Press release
direct/ SINCLAIR PHARMA PLC. (UK) - Sinclair Pharma Plc licenses US rights for lead product Decapinol®
Godalming UK, 29 June 2006: Sinclair Pharma plc ("Sinclair"), the specialty pharmaceutical company, announces that it has licensed the exclusive US rights of one of its key products, Decapinol® Rinse, to OraPharma, Inc., a subsidiary of Johnson & Johnson.Under the terms of the deal announced today, Sinclair will supply Decapinol® Rinse to OraPharma, who will be responsible for the marketing and distribution of the product in the United States market. OraPharma will have the exclusive rights to promote Decapinol to dentists´ offices for Rx sales. Sinclair will receive up-front and milestone payments, and a margin on product sales. Sales are expected to commence within the next 12 months.
Decapinol® received marketing clearance from the US Food and Drug Administration (FDA) in 2005 as a prescription product. It has also received approval in the EU where the oral rinse presentation of Decapinol® was recently launched in Italy and Spain by Sinclair´s distributors.
Sinclair believes that Decapinol® is the first new product class to enter the gingivitis market for several decades. It is an award-winning, patented product with a new mode of action for the treatment of gingivitis (gum inflammation) and dental plaque, and for the prevention of periodontitis (a severe form of gum disease causing tooth loss).
With approximately 80 per cent of the adult population in the US estimated to have some degree of gum inflammation, Decapinol® oral rinse addresses a large and growing market in the US currently exceeding $600 million[1]. Sinclair is developing a number of new products and line extensions incorporating Decapinol®.
Dr Michael Flynn, CEO of Sinclair Pharma, said:
"We are very pleased that OraPharma will market our lead product. With a respected presence in oral health, we believe there is no better company to take Decapinol® to the US market. We are confident that OraPharma will establish Decapinol® as a successful new brand in the US."
Professor Rolf Attstrom, a leading independent expert on oral health and Director of Educational Research and Technology, University of Malmo, Sweden, said of Decapinol®:
"Decapinol® is a huge leap forward for oral health and has the potential to radically change the gingivitis market. Whilst traditional mouthwashes aim to kill all oral bacteria, Decapinol® removes rather than kills bacteria. It is also more selective and preserves ´good bacteria´, leading to a healthier ecology in the mouth. We now have a tool that will help to improve gum health in a more intelligent way."
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A conference call for analysts will be held at 8.15am today, please call Mo Noonan on +44 (0) 207 269 7116 for further details.
[1] "Anti-gingivitis markets", a summary of the gingivitis market. Datamonitor, October 2004
Notes to Editors:
About Decapinol®
Gingivitis is an inflammation of the gum surrounding the teeth. Periodontitis is a more advanced and severe condition that may result in bone or tooth loss. Both conditions are associated with dental plaque bacteria.
Current treatment of gingivitis may involve the use of an oral rinse, alongside ´scaling and planing´ (mechanical cleaning of the teeth by a dental professional).
Decapinol® has a new mechanism of action that offers an ´intelligent´ way to treat gingivitis. It acts at the interface between dental plaque bacteria and the surface of the tooth/gum - the starting point for all gingivitis. Decapinol® prevents the bacteria that cause gingivitis from adhering to these surfaces and to one another. This adhesion is essential for the bacteria to cause the disease and if it is prevented it allows the desirable bacteria responsible for maintaining a healthy mouth to dominate again. This softens dental plaque, making it easier to remove, and prevents its re-formation. It therefore promotes better gum health and clinical studies have shown that Decapinol® significantly reduces gingivitis.
Decapinol® has advantages over existing products, which may cause semi-permanent tooth staining or have high alcohol content. While other leading products work by killing oral bacteria indiscriminately, Decapinol® specifically targets the ´bad´ bacteria associated with gum disease. Decapinol® therefore promotes a healthy balance of oral bacteria.
Decapinol® is already cleared for sale in the USA by the FDA, as a prescription product. It is also approved in the EC and Decapinol® has already been launched in Italy and Spain.
In March 2006, Decapinol® Oral Rinse was awarded the 2006 Oral and Dental Care Product of the Year by Frost & Sullivan in the US.
About Sinclair Pharma Plc www.sinclairpharma.com
Sinclair Pharma Plc, based in Godalming in the UK, is an international specialty pharmaceutical company focused on the sourcing and development, registration and subsequent commercialisation of those products. Sinclair currently focuses on oral health and dermatology and is expanding into eye care.
Sinclair has a global distribution network in more than 60 countries and is currently developing its own sales and marketing network.
Sinclair Pharma plc is quoted on the Alternative Investment Market (AIM) on the London Stock Exchange.
The Sinclair Portfolio in the US
Decapinol® will add to the portfolio of Sinclair oral health products that are sold in the USA. Rincinol Rinse & Gel (for mouth ulcers - sold as Aloclair® in non-US markets) is currently marketed by Sunstar Butler in the US and several other countries worldwide. Align Pharmaceuticals recently launched Numoisyn lozenges and liquid (sold as SST(TM) and Salinum(TM) in non-US markets) for xerostomia (dry mouth). Xclair(TM) Sinclair´s product for radiation dermatitis is also licensed to Align Pharmaceuticals. Chester Valley Pharmaceuticals (CVP) is licensed to market Atopiclair® and Sebclair(TM) (for atopic and seborrheic dermatitis respectively). Lastly Gelclair(TM) (for oral mucositis) is licensed to Helsinn Healthcare.
Other languages
For versions of this press release in German, French, Spanish or Japanese, please see the Sinclair website at www.sinclairpharma.com or contact investorrelations@sinclairpharma.com
"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.
For further information please contact:
Sinclair Pharma plc
Dr Michael Flynn, CEO Tel: +44 (0) 148 342 6644
John Barrington-Carver, Corp. PR Tel: +44 (0) 207 351 3409
Mike Killeen, US Tel: +1 972 478 4380
UK
Financial Dynamics
Ben Atwell Tel +44 (0) 207 831 3113
John Gilbert
Germany
MC Services
Raimund Gabriel Tel +49 89 210 228 0
Hilda Juhasz
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