Galapagos NV and AbbVie have announced that the companies have expanded their agreement in cystic fibrosis (CF) to reflect the successful expansion of their CF portfolio. Companies have agreed to increase the potential milestones to Galapagos for Phase 1 and 2 achievements, bringing the remaining total milestones in the CF alliance up to approximately $600 million, from $350 million.
Other key collaboration terms remain in place: tiered royalty payments on net sales, ranging from mid-teens to twenty percent. Galapagos retains commercial rights to China and South Korea, and has an option to co-promote in Belgium, Netherlands, and Luxembourg. Galapagos and AbbVie aim to develop a triple CFTR combination therapy to address 90% of patients with CF.
In order to bring a more effective therapy to patients, the companies have developed multiple candidates and backups for each of the three components of a potential triple combination. Triple combinations of CF compounds in the portfolio have consistently shown restoration of healthy activity levels in in vitro assays with human bronchial epithelial (HBE) cells of patients with the F508del mutation.
These combinations result in a statistically significant increase in chloride transport over Orkambi1 in HBE cells with the homozygous F508del mutation. It is expected that a triple combination therapy from this collaboration will be tested in patients having the F508del mutation in 2017. “Galapagos and AbbVie are committed to accelerate the development of a potential triple combination therapy,” said Onno van de Stolpe, CEO of Galapagos.
“The compounds in our CF franchise show exciting results in vitro, and our strong partnership with AbbVie is focused on getting these combinations into patient trials as soon as possible.” “Within a short time, AbbVie and Galapagos have been able to create an expanded portfolio of candidate CF drugs which, in combination, may offer patients new therapy options. We look forward to working rapidly with Galapagos to bring these candidate drugs through the clinic in the coming years,” said Jim Sullivan, Vice President, Discovery, AbbVie.