Regulatory Approval

GlaxoSmithKline PLC
07 March 2003



                    LevitraTM (vardenafil HCl) Approved for
          the Treatment of Erectile Dysfunction by European Commission

       A New Treatment Option Could Mean Improved Sexual Performance for

        Some 30 Million Men1 Affected by Erectile Dysfunction in Europe

Leverkusen, Germany and London, UK - 7 March 2003 - Bayer HealthCare of Bayer AG
(DAX and NYSE: BAY) and GlaxoSmithKline plc (LSE and NYSE: GSK) announced today
that they have received marketing authorisation from the European Commission for
LevitraTM (vardenafil HCl), a new oral PDE-5 inhibitor for the treatment of male
erectile dysfunction (ED). The decision follows a positive opinion by the
European Committee for Proprietary Medicinal Products (CPMP) on 21 November
2002. Bayer and GSK anticipate launching Levitra as soon as possible in European
markets. The drug has also been approved by regulatory authorities in several
Latin American countries and has been submitted for approval to regulatory
agencies in all major markets, including the United States.

"We are delighted with the European Commission's decision and look forward to
bringing Levitra to market for the millions of men in Europe who could benefit
from a new option to treat ED," said Dr. Christa Kreuzburg, Head of Europe for
Bayer HealthCare's Pharmaceuticals Division. "We know that many men are not
completely satisfied with existing treatments and are looking for effective new
options. We believe Levitra will improve sexual satisfaction for men who have ED
by providing them with a highly efficacious and reliable treatment. Together
with GSK, we are committed to bringing this product to all European markets with
initial launches starting this month," she added.


"Patients have responded extremely well to treatment with Levitra," said Mr. Ian
Eardley, MA, FRCS (Urol), a Levitra clinical trial investigator and consultant
at St. James University Hospital, Leeds, UK. "I view Levitra as an important
first-line therapy in the broad population of men with ED - even for
difficult-to-treat patients, such as men with diabetes. I will prescribe it with
confidence knowing that it will effectively treat a majority of my patients with
impaired erectile function," he concluded.

The CPMP based its decision to recommend approval of Levitra on clinical data
that included results from more than 3750 men representing a broad patient
population. Levitra has been shown to work quickly and have reliable efficacy
over time.2,5


Erectile dysfunction is a common health condition, but despite the high
prevalence of ED, the condition still goes largely untreated. Experts estimate
that only 15-20 percent of the 152 million men worldwide are currently being
treated.1,4


Simon Bicknell

Company Secretary

7 March 2003

Notes to Editors


  • Erectile dysfunction is defined as the persistent inability to attain and
    maintain an erection sufficient to permit satisfactory sexual intercourse.

  • It is estimated that some degree of ED affects more than one half of all
    men over the age of 40 and that worldwide an estimated 152 million men
    suffer from ED. The number of men with ED is expected to more than double to
    322 million by 2025.1

  • Phosphodiesterase type 5 (PDE-5) is the predominant enzyme found in human
    penile erectile tissue and is associated with erections. PDE-5 inhibitors
    typically work by blocking this enzyme to enhance or prolong the erectile
    response.


  • Levitra was specifically selected for development as an ED therapy because
    of its in vitro potency and high selectivity for the inhibition of the PDE-5
    enzyme.

  • Levitra allows some men to attain an erection in as early as 15 minutes
    after dosing (25 minutes for most men) and following sexual stimulation.2

  • Levitra is formulated as an orange, round, coated tablet in doses of 5, 10
    and 20 mg. For most patients, the recommended starting dose of Levitra is 10
    mg taken orally 25 to 60 minutes before sexual activity. The effect of
    Levitra can last up to nearly five hours.2

  • Levitra is contraindicated in men taking nitrates and nitric oxide donors
    (a group of medications used to treat angina pectoris, or chest pain). It is
    also contraindicated in men for whom sex is inadvisable and men older than
    75 years who concomitantly use potent CYP 3A4 inhibitors (such as ritonavir,
    indinavir, ketoconazole and itraconazole).2


  • The safety of vardenafil has not been studied in the following sub-groups
    of patients, and its use is therefore contraindicated until further
    information is available: those with severe hepatic impairment, endstage
    renal disease requiring dialysis, hypotension, recent history of stroke or
    myocardial infarction, unstable angina and known hereditary retinal
    degenerative disorders.


  • Levitra, researched and discovered by Bayer AG, will be marketed by Bayer
    and GlaxoSmithKline plc through a worldwide co-promotion and co-development
    agreement that the two companies signed in November 2001. Marketing
    Authorisation Applications have been approved by regulatory authorities in
    several Latin American countries and have been submitted for regulatory
    review in all major regions worldwide, including the United States and
    Japan.




About Bayer HealthCare

Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer
HealthCare, a subgroup of Bayer AG. Bayer HealthCare has annual sales amounting
to some 10 billion euro and is one of the world's leading innovators in the
health care and medical products industry. Bayer HealthCare combines the global
activities of the divisions of Bayer AG in the fields of Biological Products,
Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 employees
support the worldwide operations of Bayer HealthCare.


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 harbour 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
2002, filed with the U.S. Securities and Exchange Commission.


# # #

References


 1. Aytac IA, McKinlay JB, Krane RJ. The likely worldwide increase in erectile
    dysfunction between 1995 and 2025 and some possible policy consequences. BJU
    Int,1999;84:50-56.

 2. Summary of Product Characteristics, 7 march 2003.

 3. Valiquette L, Hellstrom W, Gittelman M, Barkin J, Thibonnier M, Padma-Nathan
    H. Vardenafil provides reliable efficacy over time in men with erectile
    dysfunction. Presented at the 10th Congress of the International Society for
    Sexual and Impotence Research, 24 September 2002, Montreal, Quebec, Canada.

 4. Southgate J. New rivals to Viagra expand the market. Scrip World
    Pharmaceutical News, 2002.





                      This information is provided by RNS
            The company news service from the London Stock Exchange