So we’ll be looking at that. as well as clinical endpoints. And very specifically, there are quite a few clinical endpoints. There’s the Bayley score, there’s the CGI and there’s a Vineland. We’ll be looking at all of them. Stepping out into what do we feel about the competitive landscape? We feel that this as designed the program is well positioned. Just from an ASO perspective, the backbone of the BIIB121 ASO, we believe, is different. That’s 1 from the Ultragenyx ASO. Second, we believe that the dosing may be needed at a quarterly level to really see the PK/PD impact that we need to have — make an impact in this disease. And we do have a 3 monthly dosing in the LTE. So the MAD is 2 doses being given 1 month apart. And then the third dose, 2 months later, and then patients go into a 3-month dosing.
So we are — we feel that we will have a data set that we can look at and really assess whether we see an adequate signal to really take it into a Phase 3. And with regards to Roche discontinuing their program, we believe, again, that this is a different product, and we believe we may have a competitive advantage. Ultimately, of course, we need to see the data.
Chuck Triano: Thank you, Priya. Let’s move to the next question, please.
Operator: We’ll go next to Mohit Bansal with Wells Fargo.
Mohit Bansal: Great. Thank you very much for taking mu question. Maybe I can — if you can comment a little bit on the previous comments you made regarding SPINRAZA returned to growth. What is happening in the market right now? And how do you plan to get back to growth on this product? Thank you.
Chris Viehbacher: Sure. So as you know, we have an oral therapy out there. We have a gene therapy, and we have SPINRAZA with the intrathecal. So short term, I think one of the data points that was very important was demonstrating the efficacy of SPINRAZA following Zolgensma because there has been some feeling that Zolgensma wanes over time. So we’re getting what we call switch packs, and the other on the oral therapy is that there has sometimes appear to be that the efficacy is limited to certain body weights. So we can actually go after more adult populations. We believe that only about 30% of patients with SMA are actually treated. Clearly, the pediatric patients are screened for and readily identified. But there are a number of adult patients where the disease is manifest, but it is sometimes difficult to diagnose.
And so we’re back to the rare disease job of hunting for patients. But we think, actually, we will be the most app most appropriate treatment for that patient population. So that’s one source of growth. And then longer term, as you know, we have a high-dose SPINRAZA program in development which could, if it’s successful, lead to just on intrathecal injection procured. And that would make an enormous difference to patients in terms of patient convenience and make SPINRAZA even more competitive compared to the others. Now that’s still going to take a number of years, but we do expect that still to come to market before the patent on SPINRAZA occurs.
Mike McDonnell: Yes. And I’ll just quickly add to that, Mohit, that in the — as we mentioned in our prepared remarks, there tends to be some lumpiness quarter-over-quarter, particularly outside of the U.S. with shipments. But overall, when you look at the full-year of 2023, we actually saw modest growth in the U.S., modest decline OUS and overall, moving back toward the modest growth trajectory that we’re hoping for, and we are pleased with how that franchise has stabilized over time.
Chris Viehbacher: Yes, there’s a dynamic as sort of the oral comes into a market at one point or the gene therapy comes into a market. If you have 100% market share and the competitor comes in mathematically, you’re going to lose market share. But what we see is that there is some churn for a year or two. And then the markets settle out, and that’s when people start focusing on efficacy and patient populations. And as I say, so far, we have been able to maintain leadership in SMA despite the competition. And I think that’s where they’ll be. There’ll be different products for different patients, but there’s still enough of a patient population and even with the switchbacks that we can find reservoirs of growth.
Chuck Triano: Great, thanks. And operator, can we move to our last question, please.
Operator: We’ll go next to Jay Olson with Oppenheimer.
Unidentified Analyst: Hey, guys. This is Matt on for Jay. Thanks so much for taking our questions, and Jay sends his regards. So we were wondering, I guess it’s still early, of course, but the PPD launch still far, just in terms of any metrics or signals that you see that support your confidence in the launch so far? And of course, over the next few months to quarters, what kind of metrics do you believe will become meaningful and that you might plan to share? And maybe just your overall longer term goals for that PPD launch and your general interest in the psychiatry space would be interesting to hear as well. I really appreciate the question.
Chris Viehbacher: Sure. Thanks, stunt double. We — so there are a number of things that I think are quite encouraging. One is our initial target has been high-prescribing psychiatrists in this space as well as OB-GYNs. And one of the things that we were wondering about is, are the OB-GYNs really going to be willing to prescribe? And so one of the encouraging signs is that they in fact are doing so. So we’re seeing quite a high percentage of the prescriptions coming from them. Another has been, I think, as I mentioned earlier, that payers have really wanted to ensure access to patients, and I’m quite thankful to them. I think Medicaid, for example, where 40% of births occur, have moved very quickly on that in a number of states.
And some of the large — at least one of the large commercial insurers is moving much quicker than we expected as well. So I think the reimbursement is a key statistic. Now, personally, I’m interested in knowing how many patients are treatment-naive versus people who have been on treatment. What is interesting is, is there a warehousing effect here as well? There’s been an awful lot of media coverage. The product was approved in July. We were not able to launch because of the DEA inspection until the very end of 2023. So what we don’t know is, are we seeing a bolus of patients come in because these are patients physicians have been following for some time who’ve been identified as being particularly important to have ZURZUVAE. So I think we’ll need to see a little bit more data about who are the patients and where are they coming from, but as I say, so far, we’re running for the first month.
I mean, we’re certainly doing much better than what we had anticipated. And we’ll give you another update at Q1. We’ll sit with Sage sometime in March to look at the data and say, what do we see as some of the trends. But so far so good.
Chuck Triano: Great. Thanks, Chris. And that will conclude our call. Appreciate you all joining us today.
Operator: That concludes today’s call. We appreciate your participation. You may now disconnect.
