FDA letter vardenafil

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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