Neuroscience Pipeline

GlaxoSmithKline PLC
13 December 2007



           GlaxoSmithKline Presents Innovative Neuroscience Pipeline



GlaxoSmithKline (GSK) plc today presented an overview of its neuroscience
portfolio and the company's disease area strategy to investors and analysts at a
meeting in New York.


                                   Highlights



•    Innovative neuroscience pipeline spans 13 different disease areas including
     Alzheimer's disease, depression, schizophrenia, and multiple sclerosis (MS):

-    More than 25 innovative compounds currently in development with 15 new 
     mechanisms of action



•    New "proof of concept" data presented on promising phase II compounds 
     773812 for schizophrenia and 742457 for Alzheimer's disease:

-    Both assets to progress to large-scale phase IIb trials assessing efficacy
     and safety compared to leading marketed therapies



•    Phase II programme for use of ofatumumab in multiple sclerosis announced, 
     with trials involving approximately 300 patients starting in 2008:



•    Phase III treatment, 1838262, profiled:

-    Filing for restless legs syndrome (RLS) expected in third quarter of 2008

-    New phase III programme for migraine prophylaxis planned

-    New phase II studies in neuropathic pain announced



•    Four CNS products with potential to be launched or approved in 2008:

-    Trexima potential "new gold standard" for migraine;

-    Lamictal XR new once daily treatment for epilepsy;

-    Lunivia, a successful treatment for insomnia in the US, expected to be 
     launched in Europe;

-    Requip XL the first non-ergot once daily dopamine agonist for the treatment 
     of Parkinson's disease


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•    Overall pipeline progress continues:

-    8 approvals, 8 filings and 9 key assets starting phase III trials so far 
     in 2007

-    GSK confirms FDA filing of Promacta, a new oral treatment for short-term 
     idiopathic thrombocytopaenic purpura, to be submitted shortly

-    Synflorix, a paediatric conjugate vaccine designed to provide protection 
     against pneumococcal disease and otitis media linked to non-typeable 
     Haemophilus influenzae (NTHi) remains on track to file with European and 
     International regulatory authorities before year-end


Moncef Slaoui, Chairman Research and Development, GlaxoSmithKline said: "GSK
continues to make good progress with its pipeline and today we have set out our
vision in the area of neuroscience.  Alongside vaccines, oncology and
biopharmaceuticals, this is a key area for additional R&D investment and future
growth for GSK.



"Diseases such as schizophrenia, Alzheimer's and Parkinson's disease present a
chronic and ever expanding burden to patients, care givers and healthcare
systems across the world. Every 72 seconds, a person is diagnosed with
Alzheimer's disease. The urgency to provide medical solutions for this and other
neurological diseases has never been greater," Slaoui said.



GSK will be increasing its focus in neurosciences with a significant investment
in China. GSK is building a fully integrated, end-to-end R&D center that will
employ more than 1,000 staff by 2010.  China's growing talent pool of scientific
expertise is leading to the rapid development of excellence in life sciences in
general and neuroscience in particular. GSK's R&D expansion in China will build
on ongoing work in neural stem cell research and natural product compound
libraries, and will focus on neurodegeneration (Alzheimer's and Parkinson's
disease) and neuroinflammation (MS).



Slaoui said: "Neuroscience is one of the most complex and challenging areas of
research and development. At GSK, we are moving ever closer to delivering
medicines that can alter the course of these debilitating neurological diseases
and radically change the lives of patients."


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GSK neuroscience portfolio has more than 25 compounds in clinical development
and spans a wide variety of central nervous system (CNS) diseases. Many of these
compounds have novel mechanisms of action, with the potential to offer
significant benefits to patients.



GSK presented new data and development plans for several compounds during the
seminar, including:



773812 - A potential major new treatment for schizophrenia:

Schizophrenia is a chronic psychiatric disorder. People with the disease often
suffer terrifying symptoms such as delusions, hallucinations, and jumbled or
illogical thoughts.



773812 is from the atypical antipsychotic class of medicines, and has the
potential to become a major new treatment. Current atypical antipsychotic
medicines work by blocking receptors for a variety of neurotransmitters in the
brain. However, they have variable receptor binding affinity resulting in
different efficacy and safety profiles.  GSK has developed '812 as a compound
with selectivity towards those receptors that are associated with efficacy, such
as the dopamine D2 and serotonin 5HT2 receptors, whilst having minimal activity
on receptors believed to be responsible for side-effects, such as dopamine D1,
histamine H1, muscarinic M1, alpha and beta adrenergic receptors.  This profile
has the potential to deliver efficacy similar to the present antipsychotics
without troublesome tolerability problems such as sedation, metabolic
disturbance, impaired cognition and orthostatic hypotension.



Two studies to assess the efficacy and safety of '812 compared to placebo and
olanzapine, a commonly used atypical antipsychotic, in patients with acute
schizophrenia have been completed. In these studies, '812 produced a
statistically significant improvement in patients compared to placebo (p<0.05),
as measured by the Positive and Negative Symptom Scale (PANSS).



Compound '812 was generally well tolerated. In particular, '812 was not
associated in either study with metabolic-related effects, such as weight gain
and blood lipid increases, which are common side effects of antipsychotic
treatments. In one study, patients receiving 60 mg daily of '812 experienced a
decrease of 1.0kg in body weight, which was a statistically significant change
compared to patients receiving placebo or olanzapine, whose body weight
increased by 0.9kg and 2.2kg respectively. In addition, patients receiving '812
did not show an increase in triglycerides or cholesterol levels.



The development programme for '812 continues with phase IIb trials, which are
expected to demonstrate benefits versus two commonly used treatments for
schizophrenia.  These trials are expected to start in 2008.



742457 - A novel treatment to delay the symptoms of Alzheimer's disease:

Alzheimer's disease is a devastating neurological condition, with significant
consequences on the quality of life for sufferers and their care givers. GSK has
a broad programme of research ongoing in Alzheimer's disease, including 742457,
a novel treatment that selectively targets the 5HT6 receptors concentrated
within the brain.  These receptors are associated with learning and memory.
Currently available treatments, such as cholinesterase inhibitors, are not brain
specific and alter the cholinergic system throughout the body leading to
possible side effects, particularly gastrointestinal side effects.



Results from a phase II placebo-controlled dose-ranging study in 371 patients
demonstrated that over a 24-week treatment period, patients receiving 35mg doses
of '457 showed statistically significant improvements in global function
compared to placebo as measured by the CIBIC+.  The CIBIC+ is a clinician-rated
scale which assesses global improvement, including input from patients' care
givers. All doses of '457 appeared generally well tolerated, with a low overall
incidence of adverse events.



Another phase II trial comparing 15-35mg of '457, and 5-10mg of donepezil, a
commonly used cholinesterase inhibitor, to placebo demonstrated that over a
24-week treatment period, patients receiving '457 had similar improvements in
global function and cognitive function compared to patients receiving donepezil.



These data demonstrate the potential of '457 for use in the treatment of
Alzheimer's disease. Two large phase II trials investigating the potential of '
457 as monotherapy and as adjunctive therapy in patients with mild-to-moderate
Alzheimer's disease are expected to start next year.



Also for the treatment of Alzheimer's disease, initial results from the ongoing
phase III development programme for rosiglitazone XR are anticipated in 2009.
Rosiglitazone XR is being studied as monotherapy, compared with donepezil and
placebo.  Two additional phase III studies with rosiglitazone XR as an adjunct
therapy are ongoing.



1838262 - Potential new treatment for RLS, neuropathic pain and migraine:

Neuropathic pain is caused by nerve injury resulting from conditions such as
shingles and diabetes. Gabapentin is one of the most widely used treatments for
neuropathic pain; however it is only effective in some patients.  GSK, in
collaboration with XenoPort, is developing a new chemical entity, 1838262
(XP13512), which utilises a novel transport mechanism to enable '262 to be
efficiently absorbed into the body where it is converted to gabapentin.  The
improved drug exposure provided by '262 offers the potential for improved
treatment of neuropathic pain and possibly other neurological disorders.


GSK and XenoPort are developing '262 for a number of different indications. The
most advanced of these is for the treatment of restless legs syndrome (RLS).
GSK expects to file '262 for use in this indication with the FDA in the third
quarter of 2008.



As a result of published studies demonstrating that gabapentin has potential
benefit in the prophylactic treatment of migraine attacks and chronic daily
headaches, together with the favourable tolerability profile seen with '262, GSK
plans to initiate a phase III clinical development programme to study the use of
'262 for migraine prophylaxis during 2008.



Preliminary data assessing '262 for treatment of neuropathic pain were also
presented at the seminar that showed a significant reduction (p=0.032) in the
pain score of patients receiving '262 compared to placebo. Development in this
indication will continue with further phase II studies scheduled to commence in
the first quarter of 2008 assessing use of '262 for the treatment of
post-herpetic neuralgia and painful diabetic neuropathy.



Ofatamumab & firategrast - Promising compounds for the treatment of MS:

Few treatments exist for MS, a chronic and debilitating neurological disease,
which means there is a significant medical need for more effective and more
convenient treatments.



Ofatumumab (HuMax-CD20), a promising monoclonal antibody, will move into phase
II development early in 2008, exploring its potential in patients with
relapsing-remitting MS.  The programme, to be conducted in approximately 300
patients, will comprise two stages: an initial safety phase, followed by a
larger placebo-controlled study/phase to evaluate efficacy.  Scientific
literature provides evidence supporting the role of B-cells in MS and the
potential of antibody therapies that target and bind to CD20 antigens.  This
evidence, together with the unique binding of ofatumumab and its potential to
cause no or a low immune response, could result in a significant new treatment
option for patients.



A phase II study with firategrast, a dual alpha4 integrin antagonist (VLA4), in
MS is ongoing in 13 countries.  Comprising 350 patients, the study aims to
provide proof-of-concept data supporting the potential for this treatment.
Firategrast has the same proven mechanism of action as a leading MS treatment,
natalizumab, but could offer a preferred oral formulation with a superior
tolerability profile.  Data from this study are anticipated in 2009.



Other pipeline news:

At the seminar today, GSK also provided an update on progress made this year on
its overall pipeline. So far in 2007, the company has gained 8 key approvals,
submitted 8 regulatory filings and started new phase III trials for 9 key
assets:


Key Approvals                      Filings                              Phase III commenced
Altabax/Altargo (US & EU)          Avodart plus alpha blocker           1838262 (RLS)
                                   co-prescription (US & EU)
Arixtra ACS (EU)                   Cervarix (US)                        Belimumab (SLE)
Veramyst (US)                      Gepirone ER (US)                     Elesclomol (STA-4783) (melanoma)
Cervarix (EU)                      H5N1 (EU)                            MAGE-A3 therapeutic vaccine (NSCLC)
ReQuip XL (EU)                     Lunivia (EU)                         MenACWY-TT meningitis vaccine
Seretide TORCH (EU)                Volibris (EU)                        Ofatumumab (RA)
Tykerb (US)                        Requip XL (PD) (US)                  Promacta (hep c)
Wellbutrin XR (EU)                 Rotarix (US)                         Tykerb (H&N cancer)
                                                                        Tykerb + Pazopanib (IBC)



Before year-end, GSK will submit a regulatory filing to the FDA for Promacta,
its first-in-class, oral platelet  growth factor, for short-term treatment of
patients with idiopathic thrombocytopaenic purpura, a condition which results in
low blood platelet counts and bleeding from the small blood vessels. The company
also confirmed that it expects to file the vaccine Synflorix with European and
International regulatory authorities by the end of the year.  The vaccine is
designed to protect against pneumococcal disease and otitis media caused by
non-typeable Haemophilus influenzae (NTHi). Otitis media is a major burden to
health care systems and a leading cause of antibiotic prescriptions among
children under five years in Europe.





Enquiries:

UK Media enquiries:                  Philip Thomson          [phone]
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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]








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