Galapagos initiated a Phase I program with the first small molecule candidate from its arthritis alliance with GlaxoSmithKline (GSK). The entry of GLPG0555 into the clinic triggered a €4 million (about $5.9 million) milestone fee from GSK.
The orally available drug candidate GLPG0555 modifies kinase target GT622. Preclinical studies showed activity in biochemical and animal models. The Phase I program will include double-blind, single-ascending, and multiple-dose studies. They will be conducted with 34 volunteers in Belgium over the coming months and will assess safety, tolerability, and pharmacokinetics.
Since the start of the companies’ partnership in June 2006, Galapagos has received €34.7 million (roughly $51.23 million) in payments from GSK: a €4 million up-front cash payment, a €4.4 million equity investment, and the rest in preclinical milestones. In July 2007 and December 2008, GSK and Galapagos expanded the alliance to include additional targets, bringing the total value of the deal up to €188 million.
GSK has an exclusive option to develop and commercialize these compounds on a worldwide basis. Galapagos will receive up to double-digit royalties on commercial sales of alliance products.
The companies have a separate agreement covering anti-infectives, which began in December 2007 with €3.5 million (approximately $5.17 million) up front. In January 2009, the alliance was expanded to include three more discovery targets with a €2 million payment (about $2.95 million). About two months ago, the firm achieved its first milestone and obtained €500,000 (roughly $737,488 million). Further milestones could reach €95 million (about $140.12 million) for each drug candidate. If a product is commercialized, Galapagos may receive up to €120 million (roughly $177 million) for achievement of specific sales milestones. Galapagos is also eligible to receive up to double-digit royalties on worldwide sales of alliance products.