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Glaxosmithkline Receives FDA Approval For Augmentin XR (Amoxicillin/Clavulanate Potassium) Extended Release Tablets

New Antibiotic Addresses Emerging Public Health Concern

PHILADELPHIA, PA -- September 26, 2002 -- GlaxoSmithKline today announced that Augmentin XR™ (amoxicillin/clavulanate potassium) Extended Release Tablets has received United States Food and Drug Administration (FDA) approval for the treatment of adults with acute bacterial sinusitis (ABS) or community-acquired pneumonia (CAP). Specifically, Augmentin XR is indicated for the treatment of patients with ABS or CAP confirmed or suspected to be caused by beta-lactamase-producing bacteria such as Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae (S. pneumoniae) with reduced susceptibility to penicillin (i.e., penicillin MICs* = 2 mcg/mL). S. pneumoniae with penicillin MIC >/= 2 mcg/mL are considered resistant to penicillin.

Augmentin XR employs a unique extended release formulation -- bi-layer tablets that provide an immediate release of amoxicillin and clavulanate potassium and an extended release of amoxicillin. This enhanced formulation prolongs the time that the bacterium is exposed to the antibiotic and promotes coverage of tough-to-treat S. pneumoniae. Augmentin XR is the first antibiotic to be approved for the treatment of both ABS and CAP caused by strains of this bacterium with reduced penicillin susceptibility (MIC = 2 mcg/mL).

"Years ago, most antibiotics approved for respiratory tract infections were effective," said Michael Benninger, M.D., Chairman of the Department of Otolaryngology -- Head and Neck Surgery at Henry Ford Hospital, Detroit, Mich. "But recently, S. pneumoniae resistance to penicillin has increased dramatically -- to about 20 percent nationwide - making antibiotic selection very important. Augmentin XR will be important in physicians' efforts to continue to successfully fight infection, given today's environment of bacterial resistance."

Bacterial Respiratory Infections Becoming Harder to Treat
In recent years, common bacteria such as S. pneumoniae, Haemophilus influenzae and Moraxella catarrhalis that cause respiratory tract infections like ABS and CAP have become increasingly resistant to antibiotics. Antibiotic resistance occurs when bacteria change in different ways that reduce or eliminate the effectiveness of drugs, chemicals or other agents designed to cure or prevent infections. The surviving bacteria continue to multiply in the body, possibly causing more harm. Widespread use of antibiotics promotes the spread of antibiotic resistance. According to the U.S. Centers for Disease Control and Prevention, antibiotic resistance is a serious public health problem.

"With Augmentin XR, GlaxoSmithKline has responded to a medical need for antibiotics that continue to be effective in this era of evolving drug resistance," said Brian Lortie, Vice President, Anti-Infectives, GlaxoSmithKline. "We are proud to offer physicians a powerful new tool to help them with this emerging public health problem."

About Augmentin XR
Augmentin XR is a member of the beta-lactam class of antimicrobials and is made up of amoxicillin and clavulanate potassium. Each Augmentin XR Extended Release Tablet contains 1000 mg of amoxicillin and 62.5 mg of clavulanate. The clavulanate component is critical because it inactivates beta-lactamase, an enzyme produced by certain bacteria, including Haemophilus influenzae and Moraxella catarrhalis, that render many beta-lactam antibiotics (e.g., amoxicillin and penicillin) inactive. Augmentin XR Extended Release Tablets and Augmentin ES-600(TM) (amoxicillin/clavulanate potassium) Powder for Oral Suspension are the only high-dose amoxicillin oral antibiotics that also inactivate beta-lactamase.

Augmentin Tablets (250 mg or 500 mg) cannot be used to provide the same dosages as Augmentin XR Extended Release Tablets. This is because Augmentin XR contains 62.5 mg of clavulanate, while the AugmentinŽ 250 mg and 500 mg tablets each contain 125 mg of clavulanate. In addition, the Extended Release Tablets provide an extended time course of plasma amoxicillin concentrations compared to immediate release Tablets. Thus two Augmentin 500 mg tablets are not equivalent to one Augmentin XR tablet.

Clinical Trial Results
Augmentin XR has shown strong clinical success. Adults with ABS were evaluated in three clinical studies. In one comparative study, the rate of clinical success in patients with ABS was 87 percent (N=123) at test of cure. In two non-comparative, multicenter trials for ABS, clinical success with Augmentin XR was 93 percent (N=677) and 94 percent (N=632) at test of cure.

In patients suffering from CAP, in three comparative studies (N=582), the clinical success rates at test of cure (day 16 to day 39 following start of therapy) ranged from 86 (N=204) to 95 percent (N=114).

Microbiologic eradication rates for key pathogens in these studies are as follows:

-- In ABS clinical trials, Augmentin XR eradicated S. pneumoniae with penicillin MIC = 2 mcg/mL in 93 percent (N= 14) of strains from clinically evaluable patients. S. pneumoniae strains with penicillin MIC >/= 2 mcg/mL are considered penicillin resistant.

-- In CAP clinical trials, Augmentin XR eradicated S. pneumoniae with penicillin MIC = 2 mcg/mL in 100 percent (N=10) of strains from clinically evaluable patients.

-- In combined ABS studies, Augmentin XR eradicated beta-lactamase producing Haemophilus influenzae and Moraxella catarrhalis in 97 percent (N=30) and 98 percent (N=57) of strains from clinically evaluable patients.

-- In addition, Augmentin XR eradicated beta-lactamase producing Haemophilus influenzae and Moraxella catarrhalis in 94 percent (N=16) and 87 percent (N=15) of strains from clinically evaluable patients, respectively in combined CAP studies.

Augmentin XR was studied in over 4,100 patients and was generally well tolerated, with only 2 percent of patients discontinuing therapy due to drug-related side effects. The most commonly reported side effects in clinical trials were diarrhea (15.6 percent), nausea (2.2 percent), yeast infection (2.1 percent) and abdominal pain (1.6 percent). Augmentin XR is contraindicated in patients with a history of allergic reaction to any penicillin and in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate potassium. Augmentin XR is also contraindicated in patients with severe renal impairment and in hemodialysis patients.

About GlaxoSmithKline
GlaxoSmithKline, one of the world's leading research-based pharmaceutical companies, is committed to improving the quality of life by enabling people to do more, feel better and live longer. For complete prescribing information for Augmentin XR Extended Release Tablets, Augmentin ES-600 or Augmentin, visit http://www.gsk.com or call 1-888-825-5249.

* MIC stands for "minimum inhibitory concentration". This is the minimum concentration or the smallest amount of an antibiotic that is needed to inhibit bacterial growth in a laboratory test. The lower the MIC, the more susceptible is the bacterium to the antibiotic.


SOURCE: GlaxoSmithKline

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