Degroof Petercam 19 juli 2017
Galapagos (Buy) - Vertex Pharmaceuticals announces triple combination data in CF (EUR 66.8 / TP 96)
Facts – Results from three triple combination regimens in cystic fibrosis
Vertex, Galapagos’ competitor in the CF field, today announced positive results of its triple combinations regimens in people with cystic fibrosis who have one F508del mutation and one minimal function mutation (F508del/Min; heterozygous patients).
Phase II data showed mean absolute improvements in ppFEV1 of 9.7 and 12.0 percentage points for VX-152 and VX-440, respectively, in triple combination with tezacaftor and ivacaftor in F508del/Min patients.
Initial data from Phase I study showed mean absolute improvement in ppFEV1 of 9.6 percentage points with VX-659 triple combination in F508del/Min patients.
In addition, initial Phase II data also showed mean absolute improvements in ppFEV1 of 7.3 and 9.5 percentage points when VX-152 or VX-440 was added in people with two copies of the F508del mutation (F508del/F508del; homozygous patients), who were already receiving tezacaftor and ivacaftor.
Our view – Efficacy bar has been set high
Vertex has pushed ahead fast with its triple combinations. The results in the heterozygous CF patients, who today have no treatment option, are positive. While we previously noted that improvements in ppFEV1 of >8% for homozygous patients and 5%-8% for heterozygous patients would be expected as the limit for efficacy, Vertex goes beyond these with >9% improvements.
While the C2 correctors, VX-152 and VX-440, have been indicated to entail some safety issues that could limit their future use, Vertex has been able to also show promising Phase I data with its third triple combination including VX-659. This last combination allows once-daily dosing.
Galapagos recently announced a slight delay in the initiation of their triple combination trials as a result of complex regulatory discussions. The first patient trial is expected to be initiated in 4Q17. The company thus remains behind 6-9 months on Vertex, while the bar for efficacy has been set high today.
Investment conclusion – Buy recommendation maintained (TP 96)
Vertex’ first triple results in combination with the recent delay in Galapagos’ CF program, are not positive for Galapagos. The company remains behind 6-9 months, while Vertex has set the bar for efficacy high. The cystic fibrosis program contributes EUR 13 to our EUR 96 target price today. These results might weigh on the share’s performance today, nevertheless we maintain our Buy recommendation and TP of EUR 96.