SOURCE: SINCLAIR PHARMA PLC.

November 29, 2006 04:37 ET

Sinclair Pharma signs deal with King's College London to acquire novel anti - caries peptide p1025

GODALMING, UK -- (MARKET WIRE) -- November 29, 2006 --



29 November 2006, Godalming, UK. Sinclair Pharma plc (SPH.L), the international specialty pharmaceutical company, today announced an agreement with King's College London to acquire the exclusive licence rights to develop and commercialise the peptide p1025, for use in the dental setting.

p1025 interferes with the mechanism that allows the bacterium Streptococccus mutans to attach to tooth surfaces and has been shown to maintain this action for 120 days[i]. Streptococcus mutans is a major contributor to dental caries[ii] and its removal is critical to preventing caries.

This mode of action is broadly similar in principle to that of Sinclair's existing anti-gingivitis product, Decapinol™. Whilst Decapinol interferes with binding of dental plaque bacteria to the surface of the tooth and gums, P1025 offers a prolonged action against a bacterium specifically implicated in the development of caries. Sinclair is exploring the possibility for synergies between p1025 and Decapinol™ technologies as part of a major thrust to develop a new approach to the treatment and prevention of dental caries.

"Sinclair has a strong commitment to oral health." said Dr Michael Flynn, CEO of Sinclair Pharma plc. "Increasing attention is being paid to the link between poor oral health and other problems such as cardiovascular disease or premature birth and we believe this will become an important consideration for the medical and dental professions. p1025 adds an important new patented technology to Sinclair's portfolio and boosts our pipeline in Oral Health. King's Dental Institute has been a centre of excellence for many years and we are very pleased to be working with them on this joint project."

"I am delighted that our research is being developed by Sinclair Pharma and that this brings the technology closer to market," added Charles Kelly, Professor of Oral Immunology. "The Dental Institute at King's is committed to working with industrial partners to transfer its expertise and knowledge, benefiting patients, the College and its partners."


Enquiries:

Capital MS&L  Tel: +44 (0) 207 307 5330
Mary Clark
Halina Kukula



Sinclair Pharma plc    Tel: +44 1483 410 600
Zoe McDougall
John Barrington-Carver


Notes to editors:

p1025 is a peptide that interferes with the cell surface adhesin, "streptococcal antigen I/II". This inhibitory mechanism was first confirmed in an in vitro model with subsequent testing in humans finding that direct application of p1025 to the teeth prevented recolonisation of the oral cavity by S. mutans for four months[iii]. The authors of this study noted that "Topical application of such peptides at mucosal surfaces does not provide sustained selective pressure and in contrast to antibiotics, may not induce resistance."

Dental Caries

Prevention of dental caries is a key target for dental professionals and governments of developed and developing nations, particularly among children. The WHO considers that dental caries and periodontal disease have historically been the most important global oral health burdens. Dental caries are still a problem in most industrialized countries, affecting 60-90% of schoolchildren and the majority of adults. In 2004 it was reported that the rate of decayed, missing or filled teeth in 12 year olds was 3.0 in the US and 2.6 in European countries, with much lower rates in developing nations (1.7 in Africa). However the rate of dental caries is increasing in developing countries as the exposure to sugar increases without a parallel increase in exposure to fluoride[iv].

S. mutans is a well-known contributing risk factor for dental caries. A recent Japanese study[v] found that 62% of a population of pre-school children had S. mutans present in the mouth. Along with fluoride and maintenance of good oral hygiene, controlling S. mutans may be a key solution to preventing dental caries.

Decapinol™ is Sinclair's novel product for the treatment of gingivitis and dental plaque, and the prevention of periodontitis. Gingivitis is an inflammation of the gums (gingiva), caused primarily by accumulated plaque bacteria at the gum, and characterised by bleeding and discolouration of the gum. First line treatments target the dental plaque, removing it and preventing its recurrence.

Decapinol™ has a novel, 'intelligent' mode of action. It works at the surface of bacteria, preventing them from adhering to each other or the surface of the tooth, rather than indiscriminately killing good and bad bacteria within the mouth. Decapinol™ also has the advantage that it does not cause the semi-permanent tooth staining caused by competitors. This novel action was recognised by the award of the prestigious Frost & Sullivan 2006 "Oral and Dental Care - Product of the Year Award".

Sinclair has recently signed a marketing partner agreement with Johnson & Johnson's OraPharma Inc. for the rights to sell Decapinol™ rinse on prescription in the US.

The link between oral health and other diseases

Poor oral health, and in particular gum disease, is increasingly considered a risk for other co-morbid conditions. These include poor outcomes in pregnancy, cardiovascular disease, respiratory infections in the acute setting and in diabetes where complications may be exacerbated by periodontitis[vi].

Various theories support these links. Bacteria may enter the bloodstream through a compromised barrier in the affected gum area, and affect various other organs. Alternatively, oral plaque bacteria release toxins that may enter the circulation, exerting an inflammatory effect for example on the arteries[vii].

Sinclair Pharma plc

Sinclair Pharma plc is an international specialty pharmaceutical company. It has a growing sales and marketing operation that is already present in France, Italy, the UK, Spain and Portugal, and a complementary marketing partner network that spans 60 countries. Sinclair has proven expertise in acquiring or developing commercially attractive and undervalued products, registering these products and bringing them to market within a short time frame. The company focuses on niche therapeutic areas and its current portfolio includes products for dermatological conditions and oral health.

www.sinclairpharma.com


King's College London Enterprises (KCLE)

King's College London Enterprises (KCLE) is the wholly owned enterprise and innovation company of King's College London. They are responsible for business development and commercialisation and for the management of the university's research grants and contracts.

King's College London

King's College London is the fourth oldest university in England with more than 13,700 undergraduates and nearly 5,600 graduate students in nine schools of study based at five London campuses. King's is in the top group of UK universities for research earnings, with income from grants and contracts of more than £100 million, and has an annual turnover of more than £363 million.

Further information
Public Relations Office, King's College London
Tel: 020 7848 3032 Email: pr@kcl.ac.uk
"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.

[i] Kelly CG et al. A synthetic peptide adhesion epitope as a novel antimicrobial agent. Nature Biotechnology 1999 17: 42-47

[ii] Wilson RF, Ashley FP, Identification of caries risk in schoolchildren: salivary buffering capacity and bacterial counts, sugar intake and caries experience as predictors of 2-year and 3-year caries increment. Br Dent J. 1989 Aug 5;167(3):99-102

[iii] Younson J; Kelly C. The rational design of an anti-caries peptide against Streptococcus mutans. Mol Divers. 2004;8(2):121-6

[iv] WHO theme paper: The global burden of oral diseases and risks to oral health http://www.who.int/bulletin/volumes/83/9/661.pdf

[v] Okada M et al. Longitudinal study of dental caries incidence associated with Streptococcus mutans and Streptococcus sobrinus in pre-school children. J Med Microbiol 54 (2005), 661-665

[vi] Jin LJ, Chiu GK, Corbet EF. Are periodontal diseases risk factors for certain systemic disorders - what matters to medical practitioners? Hong Kong Medical Journal, 2003 Feb;9(1):31-7

[vii] American Academy of Periodontology fact sheet, http://www.perio.org/consumer/mbc.heart.htm





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