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Galapagos to build cystic fibrosis drug pipeline

19 March 2010 at 07:25 CET

Click here to access the live audio webcast R&D Update presentation today at 13.00 CET/8 AM EST, call number +32 2290 1791

Mechelen, Belgium; 19 March 2010 - Galapagos NV (Euronext: GLPG) announced the decision to pursue cystic fibrosis (CF) in its strategy to deliver breakthrough medicines to patients with orphan diseases.  Details of Galapagos' CF program and its pipeline of 4 clinical and over 50 pre-clinical and discovery programs will be discussed during the R&D Update presentation webcast later today.

Over the past years, Galapagos has established a strong franchise in orphan diseases.  Galapagos has applied its proprietary target discovery platform in collaborations with the CHDI (for Huntington's disease), the Cystic Fibrosis Foundation and the ALS Foundation.  In addition, Galapagos is evaluating its SARM candidate drug, GLPG0492, for the treatment of Duchenne muscular dystrophy.

"Orphan diseases represent significant unmet clinical needs.  The lack of novel disease-modifying therapies for these diseases presents significant opportunities for a company capable of delivering new mode-of-action therapies.  Galapagos has made a strategic decision to pursue cystic fibrosis as the first orphan disease in which we will discover, develop and launch our own medicines.  This decision is based on our successful collaboration with the CF Foundation, through which we have identified the first ever disease-modifying targets for CF," said Onno van de Stolpe, CEO of Galapagos.  "With this strategy, Galapagos expects to benefit from the accelerated approval procedures and exclusive commercial rights granted to developers of orphan drugs through US and European regulatory agencies, to ultimately provide real medical benefit to this sizeable population of patients."

The CF Foundation and Galapagos entered a target discovery collaboration in 2005, which resulted in 19 novel disease-modifying targets that have been validated in the standard pre-clinical model for this disease.  Galapagos has secured all rights to these targets and has started to develop small molecule therapies against a select group of these targets.  Galapagos will retain intellectual property and commercial rights on any compounds reaching the market.  Galapagos medicines in CF will be disease-modifying agents with clear efficacy benefits relative to existing therapies, which only treat the symptoms of the disease.  A first pre-clinical candidate is scheduled to be nominated by 2013.

"We are confident that the strategic decision to enter CF drug discovery will provide new treatment options for CF patients and thus create long term value for our shareholders.  In the first years, research expenses for this new strategy will be limited and we anticipate that the clinical trials to support approval can be financed by our strengthening cashflow," said Van de Stolpe.

Conference call and webcast presentation

Galapagos will conduct a conference call open to the public today at 13.00 Central European Time (CET), which will also be webcast.  To participate in the conference call, please call +32 2290 1791 ten minutes prior to commencement.  A question and answer session will follow the presentation of the results.  Click here to access the live audio webcast.  The archived webcast also will be available for replay shortly after the close of the call.

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 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, with the global market expected to double from just over $1 billion in 2010 to $2 billion by 2015.  There currently is no cure for the disease, and most patients die in their 30s due to lung failure.  More info at: www.cff.org/AboutCF

About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of- action.  The Company is progressing one of the largest pipelines in biotech, with four clinical and over 50 small molecule discovery/pre-clinical programs.  Through risk/reward-sharing alliances with GlaxoSmithKline, Lilly, Janssen Pharmaceutica, Merck & Co. and Roche, Galapagos is eligible to receive up to 3 billion in downstream milestones, plus royalties.  With the acquisition of Argenta, Galapagos now has more than 670 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium.  More info at: www.glpg.com

CONTACT

Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028

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 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.

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