Christopher A. Viehbacher
President and Chief Executive Officer at Biogen
Thank you, Mike. So, Biogen has recently celebrated its 45th anniversary and this is a company that is really been built on multiple sclerosis. It had some hemophilia products until it was spun-off as Bioverativ [Phonetic] some of you may recall that, in the past, and we have SPINRAZA. So now we really need to think about how do we transform the business.
I know firsthand from talking to a number of neurologists that our products in MS are still considered to be at the top products, but obviously this is becoming a much more competitive environment and therefore we really need to think about how do we grow the business in the future. Now, we have an amazing opportunity with two new products. And as many of you know, I've been in this business a long time and it's pretty rare that you have this opportunity to launch, not one but two major products. And not just any products, but products that are really quite transformative in their respective therapeutic areas. And that's obviously LEQEMBI and Zuranolone. We also have existing products, we can still grow VUMERITY, we can still grow SPINRAZA, and I think we need to take a fresh approach to those and try to reinvigorate the growth of those two brands.
As many of you will point out to me, Biogen has a cost base that is probably higher than most of its peers and we need to think about that much more systematically and some of that may require a reduction in costs, some of it is actually a realignment with the new growth alternatives. And then we also need to look at the R&D pipeline. Now we don't get very much credit for what we have in R&D and Priya is going to talk to you about a number of different products that we think have an awful lot of potential equally.
The neurology franchise is [Technical Issues] slowly progressing diseases, that means you're automatically into long-term and costly clinical studies. And in addition, we have some projects in there, where our Phase 3 studies are essentially proof-of-concept studies and so that makes them also inherently riskier and I think we need to think about how do we balance the the pipeline in R&D going forward.
And finally, I think we should always be -- many companies should always be open to thinking about external growth opportunities. This hasn't always been a major thrust of the company in the past. But I do think that as we expand into other areas such as immunology, rare diseases, psychiatry, that there may be opportunities to bolster those franchises to external growth.
So as you know, LEQEMBI has received accelerated approval in the United States in early January. We have on the same day filed for a full or traditional approval. And I have to also give credit to our partner, Eisai, because within a very short period of time not only did they file for traditional approval on the same day as receiving accelerated approval, but also within weeks they have filed in Europe, in Japan, and initiated a rolling submission in China. And obviously, in the short-term the launch in the US is really going to be constricted until we get reimbursement and that's expected to occur once we have a traditional approval. When we get confirmation of filing from the FDA, at that point we will know whether we have a priority review or not.
Under the terms of the agreement, Eisai is principally responsible and lead to all of the discussions with CMS. As many of you probably have heard, Eisai has said that they are hoping to receive a broader reimbursement once they get traditional approval, and that could be as early as this summer. But as you know, this is not around like till that we're launching here. You need to have a PET scan or a lumbar puncture to confirm diagnosis. We're going to have infusion capacity restrictions. Neurologists have already been busy treating patients with other conditions. So there'll be a question about do have enough neurologists to expand the patient population. And so there is an awful lot to be done in the near-term.
In terms of though -- one of the questions that comes up is, and that'll be the main discussion for CMS. To me, the Sum of Boxes -- the CDR-Sum of Boxes is not really how we look at patient benefit here. As I talked to physicians treating Alzheimer's patients, most of them are really asking can I still drive a car, can I feed myself, can I dress myself, can I enjoy life with my family, and how can I not be a burden to others. And when you actually look at the activities of daily life, we actually saw 37% improvement versus placebo. And to me, that's where the real benefit of this product is.
Now as we look at Alzheimer's, the other message I think I would really like to drive home today is that this is not just a product launch. There is it today and there is it tomorrow. And certainly today, everybody is going to be focused on the initial sales of LEQEMBI and that's going to be a question of overcoming some of the infrastructure challenges that we just talked about. There's going to be enough lot of education of physicians around safety, around the diagnosis, and the infrastructure has to expand to be able to provide the PET scans or the CSF testing. But this is really -- this is really opening up a whole new field. This is a whole new vista both for patients and physicians. I can remember 10 years ago where we've had a lot of failures of medicines in development to reduce amyloid. People had given up hope that this was going to be effective. Actually, it was Biogen's PRIME study that was initiated about 10 years ago that actually showed that there was still hope for this. And of course, it's really the Clarity study that has really demonstrated the importance of removal of plaque and the potential to impact the decline in cognition. And what I think this is going to do is unleash a whole wave of research and development, but there is going to be other things. I mean, just even things that we're doing. Obviously, there's amyloid, but they're going to be other modalities such as tau. And Priya will talk about our own potential solution in terms of tau.
But we're also looking at this -- the trial really focused on this 18 months of treatment. But what happens at the end of the 18 months. And there are actually already data that indicate staying on drug has a continued benefit. And so, in fact, Eisai will be filing before the end of Q4 of this year an indication for the treatment on a maintenance basis. But one of the most interesting dimer and I've been obviously trying to get up to speed on Alzheimer's over the last 90 days, but it turns out that plaque burden is at its maximum just before symptoms arise. So imagine the benefit if we could actually go earlier. And in fact, there is a study called AHEAD that is looking at preclinical or pre symptomatic patients that could be quite interesting.
But to do that, of course, other things like blood-based biomarkers and other biomarkers are going to be important. We're going to have to make this a lot more convenient as a treatment and their subcutaneous treatment formulations and progress and. And so what I think you're going to see is just a flood of information over the next three to five years as new modalities and new ways of treating Alzheimer's patients come up. So here you see the AHEAD study that was launched in 2020, and looking at pre-symptomatic. One of the physicians who treat Alzheimer's told me -- we used to think about Alzheimer's as a seven-year to eight-year timeframe, which was really from the onset of symptoms and until sadly death, now they're looking at this on a 25-year frame because we know that plaque builds up over-time. And in fact, what we call early-stage Alzheimer's today with this mild cognitive improvement, it's really not. It's actually already pretty advanced by the time you have MCI. We've already talked about the potential for maintenance dosing and different modalities. So this is going to be quite an exciting area as we go along.
Now the other exciting areas in major depressive disorder, and there are 21 million people who suffer from this. And every day you are reading about the major concerns around mental health in society. In fact, staff just had an article yesterday about the number of younger people who are suffering from depression and feeling sad and even suicidal. And so there is a clear need for new treatments. There are over 400 million prescriptions written every year for MDD and other medical health illnesses. But what we see as an awful lot of switching between therapies. There's a lot of concerns around side effects. It takes a long-time for these new medicines -- these existing medicines to work. And so my personal view is there is an awful lot of unmet need. I was at GlaxoSmithKline when we had Paxil and we had Wellbutrin. So I'm pretty familiar with what the existing treatments can and cannot do.
Postpartum depression, another significant area of unmet need. One in eight mothers, we just had a tragic case that many of us in the Boston area following, and it just demonstrates that there is a real need for a new approach and new treatment here and this is not necessarily where the big commercial opportunity is, but there is a major societal need and I think zuranolone can make a big change here. So we have had a priority review granted, and we have now a PDUFA date in August. As you know, we can't launch immediately because it will have to be a DAA review of the scheduling of the drug before we can launch. So we're looking to launch more towards the end of the year.
One of the interesting things is I see this every now and then in the media about the controversial data of zuranolone because six out of seven trials were positive. You know folks, when we were developing Paxil years ago, we had to do six Phase 3 studies to get to that worked. There's an incredible placebo effect here, which is why so many companies actually abandon mental health. So when I saw six out of seven, I said, well, this is absolutely terrific. And so I think there is quite an exciting opportunity here.
We're not going to clearly go after every type of patient, and we're doing a lot of mid-market research. Today, we're finishing the SHORELINE study and that will inform us about who's the right patient for this. And obviously, the label will inform who we are interested. But there's a lot of unresolved symptoms of depression out there. MDD patients with elevated anxiety, we don't clearly have an anxiety indication, but that is an area of MDD patients that we're going to be focusing on and those who are adherence-challenged.
Going back to existing drugs, I'll just say, obviously, Biogen had enormous success with SPINRAZA. But when you look at it, there are still a lot of potential patients that have not been treated, adult patients as well as pediatric patients, and we're going to have a fresh look at how we can improve the coverage of this product. Obviously, it's an intrathecal product, which is not necessarily the most convenient. You may have seen, we've just done a collaboration with Alcyone to have a new device that would make this more convened for patients who are not wanting to go through the numerous lumbar punctures.
We are looking at costs, that's looking at the profitability of our MS franchise. Can we shift some of these costs to supporting our new product launches. We have a biosimilars business, an important business. This is part of the way that we create the economies for the healthcare system to afford new businesses, but we are looking at whether we can do more with that business or maybe whether others could on this business. We're prioritizing the near-term opportunities and really looking at our cost base on a systematic basis. Priya is going to talk about the risk profile and productivity of the R&D pipeline. As I mentioned earlier, we have appointed Priya as Head of Development. I'd like to take the opportunity to congratulate her on that. We're also looking for a new Head of Research.
While we have a lot going on, we still continue to evaluate external growth opportunities. And so I think with that, Priya, why don't we talk about R&D?
