GlaxoSmithKline receives positive opinion from EMEA’s CPMP for use of Avandamet ™ as treatment for Type 2 Diabetes

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GlaxoSmithKline receives positive opinion from EMEA’s CPMP for use of Avandamet™ as treatment for Type 2 Diabetes

AVANDAMET combines two complementary treatments in one pill for improved glucose control London, June 27, 2003 - GlaxoSmithKline plc [LSE and NYSE: GSK] announced today it has received a positive opinion from the European Agency for the Evaluation of Medicinal Products' (EMEA) Committee for Proprietary Medicinal Products (CPMP) for use of AVANDAMET (rosiglitazone maleate and metformin HCl) in the European Union for the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are uncontrolled on their maximally tolerated dose of metformin alone.

AVANDAMET will be the first treatment in Europe that combines a thiazolidinedione-- AvandiaTM (rosiglitazone maleate)-- a medication that directly targets insulin resistance, a major underlying cause of type 2 diabetes, with a leading oral diabetes therapy, metformin, in one convenient pill. The complementary mechanisms of Avandia and metformin in AVANDAMET have been shown to provide superior glucose control in patients with type 2 diabetes versus metformin alone.1 The combination of Avandia plus metformin has been shown to have a low risk of hypoglycaemia, a side effect seen with some other traditional therapies. 2

Combination Therapy is Key to Effective Type 2 Diabetes Management

"There is now mounting evidence confirming that to reach blood sugar levels recommended by experts, many people with type 2 diabetes will need to take a combination of therapies with distinct mechanisms of action to attack the disease in different ways." said Stefano Del Prato, MD, Professor of Endocrinology and Metabolism at the School of Medicine, University of Pisa, Italy. "AVANDAMET provides two different, yet complementary mechanisms of action-- Avandia targets insulin resistance, an underlying cause of type 2 diabetes, whereas metformin works primarily by reducing the amount of blood sugar produced by the liver. When used together, the two drugs help patients achieve better glucose control than metformin alone for better disease management. This could help reduce the risk of long-term complications."

According to the United Kingdom Prospective Diabetes Study (UKPDS), approximately half of patients on monotherapy with metformin or a sulphonylurea will require multiple drugs to control the disease within three years.3 Studies show that significantly more patients who take the combination of Avandia and metformin reach the HbA1C target of 7 percent compared to near maximum doses of metformin alone. In a multi-centre, randomised, placebo-controlled, six-month study with 348 treated patients, who had inadequate glucose control on metformin monotherapy, 28 percent of patients receiving a combination of rosiglitazone and metformin reached that target compared to 8 percent of patients on the near maximum dose of metformin alone.1

About Type 2 Diabetes

Diabetes is a chronic, progressive illness associated with high morbidity and mortality. It is associated with high levels of glucose in the bloodstream (hyperglycaemia) and is one of the most common chronic diseases in the world. An estimated 151 million people are currently living with diabetes. By 2025, nearly 300 million people worldwide are expected to have some form of diabetes.4

Type 2 diabetes is characterised by beta-cell dysfunction and insulin resistance, a condition where the body fails to respond to circulating insulin effectively. To compensate for insulin resistance, the pancreas produces more insulin in order to keep blood glucose levels under control until, eventually, the pancreatic beta-cells become exhausted and can no longer function properly. 5 Over time, type 2 diabetes may lead to long-term complications such as damaged blood vessels and nerve cells, blindness, kidney failure and heart disease.6

Extensive Evidence Supporting Use of Avandia plus Metformin

Data on the combination of rosiglitazone and metformin for up to 30 months have been presented at European and U.S. medical meetings and published in peer-reviewed medical journals such as the Journal of the American Medical Association .1,2,7,8

The CPMP submission for AVANDAMET was based on bioequivalence and dose proportionality studies, together with data from three, 26-week, double-blind studies and one open label extension study with concomitant use of rosiglitazone and metformin.

AVANDAMET will be available in the EU in two tablet strengths of rosiglitazone/metformin respectively: 1 mg/500 mg and 2 mg/500 mg.

AVANDAMET was approved by the U.S. Food and Drug Administration in October 2002. AVANDIA first received European approval for combination use in 2000 in a defined population of patients. Now approved for use in 96 countries worldwide, AVANDIA has been used to treat more than 4 million individuals with type 2 diabetes.

Safety information

Pending European Commission decision, safety information for AVANDAMET would include:

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.

References

1. 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.

2. Jones TA, Sautter M, Van Gaal LF, et al. Addition of rosiglitazone to metformin is effective in obese, insulin-resistant patients with type 2 diabetes. Diabetes, Obesity & Metabolism 2003; 5:163-170.

3. UK Prospective Diabetes Group. Glycemic control with diet, sulfonylurea, metformin or insulin in patients with type 2 diabetes mellitus: Progressive requirement for multiple therapies (UKPDS 49). JAMA; 1999; 281:2005-2012.

4. The International Diabetes Federation 2003: Diabetes Factsheet.

5. Groop LC. Insulin resistance: the fundamental trigger of type 2 diabetes. Diabetes, Obesity and Metabolism. 1999; 1 (Suppl 1): S1-7.

6. World Health Organization/International Diabetes Federation. The economics of diabetes and diabetes care: a report of the Diabetes Health Economics Study Group. 1999 (WHO).

7. Jariwala S, Mather R, Nadra AR et al, Long-term glycaemic control with rosiglitazone in combination with metformin: A 277 from Diabetes UK Annual Professional Conference, Glasgow, UK, 2003.

8. Gómez-Perez FJ, Fanghänel-Salmón G, Barbosa JA, et al. Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes. Diabetes Metab Res Rev 2002; 18: 127-134.

Enquiries UK Media Martin Sutton
David Mawdsley
Chris Hunter-Ward 020 8047 5502
020 8047 5502
020 8047 5502 US Media Nancy Pekarek
Mary Anne Rhyne
Patricia Seif (215) 751 7709
(919) 483 2839
(215) 751 7709 European Analyst/Investor Duncan Learmouth
Philip Thomson
Anita Kidgell 020 8047 5540
020 8047 5543
020 8047 5542 US Analyst/Investor Frank Murdolo
Tom Curry (215) 751 7002
(215) 751 5419

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