15th Jun 2006 07:08
Sinclair Pharma PLC15 June 2006 SINCLAIR PHARMA PLC RESEARCH & DEVELOPMENT UPDATE Godalming UK, 15 June 2006: Sinclair Pharma plc ("Sinclair" or the "Company")(SPH.L), the specialty pharmaceutical company, will today host a Research &Development update for analysts and investors. The briefing will focus on theCompany's pipeline, products and R&D strategy. Dr Michael Flynn, CEO of Sinclair said: "Sinclair has developed an innovative and unique approach to R&D which hasallowed us to record exceptionally strong clinical progress over the last fewyears. We have a powerful portfolio which will increasingly be marketed throughour own growing specialist salesforces. "We are pleased to say that the integration of CS Dermatologie is proceedingwell and we are also satisfied with progress on licensing discussions forDecapinol in the US market. Negotiations are at an advanced stage and we hopeto be in a position to be able to make an announcement in the near future. "Today we are highlighting the next generation of Sinclair's products, bothnovel products and line extensions. We are confident that these will all befiled with the regulators in the coming three years. We also note the commentsbeing made today by leading independent experts about the potential for ourproducts in their respective markets." Ahead of today's meeting, Sinclair provides the following update on progresssince the Company's interim results in March 2006. Significant progress hasbeen made with both our pipeline and our products. PIPELINE PROGRESS Sinclair has made exceptionally strong progress over the last few years inprogressing its products from the clinic to the market. Today, Sinclair willreveal more details about its unique approach to R&D and its pipeline of newproducts. • New product pipeline - Sinclair has continued to source and develop novel technologies with clearly differentiated characteristics and strong intellectual property that can be brought to the market within a three year time frame. The following products in development will be discussed today and more details can be found in the notes to editors: • SPD 420 - Acne topical treatment • SPHR 900 - Herpes Simplex • SPHP 700 - Dry eye syndrome • SPHD 400 - Psoriasis • SPHR 920 - Onychomycosis Sinclair also has a broad pipeline of other products in development. • Line extensions - It remains Sinclair's strategy to continue to develop line extensions for its key products, which also have clearly differentiated features to currently available treatments. Sinclair is today announcing the following new line extensions, which are in addition to others previously disclosed: • AtopiclairTM foam for the treatment of atopic dermatitis • SebclairTM foam, shampoo and non steroidal medicated cream, for seborrheic dermatitis • DermaChronicTM intensive face cream for chronic skin conditions • Decapinol(R) New Flavour and OD (Once Daily) for the treatment and prevention of gingivitis and plaque • Aloclair(R) for teething (paediatric product) In today's R&D update, Professor Rolf Attstrom, Director of Educational Researchand Technology, University of Malmo, said of Decapinol(R): "Decapinol(R) is a huge leap forward for oral health and has the potential toradically change the gingivitis market. Whilst traditional mouthwashes aim tokill all oral bacteria, Decapinol(R) is more selective and preserves 'goodbacteria' leading to a healthier ecology in the mouth. Importantly, we havealso seen a reduction of chlorhexidine staining when brushing with Decapinol(R).We now have a tool that will help to improve gum health in a more intelligentway." PRODUCT PROGRESS With its portfolio of marketed products, Sinclair has made good progress withadditional registrations and license agreements. • Product Registrations: • Decapinol(R) Toothpaste and Gel - have been filed with the FDA for line extensions of DecapinolTM Rinse • AtopiclairTM Lotion - a new line extension of AtopiclairTM is now approved for sale in the US and has been licensed to Chester Valley Pharmaceuticals • AtopiclairTM has received registration approval as a medical device for the treatment of atopic dermatitis, from the Indonesian authorities • SebclairTM FDA 510(k) application is pending, and the Company anticipates approval in H1 2007 • Licensing Agreements: Sinclair has struck five new licensing agreements, covering 18 countries, sincethe Interim results in March 2006. These are: • Aloclair(R) Gel in USA: the agreement with Sunstar Butler for the distribution of Aloclair(R) Rinse (Rincinol) has been extended to include Aloclair(R) Gel • AtopiclairTM: agreements have been signed in Turkey (with Farmatec) and Saudi Arabia, Algeria and 13 Middle Eastern countries (with Tabuk Pharma) • XclairTM has been licensed in Spain to Pharmis • Decapinol(R) Toothpaste has been licensed in Israel to Kivema Ltd • Clinical Progress: AtopiclairTM and SebclairTM Trials Our US, multicentre, randomised controlled study of AtopiclairTM in infants andchildren has completed and is in statistical analysis. Results will be presentedin the coming weeks. Professor Ruggero Caputo, Professor & Chairman, Institute of DermatologicalSciences, University of Milan will today present the full results of themulticentre, randomised, controlled trial of SebclairTM in the USA and Italy(details are provided in the notes to editors). The study concludes that SebclairTM is effective in the treatment of mild tomoderate sebhorreic dermatitis (SD) of the face and that its use in combinationwith topical or oral antimycotics might also be considered. In respect of today's R&D update, Professor Ruggero Caputo commented: "The results from this randomised trial demonstrate very clearly that SebclairTMCream is very effective in the treatment of mild to moderate sebhorreicdermatitis of the face. Since SebclairTM is the first non-steroidal product,specifically targeting a common and often very visible disease, I believe thatit will be actively welcomed as an alternative steroid-free treatment to thisoften embarrassing skin condition." PRODUCT LAUNCHES: Sinclair products continue to be launched worldwide, with marketing partners inplace for 61 countries. The following new products have been launched bySinclair's own salesforce in recent weeks: • SebclairTM has been launched in Italy • AtopiclairTM Lotion has been approved for sale in the EU and has been launched in Italy • DermaChronicTM, one of the Sinclair proprietary pipeline products revealed in June last year, is now approved for sale in the EU and has been launched in Italy (see notes to editors) • Mela'AuraTM is the first new product launched in France by CS Dermatologie since completion of the acquisition by Sinclair. Mela'AuraTM face cream is a line extension of CS Dermatologie's Mela'AuraTM derma-cosmetic range specifically developed in a pharmaceutical laboratory to address problems in coloured skins including dehydration, discolouration and un-aesthetic marking such as blotches and 'scaling.' ENDS For further information, please contact: Sinclair Pharma plcDr Michael Flynn, CEO +44 (0) 1483 426 644Jerry Randall, CFOJohn Barrington-Carver, Corp. PR +44 (0) 7831 655 630 Financial DynamicsBen Atwell +44 (0) 207 831 3113John Gilbert For further information on the R&D briefing taking place at 11am today please contact Mo Noonan at Financial Dynamics on 020 7831 3113. NOTES TO EDITORS 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 and its own salesforce in selected markets. The Company combines product evaluation, productdevelopment, regulatory and business development expertise to add value to itsacquired and in-house developed products. A key element of the Sinclair businessmodel is to minimise risk and exposure by avoiding involvement in lengthy R&Dprogrammes and rapidly achieving global distribution through a network ofmarketing partners. The Company has already licensed its products fordistribution in over 60 countries around the world. www.sinclairpharma.com SPHD400 for the treatment of psoriasis A proprietary combination discovered in house which addresses the underlyingbiochemical processes responsible for the hyperproliferation of the skin and theinflammation which are key features of this distressing condition. This productis in early clinical development with target for registration filing in 2008 SPHD420 for the treatment of acne Acne is a troublesome condition which blights the lives and damages theselfconfidence of thousand of young people. There are several distinct featuresof the disease. SPHD420 uses a multifaceted approach to the key problems of acneand is designed to break up the protective "envelope" (biofilm) in which theresponsible bacteria are usually protected from the action of antibiotics andthen delivers a naturally derived antibacterial combination to kill theorganisms. This product is in pre-clinical development with a target forregistration filing in 2008-9 SPHR 900 for the treatment of herpes simplex (cold sores) This product is designed to simultaneously kill the herpes virus with a potentnaturally occurring anti-viral agent, dry up the lesion using an anhydrous "gel"and reduce the surrounding inflammation. Unlike existing products it is designedto simultaneously treat the symptoms and suppress the responsible virus. It isin pre-clinical testing with a target for registration filing in 2008 -9 SPHP 700 for the treatment of dry eye syndrome Impairment of the quality or quantity of tears production leads to a conditioncalled dry eye syndrome which afflicts about10 million people in America andalmost 10% of women over the age of 75. The key feature is a constant feelingof "grittiness" in the eyes. It is commonly treated with artificial tears.There is a need for a rapid onset, long acting product for this condition. SPHP700 uses a natural polysaccharide combined with a polymer to provide prolongedwetting and lubrication to achieve this goal. It is in clinical testing with atarget for registration filing in 2007. SPHR 920 for the treatment of onychomycosis Fungus infections of the toenails (onychomycosis) occur in of the populationand current treatments are unsatisfactory because of low efficacy or seriousside-effects. Sinclair recently acquired an exclusive licence for theintellectual property for a novel method of treating this condition. Researchstudies showing the ability of the product to penetrate the nails and rapidlykill the responsible organisms. First observations in humans leads the companyto anticipate that clinical trials will demonstrate significant therapeuticactivity. The product is in early human testing with a target for registrationfiling in 2008 - 9 DermaChronicTM DermaChronicTM is hypoallergenic, preservative and perfume free, and istherefore appropriate for long term use for patients with sensitive skin orother skin conditions. Tests in subjects showed no allergic or sensitivityresponses. DermaChronicTM is an emollient to moisturise, soothe and soften theskin where the skin is cracked and hardened due to a chronic skin condition. Itis indicated to be used during periods of remission in chronic pathologies suchas psoriasis, atopic, seborrheic and contact dermatitis and dermatosesgenerally. Sebclair trial results Sixty patients (35 from the US and 25 from Italy) were enrolled and randomisedto receive SebclairTM (40) or a vehicle control (emollient) (20). 51 patients(85%) completed the study. The primary endpoint was physcian's Global Assessment, with a final grading of 'clear' or 'almost clear' being defined as a treatment success. With comparablelevels of disease in the two study groups at entry, the proportion of patientsachieving successful treatment after 28 days in the SebclairTM group was 68% (27/40 patients) compared with 11% in the vehicle control group (2/18 patients).Furthermore, the effects of SebclairTM were better than those of the vehiclecontrol group in the secondary endpoints (investigators' assessment of erythemaand desquamation) and patients' assessment of burning/stinging and pruritus. Patients reported a better global response to Sebclair than to the vehicle at 14days and 28 days. 28 patients out of 40 judged SebclairTM to be more effectivethan their usual treatment, in contrast to only 2 out of 18 patients in thevehicle control group. Twenty patient randomised to SebclairTM also describedthemselves as "much happier/much more satisfied" with the condition of theirskin at the end of he study with a further 15 saying they were "happier/moresatisfied". The study concludes that SebclairTM is effective in the treatment of mild tomoderate SD of the face and that its use in combination with topical or oralantimycotics might also be considered. "Safe Harbor" Statement under the US Private Securities Litigation Reform Act of1995: Some or all of the statements in this document that relate to futureplans, expectations, events, performances and the like are forward-lookingstatements, as defined in the US Private Securities Litigation Reform Act of1995. Actual results of events could differ materially from those described inthe forward- looking statements due to a variety of factors. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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