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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