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Levitra (Vardenafil) Receives Positive Opinion From European Committee For Proprietary Medicinal Products

LEVERKUSEN, GERMANY and LONDON, ENGLAND -- November 25, 2002 -- Bayer AG [DAX and NYSE: BAY] and GlaxoSmithKline plc (LSE and NYSE: GSK], announced that they have received a positive opinion from the European Committee for Proprietary Medicinal Products (CPMP) for LevitraŽ (vardenafil), a new oral drug under regulatory assessment for the treatment of erectile dysfunction (ED). This means that an European Marketing Authorisation should be granted within the next few months followed by a launch in Europe in the first half of 2003.

Levitra was selected for development because of its in-vitro potency and high selectivity for the PDE-5 enzyme. Levitra was researched and developed by Bayer AG and will be co-promoted and co-developed with GlaxoSmithKline plc (GSK). As leading European-based companies, Bayer and GSK are poised to bring Levitra to market using their extensive network of local operating companies throughout the continent.

Dr. Wolfgang Plischke, PhD, President Bayer Pharmaceuticals division of Bayer Health Care, Bayer AG said, "This positive opinion from the CPMP - received earlier than anticipated - marks another important milestone, bringing us one step closer to the global launch of Levitra. The plans are in place to ensure an expedited launch at approval".

"We are very pleased with the Committee's decision following their assessment of our extensive clinical trial data package that showed excellent efficacy following treatment with Levitra in men with ED", added Robert A. Ingram Chief Operating Officer and President, Pharmaceutical Operations, GlaxoSmithKline.

The clinical data presented to the CPMP for Levitra included results from pivotal phase III studies of almost 4,000 men representing a broad patient population, including men of varying ages and severity of ED, and those considered challenging to treat, such as men with diabetes and those who have undergone prostatectomy. In one large-scale trial including a broad range of patients, 80% and 85% of men taking Levitra 10 and 20mg respectively reported an improvement in erectile function compared with 28 percent on placebo.6 In clinical trials, the most common adverse events reported for Levitra were headache, flushing, rhinitis and dyspepsia, events typical of PDE inhibition.

Erectile Dysfunction and Levitra

Erectile dysfunction (ED) - the inability to sustain an erection sufficient for sexual intercourse - is a major medical condition among men that is largely untreated. Although an estimated 152 million men are affected worldwide, research shows that only 10 percent of men are being treated for the condition, suggesting the need for additional therapies in this area.

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. The Bayer AG Group 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.

SOURCE: Bayer AG

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