Not for distribution to US media

 

Issued – Friday 1 June 2007, London, UK

GlaxoSmithKline (GSK) today announced that the European Commission approved its novel topical antibacterial ALTARGO ^® (retapamulin ointment,1%) for the treatment of impetigo and infected small lacerations, abrasions or sutured wounds. ALTARGO is first in a class of antibacterials called pleuromutilins to be approved for treatment of skin infections in humans, and is indicated for use twice daily for a five-day period (10 doses) in patients nine months of age and older. Other prescription topical antibacterials are used as often as three times daily for at least seven days, involving more than 21 doses.

"ALTARGO provides doctors with an effective new treatment option for uncomplicated skin infections requiring half as many doses in fewer days than other topical antibiotics,” said Andrew Witty, President, Pharmaceuticals Europe, at GSK. “GSK is committed to developing new antibacterials like ALTARGO, because bacterial resistance to currently available medicines is at an increasingly high level."

European Commission approval of ALTARGO results in a single marketing authorisation with unified labeling that is immediately valid in all 29 participating EU member states. The Commission’s decision follows a Positive Opinion by the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) in March 2007, recommending the product for approval.

ALTARGO will be used to treat bacterial infections most commonly caused by Staphylococcus aureus and Streptococcus pyogenes affecting small areas of skin. The impetigo indication is based primarily on the results of a double-blind, placebo-controlled clinical study demonstrating that the efficacy of ALTARGO was superior to placebo in adults and children. In a second pivotal study, ALTARGO was found to provide an effective course of therapy for impetigo compared to another commonly used topical antibacterial, fusidic acid. In two additional Phase III clinical trials, researchers examined the efficacy and safety of ALTARGO versus oral cephalexin for the treatment of infected abrasions, minor cuts and wounds in patients nine months of age and older.

In clinical studies in which a total of 2,150 patients with superficial skin infections applied ALTARGO, the most commonly reported adverse reaction was application site irritation, which affected approximately 1% of patients.

About impetigo and skin infections

Impetigo is a highly contagious bacterial infection of the top layers of the skin. It is most common among children two to six years of age. The infection causes sores which fill with pus before breaking open and producing the characteristic honey-coloured or yellowish brown crusts. Impetigo spreads easily in schools and child care settings by direct contact with wounds, sores or nasal discharge from an infected person. Scratching may also facilitate the spread of the infection. Cuts, scratches, insect bites or other dermatological conditions, notably eczema, can leave skin vulnerable to bacterial infection, especially with Staphylococcus aureus or group A Streptococcus.

About ALTARGO

ALTARGO is the first pleuromutilin antibacterial to receive regulatory approval for use in humans. Pleuromutilins are potent and highly selective inhibitors of the bacterial protein synthesis machinery. ALTARGO demonstrates no clinically relevant target-specific cross-resistance to currently used antibacterials, possesses excellent in vitro activity against bacteria that have become resistant to other classes of antibacterials, and appears to have a low potential for the development of resistance due to its unique mode of action.

About GlaxoSmithKline

GlaxoSmithKline has an established heritage in the development of novel anti-infectives to meet clinical needs. These products include the topical antibacterial agent Bactroban ^® (mupirocin) as well as the oral agent Augmentin ^® (amoxicillin/clavulanate potassium). These products have not only helped to widen the range of bacterial infections that can be successfully treated, but also to combat emerging bacterial resistance to existing agents. GSK is committed to the discovery, development, and commercialisation of innovative, potent antibacterials. Our approach includes in-house research using leading technologies, as well as actively seeking in-licensing opportunities and partnerships.

GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Additional information about GlaxoSmithKline can be found online at www.gsk.com.

Note to editor

Altargo ^®, Bactroban ^® and Augmentin ^® are registered trademarks of the GlaxoSmithKline group of companies.

Enquiries:

UK Media enquiries:	Philip Thomson	(020) 8047 5502
	Joss Mathieson	(020) 8047 5502
	Gwenan White	(020) 8047 5502
European Analyst/Investor enquiries:	Anita Kidgell	(020) 8047 5542
	David Mawdsley	(020) 8047 5564
	Sally Ferguson	(020) 8047 5543