Galapagos NV Signs Major Arthritis Deal Potentially Worth Up to 1 Billion Euros with Janssen Pharmaceutica
MECHELEN, BELGIUM -- Oct 24, 2007 -- Mechelen, Belgium; 24 October 2007 - Galapagos NV (Euronext and LSE: GLPG) announced today that it has entered into a worldwide multi-target alliance with Janssen Pharmaceutica NV ('Janssen'), a Johnson & Johnson company, to discover and develop novel small-molecule therapeutics for the treatment of rheumatoid arthritis (RA). Under the alliance agreement, Janssen may select up to 12 programs from Galapagos' internally identified RA targets into the alliance. Janssen receives future option rights to exclusively license these programs. In addition, Janssen obtained an option to the future development and commercialization of product candidates from Galapagos' other internal RA programs, including its most advanced program based on the kinase target GT418. A compound from this proprietary drug discovery program is expected to enter Phase I clinical trials in 2008.
Terms of the agreement
With the signing of the agreement, Janssen will make an initial up-front cash payment of EUR 15 million to Galapagos. In addition, Janssen will make a EUR 2 million milestone payment for the selection of GT146, one of Galapagos' advanced RA programs, into the alliance. Under the alliance agreement, Galapagos will be responsible for the discovery of small molecule product candidates for those novel, validated RA targets that are chosen by Janssen. Galapagos will develop product candidates through to Phase IIa Proof of Concept (POC) clinical trials. During the term of the collaboration, Galapagos is eligible to receive success-based progress milestones from Janssen. Upon Galapagos' achievement of POC for a product candidate, Janssen has an exclusive option to license the product candidate from each alliance program and will then assume full responsibility for further clinical development and worldwide commercialization, at its expense. For each alliance program licensed by Janssen, contingent on discovery, development and regulatory accomplishments, Galapagos could receive option exercise fees and milestone payments up to EUR 73 million, plus royalties on net sales of each approved new RA drug. In addition to performing research on the alliance RA targets, Galapagos will continue to perform the R&D activities for its internal RA programs, including its most advanced program GT418, at its own expense up to clinical POC, subject to an exclusive option by Janssen. Janssen's license option for the Galapagos drug will become exercisable upon successful completion of Phase IIa clinical trial by Galapagos. Should Janssen elect to exercise the option, a non-refundable exercise fee of EUR 60 million will be paid and thereafter Janssen would be responsi
Development status of Galapagos R&D program in RA
Galapagos is a drug discovery company with pre-clinical programs in bone and joint diseases. In the RA program, lead compounds have shown significant disease-modifying properties and good pharmacokinetic properties in relevant animal models of the disease. These molecules also show substantial protection against bone loss in the industry standard RA animal models. The compounds target proprietary kinase proteins that were identified using the Galapagos' SilenceSelect target discovery platform. Based on these results, Galapagos anticipates initiation of pre-clinical studies later this year, with the potential of a candidate drug entering clinical Phase I in 2008.
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; this is expected to approach EUR 9 billion by 2011.
Galapagos (Euronext Brussels, GLPG; Euronext Amsterdam, GLPGA; London AiM: GLPG) is a drug discovery company with pre-clinical programs in bone and joint diseases and cachexia. 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 460 people and operates facilities in seven countries, with global headquarters in Mechelen, Belgium. More information about Galapagos and BioFocus DPI can be found at www.glpg.com and www.biofocusdpi.com.
Galapagos webcast & press conferences
Galapagos will host an audio webcast press conference starting at 10.30 Central European Time (CET) today at the Amsterdam World Trade Center, Room 6, Strawinskylaan 77, 1077 XW, Amsterdam. To participate in the conference remotely by telephone, dial +32 2290 1608 prior to 10.25 CET. The live audio webcast of the press conference can be accessed on the Galapagos website at www.glpg.com.
Galapagos will host a video webcast press conference starting at 15.45 CET today at the Diamant Conference & Business Centre, Galilei Room, 80 Bd A. Reyers Ln, 1030 Brussels. To participate in the conference remotely by telephone, dial +32 2290 1608 prior to 15.40 CET. The live video webcast of the press conference can be accessed on the Galapagos website at www.glpg.com.
Both webcasts will be available for replay later today and archived on the Galapagos website for 30 days.
Galapagos NV Onno van de Stolpe, CEO Tel: +31 6 2909 8028 [email protected]
Media contacts for Galapagos:
Smink, Van der Ploeg & Jongsma FinanciÃ«le Communicatie Leon Melens Tel: +31 653 81 64 27 [email protected]
Comfi Gunther De Backer Tel: +32 475 903 909 [email protected]
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