4th Aug 2009 07:00
Sinclair Pharma plc Sebclair launched in the US by Dr Reddy's Laboratories' subsidiary Promius Pharma, LLC Launched under brand name Promiseb(TM) Cream
04 August 2009, Godalming, UK: Sinclair Pharma plc (SPH.L), the international specialty pharma company, today announced its treatment for seborrheic dermatitis has been launched in the United States by Promius Pharma, the dermatology division of Dr Reddy's Laboratories, Inc. Sinclair licensed the exclusive rights for the USA of its seborrheic dermatitis product, Sebclair, to Dr Reddy's in September 2007. Dr Reddy's is marketing the product under the brand name of Promiseb Cream.
Promiseb / Sebclair Cream is a non-steroidal, prescription only cream for the treatment of seborrheic dermatitis, which has demonstrated both anti-inflammatory and antifungal properties.
In the United States, 3 - 5% of the general population (307M) suffers from seborrheic dermatitis and Sinclair will receive royalty payments based on the net sales of Promiseb. Promius Pharma began promotion of Promiseb Cream at the Summer Meeting of the American Academy of Dermatology in Boston, Massachusetts last week and has a sales force visiting 7000 dermatologists, who generate 65 to 70% of prescriptions in seborrheic dermatitis, to market this product.
Jeff Wasserstein, President of Promius Pharma, said "We are very excited about Promiseb Cream because it has the potential to replace both anti-inflammatory and antifungal treatments in patients with seborrheic dermatitis. In a clinical study Promiseb was shown to have efficacy comparable to desonide cream 0.05% at days 14 and 28 with fewer relapses.
"Promiseb Cream also has an excellent safety profile with no restrictions on age, duration of use or application on the face." He continued, "We are very enthusiastic about this product because our clinical research shows that Promiseb Cream may be used as a first-line treatment for seborrheic flares and for long-term maintenance"
Sebclair cream is registered in the EU and has so far been launched in France, Italy & Spain through Sinclair's own operations.
Commenting on today's announcement, Dr Michael Flynn, Chief Executive of Sinclair Pharma, said:
"The launch of Promiseb in the United States further expandsthe presenceof Sinclair products in th US market, bringing the total to seven productsnow soldinthe US ahead of the planned launch of our flagship product, Decapinol,later this financial year. Dr Reddy's Promius Pharmais a dynamic company which has built a strong dermatology portfolio and is well positioned to market Promiseb in the US.
We believe there is great potential on the market for a non-steroidal cream such as this, providing a safer alternative to existing treatments."
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For further information please contact:
Sinclair Pharma plc Tel: +44 (0) 1483 410 600
Dr Michael Flynn, CEO
Jerry Randall, CFO
Mariyam Rawat, Director of Communications & Investor relations
Email: [email protected]
Capital MS&L
Mary Clark, Joanna Whineray Tel +44 (0)20 7307 5337
Notes to Editors:
About Seborrheic Dermatitis and SebclairTM
Seborrheic dermatitis is a common skin condition that affects areas of the body with a particularly high concentration of sebaceous glands. This may include the eyebrows, bridge of the nose, naso-labial folds, ears and chest. It manifests as erythema (reddening), which progresses to flakiness and at its most severe, crusting of the skin. Seborrheic dermatitis of the scalp is also particularly common, and in its mildest form may be referred to as dandruff.
Seborrheic dermatitis is a common condition characterized by flaky, red skin. It is most common in men and is present in up to 5% of the adult population with over 1.5 million visits to physicians for seborrheic dermatitis (IMS-NDTI, 2006) whilst there is also a significant spend on over-the-counter products.
Sebclair(TM) cream is registered in the US and EU and addresses the skin market. Sebclair shampoo, recently registered in the EU, addresses the scalp sector of the market. Seborrheic dermatitis also often appears as cradle cap in infants of around six months. It usually clears by 18 months but can be a persistent problem during this time. After infancy, the condition is most common in middle age or older people. It may also be associated with a poor diet and obesity, HIV and neurological conditions such as Parkinson's disease.
At present there are various approaches to the management of seborrheic dermatitis but there is no `gold-standard' product. Many of the treatments focus on the potential presence of fungi or other organisms on the surface of the skin, and topical corticosteroids are also frequently employed. Although topical corticosteroids are commonly used, they are also disliked, as these drugs may cause atrophy of the skin and are usually restricted to short treatment periods, particularly on facial skin. Emollients, lithium-based and salicylic acid-based creams are considered to improve the condition.
Other seborrheic dermatitis treatments
Seborrheic dermatitis is frequently treated with 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 on 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. There may also be a risk of growth suppression and adrenal suppression in children with the use of topical steroidsvi. SebclairTM does not contain corticosteroids. Other topical agents used to treat seborrhheic dermatitis include antifungal and other antimicrobial products.
About Sinclair Pharma Plc www.sinclairpharma.com
Sinclair Pharma plc is an international specialty pharmaceutical company providing solutions to treat dermatological, oral care & gynaecological diseases through advanced surface technology and innovative delivery system. It has a growing sales and marketing operation in France, Italy, Spain and Portugal, and a complementary marketing partner network that spans more than 80 countries.
About Sebclair
Sebclair(R) is indicated to manage and relieve the itching, burning, scaling and pain experienced with seborrhoeic dermatitis. It is a non-steroidal, barrier enhancing, mildly keratolytc composition of ingredients formulated to help normalize skin physiology which has been altered by seborrhoeic dermatitis and cradle cap in infants.
About Promius Pharma LLC www.promiuspharma.com
Promius Pharma is a wholly owned, branded specialty company, of Dr. Reddy's Laboratories Inc. It is located in Bridgewater, NJ.
"Safe Harbour" 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.
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