Tyverb -Positive EMEA Opinion

GlaxoSmithKline PLC
14 December 2007


Issued - Friday 14 December 2007, London, UK


              GLAXOSMITHKLINE RECEIVES POSITIVE EMEA OPINION FOR 
                      A CONDITIONAL APPROVAL OF TYVERB(R) 

         Announcement signals a new way to treat advanced or metastatic
                      ErbB2 (HER2)-positive breast cancer


GlaxoSmithKline (GSK) announced today that Tyverb(R) (lapatinib) has received a
positive opinion recommending a conditional marketing authorisation from the
European Medicines Agency (EMEA). Lapatinib, in combination with capecitabine,
is indicated for the treatment of patients with advanced or metastatic breast
cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive
disease following prior therapy which must include anthracyclines, taxanes and
therapy with trastuzumab in the metastatic setting. 1.

Lapatinib is the first oral, small molecule dual targeted therapy that works by
getting inside the cancer cell to inhibit both ErbB1 (EGFR) and ErbB2 (HER2),
two receptor proteins which are responsible for tumour growth. 2 This novel
mechanism of action is a new way to treat breast cancer.

"This positive opinion is fantastic news for eligible women with ErbB2-positive
breast cancer across the European Union. Thousands of women are diagnosed every
year in Europe with ErbB2 positive breast cancer and are at a greater risk of
disease progression and death compared to women with tumours that do not
overexpress this protein," said Dr Martine Piccart, Professor of Oncology,
Universite Libre de Bruxelles and Department Head, Medicine, Jules Bordet
Institute, Brussels. "Lapatinib represents an important new treatment option for
a group of patients in real need of alternative therapies and I look forward to
the day that I can prescribe lapatinib. Not only that, but this is just the
beginning given the ongoing clinical programme investigating the potential use
of lapatinib in earlier stages of the disease."

The Data Submitted

The positive opinion was based on a pivotal Phase III trial (EGF100151) in which
women with advanced or metastatic ErbB2-positive breast cancer whose disease had
progressed following prior treatment were given either the combination of
lapatinib and capecitabine, or capecitabine alone.  The data showed that the
analysis of investigator reported median time to progression (TTP) was 23.9
weeks in the lapatinib and capecitabine arm versus 18.3 weeks in the
capecitabine arm alone (hazard ratio = 0.72 p=0.00762). 3 Significance was also
shown in the independently assessed time to progression data (hazard ratio 0.57;
p=0.00013). 4, 5, 6

In addition to the achievement of the primary endpoint, results from the trial
demonstrated the associated potential to reduce the incidence of brain
metastases as the first site of recurrence in metastatic breast cancer.
Progression of brain metastases was 2% in the combination arm compared with 6%
in the capecitabine alone arm. 7 Central nervous system metastases are a major
burden for breast cancer patients. 8 These preliminary results with lapatinib
are encouraging and are the basis of ongoing research in this area.  Latest data
on the use of lapatinib and capecitabine in brain metastases will be presented
at the San Antonio Breast Cancer Symposium (SABCS) on 16 December 2007.

The most common adverse events during therapy with lapatinib plus capecitabine
were gastrointestinal (diarrhoea, nausea and vomiting) or skin disorders (rash
and hand and foot syndrome). The majority of adverse events were mild to
moderate in severity and were not significantly higher than those seen with
capecitabine monotherapy. 5

A conditional marketing authorisation is granted to a medicinal product that
fulfils an unmet medical need when the benefit to public health of immediate
availability outweighs the risk inherent in the fact that additional data are
still required. In the case of lapatinib, GSK is to provide further data from
the pivotal study and also additional demonstration of decreased incidence of
relapse in the central nervous system, for which a study will be conducted. A
conditional marketing authorisation is valid for one year. Thereafter, the
conditional marketing authorisation may be renewed annually.

"This is an extremely significant development for patients and physicians across
Europe as lapatinib, in combination with capecitabine, will play a valuable role
in treating an especially aggressive form of advanced breast cancer by providing
an effective treatment that offers added convenience as an oral therapy," said
Paolo Paoletti, SVP and Global Head of the Oncology Medicine Development Centre
at GSK.

Andrew Witty, President, Pharmaceuticals Europe, GSK and CEO designate added,
"The innovative mechanism of action of lapatinib represents a new way to treat
breast cancer patients. It is also important to note that this is GSK's second
EMEA positive opinion for a cancer treatment in a matter of months, following
the positive opinion and approval of Atriance(R) (nelarabine) in the summer.
These positive opinions underscore our commitment to develop an industry leading
oncology portfolio to address the unmet medical needs of cancer patients,
whether they be for highly prevalent or extremely rare forms of the disease."
                                 
Future for Lapatinib - Ongoing Clinical Trials

A comprehensive clinical development programme will evaluate lapatinib both
alone and in combination with other therapies (chemotherapy, hormonal therapy,
other targeted agents and VEGF inhibitors) across the spectrum of ErbB2-positive
breast cancer, from metastatic to early breast cancer.  Trials are also ongoing
and planned in a range of other solid tumours that overexpress ErbB1 and/or
ErbB2.

GSK in Oncology

GSK Oncology is dedicated to producing innovations in cancer that will make
profound differences in the lives of patients. Through GSK's revolutionary '
bench to bedside' approach, we are transforming the way treatments are
discovered and developed, resulting in one of the most robust pipelines in the
oncology sector. Our worldwide research in oncology includes partnerships with
more than 160 cancer centres. GSK is closing in on cancer from all sides with a
new generation of patient focused cancer treatments in prevention, supportive
care, chemotherapy and targeted therapies.

S M Bicknell

Company Secretary

14 December 2007


About GlaxoSmithKline

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 at http://www.gsk.com.


Notes to editors:

Tyverb(R) and Tykerb(R) are trademarks of the GlaxoSmithKline group of
companies.
Tykerb(R) is the brand name used for lapatinib in the United States and certain
other countries.

Tyverb(R) is the brand name used for lapatinib in Switzerland and is the
proposed trade name in the European Union, pending regulatory approval.

Lapatinib is approved for sale in the United States, Australia, New Zealand,
Switzerland, South Korea and certain countries in South America and the Middle
East.

Registration dossiers for lapatinib have been filed in Canada and a number of
countries in Asia, Latin America and the Middle East.

To access the latest GSK Oncology materials visit www.gskcancermedia.com


Enquiries:

UK Media enquiries:                    Philip Thomson          [phone]
                                       Claire Brough           [phone]
                                       Alice Hunt              [phone]
                                       Joss Mathieson          [phone]

US Media enquiries:                    Nancy Pekarek           [phone]
                                       Mary Anne Rhyne         [phone]

European Analyst/Investor enquiries:   David Mawdsley          [phone]
                                       Sally Ferguson          [phone]

US Analyst/ Investor enquiries:        Frank Murdolo           [phone]
                                       Tom Curry               [phone]


References:
     
1.   EMEA Summary of Opinion

2.   Konecny GE, Pegram MD, Venkatesan N, et al. Activity of the dual kinase
     inhibitor lapatinib (GW572016) against HER-2-overexpressing and
     trastuzumab-treated breast cancer cells. Cancer Res 2006;66:1630-9
     
3.   Tykerb(R) US Prescribing Information. GSK data on file.
     
4.   Crown J, Cameron D, Martin AM, et al.  Lapatinib plus capecitabine in
     HER2+ advanced breast cancer (ABC): report of updated efficacy and 
     gene-array data. Euro J Cancer Supplements 2007; 5 (4):212: abstract 
     O#2096

5.   Geyer C, Forster J, Lindquist D, Chan S, Romieu C et al.  Lapatinib
     plus capecitabine for HER2-positive advanced breast cancer. N Engl 
     J Med 2006; 355;2733-43

6.   EGF100151. A phase III, randomized, open-label, multicenter study comparing 
     GW572016 and capecitabine (Xeloda) versus capecitabine in women with 
     refractory advanced or metastatic breast cancer (03April2006 data cut-off)
     Glaxosmithkline clinical trials register 2006; Available at: http://
     ctr.gsk.co.uk/Summary/lapatinib/studylist.asp.
     
7.   Tyverb(R) Summary of Product Characteristics. GSK data on file.
     
8.   Pelletier EM, Shim B, Goodman S, Amonkar MM. Epidemiology and economic
     burden of brain metastases among patients with primary breast cancer: 
     results from a US claims data analysis. Breast Cancer Res Treat 2007



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