* 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
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
rheumatoid arthritis and potentially other inflammatory diseases, is
enter Phase 2b studies. The program consists of 2 dose finding studies
open label follow-up study and will be conducted in multiple study
worldwide. Multiple dose levels will be tested, as well as once daily and
daily regimens, during a period of 24 weeks. Details of this program
discussed at the R&D Update.
Moving GLPG0974 to Phase 2a Proof of Concept
In a separate release today, Galapagos announced achievement of excellent
1 results with GLPG0974, the first inhibitor of FFA2 (formerly known as
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
antagonist in solid tumor patients to explore a maximum tolerated dose
biomarker response. Galapagos will announce today that the
completed. The study confirmed the safety of GLPG0187 (no treatment
SAEs) and revealed early signs of clinical response in glioblastoma
Based on these results and following requests of the investigators,
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)
first orphan disease in which the company will discover, develop and
own medicines. This decision was based on the successful collaboration
US CF Foundation. Galapagos is developing small molecule therapies to
the major CF mutation (delF508). Four separate programs are in drug
aimed at superior correctors and potentiators. Galapagos plans to
first pre-clinical candidate potentiator later this year.
Alliance with Lilly terminated
In 2007, Galapagos entered into a global collaboration with Lilly to
novel mode of action therapies in osteoporosis. This alliance did not
expected results within an acceptable timeframe, and therefore Galapagos
to end the alliance. The rights to the bone-building program have
Galapagos. During the collaboration with Lilly, Galapagos received a
EUR11 M in payments.
GSK moves selective JAK1 inhibitor GSK2586184 into Phase 2
In 2006 Galapagos and GSK initiated a drug discovery and development
deliver disease modifying drugs for GSK's global R&D organization.
GSK in-licensed GSK2586184 (formerly GLPG0778) and its corresponding
GLPG0555 in February 2012, gaining worldwide rights to further
commercialization. GSK2586184 is a selective JAK1 inhibitor which
discovered and developed within Galapagos' alliance with GSK. GSK
Phase 2 study with GSK2586184 in chronic plaque psoriasis and will
Phase 2 study in systemic lupus erythematosus (SLE). GSK2586184 is the
selective JAK1 molecule discovered by Galapagos to enter Phase 2
Galapagos is eligible, without further financial investment, to receive
GSK EUR34 M in additional milestones plus up to double-digit royalties on
commercial sales of all therapeutic indications of GSK2586184.
Galapagos will hold an audio webcast presentation for journalists,
investors today at 8:00 am ET/1:00 pm CET, and will be archived on
website for one year. To access the live webcast, go to www.glpg.com or
here, call number 2290-1608.
Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is specialized in
with a large pipeline of four clinical, six pre-clinical, and 30
small-molecule and antibody programs in cystic fibrosis,
antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the
of rheumatoid arthritis and potentially other inflammatory diseases,
enter Phase 2b studies. AbbVie and Galapagos signed a worldwide
agreement whereby AbbVie will be responsible for further
commercialization after Phase 2b. Galapagos has another selective
inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly
in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin
antagonist currently in a Phase 1b patient study in metastasis. GLPG0974
first inhibitor of GPR43 to be evaluated clinically for the treatment of
this program will start a Proof of Concept Phase 2 study in Q2 2013.
The Galapagos Group, including fee-for-service companies BioFocus,
Fidelta, has over 800 employees and operates facilities in five countries,
global headquarters in Mechelen, Belgium. Further information at:
This release may contain forward-looking statements, including, without
limitation, statements containing the words "believes," "anticipates,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will,"
"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,
or achievements of Galapagos, or industry results, to be materially
from any historic or future results, financial conditions, performance or
achievements expressed or implied by such forward-looking statements.
these uncertainties, the reader is advised not to place any undue reliance
such forward-looking statements. These forward-looking statements speak
of the date of publication of this document. Galapagos expressly disclaims
obligation to update any such forward-looking statements in this document
reflect any change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is based,
required by law or regulation
Galapagos gives R&D Update:
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