Statement re US Atopiclair sales
Sinclair Pharma plc announces US Atopiclair sales reach $10m
30 April, Godalming, UK. Sinclair Pharma plc (SPH.L), the specialty pharmaceutical company, today announced that cumulative net US sales since launch of Atopiclair(TM), by its distributor Graceway Pharmaceuticals, LLC ("Graceway"), have reached $10.0m. This event triggers a milestone payment of $2.5m to Sinclair.
Atopiclair is Sinclair's flagship product for atopic dermatitis (eczema). It was originally launched in the US in 2005 by Chester Valley Pharmaceuticals (CVP), with a sales force of approximately 40. However, the recent merger of CVP into Graceway, which happened with Graceway's acquisition of the 3M pharmaceutical product lines in December 2006, means that Atopiclair will now be promoted by approximately 160 Graceway medical sales representatives in the US.
Outside the US, Atopiclair is at the start of its commercial life with key launches planned in many EU territories in the spring. In addition to the recent launch by Sinclair's own sales and marketing operation in France as 'Atopiclair', a co-marketing arrangement with Bayer's Intendis will see the product launched as 'Zarzenda' in key European territories. Earlier this year, Atopiclair was launched by Italfarmco in Spain as 'Dersura', where sales are showing strong performance.
Dr Michael Flynn, CEO of Sinclair Pharma, commented: "Atopiclair is an efficacious product, proven to deliver symptom relief for patients, without the use of steroids. Recent positive results of a clinical study in children with atopic dermatitis have added further weight to the product. This important sales milestone reflects the positive opinions of US physicians and patients and we look forward to seeing the success repeated in Europe."
For further information please contact:
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
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