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Galapagos Business Update

Published: Friday, July 19, 2013
Last Updated: Friday, July 19, 2013
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Company to retain full year 2013 Group revenues guidance of €160 million.

Galapagos NV has announced 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.

Stolpe continued, "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.

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. 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.

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