Regulatory Approval

GlaxoSmithKline PLC
11 October 2002



Issued - Friday 11 October 2002, London, UK




        FDA Approves GlaxoSmithKline's AvandametTM for The Treatment Of

                                Type 2 Diabetes


GlaxoSmithKline, plc (GSK) announced today that the U.S. Food and Drug
Administration (FDA) approved AvandametTM (rosiglitazone maleate and metformin
HCI) for the treatment of type 2 diabetes. Avandamet is the first treatment to
combine AvandiaTM (rosiglitazone), 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. This combination offers the
opportunity to help people manage their type 2 diabetes longer1.


As an adjunct to diet and exercise, Avandamet is indicated to improve blood
sugar control in people with type 2 diabetes who are already treated with
rosiglitazone and metformin as separate tablets or who are not adequately
controlled on metformin alone. Avandamet will be commercially available in the
U.S. in approximately one month.

"The approval of Avandamet represents a significant opportunity for our diabetes
franchise, and we intend to realise the full potential of this exciting new
combination product. One pill combining Avandia and metformin is designed to
offer an effective, convenient treatment option for people suffering from
uncontrolled type 2 diabetes," said J.P. Garnier, chief executive officer of
GlaxoSmithKline.


Type 2 diabetes affects an estimated 16 million Americans and 150 million people
worldwide. The disease is characterised by high blood sugar levels that occur
when the body cannot make enough insulin and/or respond normally to the natural
insulin it makes (a condition called insulin resistance).2 In patients with type
2 diabetes, beta cells (the cells that make and release insulin in the pancreas)
may become overworked and eventually fail, producing less insulin. This may lead
to increased blood sugar levels and progressive worsening of the disease. When
blood sugar levels are elevated over an extended period of time, serious
complications can result, including cardiovascular disease, kidney damage and
blindness.2 To reach blood sugar levels recommended by experts, many people with
type 2 diabetes will need to take a combination of therapies that treat the
disease in different ways.3 According to the UK Prospective Diabetes Study
(UKPDS), approximately half of all patients on monotherapy will require multiple
drugs to control the disease within three years.4


"The combination of rosiglitazone and metformin provides two different, yet
complementary mechanisms of action to manage diabetes," said Barry Goldstein,
M.D. Ph.D., Director, Division of Endocrinology, Diabetes and Metabolic
Diseases, Jefferson Medical College of Thomas Jefferson University,
Philadelphia. "Rosiglitazone targets insulin resistance, an underlying cause of
type 2 diabetes, whereas metformin works to reduce the amount of blood sugar (or
glucose) produced by the liver. The two medications, when used in combination,
target core metabolic defects to help achieve better blood sugar control than
metformin alone, making this an important option for patients with type 2
diabetes."


Safety Information

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 cases. In
addition, rosiglitazone (another component of Avandamet) may cause fluid
retention, especially if it is used with insulin. If left unchecked, fluid
retention could lead to or worsen heart failure. Avandamet is not indicated for
use with insulin. Avandamet should not be used in patients with renal disease or
dysfunction or with congestive heart failure requiring medication. Before using
Avandamet, patients over the age of 80 should have their renal function tested
to assure that their kidney function is adequate.


Avandamet is not recommended for people with liver disease. 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.


Notes to Non-US Editors Only

For further information on Avandamet, Avandia and/or diabetes, please log onto
www.diabetespressoffice.com

Enquiries:
UK Media enquiries:                                     Martin Sutton            [phone]
                                                        Alan Chandler            [phone]
                                                        Siobhan Lavelle          [phone]

US Media enquiries:                                     Nancy Pekarek            [phone]
                                                        Mary Anne Rhyne          [phone]
                                                        Patricia Seif            [phone]

European Analyst/Investor enquiries:                    Duncan Learmouth         [phone]
                                                        Philip Thomson           [phone]
                                                        Joan Toohill             [phone]

US Analyst/ Investor enquiries:                         Frank Murdolo            [phone]
                                                        Tom Curry                [phone]




References


    1.     GlaxoSmithKline. Avandamet Prescribing Information.

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

    3.      The International Diabetes Federation 2001: About Diabetes
    Factsheet.

4.      Turner RC, Cull CA, Frighi V, Holman RR. 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.


                      This information is provided by RNS
            The company news service from the London Stock Exchange