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2016-01-19

Galapagos NV: Galapagos advances CF clinical development

* Initiation of Phase 1 study with corrector GLPG2222, earning Galapagos a
$10 million milestone payment from AbbVie
* Expansion of CF portfolio with three novel candidate drugs, with aim to
create the most effective combo

Mechelen, Belgium; 19 January 2016: Galapagos NV (Euronext&NASDAQ: GLPG)
provides
an update on progress made in the cystic fibrosis (CF) programs. Galapagos
and AbbVie (NYSE: ABBV) aim to develop a triple CFTR combination therapy to
address 90% of patients with CF. In order to bring a more
effective
therapy to patients, the companies plan to develop multiple candidates and
backups for each of the three components (1stgeneration correctors, next
generation correctors, and potentiators) with the goal of identifying a
potential triple
combination.
In addition to ourpotentiator
andcorrector
that are being tested in the clinic,
a total of four additional compounds have the potential to reach clinical
development in the CF program this year.

Triple combinations of CF compounds in the portfolio have consistently shown
restoration of healthy activity levels inin vitro
assays with human bronchial epithelial (HBE) cells of patients with the
F508del mutation. These combinations result in chloride transport with an
increase over Orkambi[1]in HBE cells with the homozygous F508del mutation.

First generation corrector series

Dosing to humans of GLPG2222, the first 1stgeneration corrector in Galapagos'
portfolio, started earlier this month. This achievement earns Galapagos a
$10 million milestone payment in connection with the global collaboration
agreement with AbbVie. Galapagos is conducting a randomized, double-blind,
placebo-controlled study over a range of doses of GLPG2222 in healthy
volunteers in Belgium and expects topline results in Q2 2016. Galapagos
further announces the selection of preclinical candidate GLPG2851, an
additional 1stgeneration corrector, aiming to initiate Phase 1 with this
compound by the end of 2016.

Next-generation corrector series

Galapagos announced selection of the first next-generation corrector GLPG2665
in October 2015, expected to enter Phase 1 by mid-2016.
Today Galapagos announces selection of an additional next-generation corrector
GLPG2737, expected to enter Phase 1 in healthy volunteers by Q4 2016.
Galapagos and AbbVie are also developing an alternative series of
next-generation correctors with different activity and expect to nominate
candidates and additional compounds from that series later in 2016.

Potentiator series

Galapagos has made regulatory filings for exploratory Phase 2 studies in CF
patients for potentiator GLPG1837, and has received the first approvals to
start from a number of countries. This early exploratory Phase 2 program
with GLPG1837 will be conducted in Europe in G551D and S1251N mutation types.
Additional potentiator GLPG2451 has entered preclinical development and is
expected to move into Phase 1 trials in Q2 2016.

"Galapagos and AbbVie continue to make strong progress with our cystic
fibrosis portfolio," said Onno van de Stolpe, CEO of Galapagos. "The CF
franchise has really expanded into a full-sized portfolio. The resulting
breadth, depth, and preclinical promise of this collection of modulators
brings us again closer to our aim of bringing a superior triple combination
therapy to CF patients."

About the Galapagos - AbbVie collaboration in cystic fibrosis

In September 2013 Galapagos and AbbVie, a global biopharmaceutical company,
entered into a global collaboration agreement focused on the discovery and
worldwide development and commercialization of potentiator and corrector
molecules for the treatment of CF. Under the terms of the agreement, AbbVie
made an upfront payment of $45 million to Galapagos. Upon successful
completion by Galapagos of clinical development through to completion of
Phase 2, AbbVie will be responsible for Phase 3, with financial contribution
by Galapagos. Galapagos has earned $20 million in milestone payments to date
and is eligible to receive up to $340 million in total additional payments
for developmental and regulatory milestones, sales milestones upon the
achievement of minimum annual net sales thresholds and additional tiered
royalty payments on net sales, ranging from mid-teens to 20%.

About cystic fibrosis (CF)

CF is a rare, life-threatening, genetic disease that affects approximately
80,000 patients worldwide and approximately 30,000 patients in the United
States. CF is a chronic disease that affects the lungs and digestive system.
CF patients, with significantly impaired quality of life, have an average
lifespan approximately 50% shorter than the population average, with the
median age of death at 40. There currently is no cure for CF. CF patients
require lifelong treatment with multiple daily medications, frequent
hospitalizations and ultimately lung transplant, which is life-extending but
not curative. CF is caused by a mutation in the gene for the CFTR protein,
which results in abnormal transport of chloride across cell membranes.
Transport of chloride is required for effective hydration of epithelial
surfaces in many organs of the body. Normal CFTR channel moves chloride ions
to outside of the cell. Mutant CFTR channel does not move chloride ions,
causing sticky mucous to build up on the outside of the cell. CFTR
dysfunction results in dehydration of dependent epithelial surfaces, leading
to damage of the affected tissues and subsequent disease, such as lung
disease, malabsorption in the intestinal tract and pancreatic insufficiency.

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. Our pipeline comprises three Phase 2, four Phase 1,
four pre-clinical, and 20 discovery studies in cystic fibrosis, inflammation,
fibrosis, osteoarthritis and other indications. We have discovered and
developed filgotinib: in collaboration with Gilead we aim to bring this
JAK1-selective inhibitor for inflammatory indications to patients all over
the world.

Galapagos is focused on the development and commercialization of novel
medicines that will improve people's lives. The Galapagos group, including
fee-for-service subsidiaryFidelta, has approximately 400 employees, operating
from its Mechelen, Belgium headquarters and facilities in The Netherlands,
France, and Croatia. More information atwww.glpg.com.

CONTACT

Galapagos NV

Investors:
Elizabeth Goodwin, VP IR&Corporate Communications
Cell: +1 781 460 1784

Media inquiries:
Evelyn Fox, Director Communications
Tel: +31 6 53 591 999

ir@glpg.com

Galapagos forward-looking statements

This release may contain forward-looking statements, including statements
regarding any anticipated milestone payment, the anticipated timing of
clinical studies, the potential activity of
GLPG 2222, GLPG2665,
GLPG 2737, GLPG 2851, GLPG1837, GLPG2451
and of a potential triple combination including these compounds for cystic
fibrosis. 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 clinical research programs in cystic fibrosis may not support
registration or further development of their correctors and potentiators due
to safety, efficacy or other reasons), Galapagos' reliance on collaborations
with third parties (including the performance by AbbVie under the
Galapagos-AbbVie Collaboration Agreement), and estimating the commercial
potential of our product candidates. A further list and description of these
risks, uncertainties and other risks can be found in the company's Securities
and Exchange Commission filing and reports, including in the company's
prospectus filed with the Securities and Exchange Commission on May 14, 2015
and subsequent filings and reports filed by the company with the Securities
and Exchange Commission. 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.
---------------------------------------[1] Orkambi®is a prescription medicine sold by Vertex Pharmaceuticals,
used for the treatment of cystic fibrosis (CF) in patients age 12 years and
older who have two copies of theF508del
mutation (F508del/F508del
) in theirCFTR
gene.

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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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