GSK Announces FDA Approval of Altabax(TM) (Retapamulin Ointment), 1%

PHILADELPHIA, April 12 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved its antibacterial Altabax for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, the two most common types of bacteria in this kind of infection.

Altabax represents the first new class of prescription topical antibacterials to be approved by the FDA in nearly two decades. Altabax is indicated for use twice daily for a five-day period in patients nine months of age and older. Other prescription topical antibacterials are used as much as three times daily for up to 12 days.

"The introduction of Altabax comes at a time when antibiotic resistance is at an increasingly high level," said Stan Block, MD, President, Kentucky Pediatric and Adult Research Inc. "Altabax provides clinicians with a convenient new means to effectively fight the bacteria that cause impetigo through an effect that is different from other antibiotics. In vitro, this new topical antibiotic has shown a low potential for the development of resistance, possibly because it works in a unique manner compared to other antibiotics."

Impetigo is a highly contagious infection of the top layers of the skin and is most common among infants and children ages 2 to 6 years. Children are especially susceptible to infections because their immune systems are still developing. Impetigo spreads easily in schools and child care settings, as well as anywhere groups of people are in close contact.

Impetigo Clinical Trial Program for Altabax

In making its decision, the FDA reviewed Phase III data examining the safety and efficacy of Altabax twice daily for five days versus placebo ointment in the treatment of impetigo, as well as additional safety data from other clinical studies. The randomized, double-blind, multi-center, placebo- controlled study enrolled a total of 210 adults and children with impetigo, of which 139 received topical Altabax. Culture-proven pathogens were seen in 82 percent of these patients, and the most common bacteria causing these infections were S. aureus and S. pyogenes.

The findings showed that after five days of treatment, the rates of clinical success, defined as response of impetigo at end of therapy wherein no further antibacterial treatment was needed, were greater in the Altabax group (85.6 percent) than in the placebo group (52.1 percent). Microbiological success rates were also greater in the Altabax group (91.2 percent) than in the placebo group (50.9 percent). Altabax was generally well tolerated throughout the study.

About Altabax

Altabax is the first in a new class of antibacterials called pleuromutilins and is approved for the treatment of impetigo. By binding to a site on the 50S sub-unit of the bacterial ribosome, Altabax inhibits protein synthesis through an interaction with the ribosome that is unique to the pleuromutilin class. In vitro, the active ingredient in Altabax has shown no target-specific cross-resistance to other established classes of antibacterials, likely because currently no other antibacterials use the exact same mode of action.

Altabax is indicated for the treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes. Altabax is indicated for use twice daily for a five-day period in patients nine months of age and older. The most common drug-related adverse event (AE) was application site irritation (1.4 percent) in the group treated with Altabax.

About Antibiotics

Antibiotics were first introduced in the 1940s. Labeled "miracle drugs" by some of the nation's leading health authorities, antibiotics transformed the medical community, dramatically reducing illnesses and deaths caused by bacterial infections. Improper use of antibiotics has promoted the spread of antibiotic resistance.

Antibiotic resistance is considered to be one of the world's most pressing public health issues by the Centers for Disease Control and Prevention (CDC). Resistance occurs when bacteria change in a way that reduces or eliminates the effectiveness of treatment. Over the past decade, almost all types of bacteria have become stronger and less responsive to antibiotics, according to the CDC.

About GlaxoSmithKline

Altabax is the product of GlaxoSmithKline research and development. GlaxoSmithKline has an established heritage in the development of novel anti- infectives to meet clinical needs. These products include the topical antibacterial agent Bactroban(R) (mupirocin) as well as the oral agent Augmentin(R) (amoxicillin/clavulanate potassium). GlaxoSmithKline, 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 http://www.gsk.com/.

GlaxoSmithKline Forward-Looking Statements

Cautionary statement regarding forward-looking statements under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report 2005.