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Release issued 25th April 2005
Godalming UK, 25 April, 2005: Sinclair Pharma plc ("Sinclair" or the "Company") (SPH.L), the specialty pharmaceutical company focused on the acquisition and development of niche patented pharmaceutical products, today announces three new licensing agreements, two for Atopiclair and the extension of an existing agreement for Aloclair® Rinse to include Aloclair® Spray.
Aloclair® Spray Sinclair has already concluded a 10 year exclusive Aloclair® Rinse distribution agreement in the UK & Republic of Ireland with Forest Laboratories UK Ltd. ("Forest"). Forest has now extended its Aloclair® licensing agreement to include Aloclair® Spray. Forest is a subsidiary of Forest Laboratories Inc. of New York USA Forest develops, manufactures and sells both branded ethical products and non-prescription healthcare products sold over-the-counter (OTC). The HealthCare Division has a number of products in its portfolio, many of which are household names, and Aloclair® Rinse is already available without prescription from pharmacies, including Boots and Superdrug in the UK and Eire. In a recent announcement, The Dental Health Foundation's independent panel of international experts concluded that Aloclair® Rinse fully meets its claims of being soothing, pain relieving, hygienic and easy to use, and that it has a safe and clinically proven formula. The DHF concluded that Aloclair®'s barrier forming agent, PVP, is designed to form a protective coating over the ulcer. This results in fast pain relief without stinging and also provides protection against the irritation of food and drink. A 2001 study by Taylor Nelson Sofres estimated that one in five people in the UK suffer from painful mouth ulcers and the probability is slightly higher if you are a woman.
Atopiclair Sinclair has concluded a 10 year exclusive Atopiclair distribution agreement in Israel with Rafa Laboratories Ltd., ("Rafa"), a long established Israeli pharma company with a major commitment to dermatology.
Sinclair has also concluded a ten year agreement in Indonesia with a leading pharma company Dankos Laboratories Indonesia, which is part of Kalbe Pharma. Kalbe Pharma is regarded as one of the largest Pharma companies in Indonesia. Dankos has turnover of 96 million Euros, and controls 16.7% share of the Indonesian OTC market and 2.6% of the ethical market.
Atopiclair is a non-steroidal cream indicated for relief and management of the itching, burning and pain that patients experience with atopic dermatitis (AD) and allergic contact dermatitis (ACD). It is already approved in both the US and the EU, and was the first prescription medical device authorised by the US FDA to relieve the symptoms of AD and ACD. Atopic dermatitis (also known as eczema) is a chronic inflammatory disease that often has its onset in childhood. Sources such as the American Medical Association and the New England Journal of Medicine cite paediatric rates of AD in Western countries at up to 20%.
Dr Michael Flynn, CEO of Sinclair, commented:
"The extension of Forest's existing agreement for Aloclair® Rinse to include Aloclair® Spray follows the similar agreement extensions in Europe in 20 European Countries and the US by Sunstar Butler for Spray and also for Gel. Existing separate agreements for Aloclair® Rinse in Italy and Hungary have also recently been extended to include the Spray Aloclair® product. We believe that our distributors having tested their markets, now recognise the potential for our Aloclair® family of Rinse, Spray and Gel to expand the product's use to cover treatment of large single ulcers and also for paediatric use as well as the handy spray application at any time. Aloclair® continues to be our a major contributor of revenues.
Atopiclair is an important product for Sinclair in dermatology. It was licensed in the important US market last December. Outside of the US, these marketing licenses are the second and third Atopiclair agreements we have made and we are looking forward to further agreement progress in the EU and elsewhere."
Sinclair Pharma plc Dr Michael Flynn, CEO Tel: 01483 426 644 John Barrington-Carver (Media Enquiries) Tel: 07831 655 630
Financial Dynamics Ben Atwell / Lucy Briggs Tel +44 (0) 207 831 3113
Notes to editors: Sinclair Pharma plc Sinclair Pharma plc based in Godalming in the UK, is quoted on the Alternative Investment Market (AIM) on the London Stock Exchange and has focused on the acquisition and development of niche patented pharmaceutical products in the fields of oral health, oncology support and dermatology, and bringing them to the international market place via out- licensing partners. The Company combines product evaluation, product development, regulatory and business development expertise to add value to its acquired and in- house developed products. A key element of the Sinclair business model is to minimise risk and exposure by avoiding involvement in lengthy R&D programmes and rapidly achieving global distribution through a network of marketing partners. The Company has already licensed its products for distribution in over 40 countries around the world.
In December 2004 Sinclair licensed Atopiclair to Chester Valley Pharmaceuticals in the US and in February this year the Company announced it had concluded it first EU distribution agreement for Atopiclair having licensed it to the Portuguese company Dysonovis.
Aloclair® Ulcer Incidence YNS Omnibus Surveys 2001 and 2003 Mouth ulcers are common particularly in children, women and the over-65. The causes of mouth ulcers are generally unknown but contributing factors may include stress, vitamin deficiencies and minor oral injuries. Mouth ulcers are painful because a layer of the oral mucosa has been removed, exposing the nerve endings beneath. Mouth ulcers may cause difficulties in eating, drinking and even speaking. Children find mouth ulcers particularly painful and distressing.
Clinicians estimate that recurrent mouth ulcers affect up to 20 per cent. of the general population. Specific UK market research found that 1 per cent. of adults "seem to permanently have mouth ulcers", 15 per cent. have frequent ulcers and a further 12 per cent. experience ulcers rarely. In addition, the under 16s experience frequent ulcers, accounting for approximately 5 million cases annually in Great Britain alone.
====================== "Safe Harbor" Statement under the US Private Securities Litigation Reform Act of 1995: Some or all of the statements in this document that relate to future plans, expectations, events, performances and the like are forward-looking statements, as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward- looking statements due to a variety of factors.
If you want to find out more about the company visit Sinclair Pharmaceuticals profile.
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