PR Newswire/Les Echos/
AbbVie and Galapagos to Co-Develop Cystic Fibrosis Therapies
Galapagos to host webcast presentation today at 15.00 CET/ 9 am ET/ 6 am PT
NORTH CHICAGO, Ill. and MECHELEN, Belgium, Sept. 24, 2013 -- 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 predetermined 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.
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
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
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: 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.
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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-0- Sep/24/2013 12:32 GMT
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