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, 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]