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Galapagos NV (GLPG.BR) Gives R&D Update



3/27/2013 10:20:18 AM

MECHELEN, BELGIUM--(Marketwire - March 27, 2013) -


* Strong progress throughout clinical and preclinical portfolio

* RA: JAK1-inhibitor GLPG0634 advances to worldwide Phase 2b study

* IBD: novel FFA2-inhibitor GLPG0974 to start Phase 2a PoC study

* Oncology: good safety and early signals of efficacy with GLPG0187

* Cystic Fibrosis: discovery of superior potentiator

* GSK advances licensed JAK1-inhibitor to Phase 2 in SLE and psoriasis


Live webcast presentation today at 8:00 am ET/1:00 pm CET on www.glpg.com,
                           call number 2290-1608

Galapagos NV (EURONEXT BRUSSELS: GLPG) will give an R&D Update today in New York City, highlighting the progress and plans for its portfolio of more than 40 research and development programs.

Starting Phase 2b program with selective JAK1 inhibitor GLPG0634

GLPG0634, an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, is about to enter Phase 2b studies. The program consists of 2 dose finding studies and an open label follow-up study and will be conducted in multiple study centers worldwide. Multiple dose levels will be tested, as well as once daily and twice daily regimens, during a period of 24 weeks. Details of this program will be discussed at the R&D Update.

Moving GLPG0974 to Phase 2a Proof of Concept

In a separate release today, Galapagos announced achievement of excellent Phase 1 results with GLPG0974, the first inhibitor of FFA2 (formerly known as GPR43) to be evaluated clinically. Galapagos will initiate a Phase 2 Proof-of-Concept study with GLPG0974 in ulcerative colitis patients next month. The study will be completed by the end of this year.

Progress with GLPG0187

In March 2011, Galapagos initiated a Phase 1b study with its integrin receptor antagonist in solid tumor patients to explore a maximum tolerated dose and a biomarker response. Galapagos will announce today that the enrollment was completed. The study confirmed the safety of GLPG0187 (no treatment related SAEs) and revealed early signs of clinical response in glioblastoma patients. Based on these results and following requests of the investigators, Galapagos has included additional patients in this study.

Moving cystic fibrosis program to preclinical candidate

In 2010 Galapagos announced that it will pursue cystic fibrosis (CF) as the first orphan disease in which the company will discover, develop and launch its own medicines. This decision was based on the successful collaboration with the US CF Foundation. Galapagos is developing small molecule therapies to address the major CF mutation (delF508). Four separate programs are in drug discovery aimed at superior correctors and potentiators. Galapagos plans to nominate a first pre-clinical candidate potentiator later this year.

Alliance with Lilly terminated

In 2007, Galapagos entered into a global collaboration with Lilly to develop novel mode of action therapies in osteoporosis. This alliance did not yield the expected results within an acceptable timeframe, and therefore Galapagos decided to end the alliance. The rights to the bone-building program have returned to Galapagos. During the collaboration with Lilly, Galapagos received a total of EUR11 M in payments.

GSK moves selective JAK1 inhibitor GSK2586184 into Phase 2

In 2006 Galapagos and GSK initiated a drug discovery and development alliance to deliver disease modifying drugs for GSK's global R&D organization. GSK in-licensed GSK2586184 (formerly GLPG0778) and its corresponding back-up compound GLPG0555 in February 2012, gaining worldwide rights to further development and commercialization. GSK2586184 is a selective JAK1 inhibitor which was discovered and developed within Galapagos' alliance with GSK. GSK initiated a Phase 2 study with GSK2586184 in chronic plaque psoriasis and will initiate a Phase 2 study in systemic lupus erythematosus (SLE). GSK2586184 is the second selective JAK1 molecule discovered by Galapagos to enter Phase 2 studies. Galapagos is eligible, without further financial investment, to receive from GSK EUR34 M in additional milestones plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.

Webcast presentation

Galapagos will hold an audio webcast presentation for journalists, analysts, and investors today at 8:00 am ET/1:00 pm CET, and will be archived on Galapagos' website for one year. To access the live webcast, go to www.glpg.com or click here, call number 2290-1608.

About Galapagos

Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is specialized in novel modes-of-action, with a large pipeline of four clinical, six pre-clinical, and 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, about to enter Phase 2b studies. AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2b. Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1b patient study in metastasis. GLPG0974 is the first inhibitor of GPR43 to be evaluated clinically for the treatment of IBD; this program will start a Proof of Concept Phase 2 study in Q2 2013.

The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has over 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information 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

Galapagos gives R&D Update:

http://hugin.info/133350/R/1688489/553964.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Galapagos NV via Thomson Reuters ONE

[HUG#1688489]


CONTACT

Galapagos NV
Elizabeth Goodwin
Director Investor Relations
Tel: +31 6 2291 6240
Email Contact


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