20 September 2006, Godalming. Sinclair Pharma plc (SPH.L), the specialty pharmaceutical company, today announced positive results of a new US pediatric study for its atopic dermatitis product, Atopiclair(TM).
The multicentre, double-blind, randomized, vehicle-controlled, 142-patient clinical trial demonstrated significant improvement of mild to moderate atopic dermatitis (eczema), for infants and children (between the ages of 6 months and 12 years) treated with Atopiclair(TM) cream versus an emollient vehicle cream. It also showed that patients using Atopiclair(TM) needed less steroid rescue treatment during the study compared to the emollient group.
The results support the use of Atopiclair(TM) in younger patients, where clinicians are more reluctant to prescribe topical steroids and need products to provide fast relief from the itch associated with atopic dermatitis. Approximately a third of atopic dermatitis prescriptions are for pediatric patients and this data will provide support to Sinclair's US marketing partner, Chester Valley Pharmaceuticals, Inc, the company's own sales force in Italy, and other global partners, to build sales for Atopiclair(TM).
Study results The primary endpoint of the study was 'treatment success', defined by whether the patient was either 'clear' or 'almost clear' of atopic dermatitis after 22 days. 77% (53 out of 69) patients using Atopiclair(TM) were considered 'treatment successes' and at the same time point there were no treatment successes in the control group (p<0.0001).
Secondary outcomes included measurement of itch and the need for rescue medication with a topical corticosteroid, in the event of a flare-up during the study period. Atopiclair(TM) achieved a significant reduction in itch when compared to the control group, and this difference was seen as early as day 3 (p<0.0001). In the Atopiclair(TM) group, 9% (6 out of 69) patients needed rescue medication with a steroid cream, compared to 40% (20 out of 70) in the control group.
Dr Mark Boguniewicz of the National Jewish Medical and Research Center, Denver, Colorado, was the lead investigator of the study: "This study shows that Atopiclair improves the symptoms and appearance of eczema in children and infants. The fast improvement in itch will be particularly important to patients and their families. When we are treating children, we try to avoid the use of topical corticosteroids, and so we were pleased that patients using Atopiclair in this study had significantly less need for steroid creams."
Study design 142 patients between the ages of 6 months and 12 years were randomized to either Atopiclair(TM) or control (a 'vehicle' emollient cream, similar to Atopiclair(TM) but without its key ingredients). After an initial washout period for existing medications, patients received the study cream for 43 days.
Outcome measurements included the Investigator's Global Assessment (IGA), pruritus (itch), Eczema Area and Severity Index (EASI), speed and duration of effect on itch, clinical signs (appearance of skin) and the need for rescue medication. Seven centres in the US participated in the study.
Atopiclair(TM) Atopiclair(TM) is a key product in Sinclair's international dermatology range. It is available in the US and EU and indicated for the treatment of atopic dermatitis and contact dermatitis in adults and pediatrics.
Dr Michael Flynn, CEO of Sinclair Pharma, commented: "This is a very important clinical trial result for Sinclair and our partners. Previous large-scale US data shows how effective Atopiclair is in adult patients. This new US study follows smaller scale European studies, showing Atopiclair to be safe and effective in infants and children. About one third of eczema prescriptions are for infants or children. Unfortunately when the usual emollients are not effective the next choices are topical steroids or immune modulating products. Atopiclair offers the possibility to avoid these products in some children. We believe that these results will help to strengthen the position of Atopiclair in the dermatitis market and be welcomed by both parents and physicians."
Bob Moccia, CEO of Chester Valley Pharmaceuticals, said: "The positive results of this paediatric study reinforce the safety and efficacy of Atopiclair in children and signifies its ability to control the symptoms of atopic dermatitis and eczema."
Atopiclair(TM) is free from corticosteroids and immunomodulators. No serious adverse events relating to Atopiclair(TM) were recorded in this study.
Notes to editors:
Atopiclair(TM) Atopiclair(TM) is a non-steroidal cream, marketed as a medical device in the US and EU, for the management of symptoms of atopic dermatitis and contact dermatitis. It is sold through Sinclair's sales and marketing team in Italy, and is also sold in the US, Spain, Portugal, Turkey, Indonesia, Israel and Jordan. For further product information please visit www.atopiclair.com.
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[ii], [iii], [iv]. The prevalence in adults is estimated at 1-3%[v],[vi].
Other atopic dermatitis treatments The current cornerstone of atopic dermatitis therapy is topical corticosteroids. However this group of drugs may have unfavourable side effects, especially when used long-term or on sensitive areas of skin such as the face, hands, or in children. These effects vary from mild and reversible thinning, to irreversible telangiectasiae (fine blood vessels becoming visible at the surface of the skin) and striae distensae (marks similar in appearance to 'stretch marks'). Steroids' effectiveness may also become less effective with continued use, which may lead to the escalation to a more potent steroid[vii]. There may also be a risk of adrenal suppression in children with the use of topical steroids[viii]. Atopiclair(TM) does not contain corticosteroids.
Another group of drugs, the topical immunomodulators (TIMs), are also used in atopic dermatitis. In January 2006, the US Food and Drug Administration (FDA) approved updated labeling for two TIMs, pimecrolimus and tacrolimus. The new labeling includes a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling). The Medication Guide is to be distributed with each prescription to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended by the FDA.
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, Spain, Italy and Portgual, and a complementary marketing partner network that spans 60 countries. Sinclair focuses in niche/specialty therapeutic areas and its current portfolio focuses on products for dermatological conditions and oral health.
Chester Valley Pharmaceuticals Inc Chester Valley Pharmaceuticals, based in Malvern, Pennsylvania, is a specialty dermatology company focused on acquiring, in-licensing and developing branded prescription dermatological products to be marketed and sold through their professional sales force within the United States.
Financial Dynamics Tel: 020 7831 3113 Ben Atwell/John Gilbert Sinclair Pharma plc Tel: +44 1483 410600 Zoe McDougall John Barrington-Carver
Din Link UK 2006, patients under 17 were given 28.5% of eczema prescriptions [ii] 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 [iii] 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 [iv] 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 [v] Schultz-Larsen F, Hanifin JM. Epidemiology of Atopic Dermatitis. Immunol Allergy Clin North Am 2002; 22: 1-24 [vi] 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 [vii] Atherton DJ, BMJ. Topical Corticosteroids in atopic dermatitis. 2003;327:942-943 [viii] Siklar Z, Bostanci I, Atli O, Dallar Y. Pediatr Dermatol. 2004 Sep-Oct;21(5):561-3
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