4th Apr 2005 07:00
Sinclair Pharma PLC04 April 2005 SINCLAIR PHARMA PLC RECEIVES EU APPROVAL FOR SEBCLAIRTM Godalming, 4 April 2005: Sinclair Pharma plc ("Sinclair" or the "Company")(SPH.L), the specialty pharmaceutical company, announces that Sebclair(TM) hasreceived EU approval as a Class 2a medical device allowing it to be sold OTC oron prescription in the EU. It is estimated that Sebclair addresses a market worth more than $500 million.SebclairTM cream is indicated for the management of seborrheic dermatitis,including relief and management of the most common signs and symptoms such asscaling/flaking, erythema (reddening), burning and pain. Sebclair(TM) is designed to moisturise and reduce the affected areas of skin. It has been classified as a Medical Device. Seborrheic dermatitis is a common skin condition characterised by red, flakyskin. It is estimated to occur in 3-5% of the general population (i). It iscommon in young adult men (iv), and the under-5s, where it may manifest as 'cradle cap' (ii). Topical corticosteroids are commonly used for seborrheic dermatitis, howevertheir side-effects are unwelcome, particularly on facial skin where thiscondition is very common. Sebclair(TM) offers the benefit of being steroid-freeand thus being useable on the face without concern and not carrying any of thewell known side effects of topical steroids. Sinclair also reports that it has now received the US $500,000 milestone paymentdue from its Gelclair agreement with OSI on issuance of the patent for Gelclairin the US. Commenting Dr Michael Flynn, CEO of Sinclair said: "With this Sebclair(TM)approval, Sinclair now has 12 of its own products approved in the EU. Followingthe recent acquisition of Euroderm and its derma oriented sales force in Italy,Sinclair plans to launch the product in Italy in the next financial year andwill commence licensing discussions with potential distribution partners inother EU territories. We believe the absence of topical steroids in this productis an important commercial benefit which should be reflected in its marketacceptance." Contact details: Sinclair Pharma plcDr Michael Flynn, CEO Tel: +44 (0) 1483 426 644Jerry Randall ACA, CFOJohn Barrington-Carver, Corp. PR Tel: Mobile +44 (0) 7831 655 630 Financial DynamicsBen Atwell / Lucy Briggs Tel +44 (0) 207 831 3113 Notes to Editors Sinclair Pharma 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 Sebhorrheic dermatitis Seborrheic dermatitis is a common dermatological condition that affects areas ofthe body with a particularly high concentration of sebaceous glands. This mayinclude the eyebrows, bridge of the nose, naso-labial folds, ears and chest. Itmanifests as erythema (reddening), which progresses to flakiness and at its mostsevere, crusting of the skin. Seborrheic dermatitis of the scalp is alsoparticularly common, and commonly referred to as dandruff. There may be a combination of causes of seborrheic dermatitis. Anoverproduction of sebum from the sebaceous glands is likely. In addition, thepresence of topical organisms such as the Malassezia and Pityrosporum yeasts mayexacerbate the condition. Seborrheic dermatitis also often appears as cradle cap in infants of around sixmonths. It usually clears by 18 months but can be a persistent problem duringthis time. After infancy, the condition is most common in middle age or olderpeople. It is associated with a poor diet and obesity, HIV and neurologicalconditions such as Parkinson's disease. At present there are various approaches to the management of seborrheicdermatitis but there is no 'gold-standard' product. Many of these focus on thepotential presence of fungal or other organisms on the surface of the skin, andtopical corticosteroids are also frequently employed (iii). Although topicalcorticosteroids are commonly used, they are also disliked, as these drugs maycause atrophy of the skin and is usually restricted to shorter periods of time,particularly on facial skin (iv). Emollients, lithium-based and salicylicacid-based creams are considered to improve the condition. As seborrheic dermatitis is particularly common on the face, there is a specificdesire for a product that is steroid-free. Therefore an effective non-steroidalproduct for a facial condition should be welcomed by the market. i Johnson M- LT, Roberts J Prevalence of dermatological diseases among persons 1- 74 years of age. Washington DC: US Department of Health Education, national Centre for Health Statistics, 1978: PHS 79- 1660 ii Foley P, Zuo Y, Plunkett A et al. The frequency of common skin conditions in preschool-aged children in Australia: seborrheic dermatitis and pityriasis capitis. Arch Dermatol 2003 Mar;139(3):318-22 iii Tofte SJ, Hanifin JM. Current Management and therapy of atopic dermatitis. J Am Acad Dermatol 2001; 44 (Suppl): S13-16 iv Dreno B, Chosidow O, Revuz J et al. Lithium gluconate 8% vs. ketonazole 2% in the treatment of seborrheic dermatitis: a multicentre, randomized study. Br J Dermatol 2003; 148: 1230-1236 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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