SOURCE: Galapagos NV

April 16, 2008 13:48 ET

Galapagos licenses clinical rheumatoid arthritis program

Webcast audio conference presentation 17 April 2008 on www.glpg.com 14.00 CET/8:00 AM EST, call number +32 2290 1791 or +1 866 225 8754 from US

MECHELEN, BELGIUM and AMSTERDAM, NETHERLANDS--(Marketwire - April 16, 2008) - Galapagos NV (Euronext: GLPG) and Enceladus Pharmaceuticals BV announce the in-licensing of Nanocort® by Galapagos. Nanocort is a patented liposome-formulation of prednisolone to treat inflammatory diseases, in particular for the acute treatment of flares in rheumatoid arthritis (RA). Nanocort is currently in a Phase I/II study. Galapagos intends to file an Investigational New Drug (IND) application in Q1 2009, and initiate a Phase II study shortly thereafter. Galapagos plans to seek approval as early as 2012, potentially using shortened registration procedures. It is expected that the license and the program costs for 2008 will not impact Galapagos' guidance for 2008 year end cash position of approximately EUR 25 million.

Nanocort is a novel pharmaceutical, developed by Enceladus for the treatment of acute RA flares. It is complementary to Galapagos' present R&D program in RA that focuses on chronic treatment. Nanocort is composed of a widely used corticosteroid enclosed in small lipid vesicles (liposomes). Corticosteroids are the most common treatment for RA-related flares, but their use as a free drug is limited due to systemic side effects. In the Nanocort treatment, the corticosteroid is confined to the liposome in the blood stream. After injection, the Nanocort liposomes selectively accumulate and form local depots at sites of inflammation, from which the corticosteroid can perform its beneficial local effects. As a result, Nanocort should be able to significantly reduce frequency of administration and use of the steroid compared to other therapies.

Both the anti-inflammatory drug and the liposomes have separately been extensively used in the clinic and have proven to be safe. Nanocort is currently in a Phase I/II investigator-led study in the Netherlands which will read out later this year. Galapagos intends to file an IND application in Q1 2009, and initiate an international multi-center Phase II study shortly thereafter. Clinquest, a product development organization for clinical trials, will be involved in the development of Nanocort. The primary therapeutic indication for Nanocort will be the treatment of flares in RA, but Galapagos will also pursue development in multiple sclerosis and inflammatory bowel disease patients.

Under the terms of the agreement, Galapagos will pay Enceladus an upfront fee and run the clinical development of Nanocort. Enceladus will receive a minority share of future revenues received by Galapagos from the commercialization of Nanocort.

"Nanocort provides us with a promising treatment for acute flares in inflammatory diseases," said Onno van de Stolpe, Chief Executive Officer of Galapagos. "This program rounds out our therapeutic approach for RA, encompassing acute flare treatment through Nanocort and chronic oral treatment with our GT418 first in class kinase program. It contributes to our goal to build a comprehensive clinical pipeline of risk-balanced programs in RA."

"We are extremely pleased with Galapagos as our development partner for Nanocort," commented Bart Metselaar, Chief Executive Officer of Enceladus Pharmaceuticals. "Their experience and commitment in rheumatoid arthritis will greatly help in the rapid development of this exciting product."

RA is one of the core therapeutic areas for Galapagos drug discovery. Galapagos' internal candidate drug for the treatment of chronic RA is based on kinase target GT418 and has demonstrated significant bone protection and reduced inflammation in RA animal models. This candidate drug is a non-steroid, novel small molecule against RA target discovered by Galapagos and which will be developed as a first-in-class treatment for chronic RA. Galapagos aims to file an IND application for this candidate drug by end 2008 and to initiate a clinical Phase I trial shortly thereafter.

Conference call and webcast presentation

Galapagos will conduct a conference call open to the public tomorrow, 17 April 2008, at 14.00 Central European Time (CET)/8:00 AM US Eastern Standard Time (EST), which will also be webcast. To participate in the conference call, please call +32 2290 1791, or toll free in the US +1 866 225 8754, ten minutes prior to commencement. A question and answer session will follow the presentation of the results. The live audio webcast can be accessed via Galapagos' website at www.glpg.com. The archived webcast also will be available for replay shortly after the close of the call.

About RA

RA is a chronic disease, mainly affecting the joints. The disease is characterized by inflammation of the affected joint, which can result in chronic pain, swelling and stiffness, and later, joint destruction and disability. RA is the most debilitating form of arthritis and the most common inflammatory joint disease. It is estimated that 1-2% of the population has RA, and although it can occur at any age, onset usually begins between the ages of 25 and 50. Women are three times more likely than men to be affected by RA. Current market for RA medicines is estimated at EUR 7 billion annually and is expected to approach EUR 10 billion by 2012, driven by the use of biopharmaceutical drugs. Despite the efficacy of these drugs, patients continue to experience acute flares, while others are not responsive. In the EU in 2006, mildly affected RA patients received steroid treatment in 45% of cases, moderately affected RA patients in 60% of cases, and severely affected RA patients in 80% of cases.[1]

About Enceladus Pharmaceuticals

Enceladus Pharmaceuticals is a privately-owned drug development company originating from Utrecht University, the Netherlands. The company envisions finding inventive combinations of drugs and drug carrier systems. Using this practical approach, Enceladus can effectively design new prototype therapeutics that require relatively straightforward clinical development tracks. The company is based in Amsterdam, the Netherlands. More information about Enceladus Pharmaceuticals can be found at www.enceladus.nl.

About Galapagos

Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical programs in bone and joint diseases and bone metastasis. Its division BioFocus DPI offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. BioFocus DPI also provides adenoviral reagents for rapid identification and validation of novel drug targets, compound libraries for drug screening as well as chemogenomics and ADMET database products to select targets and compounds. Galapagos currently employs 450 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More information about Galapagos can be found at www.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.

Nanocort is a registered trademark of Enceladus Pharmaceuticals BV

[1] Source for acute flare treatment data: Apex Healthcare Consulting survey December 2007


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