GlaxoSmithKline PLC
7 December 2001
Issued: Basel and London: 7th December 2001
GlaxoSmithKline and Roche Announce Co-Development and Co-Promotion Agreement
of Ibandronate for The Treatment of Postmenopausal Osteoporosis
GlaxoSmithKline plc (GSK) and Roche announced today that they have signed an
agreement to co-develop and co-promote ibandronate, currently in Phase III
clinical development, for the treatment and prevention of postmenopausal
osteoporosis.
Given the promising clinical trial results, Roche will be able to take full
advantage of the potential of this exciting and promising medicine by
collaborating with a strong development and marketing partner. Combining Roche
and GSK's development, marketing and sales capabilities will provide the
maximum added value for patients and prescribers.
'GSK has one of the strongest sales forces in the industry which be required
in order to succeed in this highly competitive market place. Roche and Glaxo
were among the first companies to adopt co-promotion in the 1980's with the
launch of Zantac in the US. We have demonstrated how we can work together
successfully', said William M. Burns, Head of Roche's Pharmaceutical Division.
Dr Jean-Pierre Garnier, Chief Executive Officer, GlaxoSmithKline said: 'We are
really pleased that Roche has chosen GSK as its partner of choice. The
addition of ibandronate enhances GSK's late-stage pipeline and we look forward
to working with Roche to bring this innovative treatment to women who suffer
from osteoporosis.'
Terms of Agreement
Under the terms of the agreement, Roche and GSK will share the future
development and registration costs for the product and Roche will receive
certain milestone payments from GSK. Roche will account for all sales of the
product. Both companies will share profits. The companies plan to file the
first drug applications with the US Food and Drug Administration and in Europe
in 2002. Subject to local legal requirements, Roche and GSK plan to co-promote
ibandronate in all countries, except Japan.
About ibandronate
Ibandronate, which is currently being developed by Roche, has been studied in
clinical trials involving over 9000 patients to date.
From the data generated there are already elements of a highly differentiated
medicine which will serve as the foundation for subsequent drug applications.
In order to bring to market a drug with innovative benefits to physicians and
patients, a further clinical development programme has been started, with the
aim of providing innovative oral and intravenous intermittent dosage regimens.
About Osteoporosis
Osteoporosis is a disease characterised by low bone mass and fragility and a
consequent increase in fracture risk (1) and disability.
It is estimated that 1 out of 3 postmenopausal women aged 50 years and older
are affected by osteoporosis. One in two women over the age of 50 will have an
osteoporosis-related fracture in their lifetime. Approximately 80% of
osteoporosis occurs in women, 20% in men.
(1) Consensus Development Conference. Prophylaxis and Treatment of
Osteoporosis. Osteoporosis International 1991 114-117.
--Ends--
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. For company
information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading
research-oriented healthcare groups in the fields of pharmaceuticals,
diagnostics and vitamins. Roche's products and services address prevention,
diagnosis and treatment of diseases, thus enhancing well-being and quality of
life. Roche sells its products in over 170 countries.
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: Duncan Learmouth (020) 8966 5961
Anita Kidgell (020) 8966 8369
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
Roche Enquiries
Corporate Communications +41 61 688 8888
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