Wall Street Trader schreef op 6 maart 2021 10:57:
Fireside chat with Gilead Sciences Management at Cowen 41st Annual Health Care ConferenceMarch 4, 2021
2021 is going to be an important year for Gilead. And there's a real probable sense of excitement across the company in terms of what we've been able to accomplish over the last couple of years as we work on the next chapter of Gilead.
And in terms of where we're going for growth, then I can talk about the challenges, there's a number of key areas for growth for us going forward.
Partnerships are always challenging. There are a number of things there that we're working through. Galapagos, in particular, we've talked about.Phil Nadeau (Cowen Analyst)Maybe to sneak in a question on another piece of news today. We did see the data from the MANTA studies a press release by Galapagos. In the past, Gilead has suggested it's unlikely to move forward in the US in inflammatory bowel disease with filgotinib, but not impossible.
Any update or your thinking about the filgotinib program post this top line metadata?Andrew Dickinson (CFO Gilead)I don't think anything has changed, Phil, based on the data. I mean what we've always said there are two issues with the FDA. One was the potential for testicular toxicity. And this is just the first preliminary look at that data.
The FDA wants to see how these cases resolve over a much longer period of time. So there will be additional data cuts as you saw in the press release over the coming year that will really be important on that point. And then you still have separate from that, the risk benefit profile of filgotinib and the assessment, either in RA or in IBD, including PERMs and UC, as you suggest.
So I don't think it changes anything on our end. It was good to get over that hurdle. But at a high level, there's still a lot to do.
And the bar, what we've said is the bar is very high for us. We will only move forward in the United States if we think that we have a clear path to approval in any of these indications and if we feel that we have a profile that's best in class. So the bar is high. We'll continue to monitor the data and work collaboratively with Galapagos as our partner and support them, but I don't think it's changed anything in the US.
Johanna Mercier (Chief Commercial Officer Gilead)No, I think it's fair. We'll continue to assess it. It's not like we've made a final call on it. But I think to your point, we've always said, first in class, best in class.
And so if this was something that we would go forward, it would have to be best in class. And so therefore, in the time frame that Andy was referring to and the data that's needed, it becomes much more challenging as time goes by.
Personal note: I think Gilead won’t proceed with that indication either and Gilead has decided to mostly back away from the drug.