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Galapagos Gives R&D Update

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Galapagos NV will give an R&D Update later, indicating progress and plans for its large portfolio of more than 50 research programs. In addition to laying out the competitive positioning and Phase II plans for selective JAK1 inhibitor GLPG0634 in rheumatoid arthritis, a number of other topics will be discussed, including:

Excellent First-in-Human results with GLPG0974
GLPG0974 is an orally available small molecule that reduces migration of neutrophils, one of the critical cell types in inflammatory processes, by potent inhibition of GPR43 (also known as FFAR2).

Overactivity of neutrophils is a cause of tissue damage in illnesses such as inflammatory bowel disease, and this anti-inflammatory mechanism may provide for a novel treatment approach.

GLPG0974 is the first inhibitor of GPR43 to be evaluated clinically. In this First-in-Human study, healthy volunteers were given increasing single doses of candidate drug GLPG0974 by oral administration. Encouraging safety data showed no relevant safety findings, including adverse events, changes in vital signs or laboratory parameters.

The favourable PK profile and the highly significant changes in neutrophil biomarkers are consistent with once- or twice-daily oral dosing. Galapagos intends to complete Phase I studies and determine the Phase II clinical strategy before year end 2012.

Phase I Proof of Mechanism results of GLPG0492
GLPG0492 is an orally available selective androgen receptor modulator (SARM) which was tested in a Phase I Proof of Mechanism study to assess the effect on muscle function in healthy volunteers. A biomarker effect similar to that of Oxandrolone was observed, but the data were insufficient for Galapagos to pursue GLPG0492 further in cachexia.

With the financial support of Charley's Fund and the Nash Avery Foundation, improvement of muscle strength and running performance in a pre-clinical model of Duchenne muscular dystrophy (DMD) was shown with GLPG0492 in 2011. Galapagos intends to discuss with these patient organizations the opportunity for them to develop GLPG0492 further in DMD.

Novel antibody shows in vivo Proof of Concept for inflammatory disorders
In November 2008, Galapagos and MorphoSys entered an antibody alliance aimed at discovering and developing antibody therapies based on novel modes of action in the area of immuno-inflammation disorders.

Neutralizing antibodies with high specificity towards this target have now been tested in two gold standard, disease-specific in vivo models - rheumatoid arthritis and COPD - and achieved positive Proof of Concept.

A joint program for generation of a fully human antibody directed against this target has now been initiated. Pre-clinical candidate selection could be achieved by mid 2013.

New class of compounds discovered in anti-infectives
In the alliance with GSK in anti-infectives, Galapagos discovered a new class of compounds with a novel mode-of-action by inhibiting DNA polymerase III, an enzyme essential for bacterial DNA replication.

The compounds show activity in different MRSA in vivo models and thus may offer a new approach to treat resistant S. Aureus strains, with potential for broader spectrum application.

GSK and Galapagos have ended the anti-infectives alliance, and all assets have been returned to Galapagos, including the DNA polymerase III mode-of-action programs.

Appointment of Piet Wigerinck as CSO
Dr Piet Wigerinck has been named Chief Scientific Officer, responsible for all research and development activities at Galapagos. Dr Wigerinck joined Galapagos as Senior Vice President Development in April 2008, and was responsible for the successful Proof-of-Concept study with selective JAK1 inhibitor GLPG0634.

As CSO, Dr Wigerinck will oversee target and drug discovery efforts, in addition to expanding Galapagos' development department to deliver the Phase II study data package with GLPG0634.

Prior to joining Galapagos, Dr Wigerinck was VP Drug Discovery, Early Development and CM&C, and a member of the Management Board at Tibotec (a subsidiary of Johnson & Johnson), where he played a key role in Tibotec's expansion into novel diseases such as Hepatitis C and advanced several compounds into Phase I and Phase II clinical trials, including Prezista®.