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Regulatory Update -- Stiefel, a GSK company announces a new, alternate, fixed-dose combination of Duac® (clindamycin 1% and

   Regulatory Update -- Stiefel, a GSK company announces a new, alternate,
fixed-dose combination of Duac® (clindamycin 1% and benzoyl peroxide 3%) gains
                positive recommendation for approval in Europe

  PR Newswire

  RESEARCH TRIANGLE PARK, North Carolina, March 4, 2013

RESEARCH TRIANGLE PARK, North Carolina, March 4, 2013 /PRNewswire/ -- Stiefel,
a GSK (LSE:GSK) company, announced today that it has received positive
recommendation by MHRA (Medicine and Healthcare products Regulatory Agency,
UK) for the approval of a new fixed-dose combination of Duac® (clindamycin 1%
and benzoyl peroxide 3%) gel for the topical treatment of mild to moderate
acne vulgaris, particularly inflammatory lesions, in adults and adolescents
aged 12 years and older.(1) This new fixed-dose combination of Duac is an
extension to the parent product Duac (clindamycin 1% and benzoyl peroxide 5%),
which is currently approved and available in more than 50 countries around the
world including US, Europe, Asia, Australia, Latin America and Canada.

The regulator's recommendation positively concludes the European regulatory
procedure and instigates the process of granting national licences to make it
available in 15 European countries.

This recommendation is based on review of the data on quality, safety and
efficacy of this new fixed-dose combination. The safety and efficacy was
evaluated in a phase III study of 1319 patients with mild to moderate acne.
The study compared the new fixed-dose combination to each of the individual
components (clindamycin 1% or benzoyl peroxide 3% or vehicle) applied once
daily for 12 weeks.(2)

About Acne Vulgaris Acne vulgaris is the most common skin disease. It is most
commonly seen during the teenage years but can affect males and females of any
age.(3) Acne lesions may be non-inflamed, appearing as whiteheads or
blackheads, or inflamed, developing as papules, pustules or nodules, and may
be described as mild, moderate or severe, depending on the types, numbers and
locations of lesions.(4,5) There is no single risk factor for developing acne;
hormones, genetics and environmental factors all affect the physiology of the
skin in unique ways for each person.(6) ^ Because acne is a very visible
condition, it may have a significant psychosocial impact on patients.(7)

About Duac (clindamycin 1% and benzoyl peroxide 3%) This new fixed-dose
combination of Duac contains two medicines: clindamycin 1% and benzoyl
peroxide 3% in a gel base formulation. The positive recommendation for
approval allows the 15 European countries to issue licences and make the
product available for the topical treatment of mild to moderate acne vulgaris,
particularly inflammatory lesions, in adults and adolescents aged 12 years and
older. Efficacy and safety have not been established in children under 12
years of age and therefore the product is not recommended for use in this
population.

The product is contraindicated in patients who have demonstrated
hypersensitivity to any of the ingredients and in patients with, or with a
history of, regional enteritis, ulcerative colitis, or antibiotic-associated
colitis (including pseudomembranous colitis).

Contact with the mouth, eyes, lips, and other mucuous membranes or areas of
irritated or broken skin should be avoided. Application to sensitive areas of
skin should be made with caution. In case of accidental contact, rinse well
with water.

The product should be used with caution in atopic patients, in whom further
skin drying may occur.

During the first weeks of treatment, benzoyl peroxide-containing products can
cause an increase in peeling and reddening in most patients. Depending on the
severity of these side effects, patients can use a non-comedogenic
moisturiser, temporarily reduce the frequency of application or temporarily
discontinue use; however, efficacy has not been established for less than once
daily dosing frequencies.

Concomitant topical acne therapy should be used with caution because a
possible cumulative irritancy may occur, which sometimes may be severe,
especially with the use of peeling, desquamating, or abrasive agents.

If severe local irritancy (e.g., severe erythema, severe dryness and itching,
severe stinging/burning) occurs, treatment should be discontinued.

As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps
should not be used and deliberate or prolonged exposure to sunlight should be
avoided or minimised. When exposure to strong sunlight cannot be avoided,
patients should be advised to use a sunscreen product and wear protective
clothing.

If a patient has sunburn, this should be resolved before use the product.

If prolonged or significant diarrhoea occurs or the patient suffers from
abdominal cramps, treatment should be discontinued immediately, as the
symptoms may indicate antibiotic-associated colitis. Suitable diagnostic
methods, such as the determination of Clostridium difficile and toxin and, if
necessary, colonoscopy should be employed and treatment options for colitis
considered.

The product may bleach hair and coloured or dyed fabrics. Avoid contact with
hair, fabrics, furniture or carpeting.

Patients with a recent history of systemic or topical clindamycin or
erythromycin use are more likely to have pre-existing and anti-microbial
resistant Propionibacterium acnes and commensal flora.

Cross-resistance may occur with other antibiotics such as lincomycin and
erythromycin when using antibiotic monotherapy.

This new fixed-dose combination of Duac (clindamycin 1% and benzoyl peroxide
3%) was first approved in Canada in April 2012. It is not approved or licensed
in the US and may not be approved in other parts of the world for the topical
treatment of mild to moderate acne vulgaris. The EU Summary of Product
Characteristics will be published on the EMA website, together with the
European Public Assessment Report (EPAR, http://www.ema.europa.eu ) and in the
Community Register of Medicinal Products on the European Commission's website
( http://ec.europa.eu/health/documents/community-register/html/index_en.htm ).

About Stiefel, a GSK company Stiefel, a GSK company, is committed to advancing
dermatology and skin science around the world in order to help people better
achieve healthier skin. Stiefel's dedication to innovation, along with its
focus on pharmaceutical, over-the-counter and aesthetic dermatology products,
has established Stiefel as a world leader in the skin health industry. To
learn more about Stiefel, visit www.stiefel.com .

Cautionary statement regarding forward-looking statements Under the safe
harbor provisions of the U.S. Private Securities Litigation Reform Act of
1995, GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK' s operations are
described under 'Risk factors' in the 'Financial review & risk' section in the
company's Annual Report 2011 included as exhibit 15.2 to the company's Annual
Report on Form 20-F for 2011.

References:

1.EU Summary of Product Characteristics
2.Eichenfield LF. "Safety and Efficacy of Clindamycin Phosphate 1.2% –
    Benzoyl Peroxide 3% Fixed-Dose Combination Gel for the Treatment of Acne
    Vulgaris: A Phase 3, Multicenter, Randomized, Double-Blind, Active- and
    Vehicle-Controlled Study." J Drugs Derm . December 2011; Vol. 10:
    1382-1396
3.Ferri F. Acne Vulgaris. In: Ferri, 1st ed. Ferri's Clinical Advisor
    Philadelphia, Pennsylvania: Mosby;2012:23-24
4.Ferri F. Acne Vulgaris. In: Ferri, 1st ed. Ferri's Clinical Advisor
    Philadelphia, Pennsylvania: Mosby;2012:23-24
5.Habif T. Acne, Rosacea, and Related Disorders. In: Habif, 5th ed. Clinical
    Dermatology . Philadelphia, Pennsylvania:Mosby;2009:217-239
6.Yan AC. "Current Concepts in Acne Management." Adolesc. Med. 2006; Vol.
    17:613-637.
7.Ferri F. Acne Vulgaris. In: Ferri, 1st ed. Ferri's Clinical Advisor
    Philadelphia, Pennsylvania: Mosby;2012:23-24

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