GlaxoSmithKline receives positive opinion from EMEAs CHMP for use of new strength Avandamet ™ as treatment for type 2 diabetes

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GlaxoSmithKline receives positive opinion from EMEA's CHMP for use of new strength Avandamet™ as treatment for type 2 diabetes

Not for distribution to US Media

Issued — Monday 7 June 2004, London

New dosage strengths to offer physicians and patients dosing flexibility for managing type 2 diabetes

GlaxoSmithKline plc [LSE and NYSE: GSK] announced today that the European Agency for the Evaluation of Medicinal Products' (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the new AVANDAMET dosages of 1 gram metformin combined with 2 mg or 4 mg AVANDIA® (rosiglitazone maleate) in the European Union. AVANDAMET (rosiglitazone maleate and metformin HCl) is a treatment for type 2 diabetes that combines two important medications in one convenient pill.

"GlaxoSmithKline is pleased with the positive opinion provided by the CHMP today for the new AVANDAMET 1 gram tablets. We will soon be able to offer additional dosing flexibility and reduced pill burden for the many type 2 diabetes patients who are currently taking AVANDAMET or AVANDIA plus metformin," said Andrew Witty, president of GlaxoSmithKline Pharmaceuticals Europe. "Over 60% of patients on traditional agents do not reach recommended treatment goals for blood sugar control putting them at risk of serious complications. The new dose combinations of rosiglitazone and metformin in one pill will soon offer patients an even more convenient way to reach currently recommended treatment goals for type 2 diabetes to achieve better diabetes management and sustain glycaemic control over the longterm." AVANDAMET is the first fixed-dose combination product that brings together AVANDIA, a thiazolidinedione, and metformin in one convenient pill. These two oral antidiabetics have different yet complementary mechanisms of action. AVANDIA targets insulin resistance,1-4 an underlying cause of type 2 diabetes, whereas metformin works primarily by reducing the amount of blood sugar produced by the liver.5 Together, the two drugs help patients achieve enhanced glucose control compared to metformin alone.6 Good glucose control may help to reduce the risk of some long-term complications associated with type 2 diabetes.7 In addition, the combination of AVANDIA plus metformin has been shown to have a low risk of hypoglycaemia (low blood sugar),8 a side effect commonly seen with sulphonylureas.9

AVANDAMET was originally approved in the European Union in October 2003 for the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are uncontrolled on their maximally tolerated dose of metformin alone. AVANDAMET is currently available in two tablet strengths of rosiglitazone/metformin: 1 mg/500 mg, 2 mg/500 mg.

Safety Information

Safety information for AVANDAMET includes:

A small number of people who have taken metformin, one of the components of AVANDAMET, have developed a serious yet rare condition called lactic acidosis (a build up of lactic acid in the blood). Lactic acidosis occurs most often in people with kidney problems and can be fatal in up to half of the lactic acidosis cases. In addition, rosiglitazone (the other component of AVANDAMET) may cause fluid retention, which could lead to or worsen heart failure. AVANDAMET is contraindicated for use with insulin in Europe. AVANDAMET should not be used in women who are breast feeding, patients with renal disease or dysfunction or with congestive heart failure requiring medication, or those with liver disease.

Before using AVANDAMET, elderly patients should have their renal function tested to assure that their kidney function is adequate.

Patients should inform their doctor if they drink alcohol excessively. Tests should be conducted before and while taking AVANDAMET to check for liver problems.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Enquiries:

UK Media enquiries:
Martin Sutton (020) 8047 5502
David Mawdsley (020) 8047 5502
Chris Hunter-Ward (020) 8047 5502

European Analyst/Investor enquiries:
Duncan Learmouth (020) 8047 5540
Anita Kidgell (020) 8047 5542
Philip Thomson (020) 8047 5543

References

1. Mayerson AB, Hundal RS, Dufour S, et al. The effects of rosiglitazone on insulin sensitivity, lipolysis, and hepatic and skeletal muscle triglyceride content in patients with type 2 diabetes. Diabetes 2002; 51:797-802.

2. Carey DG, Cowin GJ, Galloway GJ, et al. Rosiglitazone increases insulin sensitivity and reduces factors associated with insulin resistance in type 2 diabetics. Diabet Res Clin Prac 2000; 50(Suppl1):P311.

3. Hallsten K, Virtanen KA, Lonnqvist F, et al. Rosiglitazone but not metformin enhances insulin- and exercise-stimulated skeletal muscle glucose uptake in patients with newly diagnosed type 2 diabetes. Diabetes 2002; 51:3479-3485.

4. Matthews DR, Bakst A, Weston WM, et al. Rosiglitazone decreases insulin resistance and improves beta-cell function in patients with type 2 diabetes. Diabetologia 1999; 42(Suppl 1): A229; Abs 858 presented at EASD 1999.

5. Metformin (Hydrochloride). Therapeutic Drugs, Colin Dollery 2nd Edition, M77-M81. Harcourt Brace, 1998.

6. Fonseca V, Rosenstock J, Patwardhan R, et al. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA. 2000;283:1695-1702.

7. UK Prospective Diabetes Study Group. Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352:837-853.

8. Cobitz et al. Benefits beyond glycaemia of adding rosiglitazone rather than a glibenclamide to metformin monotherapy in type 2 diabetes mellitus. Poster #835 presented at 18th International Diabetes Federation congress 2003.

9. Charbonnel B, Lonnqvist F, Jones NP, et al. Rosiglitazone is superior to glyburide in reducing fasting plasma glucose after one year of treatment in type 2 diabetic patients. Diabetes 1999; 48 (Suppl 1): A114-115.

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