Orphan Drug Designation for GLPG1690 in systemic sclerosis
January 29 2020 - 2:00AM
Orphan Drug Designation for GLPG1690 in systemic sclerosis
Mechelen, Belgium; 29 January 2020, 8.00 CET
– Galapagos NV (Euronext & NASDAQ: GLPG) announces today that
the US Food & Drug Administration (FDA) and the European
Commission (EC) have granted investigational autotaxin inhibitor
GLPG1690 ‘orphan drug designation’ for the treatment of systemic
sclerosis (SSc).
In order to stimulate the pharmaceutical
industry to develop and market medicines for diseases affecting a
small number of patients, the EC and the FDA offer a range of
incentives to encourage the development of these ‘orphan’ medicines
for rare diseases in the European Union and the United States.
These incentives include amongst others 7 to 10
years of market exclusivity once the medicine is on the market,
regulatory fee reductions and fee waivers and access to the
centralized procedure for marketing authorization in Europe.1,2
“We are happy to see that the EC and FDA
recognize GLPG1690 as a potential new treatment for SSc patients.
With the NOVESA Phase 2 trial in SSc fully recruited, we expect to
see topline data in the second half of the year,” said Dr.
Walid-Abi-Saab, CMO of Galapagos.
About SScDiffuse cutaneous systemic
sclerosis (SSc) is an autoimmune disease involving multiorgan
fibrosis, which has one of the highest mortality rates among
rheumatic diseases.3 One of the most visible manifestions is
hardening of the skin. In diffuse cutaneous SSc, skin thickening
affects several body areas, and patients have a higher risk of
developing fibrosis of various internal organs, such as the lung.
Currently, there are no approved drugs for this disease. SSc
affects approximately 90,000 patients in the US and Europe, with a
predominance of female patients (75%).
About GLPG1690
GLPG1690 is an investigational small molecule,
selective autotaxin inhibitor that was inlicensed by Gilead
Sciences, Inc. as part of the global R&D collaboration between
Galapagos & Gilead. Autotaxin is the main enzyme responsible
for lysophosphatidic acid (LPA) production. LPA is a well-known
pro-fibrotic and pro-inflammatory lipid, acting through at least 6
g-protein coupled receptors. Galapagos identified the autotaxin
target using its proprietary target discovery platform and
developed molecule GLPG1690 as an inhibitor of this target.
GLPG1690 is currently being studied in a global Phase 3 program in
idiopathic pulmonary fibrosis (ISABELA) as well as in the NOVESA
Phase 2 trial.
GLPG1690 is an investigational drug and its
efficacy and safety have not been established by any regulatory
agency.
For more information about GLPG1690: www.glpg.com/glpg-1690
For information about the studies with GLPG1690 in systemic
sclerosis: www.clinicaltrials.gov
About GalapagosGalapagos (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. Galapagos’ pipeline comprises discovery programs through
Phase 3 programs in inflammation, fibrosis, osteoarthritis and
other indications. The Company’s ambition is to become a leading
global biopharmaceutical company focused on the discovery,
development and commercialization of innovative medicines.
Contact
Investors:Elizabeth GoodwinVP Investor Relations +1 781
460 1784
Sofie Van GijselDirector Investor Relations+32 485 19 14
15ir@glpg.com
Media:Carmen VroonenSenior Director Communications &
Public Affairs+32 473 824 874
Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com
Forward-looking statements
This release may contain forward-looking
statements, including, among other things, statements regarding
Galapagos' strategic ambitions, the mechanism of action and
potential activity of GLPG1690, the anticipated timing of clinical
trials with GLPG1690, the progression and results of such trials,
future regulatory submissions and Galapagos' interactions with
regulatory authorities. 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 that Galapagos’ expectations
regarding its GLPG1690 development program may be incorrect, 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 may not support registration or further
development of GLPG1690 due to safety, efficacy or other reasons),
Galapagos’ reliance on collaborations with third parties (including
its collaboration partner for GLPG1690, Gilead), and estimating the
commercial potential of GLPG1690. 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 other 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.
1 Source: www.ema.europe.eu2 Source : www.fda.gov3
Nikpour et al. Curr Opin Rheumatol. 2014
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