Galapagos and AbbVie expand their cystic fibrosis collaboration
April 29 2016 - 1:04AM
- Strong commitment from Galapagos and AbbVie to
accelerate development of a triple combination
therapy
- Expanded portfolio shows promise for breakthrough
therapy
- Milestones increased from $350 to $600
million
- Patient trials expected to start in 2017
Galapagos NV (Euronext & NASDAQ: GLPG)
and AbbVie (NYSE: ABBV) announce that the
companies have expanded their agreement in cystic fibrosis (CF) to
reflect the successful expansion of their CF portfolio.
Companies have agreed to increase the potential milestones to
Galapagos for Phase 1 and 2 achievements, bringing the remaining
total milestones in the CF alliance up to approximately $600
million, from $350 million. Other key collaboration terms
remain in place: t iered royalty payments on net
sales, ranging from mid-teens to twenty percent. Galapagos
retains commercial rights to China and South Korea, and has an
option to co-promote in Belgium, Netherlands, and
Luxembourg.
Galapagos and AbbVie 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 have developed multiple candidates and backups for each
of the three components of a potential triple combination.
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 a statistically significant increase in chloride transport
over Orkambi[1] in HBE cells with the homozygous F508del
mutation. It is expected that a triple combination therapy
from this collaboration will be tested in patients having the
F508del mutation in 2017.
"Galapagos and AbbVie are committed to
accelerate the development of a potential triple combination
therapy," said Onno van de Stolpe, CEO of Galapagos. "The
compounds in our CF franchise show exciting results in vitro, and
our strong partnership with AbbVie is focused on getting
these combinations into patient trials as soon as possible."
"Within a short time, AbbVie and Galapagos have
been able to create an expanded portfolio of candidate CF drugs
which, in combination, may offer patients new therapy
options. We look forward to working rapidly with Galapagos to
bring these candidate drugs through the clinic in the coming
years," said Jim Sullivan, Vice President, Discovery, AbbVie.
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 $20 million in milestone
payments to date and is eligible to receive up to approximately
$600 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 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 a maturing pipeline of 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 440 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 Communications |
Director Communications |
+1
781 460 1784 Paul van der Horst Director IR & Business
Development +31 6 53 725 199 |
+31 6 53 591 999
communications@glpg.com |
ir@glpg.com |
|
Forward-looking statements This release may contain
forward-looking statements, including statements regarding any
anticipated milestone payments or royalty payments, the anticipated
timing of clinical studies, the potential activity of its candidate
cystic fibrosis drugs 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 its 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]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#2008181
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