Galapagos doses first patient with novel CF corrector GLPG2222
02 February 2017 - 8:02AM
IND opening triggers $10 million milestone payment
from AbbVie
Mechelen, Belgium; 1 February 2017 -
Galapagos NV (Euronext & NASDAQ: GLPG) announces dosing of the
first patient with cystic fibrosis (CF) Class III (F508del and a
gating mutation like G551D) with novel CF corrector GLPG2222 as an
add-on to Kalydeco®[1] in a Phase 2a study. Galapagos further
announced the opening of an Investigational New Drug (IND) file
with the US Food & Drug Administration for GLPG2222, triggering
a $10 million milestone payment.
The ALBATROSS Phase 2a study is a multi-center,
randomized, double-blind, placebo-controlled, parallel group study
to evaluate two doses of orally administered GLPG2222 in adult
subjects with a diagnosis of CF harboring one F508del CFTR mutation
and one gating mutation. Up to 35 evaluable subjects are planned to
be included in the study. Eligible subjects must be on stable
treatment with physician prescribed Kalydeco for at least 28 days
at the baseline visit. They will receive one of two active doses of
GLPG2222 or placebo q.d. administered for 29 days.
The primary objective of ALBATROSS is to
evaluate safety and tolerability of GLPG2222 in patients. Secondary
objectives will include the assessment of ppFEV1, changes of sweat
chloride, and CFQ-R. Topline results are expected in Q4 2017.
"The aim of the ALBATROSS study is to enhance
our understanding of GLPG2222 in a CF patient population," said Dr.
Piet Wigerinck, Chief Scientific Officer of Galapagos. "With
ALBATROSS we expect to learn more about our dosing modelling for
the triple combination therapy; patients who participate may
potentially help other CF patients still in need of a life-changing
therapy."
The opening of the IND with the FDA forms the
basis for Galapagos and AbbVie to perform future studies with
GLPG2222 in the US, and triggers a $10 million milestone payment
from AbbVie to Galapagos.
About the Galapagos-AbbVie collaboration in
cystic fibrosisIn September 2013 Galapagos and AbbVie 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 $40 million in milestone
payments to date and is eligible to receive up to approximately
$580 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%. Galapagos has
commercial rights to China and South Korea, and has an option to
co-promote in Belgium, Netherlands, and Luxembourg.
About GalapagosGalapagos (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
& CorporateCommunications+1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com |
Paul van der HorstDirector IR & BusinessDevelopment+31 6 53 725
199 |
|
ir@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 StatementsThis release may contain
forward-looking statements, including statements regarding any
guidance given by Galapagos' management, Galapagos' strategic
ambitions, the anticipated timing of clinical studies with GLPG2222
and Galapagos' other cystic fibrosis product candidates, 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
Galapagos' product candidates due to safety, efficacy or other
reasons), Galapagos' reliance on collaborations with third parties
(including its collaboration partner for cystic fibrosis, AbbVie),
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.
[1] Kalydeco® is marketed by Vertex Pharmaceuticals
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