NORTH CHICAGO, Ill. and
MECHELEN, Belgium, Sept. 24, 2013 /PRNewswire/ -- Galapagos NV
(Euronext: GLPG) and AbbVie (NYSE: ABBV) announced today that they
have entered into a global alliance to discover, develop and
commercialize novel potentiator and combination therapies in cystic
fibrosis (CF), an inherited chronic disease that affects 70,000
people worldwide.
AbbVie and Galapagos will work collaboratively to contribute
technologies and resources in order to develop and commercialize
oral drugs that address the main mutations in CF patients,
including F508del and G551D. The goal of the collaboration is
to identify compounds that correct defects in expression of
(corrector) and/or increase the activity (potentiator) of the main
mutations in the cystic fibrosis transmembrane regulator (CFTR)
protein, including the F508del mutation, which is the most common
with 90 percent prevalence among patients with CF.
In the alliance, AbbVie and Galapagos will develop potentiators
and correctors discovered by Galapagos and expand the range of
molecules, with the aim to initiate Phase 1 clinical studies at the
end of 2014. Following successful clinical development and
regulatory approval, AbbVie will be responsible for commercial
activities, with Galapagos retaining exclusive rights in
China and South Korea and co-promotion rights in
Belgium, the Netherlands, and Luxembourg.
Under the terms of the agreement, AbbVie will make an initial
upfront payment of $45 million to
Galapagos for rights related to the global alliance. Upon
successful completion of pre-determined success milestones, AbbVie
and Galapagos will share responsibility and funding for Phase III
clinical development. Galapagos is eligible to receive up to
$360 million in total additional
payments for developmental and regulatory milestones, sales
milestones upon the achievement of minimum annual net sales
thresholds and additional double-digit royalty payments on net
sales.
"Galapagos is very pleased to join forces with AbbVie in this
exciting new area of CF. Our programs in CF show
promise. Partnering with AbbVie allows us to ramp up our
commitment significantly, share development risk and expertise, and
increase our chances of bringing best-in-class therapies to CF
patients," said Onno van de Stolpe,
chief executive officer, Galapagos.
"We're pleased to enhance our partnership with Galapagos to
include research in cystic fibrosis, a debilitating disease with
significant unmet medical need. Our knowledge of the patient
experience, combined with innovative advances in the understanding
of disease etiology, offers the potential for new transformational
treatments," said Jim Sullivan,
Ph.D., vice president, pharmaceutical discovery, AbbVie.
Galapagos initiated its research in CF in 2005 as part of a
collaboration with the Cystic Fibrosis Foundation. In 2010,
Galapagos decided to pursue CF as the first orphan disease in which
the company is attempting to discover, develop and launch its own
medicines. Galapagos has developed small molecule therapies
that can restore the function of the defective CF protein
(CFTR). The first pre-clinical candidate is expected to be
nominated this year, with the first clinical trials starting at the
end of 2014.
Webcast presentation
Galapagos will hold an audio
webcast presentation for journalists, analysts, and investors today
at 15.00 CET/9 am ET /6 am PT, viewable at www.glpg.com.
About Cystic Fibrosis
Cystic fibrosis (CF) is a
hereditary disease of the entire body which leads to severe
disability and early death in many cases. Symptoms include
frequent lung infections, sinus infections, poor growth, and
diarrhea. The cause is a defect in the gene which encodes for
cystic fibrosis transmembrane conductance regulator (CFTR), a
protein which regulates components of sweat, mucus, and digestive
juices. CF affects approximately 70,000 people worldwide.
Patient symptoms are treated with antibiotics and other
medicines. There currently is no cure for the disease, and
the predicted median age of survival is in the late 30s.
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most
complex and serious diseases. In 2013, AbbVie employs
approximately 21,000 people worldwide and markets medicines in more
than 170 countries. For further information on the company
and its people, portfolio and commitments, please visit
www.abbvie.com. Follow @abbvie on Twitter or view careers on
our Facebook or LinkedIn page.
About Galapagos
Galapagos (Euronext: GLPG; OTC:
GLPYY) is specialized in novel modes-of-action, with a large
pipeline of four clinical, six pre-clinical, and 20 discovery
small-molecule and antibody programs in CF, inflammation,
antibiotics, metabolic disease, and other indications.
AbbVie and Galapagos signed an agreement in CF where they work
collaboratively to develop and commercialize oral drugs that
address two mutations in the CFTR gene, the G551D and F508del
mutation. In the field of inflammation, AbbVie and Galapagos
signed a worldwide license agreement whereby AbbVie will be
responsible for further development and commercialization of
GLPG0634 after Phase 2B. GLPG0634 is an orally-available,
selective inhibitor of JAK1 for the treatment of rheumatoid
arthritis and potentially other inflammatory diseases, currently in
Phase 2B studies in RA and about to enter Phase 2 studies in
Crohn's disease.
The Galapagos Group, including fee-for-service companies
BioFocus, Argenta and Fidelta, has 800 employees and operates
facilities in five countries, with global headquarters in
Mechelen, Belgium. Further
information at: www.glpg.com
Galapagos forward-looking statements
This release
may contain forward-looking statements, including, without
limitation, statements containing the words "believes,"
"anticipates," "expects," "intends," "plans," "seeks," "estimates,"
"may," "will," "could," "stands to," and "continues," as well as
similar expressions. Such forward-looking statements may involve
known and unknown risks, uncertainties and other factors which
might cause the actual results, financial condition, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial
conditions, performance or achievements expressed or implied by
such forward-looking statements. 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,
unless required by law or regulation.
AbbVie forward-looking statements
Some statements
in this news release may be forward-looking statements for purposes
of the Private Securities Litigation Reform Act of 1995. The
words "believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking
statements are subject to risks and uncertainties that may cause
actual results to differ materially from those indicated in the
forward-looking statements. Such risks and uncertainties
include, but are not limited to, challenges to intellectual
property, competition from other products, difficulties inherent in
the research and development process, adverse litigation or
government action, and changes to laws and regulations applicable
to our industry. Additional information about the economic,
competitive, governmental, technological and other factors that may
affect AbbVie's operations is set forth in Item 1A, "Risk Factors,"
in our 2012 Annual Report on Form 10-K/A, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
SOURCE AbbVie