PHILADELPHIA and LONDON, Dec. 13 /PRNewswire-FirstCall/ --
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 program 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 program 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
-- 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."
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 60mg 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 program 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 program 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 program 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 utilizes 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 favorable tolerability profile
seen with '262, GSK plans to initiate a phase III clinical development
program 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 program, 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 Avodart plus alpha 1838262 (RLS)
(US & EU) blocker 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 Volibris (EU) Ofatumumab (RA)
(EU)
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.
SOURCE GlaxoSmithKline
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