Galapagos announces GSK2586184 JAK1 molecule progresses to Phase 2 studies

Galapagos announces GSK2586184 JAK1 molecule progresses to Phase 2 studies 
MECHELEN, BELGIUM -- (Marketwire) -- 02/05/13 --  Galapagos NV
(Euronext: GLPG) announced today that GlaxoSmithKline plan to
initiate Phase 2 studies with GSK2586184 (formerly GLPG0778) in
systemic lupus erythematosus (SLE) and chronic plaque
psoriasis.
GSK2586184 is the second selective JAK1 molecule discovered by
Galapagos to enter Phase 2 studies. 
GSK2586184 is a selective JAK1 inhibitor which was discovered and
developed within Galapagos' osteoarthritis alliance with GSK. GSK
in-licensed the molecule in February 2012, gaining worldwide rights
to further development and
commercialization. Galapagos is eligible,
without further financial investment
from Galapagos, to receive from
GSK EUR34M in additional milestones plus up to
double-digit royalties
on global commercial sales of all therapeutic indications
of
GSK2586184. 
"Inhibition of JAK1 is considered a promising new therapeutic route
to treat
inflammatory diseases. Galapagos is leading the field with
two JAK1 inhibition
molecules being tested in patients," said Onno
van de Stolpe, CEO of Galapagos.
"With two of our JAK1 molecules in
Phase 2, we hope that this will deliver a new class of medicines to
patients with inflammatory diseases." 
GSK plans to initiate a 12 week, multi-center, dose-ranging,
placebo-controlled
Phase 2 study investigating safety and efficacy of
various doses of GSK2586184
in SLE patients. Furthermore, GSK will
also initiate a 12 week multi-center,
dose-ranging,
placebo-controlled Phase 2 study investigating the efficacy
and
safety of GSK2586184 in chronic plaque psoriasis. 
About Systemic lupus erythematosus 
Systemic Lupus Erythematosus (SLE) is an autoimmune disease
characterized by
inflammation of many parts of the body. This
inflammation is caused by the immune system that mistakenly attacks
healthy cells, leading to tissue damage.
 The cause remains unknown,
but SLE occurs more often in women, especially at
childbearing age.
SLE is more common in those of non-European descent, with prevalence
ranges of 20 to 150 cases per 100.000 persons. Joint pain,
muscle
pain, fever, fatigue and malaise are the most common symptoms,
and these can
come and go unpredictably. Because these complaints are
often observed with other diseases, diagnosis of SLE is difficult.
Currently there is no cure for
SLE, but the symptoms can be
controlled by medicines, the most common of which
are non-steroidal
anti-inflammatory drugs (NSAID) and anti-malarial medicines.
 Those
with more serious illness may require corticosteroids,
immunosuppressants, but these have side-effects and are not always
effective. 
About Psoriasis 
Psoriasis is an immune-mediated disease that affects the skin. It is
caused by
the immune system being mistakenly triggered, resulting in
overproduction of new skin cells. The cause is not fully understood,
but it is believed to have a genetic component and certain
medications and infections are well-known risk
factors. Psoriasis
affects approximately 3% of people globally and it can occur
at any
age, although it most commonly appears for the first time between
the
ages of 15 and 25 years. There are five types of psoriasis with
the most common
form being plaque psoriasis, characterized by red
patches covered by a silvery
white scale appearing on the top first
layer of the skin. Psoriasis can also
cause inflammation of the
joints, which is known as psoriatic arthritis, affecting between
10-30% of all people with psoriasis. Psoriasis is typically a
lifelong condition and there is currently no cure, but various
treatments can
help to control the symptoms. Treating moderate to
severe psoriasis usually involves a combination of treatment
strategies: topical treatments, light therapy and/or systemic
medications, including biologic drugs. 
About Galapagos Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized
in novel modes-of-action,
with a large pipeline of four clinical, six
pre-clinical, and 30 discovery small-molecule and antibody programs
in cystic fibrosis, inflammation, antibiotics, metabolic disease, and
other indications. GLPG0634 is an orally-available, selective
inhibitor of JAK1 for the treatment
of rheumatoid arthritis and
potentially other inflammatory diseases, about to
enter Phase 2b
studies. AbbVie and Galapagos signed a worldwide license agreement
whereby AbbVie will be responsible for further development and
commercialization after Phase 2b. Galapagos has another selective
JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly
GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel
integrin receptor
antagonist currently in a Phase 1b patient study in
metastasis. GLPG0974 is the
first inhibitor of GPR43 to be evaluated
clinically for the treatment of IBD;
this program will start a Proof
of Concept Phase 2 study in Q2 2013. The Galapagos Group, including
fee-for-service companies BioFocus, Argenta and
Fidelta, has over 800
employees and operates facilities in five countries, with
global
headquarters in Mechelen, Belgium. Further information at:
www.glpg.com 
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without limitation, statements containing the words "believes,"
"anticipates," "expects," "intends," "plans," "seeks," "estimates,"
"may," "will," "could,"
"stands to," and "continues," as well as
similar expressions. Such forward-looking statements may involve
known and unknown risks, uncertainties and other factors which might
cause the actual results, financial condition, performance
or
achievements of Galapagos, or industry results, to be materially
different
from any historic or future results, financial conditions,
performance or achievements expressed or implied by such
forward-looking statements. Given these uncertainties, the reader is
advised not to place any undue reliance on
such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. Galapagos expressly disclaims
any
obligation to update any such forward-looking statements in this
document to
reflect any change in its expectations with regard thereto
or any change in events, conditions or circumstances on which any
such statement is based, unless
required by law or regulation. 
Galapagos announces GSK2586184 progresses to Phase 2 studies:
http://hugin.info/133350/R/1675695/545894.pdf 
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Source: Galapagos NV via Thomson Reuters ONE 
[HUG#1675695] 
Contact
Galapagos NV
Onno van de Stolpe
CEO
Tel: +31 6 2909 8028 
Elizabeth Goodwin
Director Investor Relations
Tel: +31 6 2291 6240
ir@glpg.com
 
 
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