Vertex Pharmaceuticals Earnings Call Insights: Enrollment Limitations and VX-135 Pathway

Vertex Pharmaceuticals (NASDAQ:VRTX) recently reported its second quarter earnings and discussed the following topics in its earnings conference call.

Enrollment Limitations

Geoffrey Meacham – JPMorgan: One on CF and one on hep C for the 809 KALYDECO trial on heterozygous are there any limitations on enrollment for genotype beyond G551D that’s on a (indiscernible) epithelial I just want to make sure that there may be, you are excluding patients and ASM residual KALYDECO function and I guess the question here is if this serves as a negative control for labeling but you see a signal and what’s the path beyond that?

Robert Kauffman – SVP and Chief Medical Officer: This is Bob. It’s hard to speculate on the path until we actually see what the data show, but we choose the patients for this study who have mutations on the other (indiscernible) that would not respond to KALYDECO. So, we obviously try to keep our baseline at an absolute minimum and that’s what we’ve done throughout the heterozygotes studies and we’ll do the same in this one.

Geoffrey Meacham – JPMorgan: And just a real quick one on VX-135, I know you guys have been asked a lot about spend in hep C, is there a time to get off the partial hold from FDA or some data set that you guys view as a trigger for making future investments in 135? Thanks.

Robert Kauffman – SVP and Chief Medical Officer: This is Bob. I’ll answer the sort of the first part of that and that is based on the particulars at the FDA has asked us for, we expect to be able to have complete data set in the early part of the fourth quarter and we then expect the FDA to review those data and then, response back to us. As to the other part I’ll pass it on to Ian…

Ian F. Smith – EVP and CFO: Questions has been asked the few times since both tonight actually and we’re very aware of the competitive nature of this market this disease area and we’re always looking to making a decision to see whether we can compete in, in what is a significant market and the global market. At this point in time, we have the assets and we have the internal capability that we want to progress that opportunity. As we go through both the very important let’s say Phase 2 period of establishing a potential regimen to compete in this market, we’ll be making those kind of decisions but at this point in time we plan to keep committed to HCV and drive forward for an overall regimen.


VX-135 Pathway

Geoffrey Porges – Sanford Bernstein LLC: Congrats on the additional CF Phase 3 data. Perhaps just to drilling a little bit more on 135. Bob, could you let us know first what the primary metabolic pathway is for VX-135? Secondly, the thinking behind taking it up to the 400 milligram dose, and then what the outcome was for those patients with the elevated liver functions and lastly can you just tell us whether you’ve seen any transaminase elevation not enough to get to an say a discontinuation, but any et al at the 200 milligram dose?

Robert Kauffman – SVP and Chief Medical Officer: So I’ll take – if I could remember all four of those questions I’ll take them in order. The pathway of metabolism is just primarily routinely exceeded as most nukes are. In terms of why we went to 400 milligram dose? I would say that part of the Phase 2 evaluation of any compound really is to explore the dose range. When we had completed the 100 milligram and 200 milligram doses in the European study, we had very good tolerability and therefore we decided to dose escalate. We wanted to sort of maximize of viral kinetics in order to get the best response possible.

Geoffrey Porges – Sanford Bernstein LLC: The outcome of the elevated transaminase patients in that any at 200?

Robert Kauffman – SVP and Chief Medical Officer: Yeah, they were none at 200 nor at 100 and they all resolved really quite quickly within a week or so. In terms of the other transaminase elevations, I guess I just answer that by saying we really haven’t seen anything in the 100 milligram and 200 milligram groups.

More Articles About:    

More from The Cheat Sheet