Vertex says it has updated an R&D collaboration with Cystic Fibrosis Foundation Therapeutics (CFFT) stretching back more than a decade.
Under the updated Research, Development and Commercialization Agreement, disclosed in a regulatory filing yesterday, CFFT—the Foundation’s nonprofit drug discovery and development affiliate—agreed to pay Vertex $75 million upfront, as well as up to $6 million annually toward development funding.
Vertex also said it agreed to pay CFFT royalties on compounds first synthesized and/or tested between March 1, 2014, and August 31, 2016. Those royalties will range from low single digits to mid-single digits.
The company added that it will continue to pay royalties ranging from single digits to subteens on any approved drugs first synthesized and/or tested on or before February 28, 2014.
Vertex and CFFT also agreed that in calculating royalties, net sales on combination treatments will be allocated equally to each of their active pharmaceutical ingredients, consistent with the allocation of net sales for Orkambi®, a combination of the drug candidate lumacaftor (VX-809) and the marketed drug Kalydeco® (ivacaftor).
Orkambi last year won its first FDA approval for cystic fibrosis in patients aged 12 and older with two copies of the F508del mutation. On September 28, the agency approved a new indication for Orkambi, cystic fibrosis in children ages 6 through 11 who have two copies of the F508del mutation.
The new agreement updates an agreement first inked May 24, 2004, though Vertex and CFFT have undertaken joint R&D efforts since 1998.
Through a separate agreement, Vertex said, it will pay an undisclosed sum to the Foundation for continuing access to data from its patient registry, “which we believe will be important for research, development and approval of future [cystic fibrosis] medicines.”
