Sinclair Pharma launches eczema products in UK

Sinclair Pharma, a UK-based specialty pharmaceutical company, has launched Atopiclair Cream for atopic dermatitis (eczema) and Xclair Cream for radiation dermatitis (skin damage from radiotherapy), through its UK operating company Ashbourne Pharmaceuticals.

The launches mark further progress towards Sinclair's goal of achieving an integrated European sales presence, as Atopiclair is now sold by all three of Sinclair's operating companies. In the UK it will be sold by Ashbourne in partnership with the specialist dermatology company Valeant Pharmaceuticals.

The product is already available in the US and was launched earlier this year in mainland European territories by Sinclair and through a co-marketing agreement by Intendis GmBH.

Atopiclair is an original patented product which meets an unmet market need for an effective, non-steroidal treatment for atopic dermatitis in adults and children. Data from randomised controlled clinical trials demonstrated its effectiveness at improving itch, reducing the area of skin affected by atopic dermatitis and reducing the need for the use of topical corticosteroids.

Ashbourne has also launched Xclair in the UK, for the management of radiation dermatitis. This is a skin condition commonly seen as a side effect of radiotherapy for which there is currently no gold standard treatment.

Atopic dermatitis is one of the most significant dermatology markets in terms of prevalence, but sales in this indication are relatively small, accounting for USD 375m in the seven major markets in FY05. The US and Japan account for most of the revenues and generated USD 184m and USD 102m in FY05 respectively.

Two topical immunosuppressants, pimecrolimus (Novartisís Elidel) and tacrolimus (Astellas's Protopic), were the leading branded products in this segment, producing combined revenues of USD 133m in FY05. Sales have declined sharply because of the FDAís imposition of a black box warning because of safety concerns over cancer. The impact of these safety concerns and the lack of innovative new therapeutics in latestage development for the treatment of atopic dermatitis has led to a period of negligible revenue growth. The treatments cannot be used long-term.

Sinclair's products may not bring in massive amounts of cash, but do meet, as the company says, an under-served medical need.

Dr Michael Flynn, CEO of Sinclair Pharma plc, noted: "Atopiclair is currently our biggest product. These launches of two Sinclair products by our own operation in the UK represent important steps in establishing Sinclair as a fully integrated specialty pharmaceutical company. Atopiclair and Xclair both serve an unmet market need and have demonstrated success in other territories. Commercialisation through our operating companies provides higher product margins than than those achieved by selling through marketing partners."

Loss widens in FY07
Sinclair Pharma's FY07 loss widened to GBP 4m (USD 8m), up from GBP 2.8m in FY06, after exceptional charges and delays to key products delayed the company's profitability.

Revenues rose to GBP 23m, up from GBP 11.6m, while exceptional items rose to GBP 1.4m (USD 2.8m) from GBP 56,000.

Sinclair's exceptional charges include a provision of GBP 736,000 (USD 1.5m) for bad debts related to its US marketing partner, Align Pharmaceuticals, which the company says may have to be restated if the problem is resolved before the end of the financial year.

The company also has also had to charge GBP 400,000 (USD 810,692) post-period for a failed takeover attempt in July 2007, although this charge will fall in H2 FY08.

Sinclair has also experienced product problems: the US launch of its Decapinol mouthwash product was delayed to 2008 by its licensing partner OraPharma, owned by J&J, so that a new preservative could be added.

The delay forced Sinclair to restate its revenues for Decapinol and prevented the company achieving profitability in 2007.