sNDA filing 1x monthly Boniva

GlaxoSmithKline PLC
26 May 2004



Issued -   Wednesday 26 May 2004, London, UK & Basel, Switzerland  - LSE
Announcement



Supplemental New Drug Application For Once-Monthly BonivaTM In Osteoporosis
Submitted To FDA



Roche (ROG.VX) and GlaxoSmithKline plc (LSE and NYSE: GSK) announced today the
submission of a supplemental new drug application (sNDA) with the U.S. Food and
Drug Administration (FDA) for a novel, once-monthly oral formulation of its
bisphosphonate, BonivaTM tablets (ibandronate sodium), for the treatment and
prevention of postmenopausal osteoporosis. The FDA approved the once-daily
formulation in May 2003, and the companies have been exploring more convenient
dosing options before launching the product.


"Boniva is expected to be the first once-monthly treatment for osteoporosis,
offering better convenience and potentially enhanced compliance to patients,"
commented William M. Burns, Head of Roche's pharmaceuticals division.  "We plan
to file once-monthly oral Bonviva(R) in Europe later this year."


In December 2001, Roche and GSK announced that they would co-develop and
co-promote Boniva for the treatment and prevention of postmenopausal
osteoporosis in all countries, except Japan.  The Roche/GSK collaboration
provides expertise and commitment to bring new osteoporosis therapies to market
as quickly as possible.


S M Bicknell
Company Secretary
26th May 2004



About Roche:

Headquartered in Basel, Switzerland, Roche is one of the world's leading
innovation-driven healthcare groups. Its core businesses are pharmaceuticals and
diagnostics. Roche is number one in the global diagnostics market, the leading
supplier of pharmaceuticals for cancer and a leader in virology and
transplantation. As a supplier of products and services for the prevention,
diagnosis and treatment of disease, the Group contributes on a broad range of
fronts to improving people's health and quality of life. Roche employs roughly
65,000 people in 150 countries. The Group has alliances and R&D agreements with
numerous partners, including majority ownership interests in Genentech and
Chugai.


About GSK:

GSK, 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
GSK on the World Wide Web at www.gsk.com


Notes to Editors:

BonivaTM is the US tradename.  Bonviva(R) is the European tradename.



GlaxoSmithKline Enquiries:

UK Media enquiries:                                Martin Sutton                  [phone]
                                                   David Mawdsley                 [phone]
                                                   Chris Hunter-Ward              [phone]

European Analyst/Investor enquiries:               Duncan Learmouth               [phone]
                                                   Anita Kidgell                  [phone]
                                                   Philip Thomson                 [phone]



Roche Enquiries:

European Media enquiries:                          Roche Group Media Office       [phone]
European Analyst/Investor enquiries:               Karl Mahler                    [phone]








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