Galapagos NV : Galapagos announces GSK2586184 JAK1 molecule progresses to Phase 2 studies

  Galapagos NV : Galapagos announces GSK2586184 JAK1 molecule progresses to
                               Phase 2 studies

Mechelen, Belgium; 5 February 2013  - 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 €34M 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 

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:

Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028

Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240

Galapagos forward-looking statements
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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

Galapagos announces GSK2586184 progresses to Phase 2 studies


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