Date: 2012-02-29
Type of information:
Product name: GLPG0778/GSK2586184 and its back-up compound GLPG0555
Compound: GLPG0778 and its back-up compound GLPG0555
Therapeutic area:
Action mechanism: The compounds are small molecule kinase inhibitors.
Company:
Disease:
Latest news: * On February 21, 2012, Galapagos announced that GSK has exercised its option to exclusively license investigational compound GLPG0778 (now GSK2586184) and its corresponding back-up compound GLPG0555. Both compounds have been discovered and developed within the immuno-inflammatory alliance that GSK and Galapagos have concluded in 2006. The belgian company has recently announced that GLPG0778 has shown selective effects on a biomarker in a Phase I Proof-of-Mechanism study in healthy volunteers. GSK will have the right to continue the clinical development of these candidate compounds. Galapagos will receive an option fee payment of single-digit million € from GSK, which contributes to 2011 Group revenues. Galapagos is eligible, without further financial investment from Galapagos, to receive from GSK more than €34M in future milestones plus royalties on these two compounds.
GLPG0778 was identified and progressed to a successful option exercise within 30 months, making the transition from committing to the target to clinical Proof of Mechanism in 5 years.
These products are the first Galapagos alliance compounds to be in-licensed into a large pharma portfolio.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
