Galapagos announces that Gilead received a complete response letter for filgotinib for the treatment of moderately to severel...
August 18 2020 - 7:25PM
Galapagos announces that Gilead received a complete response letter
for filgotinib for the treatment of moderately to severely active
rheumatoid arthritis
Mechelen, Belgium; 19 August 2020,
01.25 CET; regulated information – Galapagos (Euronext &
Nasdaq: GLPG) announces today that Gilead Sciences, Inc. (Nasdaq:
GILD) received a complete response letter (CRL) from the U.S. Food
and Drug Administration (FDA) for the New Drug Application (NDA)
for filgotinib, an investigational treatment for moderately to
severely active rheumatoid arthritis (RA). The FDA issues CRLs to
indicate that the review cycle for an application is complete and
that the application is not ready for approval in its present form.
Gilead is the market authorization holder for filgotinib in the
United States and is responsible for potential commercialization in
the U.S.
The FDA has requested data from the MANTA and
MANTA-RAy studies before completing its review of the NDA. The
MANTA and MANTA-RAy studies are designed to assess whether
filgotinib has an impact on sperm parameters. The FDA also has
expressed concerns regarding the overall benefit/risk profile of
the filgotinib 200 mg dose.
“We are disappointed in this outcome and will
evaluate the points raised in the CRL for discussion with the FDA.
We continue to believe in the benefit/risk profile of filgotinib in
RA, which has been demonstrated in the FINCH Phase 3 clinical
program,” said Merdad Parsey, MD, PhD, Chief Medical Officer,
Gilead Sciences.
“This CRL issued by the FDA is very
disappointing given the robust and comprehensive data package
provided. Despite today’s news, we continue to believe filgotinib
has the potential to provide an effective, new treatment option for
patients with rheumatoid arthritis, where there remains a
significant unmet need,” said Dr. Walid Abi-Saab, Chief Medical
Officer, Galapagos.
The MANTA and MANTA-RAy studies are fully
recruited, with topline results anticipated in the first half of
2021. Filgotinib is currently under review by regulatory
authorities around the world. Filgotinib recently received a
positive opinion from the European Medicines Agency’s Committee for
Medicinal Products for Human Use, recommending marketing
authorization for filgotinib in the EU for the treatment of adults
with moderate to severe RA who have responded inadequately or are
intolerant of one or more disease-modifying anti-rheumatic
drugs.
Under the terms of the agreement with Gilead,
Galapagos is entitled to an approval milestone of $100 million for
the approval of filgotinib in the US, which was included in the
Galapagos cash burn guidance. Following this CRL, Galapagos revises
its full year 2020 operational cash burn guidance to between €490
and €520 million.
About the Filgotinib Collaboration1Gilead
and Galapagos NV are collaborative partners in the global
development and commercialization of filgotinib in rheumatoid
arthritis, and other inflammatory indications. The companies have
multiple clinical study programs for filgotinib in inflammatory
diseases, including the FINCH Phase 3 program in rheumatoid
arthritis, the Phase 3 SELECTION trial in ulcerative colitis, the
DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN
trials in psoriatic arthritis, as well as Phase 2 studies in
uveitis and in small bowel and fistulizing Crohn’s disease. More
information about clinical trials with filgotinib can be accessed
at: www.clinicaltrials.gov.
About Galapagos
Galapagos NV 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 discovery
through Phase 3 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.
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.
Contacts Galapagos Investors:
Media:Elizabeth Goodwin
Carmen Vroonen VP
IR
Global Head of Communications and Public Affairs+1 781 460
1784
+32 473 824
874
Sofie Van Gijsel
Anna GibbinsSenior Director IR
Senior Director Therapeutic Areas Communications+32 485 19 14
15
+44 7717 801900ir@glpg.com
communications@glpg.com
Galapagos Forward-Looking StatementsThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, that are subject to risks, uncertainties and other factors
that could cause actual results to differ materially from those
referred to in the forward-looking statements and, therefore, the
reader should not place undue reliance on them. These risks,
uncertainties and other factors include, without limitation, 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 with filgotinib may not support
registration or further development of filgotinib due to safety,
efficacy or other reasons), whether or when regulatory authorities
would approve marketing authorization for filgotinib after receipt
of data from MANTA and MANTA RAy studies or whether regulatory
authorities will require additional studies, Galapagos’ reliance on
collaborations with third parties (including its collaboration
partner for filgotinib, Gilead), the uncertainty regarding
estimating the commercial potential of filgotinib, that Galapagos’
expectations regarding its operational cash burn for financial year
2020 may be incorrect, as well as those risks and uncertainties
identified in our Annual Report on Form 20-F for the year ended
December 31, 2019 and our subsequent filings with the SEC. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. The
forward-looking statements contained herein are based on
management’s current expectations and beliefs and speak only as of
the date hereof, and Galapagos makes no commitment to update or
publicly release any revisions to forward-looking statements in
order to reflect new information or subsequent events,
circumstances or changes in expectations.
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).
1 Gilead & Galapagos Filgotinib Clinical Program Trial
Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3
(NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561);
PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839)
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