European Committee now Issues POSITIVE Opinion on Avandia(R) in Combination Therapy

WASHINGTON, Mar 17 NDC Newswire -- Avandia™, SmithKline Beecham's
(SB) new treatment for type 2 diabetes, has now received a positive opinion from
the European Committee for Proprietary Medicinal Products (CPMP), the
scientific advisory panel for the European Agency for the Evaluation of
Medicinal Products (EMEA) but apparently not as monotherapy.

European Committee Previously Issued Negative Opinion on Avandia(R)

    WASHINGTON, Oct. 23 / NDC Newswire -- Avandia™, SmithKline Beecham's
(SB) new treatment for type 2 diabetes, has received a negative opinion from
the European Committee for Proprietary Medicinal Products (CPMP), the
scientific advisory panel for the European Agency for the Evaluation of
Medicinal Products (EMEA).
    The NDC has learned from a source close to the company that this decision
may have been based mainly on cost-benefit considerations -
not from any major safety concerns that have arisen (especially not from any 
hepatic safety concerns.) A reliable source in the FDA has said today:-
"...the European Agency requested comparative studies that the company did
not have.  Other issues should be disclosed by the company, but I believe that 
the current label addresses some of the concerns raised there in an appropriate 
manner."
    Jan Leschly, Chief Executive of SmithKline Beecham, said "We believe this is 
a temporary  setback and in the coming months we will be working with the committee
to address their concerns. We are confident that by the end of March we will
have demonstrated Avandia's unique benefits in the treatment of type 2
diabetes to the CPMP."
    Avandia is already approved by the US Food and Drug Administration (FDA)
and by 18 other country regulatory authorities worldwide.  In the US, over
500,000 prescriptions have been written for more than 250,000 patients since
the product's launch in June.  The US experience, with a large and growing
patient population, reinforces the safety and efficacy of Avandia, and clearly
demonstrates its important contribution to the treatment of type 2 diabetes.
    Avandia belongs to a new class of treatment, the thiazolidinediones
(TZDs), and is the first product of this class to be submitted to the EMEA for
centralized European approval.  Unlike existing treatments in Europe, Avandia
attacks one of the underlying causes of type 2 diabetes, insulin resistance.
    [For company information, c.f. SmithKline Beecham on the World Wide Web at 
www.sb.com]