. and marks an important milestone for both the product and the Company. Sinclair's first product launch through its own sales force is a significant step in the evolution of the Company's International sales and marketing strategy which, up to now, has been to appoint licensing partners to commercialise its products. However, in this instance Sinclair's own pharmaceutical sales company in Italy - Sinclair Srl has entered a co-promotion deal with Madaus in order to increase its focus on the paediatric market. Madaus intends to market Atopiclair(TM) through its 70 sales representatives targeting paediatricians in Italy over a period of one year. Dr. Michael Flynn, CEO of Sinclair said: "We are very pleased to be working withMadaus in Italy, particularly since they are very experienced in the Italianpaediatric market. Data from clinical trials gives clear evidence thatAtopiclair(TM) is effective in reducing the itch, the severity and the extent ofeczema lesions which are very important in the treatment of children with atopicdermatitis. We believe that as an effective steroid-free product for relievingthe symptoms of atopic dermatitis, Atopiclair(TM) will find rapid acceptanceamongst paediatricians as well as parents." Danilo Casadei Massari, VP Corporate Development of Madaus Group and ChiefExecutive Officer of Madaus Italy, added: "Partnering with Sinclair in theco-promotion of Atopiclair(TM) in Italy is for us a stimulating opportunity and we trust that our introduction in the paediatric field as well as the complementary role of the product in our specialty portfolio will contribute to the recognition of the novel treatment opportunity in our market." Decapinol(R) The Company also announces that it has signed an agreement with Pharmbio KoreaCo Ltd in South Korea for the distribution of Decapinol(R), its novel oral rinsefor the treatment of gingivitis (gum inflammation). Records indicate thatDecapinol(R) is the first new chemical entity approved to help prevent and treatgingivitis in the past 30 years. In the US the Food & Drug Administration (FDA) approved Decapinol(R) earlierthis year as a medical device which may be sold on prescription. Followingfurther discussions, the FDA have agreed to an important extension of thelabelling of the product to include prevention of plaque. Commenting Dr Michael Flynn said: "Sinclair sees the revised labelling as animportant advance and one that will assist in establishing the platform forDecapinol(R). In the US approximately 80 per cent of the adult population areestimated to have some degree of gum inflammation, resulting in a USprescription market for mouthwashes that may exceed US$100 million. OTCmouthwash brands contribute to a several fold larger total market. We believethat Decapinol(R) has the potential to become a viable contender in this marketsince clinical trials have proved Decapinol(R) to be well tolerated andeffective with clear unique advantages." END Sinclair Pharma plcDr Michael Flynn, CEO Tel: (0)1483 426 644John Barrington-Carver (Media Enquiries) Tel: (0) 7831 655 630 Financial DynamicsBen Atwell Tel: (0) 207 831 3113 Notes to editors: Sinclair Pharma plc Sinclair Pharma plc, based in Godalming in the UK, is quoted on the AlternativeInvestment Market (AIM) on the London Stock Exchange and has focused on theacquisition and development of niche patented pharmaceutical products in thefields of oral health and dermatology, and bringing them to the internationalmarket place via out-licensing partners. The Company combines productevaluation, product development, regulatory and business development expertiseto add value to its acquired and in-house developed products. A key element ofthe Sinclair business model is to minimise risk and exposure by avoidinginvolvement in lengthy R&D programmes and rapidly achieving global distributionthrough a network of marketing partners. The Company has already licensed itsproducts for distribution in over 50 countries around the world.www.sinclairpharma.com This information is provided by RNS The company news service from the London Stock Exchange

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