AbbVie and Galapagos to co-develop cystic fibrosis therapies
24 Settembre 2013 - 2:09PM
* Both parties contribute key technologies and funding
* Goal to develop novel potentiator and corrector therapies for main mutations
of CF
* Galapagos leads discovery and development through Phase 2, shares Phase 3
responsibility with AbbVie
Galapagos to host webcast presentation today at 15.00 CET/ 9 am ET/ 6 am PT
Call numbers:
Belgium: +32-2290-1608, Toll-free 0800-50930
Netherlands: +31-20-794-8504, Toll-free 0800-265-8528
US: +1-480-629-9770, Toll-free +1-888-549-7750
Other countries: +32-2290-1608, Toll-free 0800-50930
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.
Galapagos revised financial guidance
Galapagos management revises guidance for 2013 year end cash balance to €125
million (up from €100 million). The guidance for 2013 Group revenues remains
unchanged at €160 million.
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.
Call numbers:
Belgium: +32-2290-1608, Toll-free 0800-50930
Netherlands: +31-20-794-8504, Toll-free 0800-265-8528
US: +1-480-629-9770, Toll-free +1-888-549-7750
Other countries: +32-2290-1608, Toll-free 0800-50930
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
Contact
AbbVie
Media
Adelle Infante
+1 847-938-8745
Investors
Liz Shea
+1 847-935-2211
Galapagos NV
Onno van de Stolpe, Chief Executive Officer
Tel. +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir@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.
AbbVie and Galapagos to co-develop cystic fibrosis therapies: http://hugin.info/133350/R/1731081/578688.pdf
[HUG#1731081]
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