HansGarrincha schreef op 3 november 2017 16:00:
Met dank aan AvantiAvanti!
Enige interessante passages uit de reports van Cowen en Leerink n.a.v. de presentatie gisteravond:
Vooral de interpretatie van Leerink mbt de relatie AbbVie - GLPG, ook in het licht van Onno's recente mening over de relatie, is interessant...
COWEN:
Galapagos reports that database lock has now occurred in
the ALBATROSS trial of ivacaftor +/-GLPG2222 in gating mutation patients (F508del/
G551D) and data release will occur shortly.
Leerink:
The company seems to be attempting to avoid traditional phase II trials, instead aiming to jump directly from phase Ib first in patient trials with a combination regimen, all the way to phase III.
When we asked the company about the regulatory endorsement of this strategy, the company indicated that the FDA had not endorsed any aspect of their combination development, and had in fact required that the company file individual drug IND’s in the US, which had only been
completed for 2222 at this stage.
It became clear last night that Galapagos has not even discussed
these drugs and their development plans with the FDA, and only expect to start those conversations sometime in the middle of 2018, after they file the 5 individual IND’s (assuming the company wants to study all the drugs and combinations in the US as well as Europe).
AbbVie acquired the rights to Galapagos’ CF combination development programs many years ago, and now, with successive waves of data emerging from these trials, we are approaching the point when AbbVie
(ABBV, OP) would be required to opt in, or not. This decision is probably going to be made in 2018, and could well result in another significant
delay in regulatory timelines and approval. AbbVie still seems quite uninterested in this project, and definitely qualify their level of enthusiasm and degree of positive sentiment. For AbbVie, who has to fund and execute phase III trials, they would presumably prefer a more traditional, and complete, package before going ahead and committing to those expensive trials. AbbVie is also reportedly unhappy with the single LFT elevation in an otherwise healthy group of patients.
There are signs from different directions that this relationship is being viewed less positively in Chicago than in the past. Should AbbVie discontinue, or delay a decision about going forward, this would be viewed negatively for Galapagos, and positively for Vertex. Such a decision doesn’t seem imminent, which is fortunate for GLPG, but will make for challenging times for GLPG if AbbVie opts out, or doesn’t advance any of the combinations.