Sinclair Pharma plc : Les ventes d'Atopiclair atteignent 10 millions de dollars aux Etats-Unis

Statement re US Atopiclair Sales

Sinclair Pharma plc : les ventes d'Atopiclair atteignent 10 millions de dollars aux Etats-Unis

30 avril, Godalming R-U. Sinclair Pharma plc (SPH.L), une société internationale spécialisée dans les activités pharmaceutiques, a annoncé aujourd'hui que les ventes nettes cumulées d'Atopiclair(TM) avaient atteint 10 millions de dollars depuis son lancement par la société de distribution Graceway Pharmaceuticals LLC (" Graceway "). Ce seuil s'accompagne d'un paiement d'étape de 2,5 millions de dollars pour Sinclair.

Produit phare de Sinclair dans le traitement de la dermatite atopique (eczéma), Atopiclair a été originellement lancé par Chester Valley Pharmaceuticals (CVP) aux Etats-Unis en 2005, avec une force de vente de 40 collaborateurs. Fort de la récente fusion de CVP et de Graceway et de l'acquisition par cette dernière des gammes de produits pharmaceutiques 3M en décembre 2006, Atopiclair sera désormais proposé par quelque 160 représentants médicaux Graceway aux Etats-Unis.

Ce médicament, qui n'est encore qu'à ses débuts commerciaux hors des frontières américaines, devrait être lancé sur plusieurs marchés clés de l'Union européenne au cours du printemps. Outre sa récente commercialisation en France en tant qu' " Atopiclair " par les propres divisions de vente et de marketing de Sinclair, un accord de marketing conjoint passé avec la filiale de Bayer Intendis verra son lancement sous le nom de " Zarzenda " dans certains territoires clés d'Europe. Atopiclair est déjà commercialisé par Italfarmco sous le nom de " Dersura " en Espagne, où il affiche de très bonnes ventes.

Le Dr Michael Flynn, directeur général de Sinclair Pharma, résume : " Atopiclair est un produit efficace, qui permet de manière démontrée de soulager les symptômes des patients, sans recourir aux stéroïdes. Les résultats positifs d'une récente étude clinique réalisée auprès d'enfants souffrant de dermatite atopique renforcent encore ce produit. Cette étape commerciale importante reflète les opinions positives des médecins et patients américains, et nous espérons bien réitérer ce succès en Europe. "

Pour plus d'informations, veuillez contacter :

Sinclair Pharma plc
Tel: +44 (0) 1483 410 600
Dr Michael Flynn, CEO
Zoe McDougall, Director of Communications

Capital MS&L
Mary Clark, Halina Kukula
Tel +44 (0)20 7307 5340

Notes to editors:

Milestone

The figure of US$10.0 m represents sales of Atopiclair, by Graceway Pharmaceuticals, into the US supply chain. The retail value of these sales will be higher. The milestone payment triggered by this event will be payable to Sinclair Pharma plc within the current financial year.

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 France and 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 (footnotes 1, 2, & 3). The prevalence in adults is estimated at 1-3% (footnotes 4 & 5).

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 (footnote 6). There may also be a risk of adrenal suppression in children with the use of topical steroids (footnote 7). Atopiclair 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, Italy, UK, Spain and Portugal, and a complementary marketing partner network that spans more than 65 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.

"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.

Footnotes

1. 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

2. 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

3. 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

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

5. 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

6. Atherton DJ, BMJ. Topical Corticosteroids in atopic dermatitis. 2003;327:942-943

7. Siklar Z, Bostanci I, Atli O, Dallar Y. Pediatr Dermatol. 2004 Sep-Oct;21(5):561-3