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2015-09-25

Galapagos NV: Galapagos to advance filgotinib to Phase 3 in rheumatoid arthritis

* Galapagos regains all unencumbered rights to filgotinib
* Filgotinib is the most selective JAK1 inhibitor
* Best-in-class efficacy and safety in RA in 24-week Phase 2B studies in 877
patients
* Phase 3 start in RA expected in early 2016

Galapagos to hold a conference call open to the public today at 17.15
CET/11:15 AM EDT

CODE: 830162

-----------------------------
| UK: +44 330 336 6025 |
| USA: +1 719 325 2556 |
| Belgium: +32 2400 6966 |
| NL: +31 207 940454 |
| France: +33 176 7722 61 |
-----------------------------
Mechelen, Belgium; 25 September 2015: Galapagos NV (Euronext&NASDAQ: GLPG)
announced today that the Company will be moving filgotinib, its highly
selective JAK1 inhibitor, into Phase 3 in rheumatoid arthritis by early 2016.
Filgotinib has shown best-in-class efficacy and safety in the DARWIN Phase
2B studies in rheumatoid arthritis and is now fully owned by Galapagos.

Galapagos has demonstrated that high selectivity for JAK1 results in
excellent efficacy and safety in rheumatoid arthritis patients. Based on our
own human whole blood assays comparing ABT-494 to filgotinib, filgotinib is
three-fold more JAK1 selective than ABT-494. Galapagos reported
best-in-class efficacy and safety in 24-week Phase 2B studies in 877 patients
with filgotinib. Furthermore, Galapagos has more than 700 patient-years of
treatment experience with filgotinib in RA patients, of which more than 500
years at the highest 200 mg dose, all with a clean safety profile consistent
with JAK1 inhitbition: filgotinib showed a clear dose dependent increase in
hemoglobin concentration without any impact on NK cells and lymphocyte
counts.

"We see a rapid path forward in development for filgotinib, which we will be
taking into Phase 3. Galapagos is currently in advanced discussions with a
substantial number of large pharma companies to partner filgotinib. We
anticipate starting Phase 3 in rheumatoid arthritis with filgotinib early in
2016 and we are expecting data from our Phase 2B FITZROY study with
filgotinib in Crohn's disease by yearend,"said Onno van de Stolpe, CEO of
Galapagos.

On efficacy, Galapagos consistently has reported ACR scores using the most
conservative NRI approach. The table below shows the ACR scores for the
DARWIN 1 study at 24-weeks on the LOCF basis, for comparison purposes :

-------------------------------------------
| DARWIN1 (MTX-IR) ACR20 ACR50 ACR70 |
| 50mg, once-daily 61* 35** 22* |
| 100mg, once-daily 74*** 54*** 38*** |
| 200mg, once-daily 78*** 55*** 31** |
| 25mg, twice-daily 62* 38** 22* |
| 50mg, twice-daily 66* 38** 25* |
| 100mg, twice-daily 87*** 62*** 43*** |
| placebo 45 16 9 |
-------------------------------------------
* p<0.05 vs. placebo; ** p<0.01 vs. placebo; *** p<0.001 vs. placebo; ACR
scores based on LOCF analysis

AbbVie notified Galapagos today of termination of the agreement on filgotinib.Conference call and webcast presentationGalapagos will conduct a conference call open to the public today (25
September 2015) at 17:15 CET/11:15 AM EDT. To participate in the conference
call, please call one of the following numbers ten minutes prior to
commencement:
CODE: 830162

-----------------------------
| UK: +44 330 336 6025 |
| USA: +1 719 325 2556 |
| Belgium: +32 2400 6966 |
| NL: +31 207 940454 |
| France: +33 176 7722 61 |
-----------------------------
About Galapagos

Galapagos(Euronext&NASDAQ: GLPG) is a clinical-stage biotechnology company
specialized in the discovery and development of small molecule medicines with
novel modes of action, with a pipeline comprising three Phase 2 programs, two
Phase 1 trials, five pre-clinical studies, and 20 discovery small-molecule
and antibody programs in cystic fibrosis, inflammation, and other
indications. Filgotinib is an orally-available, selective inhibitor of JAK1
for the treatment of rheumatoid arthritis and potentially other inflammatory
diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn's
disease. Galapagos reported good activity and a favorable safety profile in
both the DARWIN 1 and 2 trials in RA. In the field of cystic fibrosis,
AbbVie and Galapagos signed a collaboration agreement to develop and
commercialize molecules that address mutations in the CFTR gene.
PotentiatorGLPG1837is currently in a Phase 1 trial, and corrector GLPG2222 is
at the pre-clinical candidate stage. GLPG1205, a first-in-class inhibitor of
GPR84 and fully-owned by Galapagos, is currently being tested in a Phase 2
proof-of-concept trial in ulcerative colitis patients. GLPG1690, a fully
proprietary, first-in-class inhibitor of autotaxin, has shown favorable
safety in a Phase 1 trial and is expected to enter Phase 2 in idiopathic
pulmonary fibrosis. The Galapagos Group, including fee-for-service
subsidiary Fidelta, has approximately 400 employees, operating from its
Mechelen, Belgium headquarters and facilities in The Netherlands, France, and
Croatia. More info atwww.glpg.com

CONTACT

Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications&IR
Tel: +31 6 2291 6240
ir@glpg.com

Galapagos forward-looking statements

This release may contain forward-looking statements, including without
limitation statements regarding the possibility and timing of the initiation
of Phase 3 activities in rheumatoid arthritis with filgotinib, the
possibility of partnering filgotinib with a third partyand filgotinib's
safety and/or efficacy profile. Galapagos cautions the reader that
forward-looking statements are not guarantees of future performance.
Forward-looking statements involve known and unknown risks, uncertainties and
other factors which might cause the actual results, financial condition and
liquidity, performance or achievements of Galapagos, or industry results, to
be materially different from any historic or future results, financial
conditions and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos' results,
performance, financial condition and liquidity, and the development of the
industry in which it operates are consistent with such forward-looking
statements, they may not be predictive of results or developments in future
periods. Among the factors that may result in differences are the inherent
uncertainties associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements
(including that data from Galapagos' ongoing DARWIN and FITZROY programs with
filgotinib may not support registration or further development of filgotinib
due to safety, efficacy or other reasons), Galapagos' reliance on
collaborations with third parties, and estimating the commercial potential of
Galapagos' product candidates. A further list and description of these
risks, uncertainties and other risks can be found in Galapagos' Securities
and Exchange Commission filing and reports, including in Galapagos'
prospectus filed with the SEC on May 14, 2015 and future filings and reports
by Galapagos. 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 or that may affect the
likelihood that actual results will differ from those set forth in the
forward-looking statements, unless specifically required by law or
regulation.

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Galapagos NV via Globenewswire

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