Galapagos NV and AbbVie are expanding their collaboration to continue their successful portfolio growth in cystic fibrosis (CF). The two companies are committed to increasing the potential milestones to Galapagos for Phase 1 and 2 achievements, raising the total milestones in the cystic fibrosis collaboration from $350 million up to nearly $600 million.
“Galapagos and AbbVie are committed to accelerate the development of a potential triple combination therapy,” said Galapagos CEO Onno van de Stolpe in a press release. “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.”
By developing several candidates in parallel, including backups for each of the three components of a potential triple combination, the two companies are aiming to develop a triple cystic fibrosis transmembrane conductance regulator (CFTR) combo therapy to suit 90 percent of CF patients.
Researchers expect this collaboration’s triple combination therapy to be tested in patients having the F508del mutation already in 2017, since this particular type of triple combination of cystic fibrosis compounds have shown consistent results in restoring healthy activity levels in in vitro assays – with human bronchial epithelial (HBE) cells of patients with a F508del mutation.
The studies have shown that these combination therapies could be consistently linked to a statistically significant increase in chloride transport over Orkambi (FDA-approved drug) in HBE cells with the homozygous F508del mutation.
“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, AbbVie’s vice president of Discovery.
Other agreement terms include gradual royalty payments on net sales, going from 15 to 20 percent. Galapagos will retain the commercial rights to China and South Korea, with the option to co-promote the combination therapy in Belgium, the Netherlands, and Luxembourg.
In September 2013, the two companies established a global collaboration agreement focused on the discovery, development, and commercialization of potentiator and corrector molecules for a CF treatment. The 2013 agreement led to a Phase 2 clinical trial, which will now advance to a Phase 3 clinical trial continuation.