Galapagos announces pre-clinical candidates and clinical plans in rheumatoid arthritis and bone metastasis

03-Mar-2008

Galapagos NV announced that it has selected pre-clinical candidates in its rheumatoid arthritis and bone metastasis programs. It is the Company's intention to submit IND (Investigational New Drug) applications for these programs later this year, with initiation of clinical trials for bone metastasis by yearend and for rheumatoid arthritis early 2009. The Company also intends to select a pre-clinical candidate in osteoarthritis in 2008.

"By moving the first drug from our rheumatoid arthritis program into the pre-clinical development phase, Galapagos is taking an important step toward discovering first-in-class, disease modifying small molecule drugs for bone and joint diseases," said Onno van de Stolpe, Chief Executive Officer of Galapagos. "In addition, we are excited that the bone metastasis program has accelerated to the stage where we can dose first patients in a clinical trial before year end. This program, with a potential secondary indication in osteoporosis, provides a relatively fast path toward a marketed drug with significant revenue potential for Galapagos and its shareholders."

The Company announced that its rheumatoid arthritis (RA) candidate against kinase target GT418 demonstrates significant bone protection and reduced inflammation in the industry standard mouse model. The effect of this oral compound was at least equivalent to Enbrel® (etanercept), the injectable anti-TNF treatment for rheumatoid arthritis. The compound also demonstrates good bioavailability in three animal species. Based on these encouraging results, pre-clinical development has started, with the aim to file an IND by the end of 2008 and initiate a clinical Phase I trial shortly thereafter. The Phase I trial will be designed to provide safety and dosage data as endpoints, with preliminary data on pharmacodynamic properties.

Galapagos' rheumatoid arthritis target GT418 was discovered and validated in cells from rheumatoid arthritis patients, using the Company's proprietary target discovery platform. The Company's pre-clinical program in rheumatoid arthritis marks the first ever in this undisclosed mode of action. Galapagos has filed patent protection on both the role of the target in rheumatoid arthritis as well as on the candidate drug. Galapagos' rheumatoid arthritis programs are partnered with Janssen Pharmaceutica, a Johnson & Johnson company. Galapagos' candidate drug is a compound in Galapagos' internal program within the alliance with Janssen. Upon successful completion of a Phase IIa trial in Galapagos' internal RA programs, Janssen has the exclusive option to license a program for EUR 60 million, with further potential milestones to Galapagos in excess of EUR 776 million and tiered double-digit royalties on global sales.

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