AbbVie and Galapagos to Co-Develop Cystic Fibrosis Therapies
NORTH CHICAGO, Illinois and MECHELEN, Belgium, Sept. 24, 2013
- Galapagos to host webcast presentation today at 15.00 CET/ 9 am ET/ 6 am PT
NORTH CHICAGO, Illinois 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
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
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:
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.
Contact: AbbVie, Media, Adelle Infante, 847-938-8745, or Investors, Liz Shea,
847-935-2211; Galapagos NV, Onno van de Stolpe, Chief Executive Officer, Tel.
+31 6 2909 8028, or Elizabeth Goodwin, Director Investor Relations, Tel: +31 6
2291 6240, email@example.com
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