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Gilead and Galapagos Report Updated Safety Information for Filgotinib in Rheumatoid Arthritis (RA)

March 28, 2019 Off By BusinessWire

— Pooled Interim Phase 3 FINCH Program Data up to 24 Weeks and
Phase 2b DARWIN 3 Long-Term Data Add to Evidence Supporting Filgotinib
Safety Profile —

FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD)
and Galapagos NV (Euronext & NASDAQ: GLPG) today also announced interim
safety information from four studies of the investigational compound
filgotinib for the treatment of rheumatoid arthritis (RA). The data
include 24 week results of the ongoing Phase 3 FINCH 1, 2, and 3 trials,
and updated Week 156 safety data from the Phase 2b DARWIN 3 long term
extension study in patients with RA.

Week 24 safety data from the FINCH 1, 2, and 3 studies are aggregated
and summarized in the table below. Data from 3,452 patients are
reported, including 2,088 patients who received filgotinib.


	Placebo/ csDMARD N= 1039 No. (%)	Adalimumab + MTX 40mg EOW N=325 No. (%)	Filgotinib 100 mg +MTX/csDMARD N=840 No. (%)	Filgotinib 200 mg +MTX/csDMARD N=1038 No. (%)	Filgotinib 200 mg N=210 No. (%)	Filgotinib Total N=2088 No. (%)
Serious infections^&	10 (1.0)	8 (2.5)	13 (1.5)	13 (1.3)	3 (1.4)	29 (1.4)
Herpes zoster^&	4 (0.4)	2 (0.6)	5 (0.6)	6 (0.6)	1 (0.5)	12 (0.6)
DVT/PE^&	3 (0.3)	0 (0)	0 (0)	1 (0.1)^µ	0 (0)	1 (<0.1)
Death^@	2 (0.2)	0 (0)	1 (0.1)	3 (0.3)	0 (0)	4 (0.2)
Malignancy excluding NMSC^&	4 (0.4)	1 (0.3)	1 (0.1)	0 (0)	0 (0)	1 (<0.1)
MACE^&	5 (0.5)	1 (0.3)	2 (0.2)	2 (0.2)	1 (0.5)	5 (0.2)

MTX, methotrexate; EOW, every other week; csDMARD, conventional
synthetic disease-modifying antirheumatic drug; DVT, deep venous
thrombosis; PE, pulmonary embolism; NMSC, non-melanoma skin
cancer; MACE, major adverse cardiac events

^& Treatment-emergent events

^µ Excludes one retinal vein occlusion

^@ All events

The Phase 2b DARWIN 3 long term extension trial initially enrolled 739
patients, who received filgotinib 100 mg twice daily, 100 mg or 200 mg
once daily. Safety data are summarized in the table below. Results
represent treatment through 156 weeks or longer, and comprise 2,203
patient-years of exposure (PYE) to filgotinib.


					Number of Events (Events per 100 Patient-Years) PYE=2,203
Serious infections					27 (1.2)
Herpes zoster					34 (1.5)
DVT/PE					2 (0.1)
Death					5 (0.2)
Malignancy excluding NMSC					11 (0.5)
MACE					3 (0.1)

DVT, deep venous thrombosis; PE, pulmonary embolism; NMSC,
non-melanoma skin cancer; MACE, major adverse cardiac events

“The growing body of evidence from both the DARWIN 3 long-term extension
trial combined with the results of the FINCH 1, 2, and 3 trials,
represent a larger safety database in a broader population of RA
patients, spanning from those who are treatment-naive to those who have
failed biologics,” said John McHutchison, AO, MD, Chief Scientific
Officer, Head of Research and Development, Gilead Sciences.

“The available safety data from the FINCH and DARWIN 3 studies, which
together included more than 2,700 patients receiving filgotinib, suggest
that filgotinib has the potential to deliver a much needed option for
treating people living with RA,” said Dr. Walid Abi-Saab, Chief Medical
Officer, Galapagos.

Filgotinib is an investigational agent and not approved anywhere
globally. Its efficacy and safety have not been established.

About the FINCH program

The FINCH Phase 3 program is investigating the efficacy and safety of
100 mg and 200 mg filgotinib once daily, in RA patient populations
ranging from early stage to biologic-experienced patients. FINCH 1
is a 52-week, randomized, placebo- and adalimumab-controlled trial in
combination with methotrexate (MTX) enrolling 1,759 adult patients with
moderately to severely active RA who have had inadequate response to
MTX. The primary endpoint is ACR20 at week 12. The trial includes
radiographic assessment at weeks 24 and 52. FINCH 2 was a
24-week, randomized, placebo-controlled trial in 449 patients who were
receiving conventional disease-modifying anti-rheumatic drugs (cDMARD),
and had a prior inadequate response to one or more biological therapies.
The primary endpoint was ACR20 at week 12. FINCH 3 is a 52-week,
randomized trial in 1,252 MTX-naïve patients to study filgotinib in
combination with MTX, as well as monotherapy. The primary endpoint is
ACR20 at week 24. Radiographic progression is also being assessed.

About the DARWIN 3 program

DARWIN 3 is an ongoing multi-center, open-label, long-term follow-up
safety and efficacy trial of subjects who completed either DARWIN 1 or
DARWIN 2, which were double-blind, placebo-controlled Phase 2b trials
for 24 weeks of treatment in patients with moderate to severe RA who
showed an inadequate response to methotrexate. DARWIN 1 (594 patients)
evaluated filgotinib as an addition to methotrexate, as once- and
twice-daily administration (once-daily and twice-daily dosing,
respectively) at three daily dose levels. DARWIN 2 (283 patients)
evaluated filgotinib as once-daily monotherapy administration
(once-daily dosing) at three dose levels. Both DARWIN 1 and DARWIN 2
achieved the primary endpoints (ACR20).

More information about clinical trials with filgotinib can be accessed
at: www.clinicaltrials.gov.

About the Galapagos – Gilead Collaboration

Galapagos and Gilead entered into a global collaboration for the
development and commercialization of filgotinib in inflammatory
indications. The FINCH studies are among several clinical trials of
filgotinib in inflammatory diseases, including the EQUATOR Phase 2
program in psoriatic arthritis, the TORTUGA study in ankylosing
spondylitis, the DIVERSITY Phase 3 trial in Crohn’s disease (also small
bowel and fistulizing Crohn’s disease Phase 2 studies) and the Phase 3
SELECTION trial in ulcerative colitis.

About Galapagos

Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small
molecule medicines with novel modes of action, three of which show
promising patient results and are currently in late-stage development in
multiple diseases. Our pipeline comprises Phase 3 through to discovery
programs in inflammation, fibrosis, osteoarthritis and other
indications. Our ambition is to become a leading global
biopharmaceutical company focused on the discovery, development and
commercialization of innovative medicines. More information at www.glpg.com.

This press release contains inside information within the meaning of
Regulation (EU) No 596/2014 of the European Parliament and of the
Council of 16 April 2014 on market abuse (market abuse regulation).

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care
for people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters
in Foster City, California. For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com.

Galapagos Forward-Looking Statements

This release may contain forward-looking statements with respect to
Galapagos, including statements regarding Galapagos’ strategic
ambitions, the mechanism of action and potential safety and efficacy of
filgotinib, the anticipated timing of clinical studies with filgotinib
and the progression and results of such studies. 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 the ongoing and planned
clinical research programs may not support registration or further
development of filgotinib due to safety, efficacy or other reasons),
Galapagos’ reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead), 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 (SEC) filings and
reports, including in Galapagos’ most recent annual report on form 20-F
filed with the SEC and subsequent filings and reports filed by Galapagos
with the SEC. 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.

Gilead Forward-Looking Statement

This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility that the final safety results from these studies differ
materially from those reported in this press release and the possibility
of unfavorable results from other clinical trials involving filgotinib.
Further, it is possible that the parties may make a strategic decision
to discontinue development of filgotinib, and as a result, filgotinib
may never be successfully commercialized. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. These risks, uncertainties and other factors
could cause actual results to differ materially from those referred to
in the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are described
in detail in Gilead’s Annual Report on Form 10-K for the year ended
December 31, 2018, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.