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Galapagos presents scope of GLPG0634 Phase 2b program

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Copyright © Thomson Reuters 2013. All rights reserved.
2013-04-16 18:11:04 -

* AbbVie provides additional funding of $20 million to Galapagos for Phase 2b
    program expansion
  * Phase 2b program in RA to include 875 patients

Mechelen,  Belgium; 16 April 2013 -  Galapagos NV (Euronext:  GLPG) announced an
expansion  of the Phase 2b program with  GLPG0634 in rheumatoid arthritis (RA).
Galapagos  wil increase the number of patients in the Phase 2b program to 875.
AbbVie  will provide an additional payment of  $20 million to Galapagos prior to
the  start of the Phase 2b program in RA to fund the program's expansion to 875

GLPG0634  is the  first selective  JAK1 inhibitor  in development for autoimmune
diseases.    In   February 
2012, Galapagos and AbbVie announced a global collaboration for GLPG0634 to treat autoimmune diseases.  In November 2011 Galapagos announced promising efficacy and safety in a 4 week Proof of Concept study in RA.  The results of the 4-week Phase 2a clinical study repeated the clinical benefit and safety of the drug seen in the Proof of Concept study. Galapagos will initiate a 24-week global Phase 2b program in RA in Q2 2013, with trial design finalized by both Galapagos and AbbVie.  The total number of patients to be included in the Phase 2b program will be expanded to 875, which will facilitate a final dose and regimen selection for Phase 3 clinical studies.  Galapagos expects to report topline data from the Phase 2b program in Q4 2014. The scope of the Phase 2 'Darwin' studies is as follows: +-------------------------------+ | Darwin 1 - Add-on to MTX | +------------+------------------+ | 200 mg QD | 85 patients (pt) | +------------+------------------+ | 100 mg QD | 85 pt | +------------+------------------+ | 50 mg QD | 85 pt | +------------+------------------+ | 100 mg BID | 85 pt | +------------+------------------+ | 50 mg BID | 85 pt | +------------+------------------+ | 25 mg BID | 85 pt | +------------+------------------+ | Placebo | 85 pt | +------------+------------------+ | TOTAL | 595 pt | +------------+------------------+ +------------------------------+ | Darwin 2 - Monotherapy | +-----------+------------------+ | 200 mg QD | 70 patients (pt) | +-----------+------------------+ | 100 mg QD | 70 pt | +-----------+------------------+ | 50 mg QD | 70 pt | +-----------+------------------+ | Placebo | 70 pt | +-----------+------------------+ | TOTAL | 280 pt | +-----------+------------------+ "We welcome AbbVie's support for expanding the GLPG0634 Phase 2b program in RA.  This will optimize the program to explore the once- and twice-daily dosing profile of GLPG0634.  The program is on track, with the start of the Phase 2b trials in this quarter.  We benefit from the growing experience with JAK inhibitors in clinical development and on the market, which has helped us to design data-rich studies, preparing an efficient continuation into pivotal studies in Phase 3," said Onno van de Stolpe, CEO of Galapagos. About candidate drug GLPG0634 GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos.  JAKs are critical components of signalling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients.  JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action.  GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. GLPG0634 is a fully proprietary program.  Upon successful completion of the RA Phase 2b studies, AbbVie will license the program and will assume sole responsibility for Phase 3 clinical development and global manufacturing. 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 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, about to enter Phase 2b studies.  AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2b.  Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in- licensed by GlaxoSmithKline in 2012).  GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1b patient study in metastasis.  GLPG0974 is the first inhibitor of GPR43 to be evaluated clinically for the treatment of IBD; this program will start a Proof of Concept Phase 2 study in Q2 2013. 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: Contact 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. This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Galapagos NV via Thomson Reuters ONE [HUG#1693470]

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