Mechelen, Belgium; 17 May 2013 - Galapagos NV (Euronext: GLPG) announced today
that the operational and financial results achieved thus far in 2013 encourage
the Company to retain full year 2013 Group revenues guidance of €160 million.
"Galapagos has a maturing and broad pipeline of novel mode of action programs.
Our flagship program, GLPG0634, will start a large Phase 2b study next month,
and both we and our partner AbbVie are excited about the opportunities of this
molecule for the safe treatment of rheumatoid arthritis and other inflammatory
diseases," said Onno van de Stolpe, CEO of Galapagos. "In our development
portfolio, we now have three programs in Phase 2 studies in four inflammation
disease areas, and we are well on track to having multiple Phase 1 programs with
novel, proprietary modes of action by end 2013."
In the first quarter of 2013, Galapagos reported substantial progress in its R&D
programs.
On the clinical development side, GlaxoSmithKline (GSK) initiated a Phase 2
study with GSK2586184 (formerly GLPG0778) in chronic plaque psoriasis and a
Phase 2 study in systemic lupus erythematosus. This compound was in-licensed by
GSK in February 2012. In our proprietary program GLPG0974, an inhibitor of FFA2
(free fatty acid receptor 2, formerly known as GPR43), a second Phase 1 study
confirmed that GLPG0974 was safe and well tolerated at all dose levels. Â The
positive outcome of this study supported progression to a Phase 2 Proof of
Concept study in ulcerative colitis patients, which started in April 2013.
GLPG0974 is the third compound from Galapagos' pipeline to enter Phase 2
studies, and its first drug for patients with gastro-intestinal inflammation.
On selective JAK1 inhibitor GLPG0634, Galapagos presented the design and
expanded scope of the Phase 2b program, which will start in Q2 2013. AbbVie
paid Galapagos an additional $20 million to support the expanded scope of this
program. Galapagos also announced that it plans to initiate clinical trials
with GLPG1790, a novel candidate drug with high efficacy against triple-negative
breast cancer.
In its alliances, Galapagos announced the successful delivery of a fifth pre-
clinical candidate drug in its alliance with GSK, triggering a milestone
payment. A second pre-clinical compound was identified in its alliance with
Janssen Pharmaceutica NV, triggering a milestone payment of €4 million to
Galapagos. Galapagos received payments totalling €7.5 million for the
achievement of milestones in the osteoarthritis and oncology alliances with
Servier. Roche and Galapagos agreed to end their alliance in fibrosis;
Galapagos received €5.75 million for work performed in 2012 and regained the
worldwide rights to all fibrosis assays and the targets discovered in the
alliance. Â All of these alliance payments contributed to 2012 Group revenues.
The Flemish agency for Innovation by Science and Technology (IWT) awarded
Galapagos two grants: €2.7 million to discover new antibiotic treatments, and
€2.5 million for inflammatory bowel disease research and development.
Galapagos hosted its R&D Update in New York on March 27th. Galapagos presented
the progress and plans for its portfolio of more than 40 research and
development programs. In addition to advances already described above,
Galapagos presented three Cystic fibrosis corrector programs in early drug
discovery and a potentiator program which is expected to deliver a pre-clinical
candidate by the end of 2013. The Company also announced the termination of the
osteoporosis alliance with Lilly.
In other areas, Argenta announced a drug discovery collaboration with ANTABIO.
 Galapagos acquired Cangenix to add structure-based drug discovery to the
Argenta service offering. Galapagos also created Fidelta, a third service
division for the Group. Katrine Bosley was appointed to Galapagos' Board of
Directors.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action,
with a large pipeline of four clinical, seven 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 in RA and Phase 2 studies in Crohn's disease. 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 is currently in a
Proof of Concept Phase 2 study.
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
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir@glpg.com
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
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Galapagos business update:
http://hugin.info/133350/R/1702656/562720.pdf
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