GlaxoSmithKline PLC
24 July 2002
Issued - Leverkusen, Germany and London, UK 24 July 2002
Bayer And GlaxoSmithKline Receive US FDA Approvable Letter For Vardenafil
Bayer AG (DAX and NYSE: BAY) and GlaxoSmithKline plc (LSE and NYSE: GSK),
announced today that they have received an approvable letter from the U.S. Food
and Drug Administration (FDA) for vardenafil, an oral investigational drug under
review for the treatment of erectile dysfunction (ED). The drug has been
approved by regulatory authorities in several Latin American countries and has
been submitted for approval to regulatory agencies in all major markets.
The companies said that the FDA has asked for additional clinical pharmacology
studies before granting final approval for vardenafil. A U.S. launch for the
product is now projected for 2003.
Wolfgang Plischke, Ph.D., president, Pharmaceutical Division of Bayer
HealthCare, Bayer AG, said, "Bayer and GSK are committed to bringing vardenafil
to market as quickly as possible, and believe that the compound can provide a
new alternative for millions of men."
About Bayer
Bayer is an international, research-based group with core businesses in health
care, crop science, polymers and specialty chemicals. It employs some 117,000
people throughout the world. In 2001 Bayer had sales of EUR 30.3 billion and net
income of EUR 965 million. Capital expenditures amounted to EUR 2.6 billion, R&D
spending to EUR 2.6 billion. Bayer AG stock is a component of the DAX and is
listed on the New York Stock Exchange (ticker symbol: BAY).
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in our public reports filed with the Frankfurt Stock
Exchange and with the U.S. Securities and Exchange Commission (including our
Form 20-F). The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or developments.
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 GSK, 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 company's
operations are discussed in the section "Cautionary factors that may affect
future results" in GSK's results announcement for the year ended 31 December
2001, filed with the U.S. Securities and Exchange Commission.
Enquiries:
GlaxoSmithKline
UK Media enquiries: Martin Sutton (020) 8047 5502
Alan Chandler (020) 8047 5502
Siobhan Lavelle (020) 8047 5502
US Media enquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Patricia Seif (215) 751 4390
European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540
Philip Thomson (020) 8047 5543
Joan Toohill (020) 8047 5542
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
Bayer AG
Corporate Communications, Leverkusen, Germany Dr Michael Diehl 214 30 58532
Investor Relations, Leverkusen, Germany Afssaneh Rahbar 214 30 33021
Bayer Pharmaceuticals
Corporate Communications, US Lara Crissey (203) 812-6558
This information is provided by RNS
The company news service from the London Stock Exchange
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