Biogen Inc. (NASDAQ:BIIB) Biogen and Sage Zuranolone Webcast December 6, 2022 8:00 AM ET
Company Participants
Helen Rubinstein – Director-Investor Relations-Sage Therapeutics
Chris Benecchi – Chief Business Officer-Sage Therapeutics
Maha Radhakrishnan – Group Senior Vice President and Chief Medical Officer-Biogen
Greg Mattingly – Associate Clinical Professor-Washington University
Alisha Alaimo – President-Biogen-U.S. Organization
Mike Hencke – Head-Investor Relations-Biogen
Jim Doherty – Chief Development Officer-Sage Therapeutics
Conference Call Participants
Operator
Good morning. Welcome to Sage Therapeutics and Biogen’s Joint Investor Webcast. Currently all participants are in a listen-only mode. This call is being webcast live on the Investors and Media section of Sage’s and Biogen’s websites at sagerx.com and biogen.com respectively. This call is the property of Sage Therapeutics and Biogen and recording, reproduction or transmission of this call without the express written consent of Sage Therapeutics and Biogen is strictly prohibited. Please note that this call is being recorded.
I would now like to introduce Helen Rubinstein, Director, Investor Relations at Sage Therapeutics.
Helen Rubinstein
Good morning. Mike Hencke, Head of Investor Relations at Biogen, and I are pleased to introduce Stage Therapeutics and Biogen’s joint webcast focusing on the planned commercialization strategy for zuranolone in major depressive disorder, or MDD, If approved. Before we begin, we encourage everyone to go to the Investors and Media section of our websites at sagerx.com and biogen.com where you can find the slides we will be presenting during today’s webcast.
We would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please consult the risk factors discussed in each company’s SEC filings for additional detail. We’ll begin the call with opening remarks by Chris Benecchi, Chief Business Officer at Sage. Next, Dr. Maha Radhakrishnan, Group SVP and Chief Medical Officer at Biogen will lead the discussion with Dr. Greg Mattingly, Associate Clinical Professor at Washington University. Dr. Mattingly joins us today to share a physician perspective on the unmet need in the treatment of MDD. Then Maha will provide information on the clinical experience to date with zuranolone.
In the second half of the call, Alisha Alaimo, President of Biogen’s U.S. Organization, and Chris Benecchi will provide more detail on the potential commercial opportunity for zuranolone and MDD and Sage and Biogen’s joint plan to execute a fit-for-purpose launch of zuranolone if approved. Lastly, Chris will make closing remarks before opening up the call to question. During the Q&A session, we will also be joined by Jim Doherty, Chief Development Officer at Sage. Please note that questions can be submitted at any time during today’s call through the ask-a-question box located on the left hand side of the webcast player directly under the speaker headshot. Thank you for taking the time to participate in today’s event.
With that, I’ll now turn the call over to Chris.
Chris Benecchi
Thank you, Helen, and good morning everyone. We are very happy to have you join us this exciting day. This morning we announced that the NDA for zuranolone in MDD and postpartum depression, or PPD, was submitted to the FDA. On today’s call, we look forward to providing an overview of our planned commercialization approach for zuranolone in MDD if approved. I’d like to note that while today’s event is focused on MDD, we are equally as motivated to help people with PPD and we look forward to sharing more on our planned commercialization efforts in the space in the future. I’d like to begin with Sage and Biogen’s mission for zuranolone. We are laser focused on preparing for a potential launch with the ultimate goal of transforming the way depression is treated. We feel a tremendous responsibility to patients to deliver a new treatment option, which is so desperately needed.
After hearing from hundreds of patients in healthcare providers, Sage and Biogen deeply understand the unmet needs that exist in the treatment of MDD. These perspectives have motivated us in our efforts to advance zuranolone. While treated chronically for decades, it’s increasingly understood that depression is a condition that presents in episodes that can be treated as needed with the goal of returning patients to a state of wellbeing. Our companies stand together in our mission to evolve the treatment landscape in MDD with zuranolone if approved.
With that, turning to the next slide, we would now like to play a brief video featuring several patient advocates providing their perspective on MDD.
[Video Presentation Starts]
We’re talking about very, very serious negative health outcomes, and that’s why we are just desperate for new action, new innovation in this area because it’s exactly what patients and families need and need it now.
One of the biggest concerns is the duration of time it takes for medications to work. People are looking for treatments and they need them now.
If someone is living with depression, every day is a struggle. Every day is painful. Every day is something that they’re just trying to get through.
I think the system is failing a lot of people or I wouldn’t say that the system is effectively recognizing people, getting them to care and then getting them to treatment.
This is a very serious national problem that deserves an awful lot more attention than it’s been getting.
There is a need for more innovation. There is a need for more treatment options for people living with depression.
There is a lot of people who are not being helped by their first medications that are being prescribed to them.
The hope that the voices are getting louder, the people are demanding better and more, and that we have more stakeholders across the board listening and trying to do their best to find solutions.
It’s important that we offer people living with depression and their family members hope.
[Video Presentation Ends]
MDD, we believe that if approved, zuranolone can be a part of that solution. Turning to the next Slide, this is a published visual representation of the complicated path many MDD patients endure to find a therapy that works for them that was developed using U.S. commercial claims data from an analysis of more than 2,100 patients up to one year after their first treatment change. In effect, this is what a patient goes through in their first year of treatment. If you feel like the visual is confusing and you’re struggling to find your way through the chart, you’re right.
This is just a small glimpse into the chaotic and confusing reality that exists for many MDD patients, but we’ll only spend a moment looking at this slide. MDD patients could remain in this treatment turmoil for days, weeks, or even years. Depression is one of the leading contributors to disability worldwide with more than 190 million cases of MDD estimated annually. In 2018, depression cost the healthcare system and estimated $326 billion in the U.S. alone. These patients deserve treatment options that offer the potential to simplify that turmoil and society would benefit if the cost of depression were lowered.
Slide 9 provides a high level overview of what we anticipate the treatment paradigm could look like with Zuranolone if approved. We believe that Zuranolone will fit into HCPs existing routine of checking in with patients while offering the potential to have a much earlier indication if the drug is working. To conclude Zuranolone, if approved, may provide a novel approach to treating MDD. Sage and Biogen are working with urgency to prepare for the potential launch of Zuranolone and I, alongside my colleagues, look forward to bringing this therapy to patients.
With that, I will now hand the call over to my colleague, Dr. Maha Radhakrishnan at Biogen for a discussion with Dr. Greg Mattingly. Maha?
Maha Radhakrishnan
Thanks Chris. Before I review the clinical findings with Zuranolone to date, I’m pleased to introduce Dr. Greg Mattingly, who will share his perspective on the unmet needs in the current treatment of MDD. Dr. Mattingly, thank you for joining us today. Could you please start by introducing yourself and your background?
Greg Mattingly
Glad to be here. Before I begin, I would like to note that my disclosures can be found at the bottom of this slide.
I’m a psychiatrist based out of St. Louis, Missouri and have been in practice for 30 years now. My partner and I set up a practice in the area of St. Louis that was underserved in mental healthcare 30 years ago, and in that time we’ve taken care of children, adolescents and adults struggling with complex mental health disorders. On top of that, about 25 years ago, we started a clinical research company with the goal of addressing the unmet needs in mental health care. Since that founding, I’ve served as a principal investigator in 400 clinical trials.
In addition to my clinical practice, I am a teacher and educator as an Associate Clinical Professor at Washington University, a Principal Investigator, the Midwest Research Group, and the president-elect for the American Professional Society for ADHD and Related Disorders and serve on the Steering Committee for the U.S. site Congress.
It’s also important to note for this discussion that I was an investigator for the studies in the landscape clinical program, which are the MDD studies for zuranolone that have recently completed.
Maha Radhakrishnan
Thank you. We really appreciate you sharing your background. To kick off our discussion, can you tell us a little bit more about MDD? And how the disorder presents in your patients?
Greg Mattingly
Yes. MDD is a common but serious condition. In fact, in a survey of U.S. adults conducted in 2020, approximately 21 million people reported experiencing at least one major depressive episode in the last 12 months.
Unfortunately, we’ve been losing the battle with depression as health care outcomes have improved with many conditions; disability due to depression has increased over the past decade.
More recently, it’s important to note that during the COVID-19 pandemic rates of major depression have only exacerbated. Today, analysis suggests there is a greater than threefold increase in rates of people suffering from depressive symptoms compared with pre-COVID-19 levels.
Because of how common major depression is, we all probably know someone who deals with depression. What I typically see in my practice is that major depression often presents them recurrent episodes appearing many times over the course of someone’s life. Depression can look different for each patient. Some patients have high levels of anxiety while some patients are highly withdrawn. Some people are agitated while many patients struggle with being fatigue and unmotivated. For each of these patients, the need is the same. They are all struggling with depression. These symptoms can have a profound impact on the person suffering from depression and their friends, family and colleagues.
Additionally, depression universally affects a person’s overall quality of life. And as an example, the STAR D depression study highlighted that when a mother with depression has not gotten better after a year, it had a profound impact on her family. Her children are also struggling academically, emotionally, struggling to just make a friend.
So patients usually come into my office struggling, suffering and in crisis, when the symptoms of their current episode are significantly impairing their daily lives. That is when we, as clinicians, have to think about how do we initiate or change the treatment.
Maha Radhakrishnan
How are you treating patients currently? And what do you view as the greatest unmet need?
Greg Mattingly
There are many treatments available for depression today. But despite this, there has been little innovation in terms of the mechanism-of-action in decades. Most treatments approved today are either SSRIs or SNRIs, basically raising the level of monoamines. These have become the standard of care for most clinicians and despite these medicines being widely available; many patients are still struggling with depression.
One of the problems is, first, it takes several weeks or months for many of our standard antidepressants to begin to take effect. I view this as one of the greatest unmet needs in treating depression. Imagine a close family member of yours struggling with an episode of depression and their clinician says their medicine will take weeks to take effect. For many of my patients struggling with depression, weeks can feel like a lifetime. We’re talking about weeks of potentially missing school, missing work, and missing social interactions.
So patients with MDD are often debilitated and are seeking relief as soon as possible. Equally important to note is that the longer it takes for patients to achieve a response or remission the higher is the risk for their overall health to deteriorate. That’s further impacting their quality of life. Therefore, it’s critical that we treat with urgency with the goal of returning patients to a state of well-being and functioning rapidly. On this point, I’m encouraged to see new innovations coming forward with this goal finally in mind.
A second challenge with current antidepressants is that for many patients with depression specific symptoms such as insomnia or anxiety may make treatment even more complicated and increase the risk of relapse. In that case, I frequently augmented patient’s treatment with another medication for depression, an anti-anxiety medicine, a sleep aid or an atypical antipsychotic or sometimes even switch therapies. In each of these cases, the potential side effects of the additional treatments be it weight gain, sedation or other metabolic issues must be considered.
A third unmet need stems from the current paradigm of chronic treatment for depression. For many of my patients, this feels like a chronic pain model, where our goal is to decrease suffering without a true return to wellness. As physicians, we’ve been talked to manage major depression chronically because the currently available antidepressants often require chronic use. However, there is a growing understanding that major depression present episodically, and we need treatment options to address the episode when symptoms arise. Chronic therapy may also present adherence challenges for patients who are experiencing tolerability issues.
My patients are often reluctant to continue a chronic therapy if they are only partially better, or are having side effects, and the like. In some instances these side effects can be really bothersome and may occur before they’ve started to notice any improvement in their symptoms.
Other potential side effects such as emotional blunting, insomnia, weight gain, or sexual dysfunction are not only troublesome, but are frequent reasons my patients will quit a treatment. In fact, one of my most common causes of treatment discontinuation among my patients with depression is unwanted side effects. As a result of these unmet needs, patients often cycle through multiple medications, either due to side effects or insufficient efficacy or efficacy that just takes too long, delaying the time to get to remission. Unfortunately, there can be a lot of trial and error in treating a patient with major depression, which can further delay a patient getting better.
Maha Radhakrishnan
Based on the clinical profile seen to-date, if zuranolone is approved to treat MDD, how would you see it fitting in your practice?
Greg Mattingly
Obviously, I see a lot of unmet needs in the treatment of depression. There are a lot of patients in my practice who are currently taking one of the standard antidepressants or have taken one in the past, but haven’t experienced the treatment response they’re hoping for. Instead of feeling less depressed, my patients want to feel well, many are not satisfied with the level or speed of response they’ve experienced with the antidepressants they’ve taken or they’ve had side effect issues that have prevented them from achieving the response they were looking for on a traditional antidepressant.
In addition, many patients don’t want to be treated chronically. If zuranolone is approved, I can envision trying it in some of those patients either alone or in combination with another antidepressant. As new medications are being tested and become available, they’ll be integrated in my practice, moving beyond a chronic treatment model. In terms of fitting into my practice, monitoring a short course of treatment would mean changing my expectations for what I expect to see with an antidepressant medication, watching for improvement, monitoring for relapse, trying to encourage overall wellness will be important goals for treatment.
Using the PHQ-9 to measure someone’s mental health vital statistics as their symptoms are improving, are there any symptoms being left behind? Are there any signs of relapse or recurrence? I’d envision regular check-ins with my patients. If there are any signs of a relapse or a recurrence, I’d have them come to the office and talk about the next treatment steps.
Overall, I’m looking forward to using zuranolone in clinical practice if it’s approved as I believe it would be another meaningful tool in my toolbox for treating depression in my patients.
Maha Radhakrishnan
Thank you, Dr. Mattingly. We really appreciate you joining us to discuss the unmet needs in MDD. Your thoughts were invaluable in understanding the gaps in the current treatment paradigm and potential opportunity for zuranolone if approved. I would now like to review the data from the zuranolone clinical development program and why we believe that zuranolone, if approved, could be a meaningful option for patients living with MDD and PPD based on the efficacy, safety, and tolerability profile seen in clinical trials.
To begin, zuranolone has been evaluated in two extensive clinical development programs, NEST in PPD and LANDSCAPE in MDD, which now includes more than 3,500 patients. As part of these clinical development programs, zuranolone was evaluated across multiple use cases, including as a monotherapy add onto existing antidepressant, or co-initiate it with another antidepressant.
Importantly, when we look at the results across the LANDSCAPE and NEST programs, we see a consistent improvement in depressive symptoms associated with zuranolone over that of placebo. Specifically five out of six of these placebo controlled clinical studies resulted in a statistically significant improvement in depressive symptoms in adults with either MDD or PPD who received zuranolone, 30 or 50 milligrams as compared to placebo. When assessed by change from baseline in the HAMD17 total score at day 15.
Furthermore, the CORAL study assessing the efficacy and safety of zuranolone when co-initiated with the new standard of care antidepressant showed that zuranolone treatment resulted in a statistically significant improvement in depressive symptoms as compared to placebo as early as day three when assessed by change from baseline in the HAMD17 total score. This was both the primary endpoint of the study and the earliest time point measured, underscoring the rapid reduction in depressive symptoms over standard of care associated with zuranolone in this trial.
Efficacy as early as day three was also seen across clinical studies of zuranolone in MDD and PPD. Also, in an integrated analysis of four of the completed clinical studies in MDD and PPD, a 14 day treatment course of zuranolone led to greater improvements over placebo on the SF-36 scale, a validated patient reported outcome instrument that measures functional health and wellbeing.
Importantly, patient reported benefits. We are SF-36 score in the zuranolone cohorts were observed at day 15 and importantly sustained at day 42 in MDD and day 45 in PPD. In addition to the placebo controlled studies I already discussed, the LANDSCAPE program also includes the SHORELINE study, one of the largest prospective naturalistic studies in MDD to-date. In the 50 milligram SHORELINE cohort, approximately 80% of individuals who responded to the initial course of therapy received only one or two treatment courses in total during their time in the one-year study.
It is worth noting that the majority of these participants received only the initial 14 day treatment course. Furthermore, for those that responded, the median time to first repeat treatment in the 50 milligram cohort was 249 days. Of note, across the studies in the LANDSCAPE program, zuranolone showed benefit in patients with MDD, with and without elevated anxiety. As you just heard from Dr. Mattingly, anxiety is a common feature in patients in more than 50% of MDD cases, which historically has made them very difficult to treat.
Now moving on to safety, across eight completed and ongoing zuranolone clinical trials, a consistent safety and tolerability profile in adults with MDD or PPD has been observed, where most treatment emergent adverse events were mild-to-moderate, and severity. The most common treatment emergent adverse events observed to-date have been headache, somnolent, dizziness, nausea, and sedation.
Importantly, there’ve been no signals of suicidal ideation or symptoms of withdrawal.
In addition, weight gain and sexual disconnections were not identified as safety concerns associated with zuranolone. Throughout this zuranolone development journey, we have been engaging with a broad set of key medical experts to help shape our clinical program. We have received consistent feedback on what they consider the four main strengths of the zuranolone clinical data.
First, a robust clinical development program with approximately 3,500 subjects. Second, rapid onset of action seen in clinical trials with an improvement in depressive symptoms observed as early as day three. Third, improvement in depressive symptoms observed across multiple zuranolone use cases and patient populations in MDD and PPD, including those with elevated anxiety. And fourth, a consistent safety and tolerability profile, which I just described.
U.S. key medical experts have also identified areas for further discussion, including sustainability of efficacy and the need for repeat treatment. We’re also delighted to see the approval and initial use of a combination of bupropion and dextromethorphan as a positive signal that both patients with MDD and clinicians are looking for therapies that work rapidly. In their case, one to two weeks.
Overall, physicians have highlighted that a treatment option with the potential to achieve both a rapid and sustained effect could be a meaningful addition for them and their patients in the treatment of MDD. They also are increasingly recognizing the episodic nature of depression that potentially could be treated episodically with treatment three periods.
In summary, the profile observed for zuranolone in clinical trials to date leads us to believe that if approved, zuranolone could be a meaningful new option for patients suffering from MDD and PPD. To that end, this morning, we announced the submission of the NDA filing for zuranolone in MDD and PPD to the FDA.
Should the filing be granted priority review with no review extensions, this would set up a potential launch of zuranolone in the U.S. in late 2023. We are very excited about the prospect of bringing a novel antidepressant to patients with MDD, who despite the currently available treatments may still be searching for relief from their depressive symptoms.
With that, I would like to turn the call over to Alisha Alaimo, the President of Biogen’s U.S. Organization, who will tell you more about the potential commercial opportunity for zuranolone in MDD.
Alisha Alaimo
Thank you, Maha. As you heard in the opening video, significant unmet needs remain in the treatment of depression, and there is an urgent need for new innovation. Patients with MDD want to feel relief and to feel like themselves again.
They do not want to make the trade-offs between feeling better or experiencing the types of side effects that often lead to treatment discontinuation. And we know MDD is experienced in episodes.
So why are we treating it chronically? Wouldn’t it be meaningful if we could help patients with MDD who may be feeling intense isolation, helplessness and a sense of emptiness with a therapy that has the potential to work fast without many of the side effects often associated with discontinuation of the standard of care and could be used to treat an episode when it is needed.
We want patients to have more options to help them get better quickly. This is exactly why Biogen and Sage are urgently working together. And if approved, we believe zuranolone could change the way depression is perceived and treated.
We are driven by a vision of the future to transform the care of depression where each episode that patients experience is rapidly treated and symptoms rapidly improved. We know the depression is deeply prevalent in our society and becoming more prominent in our culture. Nearly every day, we see new statistics reporting an unprecedented increase in MDD and more and more people from all walks of life are speaking up to destigmatize depression.
It’s estimated that in 2020, 21 million Americans experienced at least one major depressive episode in the last 12 months and one in six adults will experience MDD at some point in their lifetime, which means there is a strong chance all of us on this call are connected to someone who is struggling with depression.
It is hiding in plain sight, and we cannot expect better outcomes with the same approach. Based on our experience and success in highly competitive markets, we know we must begin with a focused approach to ultimately achieve our very bold vision.
This means that if zuranolone is approved, we will be intentional in our approach and engage the HCPs who we believe will be the most likely to adopt zuranolone in the treatment of MDD. Our omni-channel and in-person engagements will primarily be focused on specialists as we know we must earn their confidence before the broader base of PCPs may follow. Which brings me to the types of patients with MDD that we believe will benefit most from zuranolone.
As we heard from Dr. Mattingly and supported by [indiscernible], the largest and longest prospective clinical trial of MDD ever conducted generic SSRIs are typically the first product prescribed.
However, studies estimate that two-thirds of MDD patients do not achieve remission after first-line therapy. That means that on any given day, there are patients in the process of switching, adding on or reinitiating therapy.
Our strategic focus at launch will be on these patients who still experience residual symptoms of depression, especially early in their treatment. Because we know that longer episodes of depression or a delayed response to treatment can be associated with worse outcomes.
There are a few common patient profiles in MDD that we’ve identified as our strategic focus at launch based on our market research and in speaking with hundreds of patients. First, these patients may have achieved partial remission. For example, one woman shared that after attempting multiple treatments while not treatment-resistant, she was still experiencing some residual symptoms.
Second, these patients could be experiencing MDD with elevated anxiety, which impacts more than 50% of MDD patients and makes their MDD symptoms especially difficult to treat. Or third, they could be non-adherent. For example, because they do not want to experience the types of difficult side effects that often lead to discontinuation of treatment.
Across all of these patient types in MDD, a therapy like zuranolone, if approved, could potentially help patients achieve the response they are seeking. That said, while our efforts will prioritize these patient types, HCPs have shared that other MDD patient types may also benefit from zuranolone, if approved. For example, patients who have breakthrough episodes or young adults in college with MDD who may need a treatment with the potential to be fast acting because they can’t afford to lose time waiting six to eight weeks for a therapy to improve their symptoms.
As I shared, to help reach these patients, we have carefully identified HCPs based on a clear set of criteria. Those who treat a high volume of patients with MDD write more branded prescriptions and practice advanced therapy. Meaning they have experience treating with polypharmacy or adjunctive therapies. Our plan includes prioritizing psychiatrists, nurse practitioners, physician assistance and a targeted set of PCPs, which will also be the focus of our sales force upon a potential launch.
Of note, in the last 10 years in the U.S., the number of nurse practitioners who focus on psychiatry has accelerated by over 160% and many NPs and PAs are now independently managing patients, making treatment decisions and prescribing therapies, and they are critical and rural and underpopulated areas without access to specialist care. We plan to have a tailored approach to engaging with this community.
Finally, PCPs. There will be a subset of PCPs we plan to engage at launch as they meet our criteria because they have similar prescribing patterns in MDD as psychiatrists. We will be prepared to further expand our PCP engagements and scale with success of the launch.
Based on our experience, we know that in the last few years, the way HCPs prefer to receive information has dramatically changed. That is why we aim to have an advanced omnichannel approach to reach all of our target HCP with a strong digital strategy. Our advanced omnichannel engine is designed to unite data from our content, media and in-person interactions, including with our sales force to deeply understand customers and create a better experience with the goal of increasing the impact, efficiency and agility of our execution.
It is powered by predictive analytics designed to deliver customized and personalized information where and when HCPs want it. We plan to use our omnichannel approach to reach the broader PCP audience. We will be prepared to further expand our PCP engagements with success of the launch.
With patients, expectations have also changed for how they would like to receive information and care. And MDD patients play an important role in their own treatment because they ultimately decide when to engage or reengage with their HCP. So it is equally important to engage them on our omnichannel approach.
We believe, if approved, zuranolone profile has the potential to address many of the unmet needs that patients face today. Our goal is to inform and inspire them to advocate for new treatment options and to help them navigate their treatment journey. We know that to achieve our long-term vision of transforming the care of depression, we must begin with a focused strategy and be prepared to scale with success.
For many patients with MDD, the standard of care is not working. We believe a therapy like zuranolone that has the potential to rapidly treat patient episodes with its observed tolerability profile and make a difference in these patients’ lives if approved. As we know, we must have market access to ensure therapies get to HCPs and their patients.
So with that, I will hand it back to Chris, who will share more about our planned market access strategy.
Chris Benecchi
Thanks, Alisha. Throughout this presentation, we’ve underscored that our goal. If zuranolone is approved, is to deliver a launch that has the potential to transform the way MDD is thought about and treated. We believe that for zuranolone to truly transform the treatment of depression, it must be accessible. Accessible would mean that when an appropriate patient with MDD as prescribed zuranolone, here, she can get it rapidly and seamlessly.
With this goal in mind, our value-centric access strategy is focused on minimizing restrictions like onerous prior authorization or multiple step edits that could delay the prescription immediately from getting filled. For patients with MDD this would mean if we’re successful, that zuranolone is readily available and that their out-of-pocket cost is affordable.
And for payers, this would mean that the budget impact is predictable as they strive to improve patient outcomes. We know that price is an important component of our planned value-centric access strategy. Sage and Biogen plan to provide clarity on pricing at the time of a potential approval.
With that said, what I can say now is that we’re thinking strategically about pricing and that we believe our pricing strategy will take the needs of all stakeholders into consideration. It’s important to understand the payer landscape that zuranolone will enter, if approved in MDD. As you can see from the graph on the left side of the slide, commercial payers account for more than 50% of the current market coverage with government payers covering the rest. It’s also important to recognize the current coverage paradigm for branded drugs in MDD.
As you can see on the right side of the slide, despite the number of generics in the market, branded products are well covered by all categories of payers. In most cases, patients need to try one or two generic options, but prior authorizations are relatively uncommon outside of the Medicaid space. What that tells us is that the existing MDD treatment landscape, our target patients have access to branded medications when physicians prescribe them.
Based on the efficacy and tolerability data we generated with zuranolone in our clinical program, we believe zuranolone could potentially garner favorable coverage with payers and provide a highly desirable treatment option for people living with MDD and the clinicians treating them.
Turning to Slide 30. I’ll share more on our plans for a proactive contracting strategy with an aim to establish value-based agreements that we believe could fortify the zuranolone value proposition in MDD. Our goal with this strategy is to minimize friction and drive timely coverage of zuranolone in the treatment of MDD at launch. We want to be innovative with our access strategy as we’ve been with the way we’ve designed and developed zuranolone. Our intent is to be customer-centric in design and aim to meet the needs of MDD patients, physicians and payers.
To that end, we plan to work closely with our customers to co-design value-based agreement offerings that help meet their needs such as budget predictability, while being mindful of the considerations laid out on this slide. We have already engaged in these conversations with some of the most influential U.S. payers, with the goal of having agreements ready at the time of launch, if zuranolone is approved. It is important to note that not all payers can or want to implement value-based agreements. So while we believe this is an important component, it will only be one part of a holistic payer value proposition.
At this point in our launch preparation, we’ve already spoken with all national and most regional payers about their perception of the unmet needs in the MDD marketplace and zuranolone. We’ve had in-depth discussions on the MDD disease state as well as permitted pre-approval information exchange on zuranolone. Our customers have generally been very receptive to the information about the disease state and zuranolone’s clinical profile. Our engagements have told us that despite generic availability, a major unmet need remains in the treatment of MDD.
Payers like other stakeholders would like to see a treatment option for MDD that has the potential to work rapidly. To share some details on their feedback. First, there is a strong desire among many payers to optimize patient adherence to therapy to improve overall outcomes in MDD. We’ve repeatedly heard from payers that there are treatment tolerability issues and comorbidities associated with MDD that add complexity to the management of this patient population. Second, peers are also highly aware of the health equity issues linked to MDD and see the potential for zuranolone, if approved, to be well adapted for patients who may struggle with consistent access to care.
Third, payers have also expressed the need to achieve budget predictability and cost containment for new agents in MDD. They also recognize they’re both direct and indirect costs associated with MDD if it’s not well managed. General payer sentiment was zuranolone may offer a treatment option that aligns with their objectives of better managing MDD. These early engagements with payers have reaffirmed our belief in zuranolone as a differentiated therapy with the potential to transform the treatment of depression.
To close, our planned commercialization strategy in MDD, if zuranolone is approved, represents a focused approach intended to scale with success. We believe that if we are able to successfully act on the items we reviewed today and execute on our launch plans, we’ll see clinicians prescribing zuranolone and MDD with a sense of urgency, patients with MDD asking for zuranolone and payers enabling access to this critically needed treatment.
We have a current focus on disease state education in MDD, scientific exchange and permitted interactions with payers. These efforts and other permitted pre-launch activities will continue to broaden and ramp up as we head towards a potential launch. As we look to the potential for commercial launch for zuranolone, we believe we have the ability to make a difference for people living with depression by helping to reduce the substantial unmet needs they face.
We are excited about the opportunity to launch zuranolone if approved. There are three key points that have surfaced in our interactions with stakeholders to date. First, there is unmet need in the MDD market. Second, we have seen an increasing amount of enthusiasm from physicians for the potential utilization of zuranolone in the treatment of MDD, and an understanding of when they may want to use it either after first line failure or early in the course of patient management. And third, early interaction with payers has been broadly positive, and we have already seen positive reactions to our potential innovative contracting structures. We are executing now to deliver on this potential launch because together we believe we have an opportunity to advance the way depression is thought about and treated.
With that, I’ll turn it over to Helen and Mike to handle Q&A. Thank you.
Question-and-Answer Session
A – Mike Hencke
Thank you, Chris. As a reminder, if you’d like to ask a question, you can type it into the Ask a Question box on the webcast viewer. So our first question relates to pricing question is, should we expect a flat annual price of therapy regardless of the number of courses in order to keep things simpler? Or would the product be priced per 14 day course of therapy? And then related to that, how could pricing vary by dose? So, Alisha, would you like to start with that?
Alisha Alaimo
Yes. Thank you, Mike. Without a final label, it’s really too early to speculate on pricing. However, what I can share at the stage is that if the zuranolone is approved in both indications, our current thinking is that we would expect to have one price per treatment course for zuranolone. We also plan on exploring value-based agreements as one part of our access strategy. We anticipate that we can price this product that reflects the value it can bring to patients and to HCPs. Chris, is there anything else you’d like to add on price?
Chris Benecchi
Yes. Thanks, Alisha. As I hit my opening remarks to truly be transformational to zuranolone, we must be accessible. That’s absolutely paramount in all of this. And I think you summed it up well, in terms of what we’re doing in and around pricing, we’re thinking strategically around pricing, but also in concert with our access strategy more overarchingly.
And as we think about the strategic approach that we’re taking to both pricing and access, we’re really working to design an approach that effectively meets the needs of physicians, payers and most importantly patients. And that’s where we are today with respect to the pricing and access strategy.
Mike Hencke
Okay. Our next question relates to how might physicians think about assessing the need for retreatment in patients in the real world? What sort of criteria might they use and how do those compare to the criteria used to assess whether patients need to switch to another option or require adjunctive therapy today?
Maha Radhakrishnan
Thank you for the question. This is Maha. We did talk earlier on in the presentation about the data from the SHORELINE study, which is a naturalistic study designed to follow adult patients in with MDD and evaluate the safety and tolerability of zuranolone, as well as a need to repeat dosing for up to one year. And as I mentioned earlier, the data shows us that those patients have responded to the initial 14 day treatment course. The median time to second treatment course was 249 days with the 50 milligram dose.
So that being said, as I move to treatment in the real world, before I handed over to Dr. Mattingly, I would like to emphasize some of the points in terms of what I have heard from a key medical expert or key opinion leaders in terms of needing to watch for improvements in the patients, needing to also monitor for symptoms of relapse, as well as making sure that overall wellness is encouraging these patients.
As Dr. Mattingly said, patients don’t want to feel better from being depressed, but they want to actually feel well. And I would actually now like to hand it over to Dr. Mattingly to talk specifically maybe more about the PHQ-9 scale that he mentioned earlier, but also other assessments that will really help evaluate the need for retreatment of patients in the real world. Dr. Mattingly?
Greg Mattingly
Thank you. So we already routinely use what we call our mental health vital statistics within our office. In the same way, if you came to see an internist when he was following your blood pressure, he would follow your blood pressure. We do the same thing with the PHQ-9. So each patient, every visit, we check their PHQ-9, we make sure they’ve improved, we make sure we’re not leaving any symptoms behind.
Of note is item number nine on the PHQ-9 is measuring suicidality. So we make sure with each and every visit, if there’s any signs of suicide, we want to pick it up, we’re measuring for it, we’re making sure it’s going away. So we’re looking at mood, sleep, energy, concentration, anxiety, anhedonia, feeling pleasure in life because we know each of those can contribute to both two patients outcome, but also to disability rates, presentism, absenteeism in the workplace.
So we have already begun kind of a new language of taking care of mental health patients that is measuring outcomes. And I think with these treatment as needed, where we’re going to treat somebody, we’re going to try to get you better, and then we’re going to follow you and watch for the sign of a relapse. That’s going to be much like we do in other places of medicine. The goal isn’t just to get you a little better, but leave you struggling. The goal is to get you all the way better and then treat again as needed.
Mike Hencke
Great. The next question we have is what in the zuranolone data gives you confidence that the efficacy is durable?
Jim Doherty
So this is Jim. I’m happy to answer that question, and thank you for the question. We’re actually very confident in the sustained and durable profile of zuranolone. And I would point to several lines of evidence from the LANDSCAPE and NEST program. As you heard just a little while ago from Maha, in the SHORELINE study, we did see that the majority of patients who responded to that initial zuranolone two week course of treatment only received one treatment. And 80% of the patients at 50 milligrams received only one or two courses of treatment over their time of participating in the study. Remember as well that we saw the response retained looking at change from baseline for AMD in all those studies.
And I would also then point to the SF-36; the patient reported outcome data that Maha walked us through earlier where we saw significant improvements at both at day 15, but importantly also at the end of the study, either at day 45 or day 42. So taken together we think that there’s robust data showing the sustained response for zuranolone. And I would say if we, if zuranolone has approved, we would also consider opportunities to generate additional data on its use in real world settings.
Mike Hencke
Great. Our next question is, what are the timelines to broaden the PCP prescriber base and how are you segmenting this market? And then how will that impact the size of the ultimate field force?
Alisha Alaimo
Thank you, Mike. I’ll start that one and then pass it over to Chris. So, I think let’s first start with our go-to-market approach. Our go-to-market approach is designed to achieve the strategic objective of gaining early adoption and driving acceleration of uptake. The first key pillar of our go-to-market approach is how we’re going to prioritize our HCPs. We’ve segmented our customers and have prioritized the targeted set of psychiatrists, nurse practitioners and PAs, PCPs and OB-GYNs who are most likely to adopt Zuranolone. Specifically, these are HCPs who treat a high patient volume. They’re writing scripts for branded products, and they practice advanced therapy management, for example, they’re comfortable prescribing multiple medications at once to treat MDD symptoms.
We also have ongoing research to understand, which doctors are the first to adopt new therapies based on new entrants in the market. Now, PCPs are a very large group with about 275,000 PCPs and another 250,000 PCPs that have PAs and NPs. So our launch at first will be focused on those PCPs that behave most like psychiatrists. They’re going to have a higher volume of MDD patients, and they use branded therapies more frequently. Now, we will scale our PCP coverage, when we see success, of course, in the field. But another key pillar is how we broaden our HCP reach beyond just our field force and deepen our engagements. And to that end, we’ve developed a very strong digital strategy that leverages our omnichannel capabilities, which I think Chris can discuss.
Chris Benecchi
Yes, so I think you hit it in your opening marks, Alisha, you said that we were going to be laser focused at launch, and I think that really describes well how we’re thinking about approaching this market, being laser focused, thinking really big for this medication in the long run, and scaling fast with success and success as measured by data and analytics and insights that we’ll be garnering or gathering from the very beginning moments of the launch as we move forward.
In terms of the omnichannel component, that’s absolutely paramount in terms of how we think about launching the product, because you can only get to so many clinicians with sales representatives out of the gate, but I think you hit it. There are so many other clinicians that are treating patients that are suffering from MDD that it’s critical that we use omnichannel and in particular digital to broaden our reach, ultimately to deliver the messages they need to hear in order to affect the change that they need for their patients.
In all of this, I see this as more than just how we’re going to cover PCPs. I see this as how are we ultimately going to most effectively reach patients. And when you take a step back and you think about what patients are suffering from with depression, weeks matter, certainly days matter and the moments that are missed really, really matter. So it’s on us to make sure that we get to them as quickly and effectively as we can.
Mike Hencke
Okay. Our next question is what portion of MDD patients present as episodic versus chronic? Maha, would you like to start with that?
Maha Radhakrishnan
Sure, Mike, I’ll take that, and then I’ll also have Dr. Mattingly comment on this question. So, what we see is based on the data we have is about it takes about four weeks to six weeks or longer sometimes for patients to see impact or response with the current antidepressant therapies. The side effect burden is also quite significant with chronic therapies. The reality is that patients who are undergoing chronic treatment are living still with a burden of depression. So what we really need to be doing is to redefine depression as an episodic illness with recurrent episodes. So, I will look to Dr. Mattingly to kind of walk us through what he’s seeing in his real life practice amongst the patients that are part of his office practice.
Dr. Mattingly?
Greg Mattingly
It’s a perfect question, and the answer is the vast majority of our patients have recurrent depression. In a clinical practice like mine, that’s probably 70% to 80% of my patients come in not just with one episode, that maybe sticks around for a while, but they come out to recurrent episodes throughout their life. Having been, once again, an investigator in the SHORELINE study and many other studies throughout the year, this ability to treat as needed during an episode is a whole new paradigm when we think about treating depression. And in my practice, it’s been interesting; I’ve asked fellow clinicians, nurse practitioners, doctors what they think about treatment as needed for depression. And everybody’s excited and a little bit curious, and it’s a new way of thinking about depression.
What’s even more exciting is when I’ve asked my patients about the option of having a treatment as needed for depression, a treatment that you take when you’re depressed, hopefully for a large percentage or a percentage of people, it makes the depression go away. And then we use it again only if the depression comes back. So there’s excitement with my clinicians, but even more so there’s excitement among my patients.
Mike Hencke
Okay, thank you, Dr. Mattingly. The next question we have is regarding the filing for both indications of MDD in the same package from our conversations with the FDA, why are we confident that we won’t complicate the FDA’s review of the NDA? And then similarly, are we anticipating an advisory panel and when would we find that out?
Chris Benecchi
Absolutely. So, I think the first thing to say is that both teams have been working very hard to finalize the NDA submission. So, we’re really excited to have announced this morning that the NDA for zuranolone in both MDD and PPD was submitted to the FDA. I think it really offers the opportunity to include the data across landscape and nest programs for both PPD and MDD into one comprehensive data set, and therefore one comprehensive filing. I would also say from an efficiency point of view, it makes it a little more efficient for the agency to review in one package. So, put those things together and we are very confident in the single filing approach, and we think that it will really allow us to talk about the full scope of possibilities for zuranolone.
I think the question around an adcom first thing to say is the agency’s decision whether or not to hold an adcom. Having said that, we will prepare to be ready for a potential adcom and we would frankly quote, welcome the opportunity to discuss the totality of data for zuranolone program and potentially hear from patients, patient advocates about the needs for therapeutic innovation.
Mike Hencke
Great. The next question we have is what percentage of MDD patients would we estimate fall into the core launch target segments we talked about being partial response, adherence challenged or elevated anxiety? Maha, would you like to start with that?
Maha Radhakrishnan
Yes. Thanks Mike. I will start and then I will have Dr. Mattingly respond, and then we will have Chris comment as well, because this is a very important question. So in terms of the types of patients as we’ve described, we’ve had various patient cases, zuranolone use cases in our clinical development program, starting with monotherapy to adjunctive therapy to co-initiation with new antidepressant treatment starts.
That being said, we also recognize that the management for complex cases of patients with major depression, especially those with elevated anxiety, has been very complex. 50% or so patients fall in the category of patients with major depression with elevated anxiety. And we also hear from physicians that very often they result to using other medications in addition to their core antidepressant therapy like anxiolytics, atypical antipsychotics, sedatives, et cetera, to manage those hard to treat patients who have elevated anxiety symptoms as well.
So I – and obviously we’ve also seen data from the STAR*D program in terms of the percent of patients who actually respond, which is quite low, which is less than one third of patients who respond to initial courses of therapy. But I would like to, again, have Dr. Mattingly comment from what he’s seen in his clinical practice in terms of partial responders, endurance to treatment, as well as patients with MDD who have symptoms of elevated anxiety. Dr. Mattingly?
Greg Mattingly
Certainly. We know that anxiety is fairly ubiquitous in depression. Over half of my patients are struggling with significant anxiety. And the reason that’s important is we know that significant anxiety predicts a negative long-term course. Our standard antidepressants have not worked as well for our anxious depressions. They tend to have more recurrences, they tend not to do well, they also have higher suicide rates. So to have treatment options that have particular benefit in this anxious group of patients that have fairly rapid onset. And once again, one of the biggest unmet needs in healthcare, but especially in mental healthcare, is treatments that work quickly. Imagine if this is your wife who’s struggling with a bad depression, she’s trying to take care of the kids, she’s trying to go to work, and you try a treatment that’s going to take two to four weeks to see if it’s going to work.
Whereas if we have a treatment in this case, we can start seeing some improvement in a matter of days to a couple of weeks. That’s going to be a different way of thinking about treating depression for our patients. So I think that group that has high anxiety. I think that group that’s looking for a faster treatment approach for depression; I take care of a lot of university students. My office sits right between four large universities. Getting depressed in the middle of a college semester, quite often these days means losing a semester of college versus if we have treatment approaches that may be able to get somebody better in a couple of weeks, that’ll be a different way to think about depression for my patients.
Maha Radhakrishnan
Thank you, Dr. Mattingly. Chris?
Chris Benecchi
Yes. So as to build on what Maha and Dr. Mattingly have already said, you take a step back and you think about it. There are 21 million people in the United States who suffer from one or more episode of depression on an annual basis. A 6.5 million in a given year are making a treatment change. Many of those patients making a treatment change are the ones that are characterized in this question that we’re talking about right here.
Now, as I’ve spent time at Congresses, talking to key opinion leaders, hearing what’s being said from the podium, whether it’s the site Congress or it’s the most recent NEI conference, there’s a tremendous amount of excitement around this next or third generation, third wave of new antidepressants, of which the zuranolone is a part of it. With respect to what zuranolone offers the ability to rapidly impact patients. And to over the course of just a short 14-day course treatment, deliver the efficacy that would ultimately help some of these patients. Again, it raises a significant amount of excitement among clinicians that are really thinking about how to manage these patients.
I think Dr. Mattingly really hit it nicely. The earlier we can get to these patients with a therapy that works, patients show improvements, the earlier they show improvements, the greater the outcomes are for those patients, right? So it’s really important for us to early and effectively manage the depression for many of these patients that we talked about, because it does improve overall the treatment outcomes for these patients as we move forward. And that’s what we’re really talking about here is really reaching patients with what we do in changing or advancing the treatment paradigm so that we can ultimately reach them.
Mike Hencke
Great. And the next question we have is how does the value-based agreement approach? How would that affect pricing as more patients are identified and dosed with zuranolone?
Maha Radhakrishnan
All right. Thank you, Mike. I’ll go ahead and take this one. Obviously, Chris also has a lot of experience this area as well. First of all, we are very committed to value-based agreements as part of the overall proposition to payers. We want meaningful VBAs that help address potential uncertainties and create aligned incentives. Our teams have been appropriately engaging key payers for several months now to educate them on this zuranolone clinical data.
And interestingly, payers really understand the significant unmet needs in MDD and they do share a desire for new tools. However, also, keep in mind, VBAs will be just one element in a holistic payer value prop. We also know that many payers, which is including most government payers, are unable to do VBAs. And also that some payers perceive them as burdensome and not really worth the effort. So it’s too early to say how much the market will be covered by VBAs. But it will be one of the tools in our [indiscernible] I know Chris has more to add on to that.
Chris Benecchi
Yes, I think, for context on VBAs and more broadly the conversations we’ve already had with payers. When you think about where we are today, we’ve already spoken to all of the national payers and the vast majority of regional payers inclusive of plans, TDMs and IVF. [Ph] Alisha, I think you hit it. The conversation so far have been very well received by payers. I feel like we’re in a really good place with respect to this conversation. VBAs in and of themselves are not the only tool that we use in conversations with payers. I think it’s really important for us in these conversations first to set the stage around unmet need.
And in the conversations that we’ve had with payers to date, what we hear back is they recognize that with respect to their populations, they’re not doing a particularly good job in managing overarchingly the way that they’re thinking about or they’re seeing the results in their MDD population. That comes from how they think about this as a group of patients that they’re managing, but payers are people, too, right? They have loved ones like we all do, who suffer from MDD who not only knows some of the challenges of getting them to the efficacy that they need. But managing some of the side effects, the stigmatizing side effects, sometimes that can be associated with the utilization of some of these products like sexual dysfunction and weight gain.
So that conversation has been a really strong foundation or anchor point for our ability then to talk about the zuranolone data. And so far in those conversations, the zuranolone data across the LANDSCAPE and NEST Programs has been compelling. That’s a great degree of interest from payers around what zuranolone can offer in addition to the other therapies that they may have available in the mix. So we’ll continue to engage with payers around the unique value proposition of zuranolone and the potential opportunity that it provides for sudden inflations [ph]. So hope for many of those patients that are part of their plans.
And then lastly, the VBA piece. Payers want predictability, payers want cost containment. They want to understand what the implications are for the ability to add this medication to their armamentarium for managing depression. They also want to understand the implications on not just MDD but on the complexities and comorbidities associated oftentimes with MDD in this patient population. So in terms of the VBAs, we believe that they will give us where payers are interested in these value-based agreements. The opportunity to really lean in into collaborating with payers around how best to make this medication available to their patients where Sage is along with Biogen sharing some of the risk associated with what it means to have a VBA in place.
So we’re excited. We’ll continue those conversations as we move forward. And we’ll progress up through launch in and around having those dialogues, but it’s an important part of our value and access strategy as we move forward.
Mike Hencke
Thanks, Chris. I think we have time for maybe a few more questions. The next one is do the side effects of zuranolone continue after a two-week course. And the question states, if not this seems like a big advantage versus chronic therapies?
Chris Benecchi
Yes. So it’s a good question. As I would say, in any blinded trial, AEs can be in our reported during both the treatment and follow-up periods. However, it’s clear from the LANDSCAPE and NEST Programs that the frequency of AEs does drop after the dosing period ends. Similarly, from the SHORELINE study for those patients who have received retreatment, we see something similar, which is a reduction in frequency reported following a second or third dosing.
Mike Hencke
Great. The next question we have is very little discourse today on the approach for PPD. And the question is, is there a similar marketing plan?
Maha Radhakrishnan
So the short answer to that one would be yes. And we’re obviously extremely excited about PPD. Even though today’s webcast is really focused on MDD, PPD is the most common medical complication of childbirth and its estimated one in two women with postpartum depression are never diagnosed. So this is again another very serious illness, and it’s something that does need to be treated with urgency, especially in this population. So we are very excited out there. We also have a plan, of course, for PPD.
And Chris, you have experience in PPD. So I would love to hear from you.
Chris Benecchi
Yes. We’ve learned a significant amount from zuranolone with respect to what the PPD community looks like. We know that there are as you noted, 500,000 or so moms who are suffering from PPD on an annual basis who are in need of a medication, an oral medication specifically for postpartum depression. We’re excited to have the opportunity to capitalize on some of those insights and learnings from zuranolone and apply those to the launch of zuranolone if approved. I think with that being said, what I’d like to underscore is that Sage and Biogen have a strong plan in place, not just for MDD, for PPD as well, too. The strategy is in place. We’re operating and executing against the tactics, and we’re looking forward to introducing zuranolone for both MDD and PPD at the right time for proof.
Mike Hencke
Great. Our next question is whether we think physicians would want to see patients more or less frequently with an episodic treatment versus other chronic antidepressants. And again, how would we expect to monitor patients for relapse. So Maha, would you like to start that?
Maha Radhakrishnan
Sure. I will start, Mike, and then I will hand it over to Dr. Mattingly and Alisha I want to comment on this question as well.
So I think, first of all, I would like to actually focus on depression from a pathobiology standpoint. Depression can resolve some of the balance proven pathways as we all know, including deficits in the GABAergic signaling in the brain. GABAergic neurotransmission is vital for normal brain functioning. Zuranolone’s MOA is distinct because of its effect on GABAergic transmission, and amplifying GABAergic signaling may reset brain activity in regions start to be disregulated and depression. I’ve also talked about the data from our program. So we’ve seen the onset of effect as early as three days.
So when you look at the current paradigm or the current clinical care, where Dr. Mattingly also said there’s where physicians are used to seeing treatment effect around the two- to four- to six-week time frame, the question is that these physicians have the reset in their mind, the expectations of what they would expect to see in terms of treatment response in patients if they were to put them on zuranolone, if approved, a day three response obviously is going to meet them to start looking for signs of improvement very early on. And this is where I would like Dr. Mattingly to comment because he did mention about PHQ-9 and the various aspects that are crucial for physicians to keep in mind as they look at depression more as episodic illness with recurrent episodes more so than as a chronic element.
Dr. Mattingly, please?
Greg Mattingly
Certainly, and thank you. I think from my perspective this has the potential to be an exciting new game changer for my patients struggling with depression. To have a treatment that they can take as needed, we try to get them better and then we watch to make sure they stay better. And if they start slipping back, we have a treatment that we shown that works for their depression. That is going to mean measuring how they’re doing. So what I envision doing will be very similar to what we did in some of the research trials, which I’m going to use the PHQ-9. I’m going to use the PHQ-9 when I treat my patient. I’m going to use the PHQ-9 after two weeks to measure where they are to make sure they’ve truly gotten better, and then I’m going to send them home with a PHQ-9.
And episodically I’m going to ask them to check in with that, and if they see that they’re starting to slip backwards, I want them to give me a call. If it sounds like they’re not doing well, we’re going to bring them back in for a visit. We’re going to see if they need retreatment. I think we’ve seen data that if you do the, certain doses, it’s a portion of people that may need a retreatment. And my clinical experience having that treatment, they’ve tried once; knowing that if they need to use it again, it’s there’s another treatment option using a tool like the PHQ-9 to measure how they’re doing.
And then if they do show any signs of recurrence, I’ll bring them back in for another treatment. So I think that’s going to be the new model going forward, I think and it’s an exciting new model that when I, once again, when I talk to my patients, this ability to treat when needed to measure how you’re doing, I think it’s an exciting new option. Not for us, but for our patients.
Alisha Alaimo
Thank you, Dr. Mattingly. I think it’s also good to share what we’ve learned from market research about the process for when a new treatment’s actually prescribed for a patient, because that will give you the context of why Zuranolone could be easily adopted into their existing clinical workflow with chronic therapies. So generally speaking today after a patient receives a new therapy, there are two follow ups. One is to assess the side effects and one to determine efficacy because side effects are so prevalent amongst the current treatments. HCPs commonly follow up with patients two weeks after new treatment. So with Zuranolone, if approved that this two-week check-in, the patient would have completed the full treatment course. So the HCP can discuss the Zuranolone was effective at that point in time. When we talk through this with HCPs, many of them share that this could have huge implications for being able to provide earlier intervention without any changes to their current clinical process.
So now, because current treatments also take on average, six to eight weeks to determine efficacy, there is a follow up at eight to 12 weeks to see if a chronic therapy is working. So again, if Zuranolone is approved, the HCP could leverage the same check-in to determine the need for potential re-dose. And we know the depression is a highly patient driven market, just like Dr. Mattingly was speaking about, and HCPs do rely on patients to raise their hands in order to drive action. So we do anticipate a similar dynamic if Zuranolone is approved.
Mike Hencke
Great. And I think we have time for one final question. Question is how significant of a product do we think this can be in light of the existing treatment landscape?
Maha, would you like to maybe start on that?
Maha Radhakrishnan
Yep. I can definitely start on that and start with the data from our robust clinical trial program that provides information about the 3,500 patients. Secondly, as I said earlier on in the webcast, the rapid onset of action seen in our clinical trials with an improvement in depressive symptoms observed as early as day three could be something that could help differentiate this program Zuranolone if approved. Thirdly, the improvement in depressive symptoms observed across multiple Zuranolone use cases and patient populations both in MDD and PPD, including those in patients with elevated anxiety. And fourthly, as we have described, a consistent safety and tolerability profile. Having said all of this, I also just mentioned the, the unique MOA, the mechanism of action, which really helps reset the neurotransmitters in the brain.
We believe if approved will help bridge the gaps in the current un-mathematical needs. But Dr. Mattingly, I would like for you to comment in terms of where do you see the role for Zuranolone if approved? How will this help bridge the current gaps in care that you see in your patients with major depression?
Greg Mattingly
I’ll just echo something Chris said earlier. Which of us haven’t had a friend or a family member or loved one, or someone we know that’s struggled with depression? And if we had the option to take something that could get them better within two weeks that had the option we could take again, as needed, which of us wouldn’t want to think about this as a treatment option if it was our loved one? So I think it’ll have wide acceptance. We maybe use a generic something first, but I can see quite often, once again, I take care of university students. They don’t have weeks to wait. So, in my – a lot of my patient population, I think this will be, a very favorable tool that will rise at the top of the toolbox.
Chris Benecchi
Yeah, I think is a build onto what Maha and Dr. Mattingly said. So you’ve heard words today used in the presentation. I think Dr. Mattingly used the word game changer. I think that feedback echoes what I’ve heard as I’ve been out and about at the various congresses talking to key opinion leaders and prescribers around how they see the place for Zuranolone to be used. There’s a great degree of excitement around what Zuranolone has the potential to offer if approved for patients suffering with both MDD and PPD. I think in terms of where it fits in the standard of care, I don’t think it actually does fit in the standard of care. I think it actually advances the standard of care for many patients that are out there that are suffering with depression. I think we touched on it, the rapid efficacy, the 14-day course of treatment, the fact that it’s well tolerated, the ability to ultimately return patients back to a state of wellbeing and to potentially experience treatment free periods.
That to me is something that is really significant for so many of the 6.5 million people that are seeking a new treatment on an annual basis where we stand with respect to bringing Zuranolone to market. We touched on, obviously the go-to-market work that we have to do in front of us, but we’ll continue with scientific exchange over the course of the year, continuing to take the data from both the LANDSCAPE and the NEST programs and making sure that it is well understood, so that at the time of launch that data is well incorporated into the, the thinking of clinicians will also advance disease state education or disease state awareness around the importance of treating with urgency in the extreme importance of innovation in this space as we move forward.
And not only will we reach physicians at the time of launch, we’ll also reach patients quite directly. We feel like it’s really important for us not only to reach prescribers, but to activate patients to ask for Zuranolone by name. And again, that’s at the approval of the product. So we have a profound opportunity in front of us with Zuranolone to advance the treatment paradigm here. We take that mission very, very seriously because we know so many patients are counting on both Sage and Biogen to do that with Zuranolone.
Mike Hencke
Thank you, Chris. That concludes our webcast for today. Thank you everyone for joining us.
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