Re Agreement
GlaxoSmithKline PLC
15 November 2001
Issued: London and Leverkusen, 15 November 2001
GlaxoSmithKline and Bayer Announce World-wide Co-Promotion Agreement
For Vardenafil to Treat Erectile Dysfunction
GlaxoSmithKline plc (GSK) and Bayer AG today announce that they have signed a
world-wide co-promotion agreement for vardenafil, a new agent in development
for the treatment of erectile dysfunction (ED). The US Food and Drug
Administration (FDA) is currently assessing an application, submitted by
Bayer, for use of vardenafil to treat ED, and the results of this assessment
are expected in the second half of 2002. Bayer estimates global peak sales for
vardenafil of over 1 billion Euros a year.
Under the terms of the agreement and subject to local legal requirements, GSK
and Bayer will co-promote vardenafil on a world-wide basis, excluding Japan.
Bayer will manufacture the product and be responsible for all regulatory work
required to obtain product approval. Bayer will account for all sales of the
product. GSK and Bayer will share selling and future development expenses, and
both companies will share profits. The companies will form a Joint Steering
Committee to oversee marketing and future development of the product.
Commenting on the agreement, Dr Jean-Pierre Garnier, Chief Executive Officer,
GlaxoSmithKline said: 'This agreement represents a significant addition to
GlaxoSmithKline's product portfolio. Clinical data for vardenafil have
suggested that it is an effective treatment of ED in a wide range of male
patients, and we are very pleased to be able to bring this valuable new
medicine to patients in partnership with Bayer. '
Dr. David R. Ebsworth, General Manager of Bayer's global Pharmaceuticals
Business Group explained, 'vardenafil will allow us to establish ourselves in
a market with dynamic growth - the market for the therapy of erectile
dysfunction. There is no doubt that this is a highly competitive market. But
equally, I have no doubt that we will be able to offer an excellent product
for men suffering from impaired erectile function and that together with our
co-promotion partner, we will ensure the market presence necessary for success
with vardenafil'
Vardenafil, researched and developed by Bayer, is a potent and selective
phosphodiesterase-5 (PDE V) inhibitor. Its clinical development programme to
date has included eight phase III trials encompassing approximately 4000
patients. Vardenafil has reliably demonstrated good efficacy across many
populations regardless of age, severity, or cause of erectile dysfunction. For
example, men with diabetes - who are three times more likely to have ED
because of their condition - are one of the most challenging-to-treat
populations. A Phase III study of 452 men with type 1 and type 2 diabetes
showed improved erections in 72 percent of patients who took vardenafil, in
comparison to only 13 percent of patients on placebo.
Bayer submitted an application for approval of vardenafil for the treatment of
ED to the FDA, on September 24, 2001, with a parallel submission in Mexico. In
addition Bayer submitted vardenafil for review in Canada on October 26th,
2001. The companies anticipate submitting an application for approval of
vardenafil to the European Union in December 2001.
It is estimated that ED - the inability to sustain an erection sufficient for
sexual intercourse - affects more than half of all men aged over 40 years (1).
While it is estimated 140 million men world-wide are affected by ED, only one
in 20 seeks medical treatment, thus demonstrating the clear need for
additional therapies in this area.
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.
Bayer is an international, research-based group with major businesses in
health care, agriculture, polymers and specialty chemicals.
Reference:
1. Glasser D, Sweeney M. The prevalence of erectile dysfunction in four
countries: Italy, Brazil, Malaysia and Japan. Poster presented at the 1st
International Consultation on Erectile Dysfunction in Paris 1999.
GSK Enquiries:
UK Media enquiries: Martin Sutton (020) 8966 8372
Philip Thomson (020) 8966 8372
Alan Chandler (020) 8966 8372
US Media enquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
European Analyst/Investor enquiries: Jennie Younger (020) 8966 8378
Duncan
Learmouth (020) 8966 5961
Anita Kidgell (020) 8966 8369
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
Bayer Enquiries
Christina Sehnert, telephone: +49 214-30 66 102,
E-mail: christina.sehnert.cs@bayer-ag.de
--Ends--
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