AbbVie and Galapagos to co-develop cystic fibrosis therapies

AbbVie and Galapagos to co-develop cystic fibrosis therapies

NORTH CHICAGO, Ill. and MECHELEN, Belgium, Sept. 24, 2013 (GLOBE NEWSWIRE) --

  * 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,

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
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

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  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:


Adelle Infante
+1 847-938-8745

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

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:

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