Sinclair Pharma plc Announces US Registration of (TM) , for
Seborrheic Dermatitis and Canadian registration of oncology support
products Xclair and SST
2 November 2006, Godalming. Sinclair Pharma plc (SPH.L), the
specialty pharmaceutical company, today announced that Sebclair (TM),
its product for seborrheic dermatitis, has been cleared for marketing
by the US Food and Drug Administration (FDA). Sebclair (TM) will be
sold on prescription in the US.
SD is a common and visible condition characterized by flaky, red
skin. It is most common in men and may be present in 5% of the adult
population [i]. It usually affects areas of the skin with high oil
production, such as the nose, eyebrows, ears and chest.
Sebclair (TM) is the first topical non-steroidal product cleared for
marketing in the US through 510k registration, that can also
specifically claim reduction of erythema (redness) as a symptom of
seborrheic dermatitis (SD). This is significant because the
appearance of SD can make patients self-conscious and distressed and
leads to them seeking treatment, when the reduction of redness and
flaking is an important goal. SD is often treated with topical
corticosteroids, however there are reservations about the use of
steroids on the face. As SD is particularly common on the face, there
is a specific need for a product that is steroid-free.
Earlier this year, Sinclair announced the results of a US and
European, randomized, double-blind study that compared Sebclair (TM)
with an emollient cream. In this study, after 28 days, 68% of
patients receiving Sebclair (TM) were 'clear' or 'almost clear' of SD
of the face, compared to 11% of patients using the emollient cream.
Professor Stefano Veraldi of the Institute of Dermatological
Sciences, Milan, Italy, the lead investigator of that trial
commented: "Our study showed that Sebclair (TM) is effective in
reducing the appearance and symptoms of seborrheic dermatitis. The
condition is very visible and often affects the self esteem of
patients and we welcome a steroid-free treatment for seborrheic
dermatitis
Sinclair's marketing partner for Sebclair (TM) in the US is Chester
Valley Pharmaceuticals (CVP). CVP is already achieving growing sales
for Atopiclair (TM), Sinclair's atopic dermatitis product. Atopiclair
(TM), like Sebclair, is classified by the FDA as a medical device,
cleared for marketing by 510(k). In Europe, Sebclair (TM) is approved
as a Class 2a medical device and has already been launched in Italy
by Sinclair's own sales team. The seborrheic dermatitis market is
worth an estimated US$272 million in the US and a further US$150.9
million combining the UK, French, German and Japanese markets [ii].
Bob Moccia, CEO of CVP, said: "With this registration, we now look
forward to launching Sebclair (TM) to the US dermatology community.
Sebclair (TM) meets a clear market need, and based on the compelling
results of the pivotal clinical study we anticipate that it will be
welcomed by physicians and their patients."
Dr Michael Flynn, CEO of Sinclair Pharma, commented: "The
registration of Sebclair (TM) in the US is a very important step
towards establishing a steroid free product range to effectively
treat skin conditions which are at present often treated with
corticosteroids. The proven effectiveness and registration of
Sebclair (TM) provides an alternative, and importantly steroid-free,
first line treatment in the US for this distressing condition. As
with our products Atopiclair (TM) and Decapinol (TM) we are very
pleased to have achieved another first in class registration in the
US . Sebclair (TM) is already sold by our own sales force in Italy
and we expect further sales boosts as it is launched in other EU
countries and the US during the next 12 months."
Sinclair also announces that both Xclair (TM), its product for
radiation dermatitis, and SST (TM), its product for xerostomia (dry
mouth), have received regulatory approval in Canada.
Enquiries:
+---------------------------------------------------+
| Financial Dynamics | Tel: | +44 20 7831 3113 |
|-------------------------+------+------------------|
| Ben Atwell/John Gilbert | | |
|-------------------------+------+------------------|
| Sinclair Pharma plc | Tel: | +44 1483 410 600 |
|-------------------------+------+------------------|
| Zoe McDougall | Tel: | +44 7973 792 520 |
| John Barrington-Carver | | +44 7831 655 630 |
|-------------------------+------+------------------|
| Sinclair US | Tel | +1 972 478 4380 |
| Mike Killeen | | |
+---------------------------------------------------+
Notes to editors:
Seborrheic dermatitis
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; Sebclair (TM) cream addresses the skin; a shampoo is in
development to address the scalp sector of the market.
There may be a combination of causes of seborrheic dermatitis. An
overproduction of sebum from the sebaceous glands is likely. In
addition, the presence of topical organisms such as the Malassezia
and Pityrosporum yeasts may exacerbate the condition.
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 [iii]. 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 [iv]. 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 [v]. There
may also be a risk of growth suppression and adrenal suppression in
children with the use of topical steroids [vi]. Sebclair (TM) does
not contain corticosteroids.
There are also other therapeutic agents that may be used in SD; these
include topical antifungal agents, sulfur-sulfacetamide combinations,
sulfacetamide, zinc pyrithione and selenium sulfide.
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, the UK, Spain and Portugal, and a
complementary marketing partner network that spans 60 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.
Chester Valley Pharmaceuticals, Inc.
Based in Malvern, Pennsylvania, Chester Valley Pharmaceuticals is a
specialty dermatology company focused on acquiring, in-licensing, and
developing branded prescription dermatological products for sale in
the United States.
[i] Pirkhammer D et al, Brit Journal Dermatology 2000, 143 (5),
964-968
[ii] Euromonitor report 2005
[iii] Tofte SJ, Hanifin JM. Current Management and therapy of atopic
dermatitis. J Am Acad Dermatol 2001; 44 (Suppl): S13-16
[iv] Dreno B, Chosidow O, Revuz J et al. Lithium gluconate 8% vs.
ketonazole 2% in the treatment of seborrheic dermatitis: a
multicentre, randomized study. Br J Dermatol 2003; 148: 1230-1236
[v]Atherton DJ, BMJ. Topical Corticosteroids in atopic
dermatitis. 2003;327:942-943
[vi] Siklar Z, Bostanci I, Atli O, Dallar Y. Pediatr Dermatol. 2004
Sep-Oct;21(5):561-3
