Galapagos doses first patient with novel CF corrector GLPG2222
(Thomson Reuters ONE) -
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 fibrosis
In 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 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, 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.
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[1] Kalydeco(®) is marketed by Vertex Pharmaceuticals
GLPG starts Phase2a study with GLPG2222:
http://hugin.info/133350/R/2075382/780345.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: 01.02.2017 - 22:01 Uhr
Sprache: Deutsch
News-ID 521471
Anzahl Zeichen: 8721
contact information:
Town:
Mechelen
Kategorie:
Business News
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