We will present data from our 4 Phase II studies with AMG 145, our PCSK9 inhibitor for hypercholesterolemia, at the American Heart Association meeting in November in Los Angeles. As you may recall, these studies enrolled some 1,300 subjects, including patients with heterozygous familial hypercholesterolemia and statin-intolerant subjects. We also generated data as monotherapy and in combination with other lipid-lowering therapies. We look forward to discussing these data, and we hope to see many of you at our investor event on November 6
Editors Note: Click for slides from Amgen PCKS9 event at AHA.
There's a lot of FDA activity there in the homozygous FH category recently. And what do you take away from that in terms of thinking about Phase III trial design for 145?
We are going to be looking at both the heterozygous familial hypercholesterolemia and the homozygous patients with great interest with respect to PCSK9 innovation. I think that the studies in the homozygous population are at a proof-of-concept kind of stage, so we're pretty far away from thinking about Phase III designs there. But I think the Phase III approach to the heterozygous patients is really not meaningfully different than that, that we're using for the rest of the patient population who, for whatever reason, can't reach their target despite use of all available therapies.
when you think about PCSK9, just with that being an antibody and a lower price point overall, high-volume cholesterol market, I'm just trying to understand if that product is going to be consistent with current margins for the business?
Yes, the cost-of-sales, Rachel, for that should be -- it'll be an antibody, so it won't be very different from the cost structure we face with other of our large biologic antibody molecules. And with respect to this -- the commercialization, sales force channels, just still awfully early days to be talking about what the cost structure of that effort will be.
on the formulation of your PCSK9 antibody, can you give us a little bit of a sense it's between 3 and 6 CC that this used to be, and what is it now as a part of the Phase III? I'm trying to get a sense how many shots you're going to have to give.
"I think you're asking for a level of detail there that's probably not appropriate for the call. "
Question on 145, the PCSK9 inhibitor. This is a new therapeutic category for Amgen and perhaps requiring larger sales force. So when you move -- plan to move into Phase III early next year, can you comment on your commercialization strategy?
We're excited about all the data that we've seen about the biology so far as we understand it, and we're looking forward to advancing the product in Phase III clinical trials. It's early now to be commenting about our commercialization strategy. We're hard at work on that, as you would imagine, but I just think it's a little premature for us to start talking in any detail about how we'll go to market with that before we've even completed a Phase III trial.
And then, just for Sean, this is super easy. I know it's a second question, but how would the PCSK9 antibody work in homozygous FH patients? (question was not answered)
REGN (transcript via SeekingAlpha)
Turning to our late stage R&D pipeline, as we reported in our last conference call, early in the third quarter, Sanofi and Regeneron announced the launch of the 22,000 patients global Phase III program for Regeneron 727, our PCSK9 antibody for lowering LDL cholesterol. This program called Odyssey consists of more than 10 clinical trials to evaluate the safety and efficacy of Regeneron 727 in a broad range of patients.
At the upcoming American Heart Association meeting in Los Angeles, we will present some novel analysis from our Phase II program for Regeneron 727. We along with our partner Sanofi will be hosting a webcast and teleconference for investors on Monday, November 5th from the American Heart Association annual meeting to provide some additional perspective on our Phase III program
Editor's note: Click for slides from REGN/SNY PCSK9 event at AHA.
And second on PCSK9, what would be the first trial you think to roll and read out? And how do we think about timelines for data read outs for PCSK9?
Okay. So let me take the second question first, as far as PCSK9 goes, we're going to have an event at the American Heart Association with Sanofi and so that’s probably a better form to give you guidance on the various aspects of the program