2nd Nov 2006 07:00
Sinclair Pharma PLC02 November 2006 Sinclair Pharma plc Announces US Registration of SebclairTM for Treatment of Seborrheic Dermatitis and Canadian registration of oncology support products Xclair and SST 2 November 2006, Godalming: Sinclair Pharma plc (SPH.L), the specialtypharmaceutical company, today announces that SebclairTM, its product forseborrheic dermatitis, has been cleared for marketing by the US Food and DrugAdministration (FDA). SebclairTM will be sold on prescription in the US. Seborrheic Dermatitis (SD) is a common and visible condition characterized byflaky, red skin. It is most common in men and may be present in 5% of the adultpopulation (i). It usually affects areas of the skin with high oil production,such as the nose, eyebrows, ears and chest. SebclairTM is the first topical non-steroidal product cleared for marketing inthe US through 510k registration, that can also specifically claim reduction oferythema (redness) as a symptom of SD. This is significant because theappearance of SD can make patients self-conscious and distressed and leads tothem seeking treatment, when the reduction of redness and flaking is animportant goal. SD is often treated with topical corticosteroids, however thereare reservations about the use of steroids on the face. As SD is particularlycommon on the face, there is a specific need for a product that is steroid-free. Earlier this year, Sinclair announced the results of a US and European,randomized, double-blind study that compared SebclairTM with an emollient cream.In this study, after 28 days, 68% of patients receiving SebclairTM were 'clear' or 'almost clear' of SD of the face, compared to 11% of patients usingthe emollient cream. Professor Stefano Veraldi of the Institute of Dermatological Sciences, Milan,Italy, the lead investigator of that trial commented: "Our study showed that SebclairTM is effective in reducing the appearance andsymptoms of seborrheic dermatitis. The condition is very visible and oftenaffects the self esteem of patients and we welcome a steroid-free treatment forseborrheic dermatitis." Sinclair's marketing partner for SebclairTM in the US is Chester ValleyPharmaceuticals (CVP). CVP is already achieving growing sales for AtopiclairTM,Sinclair's atopic dermatitis product. AtopiclairTM, like Sebclair, isclassified by the FDA as a medical device and has been cleared for marketing byreceiving 510(k) approval. In Europe, SebclairTM is approved as a Class 2amedical device and has already been launched in Italy by Sinclair's own salesteam. The seborrheic dermatitis market is worth an estimated US$272 million inthe US and a further US$150.9 million combining the UK, French, German andJapanese markets (ii). Bob Moccia, CEO of CVP, said: "With this registration, we now look forward to launching SebclairTM to the USdermatology community. SebclairTM meets a clear market need, and based on thecompelling results of the pivotal clinical study we anticipate that it will bewelcomed by physicians and their patients." Dr Michael Flynn, CEO of Sinclair Pharma, commented: "The registration of SebclairTM in the US is a very important step towardsestablishing a steroid free product range to effectively treat skin conditionswhich are at present often treated with corticosteroids. The proveneffectiveness and registration of SebclairTM provides an alternative, andimportantly steroid-free, first line treatment in the US for this distressingcondition. As with our products AtopiclairTM and DecapinolTM we are verypleased to have achieved another first in class registration in the US.SebclairTM is already sold by our own sales force in Italy and we expect furthersales boosts as it is launched in other EU countries and the US during the next12 months." Sinclair also announces that both XclairTM, its product for radiationdermatitis, and SSTTM, its product for xerostomia (dry mouth), have receivedregulatory approval in Canada. Enquiries: Financial Dynamics Tel: +44 20 7831 3113Ben Atwell/John Gilbert Sinclair Pharma plc Tel: +44 1483 410 600Zoe McDougall John Barrington-CarverSinclair US Mike Killeen Tel +1 972 478 4380 Notes to editors: Seborrheic dermatitis Seborrheic dermatitis is a common skin condition that affects areas of the bodywith a particularly high concentration of sebaceous glands. This may includethe 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 in its mildest form may be referred to as dandruff;SebclairTM cream addresses the skin; a shampoo is in development to address thescalp sector of the market. 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 may also be associated with a poor diet and obesity, HIV andneurological conditions 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 the treatmentsfocus on the potential presence of fungi or other organisms on the surface ofthe skin, and topical corticosteroids are also frequently employed (iii).Although topical corticosteroids are commonly used, they are also disliked, asthese drugs may cause atrophy of the skin and are usually restricted to shorttreatment periods, particularly on facial skin (iv). Emollients, lithium-basedand salicylic acid-based creams are considered to improve the condition. Other seborrheic dermatitis treatments Seborrheic dermatitis is frequently treated with topical corticosteroids.However, this group of drugs may have unfavourable side effects, especially whenused long-term or on sensitive areas of skin such as the face, hands, or onchildren. These effects vary from mild and reversible thinning, to irreversibletelangiectasiae (fine blood vessels becoming visible at the surface of the skin)and striae distensae (marks similar in appearance to 'stretch marks').Steroids' effectiveness may also become less effective with continued use, whichmay lead to the escalation to a more potent steroid (v). There may also be arisk of growth suppression and adrenal suppression in children with the use oftopical steroids(vi). SebclairTM does not contain corticosteroids. There are also other therapeutic agents that may be used in SD; these includetopical antifungal agents, sulfur-sulfacetamide combinations, sulfacetamide,zinc pyrithione and selenium sulfide. Sinclair Pharma plc Sinclair Pharma plc is an international specialty pharmaceutical company. Ithas a growing sales and marketing operation that is already present in France,Italy, the UK, Spain and Portugal, and a complementary marketing partner networkthat spans 60 countries. Sinclair has proven expertise in acquiring or developing commercially attractiveand undervalued products, registering these products and bringing them to marketwithin a short time frame. The company focuses on niche therapeutic areas andits current portfolio includes products for dermatological conditions and oralhealth. Chester Valley Pharmaceuticals, Inc. Based in Malvern, Pennsylvania, Chester Valley Pharmaceuticals is a specialtydermatology company focused on acquiring, in-licensing, and developing brandedprescription dermatological products for sale in the United States. (i) Pirkhammer D et al, Brit Journal Dermatology 2000, 143 (5), 964-968 (ii) Euromonitor report 2005 (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 (v) Atherton DJ, BMJ. Topical Corticosteroids in atopic dermatitis. 2003;327:942-943 (vi) Siklar Z, Bostanci I, Atli O, Dallar Y. Pediatr Dermatol. 2004 Sep-Oct;21(5):561-3 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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