Galapagos and AbbVie said today they have expanded their 2-1/2-year-old cystic fibrosis (CF) collaboration by nearly doubling the size of AbbVie’s total potential payments to Galapagos tied to achieving Phase I and Phase II milestones.
Those milestone payments will rise from $350 million to $600 million under the expanded collaboration, which the companies said reflected expansion of their CF portfolio.
AbbVie and Galapagos are working to develop a triple CF transmembrane conductance regulator (CFTR) combination therapy intended to address 90% of patients with CF, people with Class II and other mutations.
The companies have said they plan to develop multiple candidates and backups for each component of the combination—three Galapagos compounds consisting of two corrector molecules and a potentiator:
- GLPG2222, Galapagos’ first oral corrector candidate, now in a Phase I study. The first-generation corrector is expected to generate topline results later in the first half of this year.
- GLPG2665, a second corrector candidate set to enter Phase I study by the middle of this year. The compound is the first next-generation corrector candidate under study; in January, Galapagos said a second, GLP2737, was expected to enter Phase I testing in healthy volunteers by Q4 2016.
- GLPG1837, a novel oral potentiator for Class III mutation CF patients. In February, Galapagos began a Phase II study of the compound in Class III mutation patients.
The companies expect in 2017 to start testing a triple combination therapy in patients having the F508del mutation.
According to AbbVie and Galapagos, 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 mutation.
The companies say that the combinations have resulted in a statistically significant increase in chloride transport in HBE cells with the homozygous F508del mutation over the marketed Vertex Pharmaceuticals drug Orkambi (lumacaftor/ivacaftor). Orkambi, which won FDA approval in July 2015, is the first approved drug indicated for CF in patients 12 years old and older who have two copies of the F508del mutation in their CFTR gene.
Following successful completion by Galapagos of clinical development through Phase II, AbbVie has agreed to oversee Phase III, with an unspecified “financial contribution” by Galapagos.
Galapagos and AbbVie launched their collaboration in September 2013, focused on treating CF by discovering, developing, and commercializing potentiator and corrector molecules. AbbVie paid Galapagos $45 million upfront and agreed to pay up to $405 million.
To date, Galapagos has earned $20 million in milestone payments to date and is eligible to receive up to approximately $600 million toward achieving developmental and regulatory milestones, plus additional payments tied to minimum annual net sales milestones and additional tiered royalty payments on net sales, ranging from the mid-teens to 20%.
Galapagos retains commercial rights to collaboration products in China and South Korea and has an option to co-promote products in Belgium, The Netherlands, and Luxembourg.
“Galapagos and AbbVie are committed to accelerate the development of a potential triple combination therapy,” Galapagos CEO Onno van de Stolpe said in a statement.
Added Jim Sullivan, AbbVie vp, discovery: “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.”