Galapagos gives R&D Update

Galapagos gives R&D Update 
MECHELEN, BELGIUM -- (Marketwire) -- 03/27/13 --  
* Strong progress throughout clinical and preclinical portfolio 
* RA: JAK1-inhibitor GLPG0634 advances to worldwide Phase 2b study 
* IBD: novel FFA2-inhibitor GLPG0974 to start Phase 2a PoC study 
* Oncology: good safety and early signals of efficacy with GLPG0187 
* Cystic Fibrosis: discovery of superior potentiator 
* GSK advances licensed JAK1-inhibitor to Phase 2 in SLE and
psoriasis 


 
 
Live webcast presentation today at 8:00 am ET/1:00 pm CET on www.glpg.com,
                           call number 2290-1608

 
Galapagos NV (EURONEXT BRUSSELS: GLPG) will give an R&D  Update today
in New York City,  highlighting the progress and plans for its
portfolio of more than 40 research and development programs. 
Starting Phase 2b program with selective JAK1 inhibitor GLPG0634 
GLPG0634,  an orally-available, selective inhibitor of JAK1 for the
treatment of rheumatoid  arthritis and potentially  other
inflammatory diseases,  is about to enter  Phase 2b studies.  The
program consists  of 2 dose finding studies and an open  label 
follow-up  study  and  will  be conducted in multiple study
centers
worldwide.  Multiple dose levels will be tested, as well as
once daily and twice
daily  regimens, during a period  of 24 weeks. 
Details of  this program will be discussed at the R&D Update. 
Moving GLPG0974 to Phase 2a Proof of Concept 
In  a separate release today, Galapagos announced achievement of
excellent Phase
1 results  with GLPG0974, the first inhibitor  of FFA2
(formerly known as GPR43)
to  be evaluated clinically.  Galapagos
will initiate a Phase 2 Proof-of-Concept study  with GLPG0974 in
ulcerative colitis  patients next month.  The study will be completed
by the end of this year. 
Progress with GLPG0187 
In  March 2011, Galapagos initiated a Phase  1b study with its
integrin receptor
antagonist  in solid tumor  patients to explore  a
maximum tolerated  dose  and a biomarker  response.   Galapagos  will
 announce  today  that the enrollment was completed.   The study 
confirmed the  safety of  GLPG0187 (no treatment related
SAEs)  and
revealed early signs of  clinical response in glioblastoma
patients.
Based  on these results  and following requests  of the
investigators, Galapagos
has included additional patients in this
study. 
Moving cystic fibrosis program to preclinical candidate 
In  2010 Galapagos announced  that it  will pursue  cystic fibrosis 
(CF) as the first  orphan disease in which the company will discover,
develop and launch its own medicines.  This decision was based on the
successful collaboration with the US  CF Foundation.  Galapagos is
developing  small molecule therapies to address
the  major CF
mutation (delF508).  Four  separate programs are in drug
discovery
aimed  at superior correctors  and potentiators.  Galapagos
 plans to nominate a first pre-clinical candidate potentiator later
this year. 
Alliance with Lilly terminated 
In  2007, Galapagos entered  into a  global collaboration  with Lilly
to develop
novel mode of action therapies in osteoporosis.  This
alliance did not yield the expected results within an acceptable
timeframe, and therefore Galapagos decided
to  end the alliance.  The
rights to  the bone-building program have returned to Galapagos.  
During the collaboration with Lilly,  Galapagos received a total of
EUR11 M in payments. 
GSK moves selective JAK1 inhibitor GSK2586184 into Phase 2 
In 2006 Galapagos and GSK initiated a drug discovery and development
alliance to deliver  disease modifying  drugs for  GSK's global  R&D
organization. GSK in-licensed  GSK2586184 (formerly GLPG0778) and  its
corresponding back-up compound GLPG0555  in February 2012, gaining
worldwide  rights to further development and commercialization.   
GSK2586184   is  a  selective  JAK1  inhibitor  which was
discovered 
and developed within Galapagos' alliance  with GSK.  GSK initiated a
Phase  2 study with GSK2586184  in chronic plaque  psoriasis and will
initiate a Phase  2 study in systemic  lupus erythematosus (SLE). 
GSK2586184 is the second
selective  JAK1  molecule  discovered  by 
Galapagos  to  enter Phase 2 studies.
 Galapagos  is eligible,
without  further financial investment,  to receive from
GSK  EUR34 M
in additional milestones plus  up to double-digit royalties on
global
commercial sales of all therapeutic indications of GSK2586184. 
Webcast presentation 
Galapagos will hold an audio webcast presentation for journalists,
analysts, and investors  today at 8:00 am ET/1:00  pm CET, and will 
be archived on Galapagos'
website  for one year.  To access the  live
webcast, go to www.glpg.com or  click
here, call number 2290-1608. 
About Galapagos 
Galapagos  (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: 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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Galapagos gives R&D Update: 
http://hugin.info/133350/R/1688489/553964.pdf 
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[HUG#1688489] 
CONTACT 
Galapagos NV
Elizabeth Goodwin
Director Investor Relations
Tel: +31 6 2291 6240
ir@glpg.com
 
 
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