28th Nov 2005 07:00
Sinclair Pharma PLC28 November 2005 SINCLAIR PHARMA PLC AGM STATEMENT Godalming, 28 November, 2005: At today's Annual General Meeting, Mr SteveHarris, Chairman of Sinclair Pharma plc, will make the following comments: In the year to 30 June 2005, Sinclair made substantial progress towards becominga leading specialty pharmaceutical company. Six regulatory approvals weregained, 34 licence agreements were signed, and turnover from continuingoperations increased 174% to £7.0m. Since the preliminary results on 6 October, Sinclair has continued to makestrong commercial, regulatory and financial progress. Sales of our productscontinue to grow in line with expectations, with US sales of AtopiclairTMperforming strongly. We have made further progress with product launches andthe following products have been launched this financial year: • Aloclair(R) rinse launched in Sweden by Sunstar Butler • Aloclair(R) Spray launched in Turkey by our licencee SSM who have in addition extended their agreement to include Aloclair(R) rinse, Aloclair Gel (R) and SalinumTM • AtopiclairTM launched in Portugal by Dysanovis and in Italy by Sinclair's own sales force • SalinumTM launched in Austria by Novapharm • XclairTM launched in the UK by Crawford Pharmaceuticals On the regulatory front, Sinclair has filed Decapinol(R) rinse for registrationas an OTC product with the Food and Drugs Administration (FDA) in the UnitedStates. Although Decapinol(R) rinse was approved as an ethical product in Q22005 by the FDA, which gives the product important professional endorsement,the OTC market is a considerably larger opportunity. We hope to receive aresponse from the FDA during the first quarter of next year. Since the preliminary results, we have also received results of a 60 patientdouble-blind trial for SebclairTM, Sinclair's non steroidal cream for thetreatment of seborrhoieic dermatitis. The trial was carried out in two centres,in the United States (Texas Dermatology Research Institute - TDRI) and in Italy(European Dermatology Institute - IDE) . The primary endpoint was theInvestigators' Global Assessment (IGA). Forty patients were allocated toSebclairTM and twenty allocated to vehicle control. Preliminary information onthe trial results is very positive with a highly statistically significantdifference (Fisher's exact test: p < 0.0001) being observed for the primaryendpoint. Twenty-seven out of 40 patients using SebclairTM were clear or almosttotally clear of symptoms and signs on IGA versus two out of 18 patients in thecontrol group after four weeks of treatment. The Company is very encouraged bythese results, which confirm the efficacy of SebclairTM in sebborrhoeicdermatitis and support the results obtained from earlier studies. SebclairTM isalready registered in the EU and has been filed with the FDA for registration inthe US. First launches of SebclairTM are planned during the current financialyear. Alexis Prenn, who has been a non-executive director for more than five years,has decided not to offer himself for re-election at this year's AGM. The Boardand I would like to thank him for his valuable contribution to Sinclair. Overall, I am pleased to say that Sinclair has started the current financialyear as it ended the previous year - with strong momentum in the key areas.Sinclair continues to grow sales, launch products in new markets and make goodclinical progress. Enquiries:Sinclair Pharma plcDr Michael Flynn, CEO Tel: (0)1483 426 644Jerry Randall, CFOJohn Barrington-Carver (Corp. Office) Tel: (0)7831 655 630 Financial DynamicsBen Atwell Tel: (0)207 831 3113John Gilbert 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, oncology support and dermatology, and bringing them tothe international market place via out-licensing partners. The Company combinesproduct evaluation, product development, regulatory and business developmentexpertise to add value to its acquired and in-house developed products. A keyelement of the Sinclair business model is to minimise risk and exposure byavoiding involvement in lengthy R&D programmes and rapidly achieving globaldistribution through a network of marketing partners. The Company has alreadylicensed its products for distribution in over 40 countries around the world.www.sinclairpharma.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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