SOURCE: Sinclair Pharma PLC

June 21, 2005 03:57 ET

Sinclair Pharma Plc - Research Update and Launch

Surrey, UK -- (MARKET WIRE) -- June 21, 2005 --

         Sinclair Pharma Plc announces positive trial results:
  US multicentre trial confirms efficacy of AtopiclairTM in atopic dermatitis
                        AtopiclairTM launched in the US

Godalming, UK: 21 June 2005: Sinclair Pharma plc ("Sinclair" or the "Company") (SPH.L), the specialty pharmaceutical company, today announced positive results of a multicentre clinical double blind study on AtopiclairTM, for atopic dermatitis (AD, eczema) and the launch of the product in the US.

The study, conducted in 216 adult patients in the USA, demonstrated significant clinical benefits with AtopiclairTM, when compared to a vehicle cream control group The primary endpoint was the EASI score which is a standard method of assessment of the severity and extent of atopic dermatitis. Compared with the control group Atopiclair already showed a highly significant improvement of the EASI score within the first 8 days of this 50 day trial which was maintained throughout the trial. Similar benefits were observed for itch, erythema, area of atopic dermatitis, physicians global assessment, patients' preferences and the need for rescue medication when 5.5% of patients receiving AtopiclairTM needed rescue medication because of disease flare up versus 40% of patients receiving the vehicle control. AtopiclairTM was well tolerated with no significant side effects reported.

In addition to the study results Sinclair announce that their US licensee, Chester valley Pharmaceuticals Inc launched AtopiclairTM in the US on 20th June 2005. CVP is a newly founded company that is committed to bringing innovative solutions to the field of dermatology. The company was formed through a partnership between industry veteran Bob Moccia and GTCR Golder Rauner LLC, a leading private equity fund based in Chicago.

Dr Michael Flynn, CEO of Sinclair Pharma Plc, commented "The results of this study reinforce previous positive study results for AtopiclairTM in atopic dermatitis and contact dermatitis. There is a real need for an efficacious, steroid-free product for atopic dermatitis. These study results confirm that AtopiclairTM will be able to meet that need. We expect AtopiclairTM to be one of our most important revenue drivers over the next three years and the launch of our biggest product to date in the biggest market is a very significant event for us".

Bob Moccia, CEO of CVP commented: "This large scale study shows that Atopiclair TM is an effective new approach to manage the symptoms of atopic dermatitis. The results for itch are particularly encouraging; itch associated with atopic dermatitis is one of the most challenging and distressing symptoms of the disease. The dramatic reductions in itch, as well as other results from the study, confirm that AtopiclairTM will be welcomed by physicians and patients in the US."

Dr. William Abramovits, principal investigator of a multicenter study performed in the US said: "Our experience, from clinical trials and from anecdotal reports evidencing that AtopiclairTM is effective in reducing the itch, the severity and the extent of eczema lesions and the rapid onset of action and very good tolerance seen in this trial, has us very optimistic about the success of the product as soon as it hits the market. "

Contact details:

Sinclair Pharma plc
Dr Michael Flynn, CEO                             Tel:  01483 426 6444
John Barrington-Carver (Corporate PR)             Tel:  07831 655 630

In the US
Michael Killeen, Vice President                   Tel: +1 972 478 4380

Financial Dynamics
Ben Atwell
Lucy Atwell                                       Tel: 0207 269 7242

Notes to Editors

AtopiclairTM is a non-steroidal cream, approved as a medical device in the US and EU, for the management of symptoms of atopic dermatitis and contact dermatitis. As well as the US launch, it will be launched in Italy and Portugal in forthcoming months and further territories are in negotiation. For further product information please visit

Atopic dermatitis (also known as eczema) is one of the most common dermatological complaints and accounts for a large number of physician consultations. It is known to affect approximately 20% of school aged children (I, II, III). The prevalence in adults is estimated at 1-3%(iv, v). The current cornerstone of therapy is topical corticosteroids, which may have unfavourable side effects.

I    Yura A, Shimizu T. .  Trends in the prevalence of atopic dermatitis in 
     school children: longitudinal study in Osaka Prefecture, Japan, from 1985 
     to 1997 Br J Dermatol 2001; 145 (6): 966-73

II   Tay YK, Kong KH, Khoo L et al.  The prevalence and descriptive
     epidemiology of atopic dermatitis in Singapore school children. Br J 
     Dermatol 2002; 146 (1): 101-6

III  Mortz CG, Lauritsen JM, Bindslev-Jensen C, Prevalence of atopic
     dermatitis, asthma, allergic rhinitis, and hand and contact dermatitis in
     adolescents. Br J Dermatol 2001; 144 (3): 523-32

IV   Schultz-Larsen F, Hanifin JM.  Epidemiology of Atopic Dermatitis.
     Immunol Allergy Clin North Am 2002; 22: 1-24

V    Ellis CN, Drake LA, Prendergast MM.  Cost of Atopic Dermatitis and
     eczema in the United States. J Am Acad Dermatol 2002; 46 (3): 361-70

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