13th Mar 2006 07:03
Sinclair Pharma PLC13 March 2006 SINCLAIR PHARMA PLC SALES FORCE PROMOTING ATOPICLAIRTM IN USA EXPANDED AND SINCLAIR ACQUIRES NEW PRODUCT IP FOR ONYCHOMYCOSIS Godalming, 13 March 2006: Sinclair Pharma plc ("Sinclair" or the "Company"), therapidly growing specialty pharmaceutical company, today announces that its USAtopiclairTM licensee Chester Valley Pharmaceuticals Inc ("CVP") has enlargedits sales force to sell AtopiclairTM, Sinclair's product for the treatment ofatopic and contact dermatitis. CVP has also entered into a US marketingco-operation agreement with Lupin Pharmaceutical Inc ("Lupin") to target thepaediatric atopic dermatitis market. Sinclair announces today that it has also in-licensed from a US inventor, DrMark Bogart, the rights to patents for a new product to treat onychomycosis, atreatment refractory chronic fungal infection that causes the toenails tothicken, discolour, disfigure, and split. AtopiclairTM CVP Inc launched AtopiclairTM in June 2005. They have now increased their salesforce from 28 to 40 sales representatives and entered a marketing co-operationagreement with Lupin, whose 41 strong sales force started promotion ofAtopiclairTM to paediatricians and some general practitioners on 6 March. BothLupin and CVP are planning to further increase the size of their sales forcesduring 2006. Dr. Michael Flynn, CEO of Sinclair said: " We believe that AtopiclairTM, aneffective steroid-free product for relieving the symptoms of atopic dermatitis,will find rapid acceptance amongst dermatologists, paediatricians and parents asa safer alternative to steroids and topical immuno modulating agents whichtogether comprise a major part of the market for this disease. Data fromclinical trials convincingly demonstrates that AtopiclairTM is effective inreducing the itch, the severity and the extent of atopic dermatitis and apositive double blind multicentre trial carried out in the US has been publishedthis month. US sales of Atopiclair are increasing steadily and we are verypleased that CVP have entered these arrangements to more than double the salesteam promoting AtopiclairTM which increases its interface with dermatologistsand its access to paediatricians." Bob Moccia, CEO of CVP commented: "Market feedback on AtopiclairTM hasencouraged us not only to expand our own sales force, but also to exploit thepotential of this product by entering this marketing co-operation agreement withLupin Pharmaceuticals Inc. Their 41 strong and experienced workforce startedselling AtopiclairTM this week and will expand our coverage into the paediatricmarket in the US. We believe that since Atopiclair contains no corticosteroidsand the fact that two main competitive products have recently received "BlackBox" notices from the FDA, Lupin's sales force will achieve significantpenetration in the paediatric market." Onychomycosis Sinclair also today announced it has licensed the rights from Dr Mark Bogart, aUS inventor, to develop and commercialise a new topical product to treat fungalinfections of the nails - usually the toenails. The patents claim a method oftreating onychomycosis using compositions consisting of carboxylic acids andalcohols. The IP includes a granted US patent and corresponding applications inEurope, Japan, Australia, and Canada. Onychomycosis is difficult to treat and clinical clearance of the disease ispoor with current treatments. The nails of people with onychomycosis areinitially a cosmetic concern. Without treatment, however, the nails can becomethick and disfigured. The product to be developed acts predominantly bydehydrating the environment surrounding the causative fungal infection. Thepreparation is applied topically and penetrates nails readily. The organisms that usually cause onychomycosis are Trichophyton rubrum andTrichophyton mentagrophytes. They are dermatophytes (fungi that infect hair,skin, and nails) and feed on keratinized (nail) tissue. The infections theycause are normally confined to the nails, but occasionally spread to thesurrounding skin. Preclinical studies have shown that the product kills the maincausative agent T. rubrum on contact. Dr Michael Flynn, CEO of Sinclair commented: "Sinclair has been evaluating andtesting this promising dermatological product for more than a year and arepleased that we have now secured the rights to commercialise it. It sits wellin our area of niche dermatological products and addresses a significant andcommon medical condition. The yet to be named product joins an already robustpipeline of products which we expect to commercialise over the next severalyears." Market data ATOPIC DERMATITIS. Atopic dermatitis is one of the most common dermatological complaints andaccounts for a large number of physician consultations. It is known fromindependent studies to affect approximately 20% of school-aged children.Independent studies also suggest that the prevalence in adults is 1-3%. The sector of the dermatology market in which AtopioclairTM competes was worthUS$1.9 billion in 2004 having grown in the previous year by 11%. ONYCHOMYCOSIS. Rates of onychomycosis vary with the population considered. A recent study5 in ageneral U.S. population revealed a prevalence of 2 to 3%, in the UK 2-4% ofadults suffer from onychomycosis1-4. Patients with diabetes commonly developonychomycosis because blood circulation is poor in the extremities, and thebody's ability to fight infections is compromised. Small cuts, infections, andfoot injuries can have serious consequences for diabetics. Recent studies6 haveshown a higher rate of amputation in diabetics with onychomycosis compared tothose without the infection. Treatments currently available are either systemic which can have unwelcome sideeffects or topical. The combined systemic and topical US market in 2003 wasUS$1,068 million of which US$900 million was for prescription systemic products. Contacts: Sinclair Pharma plc Tel: 01483 426644Dr Michael Flynn, Chief Executive OfficerJerry Randall ACA, Chief Financial Officer Financial Dynamics Tel: 020 7831 3113Ben Atwell / John Gilbert References 1. Roberts DT. Prevalence of dermatophyte onychomycosis in the United Kingdom:results of an omnibus survey. Br J Dermatol. 1992;126(suppl 39):23-27. 2. Sais G, Juggla A, Peyri J. Prevalence of dermatophyte onychomycosis in Spain:a cross-sectional study. Br J Dermatol. 1995;132:758-761. 3. Editorial. Prevalence, morbidity and cost of dermatological diseases. JInvest Dermatol. 1979;73:395-401. 4. Heikkila H, Stubb S. The prevalence of onychomycosis in Finland. Br JDermatol. 1995;133:699-703. 5. Elewski B E, Charif M A. Prevalence of onychomycosis in patients attending adermatology clinic in northeastern Ohio for other conditions. Arch Dermatol.1997;133:1172-1173. . (Letter.). 6. Gupta, A.J., N. Konnikov, P. MacDonald, P.Rich, N.W. Rodger, M.W. Edmonds, R.McManus, and R.G. Summerbell; 1998 Prevalence and epidemiology of toenailonychomycosis in diabetic subjects: A multicentre Study: Br. J. Dermatol 139:665-71 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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