21st Jun 2005 07:02
Sinclair Pharma PLC21 June 2005 Sinclair Pharma Plc announces positive trial results: US multicentre trial confirms efficacy of AtopiclairTM in atopic dermatitis AtopiclairTM launched in the US Godalming, UK: 21 June 2005: Sinclair Pharma plc ("Sinclair" or the "Company")(SPH.L), the specialty pharmaceutical company, today announced positive resultsof a multicentre clinical double blind study on AtopiclairTM, for atopicdermatitis (AD, eczema) and the launch of the product in the US. The study, conducted in 216 adult patients in the USA, demonstrated significantclinical benefits with AtopiclairTM, when compared to a vehicle cream controlgroup The primary endpoint was the EASI score which is a standard method ofassessment of the severity and extent of atopic dermatitis. Compared with thecontrol group Atopiclair already showed a highly significant improvement of theEASI score within the first 8 days of this 50 day trial which was maintainedthroughout the trial. Similar benefits were observed for itch, erythema, area ofatopic dermatitis, physicians global assessment, patients' preferences and theneed for rescue medication when 5.5% of patients receiving AtopiclairTM neededrescue medication because of disease flare up versus 40% of patients receivingthe vehicle control. AtopiclairTM was well tolerated with no significant sideeffects reported. In addition to the study results Sinclair announce that their US licensee,Chester valley Pharmaceuticals Inc launched AtopiclairTM in the US on 20thJune 2005. CVP is a newly founded company that is committed to bringinginnovative solutions to the field of dermatology. The company was formedthrough a partnership between industry veteran Bob Moccia and GTCR Golder RaunerLLC, a leading private equity fund based in Chicago. Dr Michael Flynn, CEO of Sinclair Pharma Plc, commented "The results of thisstudy reinforce previous positive study results for AtopiclairTM in atopicdermatitis and contact dermatitis. There is a real need for an efficacious,steroid-free product for atopic dermatitis. These study results confirm thatAtopiclairTM will be able to meet that need. We expect AtopiclairTM to be one ofour most important revenue drivers over the next three years and the launch ofour biggest product to date in the biggest market is a very significant eventfor us". Bob Moccia, CEO of CVP commented: "This large scale study shows that AtopiclairTM is an effective new approach to manage the symptoms of atopic dermatitis. Theresults for itch are particularly encouraging; itch associated with atopicdermatitis is one of the most challenging and distressing symptoms of thedisease. The dramatic reductions in itch, as well as other results from thestudy, confirm that AtopiclairTM will be welcomed by physicians and patients inthe US." Dr. William Abramovits, principal investigator of a multicenter study performedin the US said: "Our experience, from clinical trials and from anecdotalreports evidencing that AtopiclairTM is effective in reducing the itch, theseverity and the extent of eczema lesions and the rapid onset of action and verygood tolerance seen in this trial, has us very optimistic about the success ofthe product as soon as it hits the market. " Contact details: Sinclair Pharma plcDr Michael Flynn, CEO Tel: 01483 426 6444John Barrington-Carver (Corporate PR) Tel: 07831 655 630 In the USMichael Killeen, Vice President Tel: +1 972 478 4380 Financial DynamicsBen AtwellLucy Atwell Tel: 0207 269 7242 www.Sinclairpharma.com Notes to Editors AtopiclairTM is a non-steroidal cream, approved as a medical device in the USand EU, for the management of symptoms of atopic dermatitis and contactdermatitis. As well as the US launch, it will be launched in Italy and Portugalin forthcoming months and further territories are in negotiation. For furtherproduct information please visit www.atopiclair.com. Atopic dermatitis (also known as eczema) is one of the most commondermatological complaints and accounts for a large number of physicianconsultations. It is known to affect approximately 20% of school aged children(I, II, III). The prevalence in adults is estimated at 1-3%(iv, v). Thecurrent cornerstone of therapy is topical corticosteroids, which may haveunfavourable side effects. I Yura A, Shimizu T. . Trends in the prevalence of atopic dermatitis in school children: longitudinal study in Osaka Prefecture, Japan, from 1985 to 1997 Br J Dermatol 2001; 145 (6): 966-73 II Tay YK, Kong KH, Khoo L et al. The prevalence and descriptive epidemiology of atopic dermatitis in Singapore school children. Br J Dermatol 2002; 146 (1): 101-6 III Mortz CG, Lauritsen JM, Bindslev-Jensen C, Prevalence of atopic dermatitis, asthma, allergic rhinitis, and hand and contact dermatitis in adolescents. Br J Dermatol 2001; 144 (3): 523-32 IV Schultz-Larsen F, Hanifin JM. Epidemiology of Atopic Dermatitis. Immunol Allergy Clin North Am 2002; 22: 1-24 V Ellis CN, Drake LA, Prendergast MM. Cost of Atopic Dermatitis and eczema in the United States. J Am Acad Dermatol 2002; 46 (3): 361-70 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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