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2015-04-27

Galapagos NV: Filgotinib as monotherapy also hits primary endpoint in DARWIN 2 trial

* ACR20 scores up to 73% as once -daily monotherapy at 12 weeks
* Statistically significant ACR20 and ACR50 responses at all dose levels
* Onset of efficacy within first week of treatment in this trial
* Safety profile in DARWIN 2 consistent with previous filgotinib RA studies

Webcast presentation of the results to be held on 28 April 2015, 16.00 CET/10
AM EDT/ 8 AM PDT,
+32 2 620 0138, access code6206795
,
more
call number info further down

Mechelen, Belgium; 27 April 2015: Galapagos NV (Euronext: GLPG)
announced today that the selective JAK1 inhibitor filgotinib as once-daily
monotherapy showed rapid improvements in signs and symptoms of moderately
severe, active rheumatoid arthritis (RA) and met key efficacy endpoints after
12 weeks of treatment in the DARWIN 2 Phase 2B study. The study achieved its
primary endpoint at all doses and demonstrated statistically significant
improvements in ACR20 response versus placebo after 12 weeks of treatment.
In addition, statistically significant ACR50 response and DAS28(CRP) decrease
were achieved with all dose levels. Filgotinib was well tolerated in this
study. Hemoglobin levels increased. These first 12 week results in the
ongoing 24 week study are consistent with the efficacy and safety profile of
filgotinib observed in prior clinical studies.

DARWIN 2 is an ongoing, 24 week, double-blind, placebo-controlled evaluation
of filgotinib, as once-daily administration (QD dosing) at 3 dose levels.
Results were reported for 283 patients with moderate to severe rheumatoid
arthritis who showed an inadequate response to methotrexate. Filgotinib or
placebo was given as monotherapy. The patients were evaluated up to 12 weeks,
the time of the primary endpoint of the study. Galapagos expects to report
the full 24 week results for DARWIN 2 in the 3rdquarter of this year.

Summary of the ACR responses and DAS28(CRP) changes at 12 weeks of once-daily
monotherapy:

-------------------------------------------------------------------
| Placebo 50 mg 100 mg 200 mg |
| |
| n=72 n=72 n=70 n=69 |
| ACR20 responders, 31 67*** 66*** 73*** |
| |
|NRI, % |
| ACR50 responders, 11 36** 34** 44*** |
| |
|NRI, % |
| ACR70 responders, 4 8 19* 13 |
| |
|NRI, % |
| DAS28(CRP), -1.0 -1.7*** -2.0*** -2.3*** |
| |
|LOCF, mean change from baseline |
-------------------------------------------------------------------
* p<0.05 vs. placebo; ** p<0.01 vs. placebo; *** p<0.001 vs. placebo

ACR responses based on intent to treat (ITT) analysis, with non-responder
imputation (NRI).
Mean baseline DAS28(CRP) varied between 6.0 and 6.2. The DAS28(CRP) is
analyzed by ITT with last observation carried forward (LOCF).

The results from this study show a rapid onset of efficacy, with ACR20
response, investigator's assessment of disease and patient-reported
improvements (global assessment of disease and pain) reaching statistical
significance after one week of treatment.

Over all dose groups including placebo, 1.8% of patients stopped treatment
during the study for safety reasons. Within this low number of
discontinuations, the distribution across treatment groups is not disclosed
to avoid individual treatment unblinding while the study is ongoing. Serious
(2% overall) and non-serious treatment-emergent adverse events overall were
evenly spread over the dose groups including placebo. Infections and
infestations were the most common (15% for filgotinib vs 10% for placebo),
with only 2 (0.7%) serious infections which remain blinded for the treatment
group. Consistent with its selective JAK1 inhibition, filgotinib treatment
led to a dose-dependent improvement in hemoglobin (up to 0.4 g/dL, or 3.4%
increase from baseline). A decline in neutrophils, consistent with
anti-inflammatory activity, was observed during the first 4 weeks, with
stable levels in the normal range thereafter. No discontinuations due to
anemia, neutropenia, or increase in transaminases were reported.
Dose-dependent, well-balanced increases in LDL and HDL were observed.

"The results from the DARWIN 2 study are truly exciting, with consistent
efficacy meeting key endpoints across the different geographical regions. If
confirmed in longer-term studies, selective inhibition of JAK1 by filgotinib
may lead to a differentiated safety profile without compromising efficacy,"
said Professor Arthur Kavanaugh, MD, Professor of Medicine at the University
of California, San Diego (UCSD) School of Medicine, and Principal
Investigator for DARWIN 2.

"Once-daily monotherapy in DARWIN 2 led to similar efficacy as that observed
at the high doses in DARWIN 1, where patients took once- or twice-daily
filgotinib with methotrexate. And we found the same fast onset of action.
These data support our belief that filgotinib could be used prior to
initiating anti-TNF therapy," said Dr Piet Wigerinck, Chief Scientific
Officer of Galapagos. "Selective inhibition of JAK1 increases hemoglobin,
which is important to improve the patient's fatigue and thereby overall
condition. These 12-week monotherapy results in RA further support our
belief that filgotinib has a promising future to address a significant
medical need. We look forward to the final 24 week data for both DARWIN 1
and 2, later this year."

About the DARWIN 2 trial and its measures

The primary endpoint of the DARWIN 2 study is efficacy in terms of percentage
of subjects achieving an ACR20 response after 12 weeks of treatment. In
accordance with the protocol for the DARWIN 2 study, at week 12, all subjects
on placebo and those who received 50 mg once-daily filgotinib but did not
achieve a 20% improvement in swollen joint count and tender joint count have
been re-randomized to a 100 mg once-daily dose. Other subjects will maintain
their randomized treatment until week 24. Secondary trial objectives include
efficacy in terms of the percentage of subjects achieving an ACR20 response
at week 24, ACR50 and ACR70 response and other disease activity measures, as
well as safety and tolerability and effects on fatigue and quality of life.

The improvement of rheumatoid arthritis can be assessed using composite scores
as recommended by the American College of Rheumatology, or ACR. The ACR
criteria measure improvement in tender and swollen joint counts and include
other parameters which take into account the patient's and physician's
assessment of disease, pain, and an anti-inflammatory biomarker. These
clinical and laboratory disease activity parameters are combined to form a
composite score and are expressed as percentages of clinical response that
are known as ACR20, ACR50, and ACR70. An ACR20 score represents at least a
20% improvement in these criteria and is considered a modest improvement in a
patient's disease. An ACR50 and ACR70 represent a minimal 50% and 70%
improvement in the response criteria, respectively, and each is considered
evidence of a substantial improvement in a patient's disease.

The DAS28(CRP), or the Disease Activity Score, considers 28 tender and swollen
joint counts, general health, plus levels of an inflammatory biomarker, being
CRP. DAS28(CRP) is used to give an overall picture of the disease state,
resulting in a score on a scale from 0 to 10 indicating current RA disease
activity, whereby remission is less than or equal to 2.6, low disease
activity is less than or equal to 3.2, moderate disease activity is less
than or equal to 5.1, and high disease activity is greater than 5.1.

Conference call and webcast presentationGalapagos will conduct a conference call open to the public tomorrow, 28 April
2015, at 16:00 CET/10 AM EDT/8 AM PDT, which will also be webcast. To
participate in the conference call, please call one of the following numbers
ten minutes prior to commencement:

---------------------------------
| Confirmation Code: 6206795 |
| |
| |
---------------------------------

-------------------------------------------------
| London, United Kingdom: +44 20 3478 5300 |
| Toll free - United Kingdom: 0800 279 4841 |
| New York, NY, USA: +1 718 354 1357 |
| Toll free - USA: 1 877 280 1254 |
| Amsterdam, Netherlands: +31 20 713 2790 |
| Toll free - Netherlands: 0800 020 2576 |
| Brussels, Belgium: +32 2 620 0138 |
| Toll free - Belgium: 0800 58032 |
| Paris, France: +33 1 76 77 22 29 |
| Toll free - France: 0805 631 580 |
-------------------------------------------------
A question and answer session will follow the presentation of the results. Go
to www.glpg.com to access the live audio webcast. The archived webcast, PDF
of the slides, and a transcript will also be available on the Galapagos
website later in the day.

About Galapagos

Galapagos(Euronext: GLPG; OTC: GLPYY) 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 25 discovery
small-molecule and antibody programs in cystic fibrosis, inflammation, and
other indications. In the field of inflammation, AbbVie and Galapagos signed
a collaboration agreement for the development and commercialization
offilgotinib. 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 at
12 weeks in both the DARWIN 1 and 2 trials in RA. AbbVie and Galapagos also
signed a collaboration agreement in cystic fibrosis 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-clas...

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