Phase 3 study with filgotinib initiated in Crohn's disease
(Thomson Reuters ONE) -
First patient dosed triggers $50 million milestone payment
Mechelen, Belgium; 22 November 2016 - Galapagos NV (Euronext & NASDAQ: GLPG)
reports the first dosing of a patient in the DIVERSITY Phase 3 study with
filgotinib in Crohn's disease (CD). The start of the DIVERSITY study triggers a
$50 million milestone payment from Gilead.
The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of
100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients
with moderately to severely active Crohn's disease, including those with prior
biological therapy failure.
"With the FITZROY Phase 2 study, Galapagos demonstrated that filgotinib has a
promising efficacy and safety profile in Crohn's disease. The start of the Phase
3 DIVERSITY study is good news for patients with Crohn's disease," said Dr Piet
Wigerinck, CSO of Galapagos. "We look forward to seeing the results of
DIVERSITY."
Galapagos and Gilead entered into a global collaboration for the development and
commercialization of filgotinib in inflammatory indications. In addition to the
DIVERSITY study, Gilead initiated the FINCH Phase 3 program in rheumatoid
arthritis in August 2016 and is expected to start the SELECTION Phase 2b/3 study
in ulcerative colitis later this quarter.
Filgotinib is an investigational drug and its efficacy and safety have not been
established.
For information about the studies with filgotinib in IBD: www.clinicaltrials.gov
For more information about filgotinib: www.glpg.com/filgotinib
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 a pipeline of Phase 3, Phase 2,
Phase 1, pre-clinical, and discovery programs 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
subsidiary Fidelta, has approximately 480 employees, operating from its
Mechelen, Belgium headquarters and facilities in The Netherlands, France, and
Croatia. More information at www.glpg.com.
Contacts
Investors: Media:
Elizabeth Goodwin Evelyn Fox
VP IR & Corporate Director Communications
Communications +31 6 53 591 999
+1 781 460 1784 communications(at)glpg.com
Paul van der Horst
Director IR & Business
Development
+31 6 53 725 199
ir(at)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).
Forward-Looking Statements
This release may contain forward-looking statements, including statements
regarding any guidance given by Galapagos' management, 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 in rheumatoid arthritis, Crohn's disease and/or ulcerative colitis 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.
Phase 3 study with filgotinib initiated in Crohn's disease:
http://hugin.info/133350/R/2058707/771584.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 22.11.2016 - 22:00 Uhr
Sprache: Deutsch
News-ID 508728
Anzahl Zeichen: 6866
contact information:
Town:
Mechelen
Kategorie:
Business News
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