Regulatory Approval

GlaxoSmithKline PLC 20 August 2003 U.S. FDA APPROVES LEVITRA(R) (vardenafil HCl) Philadelphia, PA, and London, August 19, 2003 - GlaxoSmithKline plc (LSE and NYSE: GSK) announced today that LEVITRA(R) (vardenafil HCl) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED). Co-developed and co-promoted with Bayer AG (DAX and NYSE: BAY), Levitra is a PDE-5 inhibitor and provides men in the United States with the first alternative treatment option for the treatment of ED in five years. It is expected that Levitra will be available in U.S. pharmacies nationwide within the next few weeks. "We're delighted with the approval of this promising new therapy," said Chris Viehbacher, President, U.S. Pharmaceuticals, GlaxoSmithKline. "Together with Bayer, we are committed to educating men and their doctors about Levitra and the important role it can play in improving their sexual health." Levitra has now been approved in more than 50 countries globally. As previously disclosed, Pfizer has filed suit in the USA alleging that one of its patents would be infringed by the sale of Levitra. The case is in its early stages. S M Bicknell Company Secretary 19 August 2003 About GSK: GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GlaxoSmithKline cautions investors that any forward-looking statements or projections made by GlaxoSmithKline, including those made in this news release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the GlaxoSmithKline group of companies' operations are described under Risk Factors in the Operating and Financial Review and Prospects in GlaxoSmithKline's Annual Report on Form 20-F for 2002, filed with the US Securities and Exchange Commission." # # # For further information, please contact: GSK Enquiries UK Media Martin Sutton 020 8047 5502 David Mawdsley 020 8047 5502 Chris Hunter-Ward 020 8047 5502 US Media Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Patricia Seif (215) 751 7709 European Analyst/Investor Duncan Learmouth Philip Thomson 020 8047 5540 Anita Kidgell 020 8047 5543 020 8047 5542 US Analyst/Investor Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 This information is provided by RNS The company news service from the London Stock Exchange

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