Earnings call transcript excerpt c/o SeekingAlpha.
Can you remind us of your development strategy with regards to the target setting compared to some of the other PCSK9s in development? For example, some of them are testing in post-ACS patients but only after a month or so after the cardiovascular event. So can you describe maybe some of the differences that you have in your program or development strategy?
Can you remind us of your development strategy with regards to the target setting compared to some of the other PCSK9s in development? For example, some of them are testing in post-ACS patients but only after a month or so after the cardiovascular event. So can you describe maybe some of the differences that you have in your program or development strategy?
"Well, we’re not really expert students in what everyone else is doing yet but our philosophy is that the decision to assign a patient to costly resources that might be associated with the use of these amazing new antibodies and now gene silencing approaches, those decisions are going to have to be made with some pretty sophisticated imaging and some pretty sophisticated staging of disease, if you would like – whether that’s ultrasound or MRI or angiography or some combination – and of course many, many biomarkers.
We think that starts in the hospital and that the CATH lab and the associated imaging advances with the CATH lab represents a crossroads for making the decision accurately to assign a patient or to assign such resources to a patient. And we think purchasers and payers are going to demand that level of evidence before they’re going to pay for potentially disease-modifying treatments such as the antibodies or gene silencing.
So I think our entire philosophy is that these are not outpatient or even primary care or even cardiology office drugs at the beginning. We think they’re hospital-initiated products, and that will guide our approach to the value proposition. We don’t want to treat anybody who doesn’t need it or who doesn’t clearly expect to get benefit from it. So that’s our main focus. Obviously other companies may take a more mass market approach than that and hopefully they’ll be successful, too, but our view is that these need to be niched.
Now, whether or not it’s an ACS patient I think is questionable. We know that ACS patients have incredible residual risk for the next twelve months based upon studies such as the PROSPECT-1 trial. There’s going to be another prospective natural history trial with imaging done. We’re going to be involved with that, and I think picking the right patients may not be as simple as saying “You have ACS.” It may be necessary to pick other attributes.
So it’s a little early for us to commit to say “Yes, it will be an ACS-picked patient,” and you know, defining a patient who needs that kind of costly investment for disease modification may not be as simple as saying they just popped a [veritable plaque]. There are many other factors. So again, without being evasive I can just tell you it’s complicated and we’re not quite ready to answer your question."
We think that starts in the hospital and that the CATH lab and the associated imaging advances with the CATH lab represents a crossroads for making the decision accurately to assign a patient or to assign such resources to a patient. And we think purchasers and payers are going to demand that level of evidence before they’re going to pay for potentially disease-modifying treatments such as the antibodies or gene silencing.
So I think our entire philosophy is that these are not outpatient or even primary care or even cardiology office drugs at the beginning. We think they’re hospital-initiated products, and that will guide our approach to the value proposition. We don’t want to treat anybody who doesn’t need it or who doesn’t clearly expect to get benefit from it. So that’s our main focus. Obviously other companies may take a more mass market approach than that and hopefully they’ll be successful, too, but our view is that these need to be niched.
Now, whether or not it’s an ACS patient I think is questionable. We know that ACS patients have incredible residual risk for the next twelve months based upon studies such as the PROSPECT-1 trial. There’s going to be another prospective natural history trial with imaging done. We’re going to be involved with that, and I think picking the right patients may not be as simple as saying “You have ACS.” It may be necessary to pick other attributes.
So it’s a little early for us to commit to say “Yes, it will be an ACS-picked patient,” and you know, defining a patient who needs that kind of costly investment for disease modification may not be as simple as saying they just popped a [veritable plaque]. There are many other factors. So again, without being evasive I can just tell you it’s complicated and we’re not quite ready to answer your question."
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