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GlaxoKline Reviews Novel Therapeutics for CNS Disorders and Confirms Strong Pipeline Momentum

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Check out the new drugs by GlaxoBinLaudin, especially under " depression "

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109 & STORY=/www/story/11-23-200\

4/0002499330 & EDATE=

PHILADELPHIA, Nov. 23 /PRNewswire-FirstCall/ -- Today GlaxoKline

(NYSE: GSK) gave investors and financial analysts an update on its compounds

in development to treat Central Nervous System disorders, a therapy area

that

represents approximately 20% of the company's total R & D pipeline. The CNS

seminar represents the first in a series of key therapy area updates that

GSK

will conduct once or twice a year to provide an in-depth look at segments of

its research portfolio.

Separately, the company also issued today an updated listing of all

compounds in its clinical research pipeline, which is available on the

company's website, http://www.gsk.com.

CNS Therapy Area Highlights

-- GSK's broad CNS research portfolio offers the opportunity to provide

significant patient benefit in a range of painful and debilitating

disorders for which current therapy is often inadequate.

-- New compounds have significant potential to fight

neurodegenerative

and psychiatric diseases, including the first oral integrin

antagonist for multiple sclerosis, novel treatments for Alzheimer's

disease and schizophrenia, and new mechanisms to treat depression

and anxiety.

-- '381, a new dual-acting -2 inhibitor, shows significant

efficacy

in a variety of pain models.

-- Radafaxine ('162) continues in development as a treatment for

depression. Based on clinical trial results showing weight loss,

GSK

now also expects to develop radafaxine for the treatment of

obesity.

-- Several key product launches and filings are planned for

2005-2007,

including Entereg for Post Operative Ileus; Requip/Adartrel for

Restless Leg Syndrome; Trexima, a new combination therapy for

migraine; Lamictal for schizophrenia; and Lamictal XR, an improved

once-daily formulation.

-- GSK's R & D pipeline productivity continues to increase:

-- 148 projects in clinical development, including 90 new chemical

entities (NCEs) - an 80% increase since the merger

-- 45 NCEs now in Phase II development, a 41% increase over last year

-- 21 NCEs/Vaccines in Phase III/registration, including Allermist,

Boniva, Cervarix, lapatinib, Rotarix, and Vesicare.

" Within a growing research pipeline of quality compounds that cross a

wide

range of disease areas, GlaxoKline is building a strong stable of

medicines with significant potential to fight neurodegenerative and

psychiatric diseases. With '381, for example, we have a potential best-in-

class pain medicine, " said Tachi Yamada, Chairman of R & D at GlaxoKline.

" Our scientists are developing a new oral treatment for multiple sclerosis,

novel treatments for Alzheimer's disease and schizophrenia, and new ways to

treat depression and anxiety. Our emerging CNS portfolio could potentially

make a huge difference to the lives of millions of patients. "

PAIN

Dual-acting -2 inhibitor shows strong efficacy for the treatment of

pain.

406381, a new dual-acting -2 inhibitor, is active in pre-clinical

models in both inflammatory and neuropathic pain.

In Phase II studies for rheumatoid arthritis and osteoarthritis, '381

had

better efficacy in the treatment of pain than placebo. In some

pre-determined

endpoints involving head-to-head comparisons, '381 was more effective than

celecoxib, the current market leader. An initial study in neuropathic pain

also suggested efficacy in this difficult-to-treat condition.

In these Phase II studies, the adverse event profile was similar to

celecoxib, and the overall safety evaluation supports progression to larger

studies of longer duration. The company will meet with regulatory agencies

over the next few months to finalize Phase III development plans, and will

then have better information on which to project a filing date for the

product. GSK believes '381 has the potential to become a class-leading

medicine for the treatment of pain.

DEPRESSION AND ANXIETY

Several new medicines to treat depression and anxiety in development.

Radafaxine (353162), a potent metabolite of bupropion, continues in

development as a treatment for depression. While results from Phase II

clinical trials that evaluated lower doses of radafaxine did not meet

primary

end points for efficacy, the results of secondary endpoint analysis provide

a

basis for undertaking further clinical studies at higher doses. The target

date for regulatory filing is 2007.

Importantly, in the completed Phase II trials for depression, weight

loss

was observed in obese individuals after 8 weeks compared to a small weight

gain among patients on placebo. On the basis of these data, GSK is now

planning to develop this compound for the treatment of obesity.

GSK is also continuing to investigate two novel approaches for the

treatment of anxiety and depression. One explores the potential synergistic

advantages of combining low doses of 597599, an NK1 antagonist, and a

low-dose

SSRI in the treatment of anxiety. A second approach focuses on 372475, a

first-in-class, potent, and selective serotonin, noradrenaline and dopamine

reuptake inhibitor being developed in partnership with NeuroSearch. With

this

compound, GSK expects significant efficacy in depression with the potential

to

also improve cognitive function.

MULTIPLE SCLEROSIS

The first oral integrin antagonist in development for MS.

683699, being developed in collaboration with Tanabe, is expected to be

the first oral integrin antagonist for the treatment of multiple sclerosis.

In a recent study, oral '699 matched the biomarker activity of intravenous

Antegren - the latest advance in the treatment of the disease. The compound

is in Phase IIb with filing expected in 2008.

ALZHEIMER'S DISEASE

Two novel therapies in development for neurodegenerative diseases.

GSK's 5-HT6 receptor antagonist, 742457, is highly brain penetrant, and

has been shown to enhance neurotransmitters and improve learning and memory

in

pre-clinical models. The compound has recently completed Phase I testing,

with Phase II expected to begin in 2005.

GSK is also investigating Avandia for the treatment of Alzheimer's

disease

in two clinical studies. Evidence suggests that PPARs (peroxisome

proliferator activated receptors) play a role in modulating CNS inflammation

and glucose metabolism, which may be important in Alzheimer's disease. Data

already published supports the concept that Avandia has an effect against

Alzheimer's. Therefore, GSK is conducting Phase IIb clinical trials with

Avandia for the treatment of Alzheimer's disease, with data from the first

study expected in 2005.

SCHIZOPHRENIA

Talnetant: potential novel treatment with favorable tolerability.

Talnetant is an NK3 antagonist for the treatment of schizophrenia. In

Phase II studies, a small subset of patients with high exposures to the

compound experienced good efficacy with a benign safety and tolerability

profile, including lack of weight gain. A Phase II study is underway with a

new formulation that permits higher dosing; data is expected in 2005.

Recent

data from this subset of patients also suggest that this compound has the

potential to deliver a cognitive benefit, which is increasingly recognized

as

a major disability in schizophrenic patients.

2005-2007 CNS PRODUCT FILINGS

In addition to its promising CNS research compounds, GSK also showcased

further opportunities for near-term momentum with late-stage assets and

currently marketed products:

Lamictal: Having seen encouraging results in preliminary efficacy

studies, GSK is initiating a Phase III development program for Lamictal for

adjunctive treatment of schizophrenia. In addition, Lamictal for the acute

treatment of bipolar disorder is expected to be filed in 2006. Lamictal XR,

an improved once-daily formulation, will also be filed for treatment of

epilepsy in 2006, and in 2007 for adjunctive treatment of schizophrenia and

diabetic neuropathy.

Entereg: Currently physicians lack treatments for post operative ileus

(POI), a bowel impairment occurring after abdominal and other surgery that

can

be a major contributing factor to patient discomfort (including nausea,

vomiting, bloating and constipation). POI can often prolong hospital stays,

and may pose additional costs to payers. Entereg (alvimopan) has been shown

to accelerate gastrointestinal (GI) recovery following abdominal surgery,

allowing patients to be ready to leave the hospital sooner. The FDA has

accepted for review an NDA for Entereg in the management of POI. The FDA

action date is April 25, 2005.

Entereg also appears to reduce the lower GI side effects of opioids

without interfering with the analgesic effects on the central nervous

system.

In clinical trials, Adolor and GSK are studying Entereg for opioid-induced

bowel dysfunction - the constipation and the associated symptoms of chronic

opioid use - as well as chronic constipation. Phase IIb studies are

ongoing,

and NDA submissions are targeted for 2007.

Trexima for Migraine: Developed in collaboration with Pozen, Trexima,

an

innovative formulation combining the active ingredient in Imitrex - the

current market leader - and naproxen sodium, is expected to provide superior

efficacy compared to each of the individual components alone. In a Phase II

trial, the combination of Imitrex and naproxen sodium relieved pain more

effectively than either agent administered alone, both at the 2-hour time

point, and on a sustained basis from 2-24 hours. Filing is expected in

2H2005.

Requip/Adartrel in Restless Leg Syndrome (RLS): RLS is the third most

common cause of sleep disturbance. Treatment often focuses on symptom

control, rather than on the underlying condition; 50% of patients on

medication are not treated effectively. Phase III clinical data show that

Requip/Adartrel reduced leg movements and improved outcome measures like

sleep

and quality of life, in some cases within one week of treatment.

Requip/Adartrel was approved in France in July 2004; GSK expects to gain US

approval for the treatment of RLS in 1H2005.

GlaxoKline, 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 more

information, please visit the company's web site at http://gsk.com.

Under the safe harbor provisions of the US Private Securities Litigation

Reform Act of 1995, the company cautions investors that any forward-looking

statements or projections made by the company, including those made in this

Announcement and the Meeting presentation materials to which it relates, are

subject to risks and uncertainties that may cause actual results to differ

materially from those projected. Factors that may affect the Group's

operations are described under 'Risk Factors' in the Operating and Financial

Review and Prospects in the GlaxoKline Annual Report on Form 20-F for

2003.

Without limiting the foregoing, this Announcement and the Meeting

presentation materials to which it relates contain forward-looking

statements

regarding ongoing drug discovery and development activities, the progress of

which depends in significant part on factors not fully within the Group's

control, including but not limited to the pace of clinical trial enrolment,

the nature of the results of pending and prospective preclinical and

clinical

trials, the resolution of any unusual difficulties with drug formulation or

manufacturing, the outcome of review by regulatory authorities, changes in

the

prevailing legal/regulatory climate, and the like. The Group's current

expectations and other information included in this Announcement and the

related Meeting presentation materials reflect data currently in hand, which

may be preliminary in nature, whereas the ultimate progress of

investigational

drugs through remaining stages of development to regulatory submission,

regulatory approval, and commercialization may differ materially, given

inherent risks and uncertainties.

Brand names throughout this document are trade marks of GSK or

associated

companies with the exception of Antegren, a trade mark of Elan

Pharmaceuticals; Entereg, a trade mark of Adolor Corporation; Vesicare, a

trade mark of Yamanouchi Pharmaceutical Co. Ltd.; and Boniva, a trade mark

of

F. Hoffmann-LaRoche Ltd.; which are used under license by the Group.

SOURCE GlaxoKline

Web Site: http://www.gsk.com

Company News On Call: Company News On-Call:

http://www.prnewswire.com/comp/801350.html

Link to comment
Share on other sites

Check out the new drugs by GlaxoBinLaudin, especially under " depression "

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109 & STORY=/www/story/11-23-200\

4/0002499330 & EDATE=

PHILADELPHIA, Nov. 23 /PRNewswire-FirstCall/ -- Today GlaxoKline

(NYSE: GSK) gave investors and financial analysts an update on its compounds

in development to treat Central Nervous System disorders, a therapy area

that

represents approximately 20% of the company's total R & D pipeline. The CNS

seminar represents the first in a series of key therapy area updates that

GSK

will conduct once or twice a year to provide an in-depth look at segments of

its research portfolio.

Separately, the company also issued today an updated listing of all

compounds in its clinical research pipeline, which is available on the

company's website, http://www.gsk.com.

CNS Therapy Area Highlights

-- GSK's broad CNS research portfolio offers the opportunity to provide

significant patient benefit in a range of painful and debilitating

disorders for which current therapy is often inadequate.

-- New compounds have significant potential to fight

neurodegenerative

and psychiatric diseases, including the first oral integrin

antagonist for multiple sclerosis, novel treatments for Alzheimer's

disease and schizophrenia, and new mechanisms to treat depression

and anxiety.

-- '381, a new dual-acting -2 inhibitor, shows significant

efficacy

in a variety of pain models.

-- Radafaxine ('162) continues in development as a treatment for

depression. Based on clinical trial results showing weight loss,

GSK

now also expects to develop radafaxine for the treatment of

obesity.

-- Several key product launches and filings are planned for

2005-2007,

including Entereg for Post Operative Ileus; Requip/Adartrel for

Restless Leg Syndrome; Trexima, a new combination therapy for

migraine; Lamictal for schizophrenia; and Lamictal XR, an improved

once-daily formulation.

-- GSK's R & D pipeline productivity continues to increase:

-- 148 projects in clinical development, including 90 new chemical

entities (NCEs) - an 80% increase since the merger

-- 45 NCEs now in Phase II development, a 41% increase over last year

-- 21 NCEs/Vaccines in Phase III/registration, including Allermist,

Boniva, Cervarix, lapatinib, Rotarix, and Vesicare.

" Within a growing research pipeline of quality compounds that cross a

wide

range of disease areas, GlaxoKline is building a strong stable of

medicines with significant potential to fight neurodegenerative and

psychiatric diseases. With '381, for example, we have a potential best-in-

class pain medicine, " said Tachi Yamada, Chairman of R & D at GlaxoKline.

" Our scientists are developing a new oral treatment for multiple sclerosis,

novel treatments for Alzheimer's disease and schizophrenia, and new ways to

treat depression and anxiety. Our emerging CNS portfolio could potentially

make a huge difference to the lives of millions of patients. "

PAIN

Dual-acting -2 inhibitor shows strong efficacy for the treatment of

pain.

406381, a new dual-acting -2 inhibitor, is active in pre-clinical

models in both inflammatory and neuropathic pain.

In Phase II studies for rheumatoid arthritis and osteoarthritis, '381

had

better efficacy in the treatment of pain than placebo. In some

pre-determined

endpoints involving head-to-head comparisons, '381 was more effective than

celecoxib, the current market leader. An initial study in neuropathic pain

also suggested efficacy in this difficult-to-treat condition.

In these Phase II studies, the adverse event profile was similar to

celecoxib, and the overall safety evaluation supports progression to larger

studies of longer duration. The company will meet with regulatory agencies

over the next few months to finalize Phase III development plans, and will

then have better information on which to project a filing date for the

product. GSK believes '381 has the potential to become a class-leading

medicine for the treatment of pain.

DEPRESSION AND ANXIETY

Several new medicines to treat depression and anxiety in development.

Radafaxine (353162), a potent metabolite of bupropion, continues in

development as a treatment for depression. While results from Phase II

clinical trials that evaluated lower doses of radafaxine did not meet

primary

end points for efficacy, the results of secondary endpoint analysis provide

a

basis for undertaking further clinical studies at higher doses. The target

date for regulatory filing is 2007.

Importantly, in the completed Phase II trials for depression, weight

loss

was observed in obese individuals after 8 weeks compared to a small weight

gain among patients on placebo. On the basis of these data, GSK is now

planning to develop this compound for the treatment of obesity.

GSK is also continuing to investigate two novel approaches for the

treatment of anxiety and depression. One explores the potential synergistic

advantages of combining low doses of 597599, an NK1 antagonist, and a

low-dose

SSRI in the treatment of anxiety. A second approach focuses on 372475, a

first-in-class, potent, and selective serotonin, noradrenaline and dopamine

reuptake inhibitor being developed in partnership with NeuroSearch. With

this

compound, GSK expects significant efficacy in depression with the potential

to

also improve cognitive function.

MULTIPLE SCLEROSIS

The first oral integrin antagonist in development for MS.

683699, being developed in collaboration with Tanabe, is expected to be

the first oral integrin antagonist for the treatment of multiple sclerosis.

In a recent study, oral '699 matched the biomarker activity of intravenous

Antegren - the latest advance in the treatment of the disease. The compound

is in Phase IIb with filing expected in 2008.

ALZHEIMER'S DISEASE

Two novel therapies in development for neurodegenerative diseases.

GSK's 5-HT6 receptor antagonist, 742457, is highly brain penetrant, and

has been shown to enhance neurotransmitters and improve learning and memory

in

pre-clinical models. The compound has recently completed Phase I testing,

with Phase II expected to begin in 2005.

GSK is also investigating Avandia for the treatment of Alzheimer's

disease

in two clinical studies. Evidence suggests that PPARs (peroxisome

proliferator activated receptors) play a role in modulating CNS inflammation

and glucose metabolism, which may be important in Alzheimer's disease. Data

already published supports the concept that Avandia has an effect against

Alzheimer's. Therefore, GSK is conducting Phase IIb clinical trials with

Avandia for the treatment of Alzheimer's disease, with data from the first

study expected in 2005.

SCHIZOPHRENIA

Talnetant: potential novel treatment with favorable tolerability.

Talnetant is an NK3 antagonist for the treatment of schizophrenia. In

Phase II studies, a small subset of patients with high exposures to the

compound experienced good efficacy with a benign safety and tolerability

profile, including lack of weight gain. A Phase II study is underway with a

new formulation that permits higher dosing; data is expected in 2005.

Recent

data from this subset of patients also suggest that this compound has the

potential to deliver a cognitive benefit, which is increasingly recognized

as

a major disability in schizophrenic patients.

2005-2007 CNS PRODUCT FILINGS

In addition to its promising CNS research compounds, GSK also showcased

further opportunities for near-term momentum with late-stage assets and

currently marketed products:

Lamictal: Having seen encouraging results in preliminary efficacy

studies, GSK is initiating a Phase III development program for Lamictal for

adjunctive treatment of schizophrenia. In addition, Lamictal for the acute

treatment of bipolar disorder is expected to be filed in 2006. Lamictal XR,

an improved once-daily formulation, will also be filed for treatment of

epilepsy in 2006, and in 2007 for adjunctive treatment of schizophrenia and

diabetic neuropathy.

Entereg: Currently physicians lack treatments for post operative ileus

(POI), a bowel impairment occurring after abdominal and other surgery that

can

be a major contributing factor to patient discomfort (including nausea,

vomiting, bloating and constipation). POI can often prolong hospital stays,

and may pose additional costs to payers. Entereg (alvimopan) has been shown

to accelerate gastrointestinal (GI) recovery following abdominal surgery,

allowing patients to be ready to leave the hospital sooner. The FDA has

accepted for review an NDA for Entereg in the management of POI. The FDA

action date is April 25, 2005.

Entereg also appears to reduce the lower GI side effects of opioids

without interfering with the analgesic effects on the central nervous

system.

In clinical trials, Adolor and GSK are studying Entereg for opioid-induced

bowel dysfunction - the constipation and the associated symptoms of chronic

opioid use - as well as chronic constipation. Phase IIb studies are

ongoing,

and NDA submissions are targeted for 2007.

Trexima for Migraine: Developed in collaboration with Pozen, Trexima,

an

innovative formulation combining the active ingredient in Imitrex - the

current market leader - and naproxen sodium, is expected to provide superior

efficacy compared to each of the individual components alone. In a Phase II

trial, the combination of Imitrex and naproxen sodium relieved pain more

effectively than either agent administered alone, both at the 2-hour time

point, and on a sustained basis from 2-24 hours. Filing is expected in

2H2005.

Requip/Adartrel in Restless Leg Syndrome (RLS): RLS is the third most

common cause of sleep disturbance. Treatment often focuses on symptom

control, rather than on the underlying condition; 50% of patients on

medication are not treated effectively. Phase III clinical data show that

Requip/Adartrel reduced leg movements and improved outcome measures like

sleep

and quality of life, in some cases within one week of treatment.

Requip/Adartrel was approved in France in July 2004; GSK expects to gain US

approval for the treatment of RLS in 1H2005.

GlaxoKline, 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 more

information, please visit the company's web site at http://gsk.com.

Under the safe harbor provisions of the US Private Securities Litigation

Reform Act of 1995, the company cautions investors that any forward-looking

statements or projections made by the company, including those made in this

Announcement and the Meeting presentation materials to which it relates, are

subject to risks and uncertainties that may cause actual results to differ

materially from those projected. Factors that may affect the Group's

operations are described under 'Risk Factors' in the Operating and Financial

Review and Prospects in the GlaxoKline Annual Report on Form 20-F for

2003.

Without limiting the foregoing, this Announcement and the Meeting

presentation materials to which it relates contain forward-looking

statements

regarding ongoing drug discovery and development activities, the progress of

which depends in significant part on factors not fully within the Group's

control, including but not limited to the pace of clinical trial enrolment,

the nature of the results of pending and prospective preclinical and

clinical

trials, the resolution of any unusual difficulties with drug formulation or

manufacturing, the outcome of review by regulatory authorities, changes in

the

prevailing legal/regulatory climate, and the like. The Group's current

expectations and other information included in this Announcement and the

related Meeting presentation materials reflect data currently in hand, which

may be preliminary in nature, whereas the ultimate progress of

investigational

drugs through remaining stages of development to regulatory submission,

regulatory approval, and commercialization may differ materially, given

inherent risks and uncertainties.

Brand names throughout this document are trade marks of GSK or

associated

companies with the exception of Antegren, a trade mark of Elan

Pharmaceuticals; Entereg, a trade mark of Adolor Corporation; Vesicare, a

trade mark of Yamanouchi Pharmaceutical Co. Ltd.; and Boniva, a trade mark

of

F. Hoffmann-LaRoche Ltd.; which are used under license by the Group.

SOURCE GlaxoKline

Web Site: http://www.gsk.com

Company News On Call: Company News On-Call:

http://www.prnewswire.com/comp/801350.html

Link to comment
Share on other sites

Write your congressman or MP. Don't take it lying down :)

Best,

Jim

GlaxoKline Reviews Novel Therapeutics for

CNS Disorders and Confirms Strong Pipeline Momentum

Check out the new drugs by GlaxoBinLaudin, especially under " depression "

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109 & STORY=/www/story/11-23-200\

4/0002499330 & EDATE=

PHILADELPHIA, Nov. 23 /PRNewswire-FirstCall/ -- Today GlaxoKline

(NYSE: GSK) gave investors and financial analysts an update on its

compounds

in development to treat Central Nervous System disorders, a therapy area

that

represents approximately 20% of the company's total R & D pipeline. The CNS

seminar represents the first in a series of key therapy area updates that

GSK

will conduct once or twice a year to provide an in-depth look at segments

of

its research portfolio.

Separately, the company also issued today an updated listing of all

compounds in its clinical research pipeline, which is available on the

company's website, http://www.gsk.com.

CNS Therapy Area Highlights

-- GSK's broad CNS research portfolio offers the opportunity to

provide

significant patient benefit in a range of painful and debilitating

disorders for which current therapy is often inadequate.

-- New compounds have significant potential to fight

neurodegenerative

and psychiatric diseases, including the first oral integrin

antagonist for multiple sclerosis, novel treatments for

Alzheimer's

disease and schizophrenia, and new mechanisms to treat depression

and anxiety.

-- '381, a new dual-acting -2 inhibitor, shows significant

efficacy

in a variety of pain models.

-- Radafaxine ('162) continues in development as a treatment for

depression. Based on clinical trial results showing weight loss,

GSK

now also expects to develop radafaxine for the treatment of

obesity.

-- Several key product launches and filings are planned for

2005-2007,

including Entereg for Post Operative Ileus; Requip/Adartrel for

Restless Leg Syndrome; Trexima, a new combination therapy for

migraine; Lamictal for schizophrenia; and Lamictal XR, an

improved

once-daily formulation.

-- GSK's R & D pipeline productivity continues to increase:

-- 148 projects in clinical development, including 90 new chemical

entities (NCEs) - an 80% increase since the merger

-- 45 NCEs now in Phase II development, a 41% increase over last

year

-- 21 NCEs/Vaccines in Phase III/registration, including Allermist,

Boniva, Cervarix, lapatinib, Rotarix, and Vesicare.

" Within a growing research pipeline of quality compounds that cross a

wide

range of disease areas, GlaxoKline is building a strong stable of

medicines with significant potential to fight neurodegenerative and

psychiatric diseases. With '381, for example, we have a potential best-in-

class pain medicine, " said Tachi Yamada, Chairman of R & D at

GlaxoKline.

" Our scientists are developing a new oral treatment for multiple

sclerosis,

novel treatments for Alzheimer's disease and schizophrenia, and new ways

to

treat depression and anxiety. Our emerging CNS portfolio could potentially

make a huge difference to the lives of millions of patients. "

PAIN

Dual-acting -2 inhibitor shows strong efficacy for the treatment of

pain.

406381, a new dual-acting -2 inhibitor, is active in pre-clinical

models in both inflammatory and neuropathic pain.

In Phase II studies for rheumatoid arthritis and osteoarthritis, '381

had

better efficacy in the treatment of pain than placebo. In some

pre-determined

endpoints involving head-to-head comparisons, '381 was more effective than

celecoxib, the current market leader. An initial study in neuropathic

pain

also suggested efficacy in this difficult-to-treat condition.

In these Phase II studies, the adverse event profile was similar to

celecoxib, and the overall safety evaluation supports progression to

larger

studies of longer duration. The company will meet with regulatory

agencies

over the next few months to finalize Phase III development plans, and will

then have better information on which to project a filing date for the

product. GSK believes '381 has the potential to become a class-leading

medicine for the treatment of pain.

DEPRESSION AND ANXIETY

Several new medicines to treat depression and anxiety in development.

Radafaxine (353162), a potent metabolite of bupropion, continues in

development as a treatment for depression. While results from Phase II

clinical trials that evaluated lower doses of radafaxine did not meet

primary

end points for efficacy, the results of secondary endpoint analysis

provide

a

basis for undertaking further clinical studies at higher doses. The

target

date for regulatory filing is 2007.

Importantly, in the completed Phase II trials for depression, weight

loss

was observed in obese individuals after 8 weeks compared to a small weight

gain among patients on placebo. On the basis of these data, GSK is now

planning to develop this compound for the treatment of obesity.

GSK is also continuing to investigate two novel approaches for the

treatment of anxiety and depression. One explores the potential

synergistic

advantages of combining low doses of 597599, an NK1 antagonist, and a

low-dose

SSRI in the treatment of anxiety. A second approach focuses on 372475, a

first-in-class, potent, and selective serotonin, noradrenaline and

dopamine

reuptake inhibitor being developed in partnership with NeuroSearch. With

this

compound, GSK expects significant efficacy in depression with the

potential

to

also improve cognitive function.

MULTIPLE SCLEROSIS

The first oral integrin antagonist in development for MS.

683699, being developed in collaboration with Tanabe, is expected to

be

the first oral integrin antagonist for the treatment of multiple

sclerosis.

In a recent study, oral '699 matched the biomarker activity of intravenous

Antegren - the latest advance in the treatment of the disease. The

compound

is in Phase IIb with filing expected in 2008.

ALZHEIMER'S DISEASE

Two novel therapies in development for neurodegenerative diseases.

GSK's 5-HT6 receptor antagonist, 742457, is highly brain penetrant,

and

has been shown to enhance neurotransmitters and improve learning and

memory

in

pre-clinical models. The compound has recently completed Phase I testing,

with Phase II expected to begin in 2005.

GSK is also investigating Avandia for the treatment of Alzheimer's

disease

in two clinical studies. Evidence suggests that PPARs (peroxisome

proliferator activated receptors) play a role in modulating CNS

inflammation

and glucose metabolism, which may be important in Alzheimer's disease.

Data

already published supports the concept that Avandia has an effect against

Alzheimer's. Therefore, GSK is conducting Phase IIb clinical trials with

Avandia for the treatment of Alzheimer's disease, with data from the first

study expected in 2005.

SCHIZOPHRENIA

Talnetant: potential novel treatment with favorable tolerability.

Talnetant is an NK3 antagonist for the treatment of schizophrenia. In

Phase II studies, a small subset of patients with high exposures to the

compound experienced good efficacy with a benign safety and tolerability

profile, including lack of weight gain. A Phase II study is underway with

a

new formulation that permits higher dosing; data is expected in 2005.

Recent

data from this subset of patients also suggest that this compound has the

potential to deliver a cognitive benefit, which is increasingly recognized

as

a major disability in schizophrenic patients.

2005-2007 CNS PRODUCT FILINGS

In addition to its promising CNS research compounds, GSK also

showcased

further opportunities for near-term momentum with late-stage assets and

currently marketed products:

Lamictal: Having seen encouraging results in preliminary efficacy

studies, GSK is initiating a Phase III development program for Lamictal

for

adjunctive treatment of schizophrenia. In addition, Lamictal for the

acute

treatment of bipolar disorder is expected to be filed in 2006. Lamictal

XR,

an improved once-daily formulation, will also be filed for treatment of

epilepsy in 2006, and in 2007 for adjunctive treatment of schizophrenia

and

diabetic neuropathy.

Entereg: Currently physicians lack treatments for post operative

ileus

(POI), a bowel impairment occurring after abdominal and other surgery that

can

be a major contributing factor to patient discomfort (including nausea,

vomiting, bloating and constipation). POI can often prolong hospital

stays,

and may pose additional costs to payers. Entereg (alvimopan) has been

shown

to accelerate gastrointestinal (GI) recovery following abdominal surgery,

allowing patients to be ready to leave the hospital sooner. The FDA has

accepted for review an NDA for Entereg in the management of POI. The FDA

action date is April 25, 2005.

Entereg also appears to reduce the lower GI side effects of opioids

without interfering with the analgesic effects on the central nervous

system.

In clinical trials, Adolor and GSK are studying Entereg for opioid-induced

bowel dysfunction - the constipation and the associated symptoms of

chronic

opioid use - as well as chronic constipation. Phase IIb studies are

ongoing,

and NDA submissions are targeted for 2007.

Trexima for Migraine: Developed in collaboration with Pozen, Trexima,

an

innovative formulation combining the active ingredient in Imitrex - the

current market leader - and naproxen sodium, is expected to provide

superior

efficacy compared to each of the individual components alone. In a Phase

II

trial, the combination of Imitrex and naproxen sodium relieved pain more

effectively than either agent administered alone, both at the 2-hour time

point, and on a sustained basis from 2-24 hours. Filing is expected in

2H2005.

Requip/Adartrel in Restless Leg Syndrome (RLS): RLS is the third most

common cause of sleep disturbance. Treatment often focuses on symptom

control, rather than on the underlying condition; 50% of patients on

medication are not treated effectively. Phase III clinical data show that

Requip/Adartrel reduced leg movements and improved outcome measures like

sleep

and quality of life, in some cases within one week of treatment.

Requip/Adartrel was approved in France in July 2004; GSK expects to gain

US

approval for the treatment of RLS in 1H2005.

GlaxoKline, 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 more

information, please visit the company's web site at http://gsk.com.

Under the safe harbor provisions of the US Private Securities

Litigation

Reform Act of 1995, the company cautions investors that any

forward-looking

statements or projections made by the company, including those made in

this

Announcement and the Meeting presentation materials to which it relates,

are

subject to risks and uncertainties that may cause actual results to differ

materially from those projected. Factors that may affect the Group's

operations are described under 'Risk Factors' in the Operating and

Financial

Review and Prospects in the GlaxoKline Annual Report on Form 20-F for

2003.

Without limiting the foregoing, this Announcement and the Meeting

presentation materials to which it relates contain forward-looking

statements

regarding ongoing drug discovery and development activities, the progress

of

which depends in significant part on factors not fully within the Group's

control, including but not limited to the pace of clinical trial

enrolment,

the nature of the results of pending and prospective preclinical and

clinical

trials, the resolution of any unusual difficulties with drug formulation

or

manufacturing, the outcome of review by regulatory authorities, changes in

the

prevailing legal/regulatory climate, and the like. The Group's current

expectations and other information included in this Announcement and the

related Meeting presentation materials reflect data currently in hand,

which

may be preliminary in nature, whereas the ultimate progress of

investigational

drugs through remaining stages of development to regulatory submission,

regulatory approval, and commercialization may differ materially, given

inherent risks and uncertainties.

Brand names throughout this document are trade marks of GSK or

associated

companies with the exception of Antegren, a trade mark of Elan

Pharmaceuticals; Entereg, a trade mark of Adolor Corporation; Vesicare, a

trade mark of Yamanouchi Pharmaceutical Co. Ltd.; and Boniva, a trade mark

of

F. Hoffmann-LaRoche Ltd.; which are used under license by the Group.

SOURCE GlaxoKline

Web Site: http://www.gsk.com

Company News On Call: Company News On-Call:

http://www.prnewswire.com/comp/801350.html

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Best,

Jim

GlaxoKline Reviews Novel Therapeutics for

CNS Disorders and Confirms Strong Pipeline Momentum

Check out the new drugs by GlaxoBinLaudin, especially under " depression "

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109 & STORY=/www/story/11-23-200\

4/0002499330 & EDATE=

PHILADELPHIA, Nov. 23 /PRNewswire-FirstCall/ -- Today GlaxoKline

(NYSE: GSK) gave investors and financial analysts an update on its

compounds

in development to treat Central Nervous System disorders, a therapy area

that

represents approximately 20% of the company's total R & D pipeline. The CNS

seminar represents the first in a series of key therapy area updates that

GSK

will conduct once or twice a year to provide an in-depth look at segments

of

its research portfolio.

Separately, the company also issued today an updated listing of all

compounds in its clinical research pipeline, which is available on the

company's website, http://www.gsk.com.

CNS Therapy Area Highlights

-- GSK's broad CNS research portfolio offers the opportunity to

provide

significant patient benefit in a range of painful and debilitating

disorders for which current therapy is often inadequate.

-- New compounds have significant potential to fight

neurodegenerative

and psychiatric diseases, including the first oral integrin

antagonist for multiple sclerosis, novel treatments for

Alzheimer's

disease and schizophrenia, and new mechanisms to treat depression

and anxiety.

-- '381, a new dual-acting -2 inhibitor, shows significant

efficacy

in a variety of pain models.

-- Radafaxine ('162) continues in development as a treatment for

depression. Based on clinical trial results showing weight loss,

GSK

now also expects to develop radafaxine for the treatment of

obesity.

-- Several key product launches and filings are planned for

2005-2007,

including Entereg for Post Operative Ileus; Requip/Adartrel for

Restless Leg Syndrome; Trexima, a new combination therapy for

migraine; Lamictal for schizophrenia; and Lamictal XR, an

improved

once-daily formulation.

-- GSK's R & D pipeline productivity continues to increase:

-- 148 projects in clinical development, including 90 new chemical

entities (NCEs) - an 80% increase since the merger

-- 45 NCEs now in Phase II development, a 41% increase over last

year

-- 21 NCEs/Vaccines in Phase III/registration, including Allermist,

Boniva, Cervarix, lapatinib, Rotarix, and Vesicare.

" Within a growing research pipeline of quality compounds that cross a

wide

range of disease areas, GlaxoKline is building a strong stable of

medicines with significant potential to fight neurodegenerative and

psychiatric diseases. With '381, for example, we have a potential best-in-

class pain medicine, " said Tachi Yamada, Chairman of R & D at

GlaxoKline.

" Our scientists are developing a new oral treatment for multiple

sclerosis,

novel treatments for Alzheimer's disease and schizophrenia, and new ways

to

treat depression and anxiety. Our emerging CNS portfolio could potentially

make a huge difference to the lives of millions of patients. "

PAIN

Dual-acting -2 inhibitor shows strong efficacy for the treatment of

pain.

406381, a new dual-acting -2 inhibitor, is active in pre-clinical

models in both inflammatory and neuropathic pain.

In Phase II studies for rheumatoid arthritis and osteoarthritis, '381

had

better efficacy in the treatment of pain than placebo. In some

pre-determined

endpoints involving head-to-head comparisons, '381 was more effective than

celecoxib, the current market leader. An initial study in neuropathic

pain

also suggested efficacy in this difficult-to-treat condition.

In these Phase II studies, the adverse event profile was similar to

celecoxib, and the overall safety evaluation supports progression to

larger

studies of longer duration. The company will meet with regulatory

agencies

over the next few months to finalize Phase III development plans, and will

then have better information on which to project a filing date for the

product. GSK believes '381 has the potential to become a class-leading

medicine for the treatment of pain.

DEPRESSION AND ANXIETY

Several new medicines to treat depression and anxiety in development.

Radafaxine (353162), a potent metabolite of bupropion, continues in

development as a treatment for depression. While results from Phase II

clinical trials that evaluated lower doses of radafaxine did not meet

primary

end points for efficacy, the results of secondary endpoint analysis

provide

a

basis for undertaking further clinical studies at higher doses. The

target

date for regulatory filing is 2007.

Importantly, in the completed Phase II trials for depression, weight

loss

was observed in obese individuals after 8 weeks compared to a small weight

gain among patients on placebo. On the basis of these data, GSK is now

planning to develop this compound for the treatment of obesity.

GSK is also continuing to investigate two novel approaches for the

treatment of anxiety and depression. One explores the potential

synergistic

advantages of combining low doses of 597599, an NK1 antagonist, and a

low-dose

SSRI in the treatment of anxiety. A second approach focuses on 372475, a

first-in-class, potent, and selective serotonin, noradrenaline and

dopamine

reuptake inhibitor being developed in partnership with NeuroSearch. With

this

compound, GSK expects significant efficacy in depression with the

potential

to

also improve cognitive function.

MULTIPLE SCLEROSIS

The first oral integrin antagonist in development for MS.

683699, being developed in collaboration with Tanabe, is expected to

be

the first oral integrin antagonist for the treatment of multiple

sclerosis.

In a recent study, oral '699 matched the biomarker activity of intravenous

Antegren - the latest advance in the treatment of the disease. The

compound

is in Phase IIb with filing expected in 2008.

ALZHEIMER'S DISEASE

Two novel therapies in development for neurodegenerative diseases.

GSK's 5-HT6 receptor antagonist, 742457, is highly brain penetrant,

and

has been shown to enhance neurotransmitters and improve learning and

memory

in

pre-clinical models. The compound has recently completed Phase I testing,

with Phase II expected to begin in 2005.

GSK is also investigating Avandia for the treatment of Alzheimer's

disease

in two clinical studies. Evidence suggests that PPARs (peroxisome

proliferator activated receptors) play a role in modulating CNS

inflammation

and glucose metabolism, which may be important in Alzheimer's disease.

Data

already published supports the concept that Avandia has an effect against

Alzheimer's. Therefore, GSK is conducting Phase IIb clinical trials with

Avandia for the treatment of Alzheimer's disease, with data from the first

study expected in 2005.

SCHIZOPHRENIA

Talnetant: potential novel treatment with favorable tolerability.

Talnetant is an NK3 antagonist for the treatment of schizophrenia. In

Phase II studies, a small subset of patients with high exposures to the

compound experienced good efficacy with a benign safety and tolerability

profile, including lack of weight gain. A Phase II study is underway with

a

new formulation that permits higher dosing; data is expected in 2005.

Recent

data from this subset of patients also suggest that this compound has the

potential to deliver a cognitive benefit, which is increasingly recognized

as

a major disability in schizophrenic patients.

2005-2007 CNS PRODUCT FILINGS

In addition to its promising CNS research compounds, GSK also

showcased

further opportunities for near-term momentum with late-stage assets and

currently marketed products:

Lamictal: Having seen encouraging results in preliminary efficacy

studies, GSK is initiating a Phase III development program for Lamictal

for

adjunctive treatment of schizophrenia. In addition, Lamictal for the

acute

treatment of bipolar disorder is expected to be filed in 2006. Lamictal

XR,

an improved once-daily formulation, will also be filed for treatment of

epilepsy in 2006, and in 2007 for adjunctive treatment of schizophrenia

and

diabetic neuropathy.

Entereg: Currently physicians lack treatments for post operative

ileus

(POI), a bowel impairment occurring after abdominal and other surgery that

can

be a major contributing factor to patient discomfort (including nausea,

vomiting, bloating and constipation). POI can often prolong hospital

stays,

and may pose additional costs to payers. Entereg (alvimopan) has been

shown

to accelerate gastrointestinal (GI) recovery following abdominal surgery,

allowing patients to be ready to leave the hospital sooner. The FDA has

accepted for review an NDA for Entereg in the management of POI. The FDA

action date is April 25, 2005.

Entereg also appears to reduce the lower GI side effects of opioids

without interfering with the analgesic effects on the central nervous

system.

In clinical trials, Adolor and GSK are studying Entereg for opioid-induced

bowel dysfunction - the constipation and the associated symptoms of

chronic

opioid use - as well as chronic constipation. Phase IIb studies are

ongoing,

and NDA submissions are targeted for 2007.

Trexima for Migraine: Developed in collaboration with Pozen, Trexima,

an

innovative formulation combining the active ingredient in Imitrex - the

current market leader - and naproxen sodium, is expected to provide

superior

efficacy compared to each of the individual components alone. In a Phase

II

trial, the combination of Imitrex and naproxen sodium relieved pain more

effectively than either agent administered alone, both at the 2-hour time

point, and on a sustained basis from 2-24 hours. Filing is expected in

2H2005.

Requip/Adartrel in Restless Leg Syndrome (RLS): RLS is the third most

common cause of sleep disturbance. Treatment often focuses on symptom

control, rather than on the underlying condition; 50% of patients on

medication are not treated effectively. Phase III clinical data show that

Requip/Adartrel reduced leg movements and improved outcome measures like

sleep

and quality of life, in some cases within one week of treatment.

Requip/Adartrel was approved in France in July 2004; GSK expects to gain

US

approval for the treatment of RLS in 1H2005.

GlaxoKline, 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 more

information, please visit the company's web site at http://gsk.com.

Under the safe harbor provisions of the US Private Securities

Litigation

Reform Act of 1995, the company cautions investors that any

forward-looking

statements or projections made by the company, including those made in

this

Announcement and the Meeting presentation materials to which it relates,

are

subject to risks and uncertainties that may cause actual results to differ

materially from those projected. Factors that may affect the Group's

operations are described under 'Risk Factors' in the Operating and

Financial

Review and Prospects in the GlaxoKline Annual Report on Form 20-F for

2003.

Without limiting the foregoing, this Announcement and the Meeting

presentation materials to which it relates contain forward-looking

statements

regarding ongoing drug discovery and development activities, the progress

of

which depends in significant part on factors not fully within the Group's

control, including but not limited to the pace of clinical trial

enrolment,

the nature of the results of pending and prospective preclinical and

clinical

trials, the resolution of any unusual difficulties with drug formulation

or

manufacturing, the outcome of review by regulatory authorities, changes in

the

prevailing legal/regulatory climate, and the like. The Group's current

expectations and other information included in this Announcement and the

related Meeting presentation materials reflect data currently in hand,

which

may be preliminary in nature, whereas the ultimate progress of

investigational

drugs through remaining stages of development to regulatory submission,

regulatory approval, and commercialization may differ materially, given

inherent risks and uncertainties.

Brand names throughout this document are trade marks of GSK or

associated

companies with the exception of Antegren, a trade mark of Elan

Pharmaceuticals; Entereg, a trade mark of Adolor Corporation; Vesicare, a

trade mark of Yamanouchi Pharmaceutical Co. Ltd.; and Boniva, a trade mark

of

F. Hoffmann-LaRoche Ltd.; which are used under license by the Group.

SOURCE GlaxoKline

Web Site: http://www.gsk.com

Company News On Call: Company News On-Call:

http://www.prnewswire.com/comp/801350.html

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