- Initiation of Phase 1 study with corrector GLPG2222, earning
Galapagos a $10 million milestone payment from AbbVie
- Expansion of CF portfolio with three novel candidate drugs,
with aim to create the most effective combo
MECHELEN, Belgium, Jan. 19, 2016 (GLOBE NEWSWIRE)
-- Galapagos NV (Euronext & NASDAQ: GLPG) provides
an update on progress made in the cystic fibrosis (CF) programs.
Galapagos and AbbVie (NYSE: ABBV) aim to develop a triple CFTR
combination therapy to address 90% of patients with CF. In
order to bring a more effective therapy to patients,
the companies plan to develop multiple candidates and backups for
each of the three components (1st generation correctors, next
generation correctors, and potentiators) with the goal of
identifying a potential triple combination. In
addition to our potentiator and corrector that are being tested in
the clinic, a total of four additional compounds have the
potential to reach clinical development in the CF program this
year.
Triple combinations of CF compounds in the portfolio have
consistently shown restoration of healthy activity levels in in
vitro assays with human bronchial epithelial (HBE) cells of
patients with the F508del mutation. These combinations result
in chloride transport with an increase over Orkambi1 in HBE cells
with the homozygous F508del mutation.
First generation corrector series
Dosing to humans of GLPG2222, the first 1st generation corrector
in Galapagos' portfolio, started earlier this month. This
achievement earns Galapagos a $10 million milestone payment in
connection with the global collaboration agreement with AbbVie.
Galapagos is conducting a randomized, double-blind,
placebo-controlled study over a range of doses of GLPG2222 in
healthy volunteers in Belgium and expects topline results in Q2
2016. Galapagos further announces the selection of
preclinical candidate GLPG2851, an additional 1st generation
corrector, aiming to initiate Phase 1 with this compound by the end
of 2016.
Next-generation corrector series
Galapagos announced selection of the first next-generation
corrector GLPG2665 in October 2015, expected to enter Phase 1 by
mid-2016. Today Galapagos announces selection of an
additional next-generation corrector GLPG2737, expected to enter
Phase 1 in healthy volunteers by Q4 2016. Galapagos and
AbbVie are also developing an alternative series of next-generation
correctors with different activity and expect to nominate
candidates and additional compounds from that series later in
2016.
Potentiator series
Galapagos has made regulatory filings for exploratory Phase 2
studies in CF patients for potentiator GLPG1837, and has received
the first approvals to start from a number of countries. This
early exploratory Phase 2 program with GLPG1837 will be conducted
in Europe in G551D and S1251N mutation types. Additional
potentiator GLPG2451 has entered preclinical development and is
expected to move into Phase 1 trials in Q2 2016.
"Galapagos and AbbVie continue to make strong progress with our
cystic fibrosis portfolio," said Onno van de Stolpe, CEO of
Galapagos. "The CF franchise has really expanded into a
full-sized portfolio. The resulting breadth, depth, and
preclinical promise of this collection of modulators brings us
again closer to our aim of bringing a superior triple combination
therapy to CF patients."
About the Galapagos - AbbVie collaboration in cystic
fibrosis
In September 2013 Galapagos and AbbVie, a global
biopharmaceutical company, 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 $20 million in milestone payments to date and is eligible to
receive up to $340 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%.
About cystic fibrosis (CF)
CF is a rare, life-threatening, genetic disease that affects
approximately 80,000 patients worldwide and approximately 30,000
patients in the United States. CF is a chronic disease that
affects the lungs and digestive system. CF patients, with
significantly impaired quality of life, have an average lifespan
approximately 50% shorter than the population average, with the
median age of death at 40. There currently is no cure for
CF. CF patients require lifelong treatment with multiple
daily medications, frequent hospitalizations and ultimately lung
transplant, which is life-extending but not curative. CF is
caused by a mutation in the gene for the CFTR protein, which
results in abnormal transport of chloride across cell
membranes. Transport of chloride is required for effective
hydration of epithelial surfaces in many organs of the body.
Normal CFTR channel moves chloride ions to outside of the
cell. Mutant CFTR channel does not move chloride ions,
causing sticky mucous to build up on the outside of the cell.
CFTR dysfunction results in dehydration of dependent epithelial
surfaces, leading to damage of the affected tissues and subsequent
disease, such as lung disease, malabsorption in the intestinal
tract and pancreatic insufficiency.
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 three Phase 2, four Phase 1, four pre-clinical,
and 20 discovery studies 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 400 employees, operating from its Mechelen, Belgium
headquarters and facilities in The Netherlands, France, and
Croatia. More information at www.glpg.com.
CONTACT Galapagos NV
Investors: Elizabeth Goodwin, VP IR &
Corporate Communications Cell: +1 781 460 1784
Media inquiries: Evelyn Fox, Director Communications Tel: +31 6
53 591 999 ir@glpg.com
Galapagos forward-looking statements
This release may contain forward-looking statements, including
statements regarding any anticipated milestone payment, the
anticipated timing of clinical studies, the potential activity of
GLPG 2222, GLPG2665, GLPG 2737, GLPG 2851, GLPG1837, GLPG2451 and
of a potential triple combination including these compounds for
cystic fibrosis. 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 Galapagos' ongoing clinical
research programs in cystic fibrosis may not support registration
or further development of their correctors and potentiators due to
safety, efficacy or other reasons), Galapagos' reliance on
collaborations with third parties (including the performance by
AbbVie under the Galapagos-AbbVie Collaboration Agreement), and
estimating the commercial potential of our product
candidates. A further list and description of these risks,
uncertainties and other risks can be found in the company's
Securities and Exchange Commission filing and reports, including in
the company's prospectus filed with the Securities and Exchange
Commission on May 14, 2015 and subsequent filings and reports filed
by the company with the Securities and Exchange Commission.
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 Orkambi® is a prescription medicine sold by Vertex
Pharmaceuticals, used for the treatment of cystic fibrosis (CF) in
patients age 12 years and older who have two copies of the F508del
mutation (F508del/F508del) in their CFTR gene.
HUG#1979793
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