Home Videos Biogen CEO Michel Vounatsos On Approval Of Alzheimer’s Drug

Biogen CEO Michel Vounatsos On Approval Of Alzheimer’s Drug

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First on CNBC: CNBC Transcript: Biogen Inc (NASDAQ:BIIB) CEO Michel Vounatsos Speaks with CNBC’s “Power Lunch” today, discussing FDA’s approval of its Alzheimer’s drug.

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WHEN: Today, Monday, June 7th

WHERE: CNBC’s “Power Lunch”

Biogen CEO On FDA Approval For Its Alzheimer’s Drug

All references must be sourced to CNBC.

MEG TIRRELL: Kelly, thanks so much. Michel Vounatsos joins us now, the news of the week, the year, this is huge. Michel, the first Alzheimer’s drug approved in 18 years. The first ever to potentially slow the course of the disease but I say potentially because this is a controversial decision. How are you looking at this moment, this historic moment for Alzheimer’s disease but also the number of people who say this was the wrong decision by the FDA and they need more data?

MICHEL VOUNATSOS: Thank you Meg for having me. It's a historic day for the company, and I want to applaud the amazing job made by the, all my colleagues. It's an honor to be leading the company at this stage but today, I want to think first about the patients, the caregivers and their families as you rightly say after almost two decades without having any innovation. It's a new day, it's some hope finally for the patients and their families. It's a new chapter that is being open that we're going to write together with the patients and their families and the caregivers.

TIRRELL: Now the FDA approved the drug in this sort of creative new pathway as an accelerated approval saying it's approved based on the fact that it clears amyloid plaques from the brain and that should confer a clinical benefit, meaning slow the progression of Alzheimer's disease and they're requiring you to do a post-marketing study essentially a Phase IV trial. What can you tell us about your timing for that, when you would expect to have results really proving the clinical benefits of Aducanumab?

VOUNATSOS: Well accelerated approval is a well-established pathway by the US FDA so there is nothing new or revolutionary here. Many entities used mostly for, you know, largely with oncology products and this is a new way in order to open a new space with eventually some indication about clinical outcome over time. We are delighted about this approval and we are committed to continue to study the product. This was the plan in any case so having to do another study is nothing extraordinary. We are committed to learn even more. It's a new beginning.

TIRRELL: If the confirmatory trial does not prove the clinical benefit of the drug that it is hoped to prove, would you support the FDA pulling the drug back off the market?

VOUNATSOS: So, if I'm not mistaken, we have more than nine years in order to deliver, up to nine years you know, to deliver the final results of the study that we designed together with the US FDA for which the protocol is not yet, not yet over and finalized and as importantly, before the nine years and we are committed to deliver the data as soon as we can, obviously, we will be in a position to generate real world evidence data that hopefully will substantiate the mechanism of action. Let me remind you that today and this hypothesis that was so challenged by many that today we have three independent compounds showing similar binding characteristics the way the Aducanumab show with similar results. So, it's not solely Aducanumab, now we have three independent compounds that are able to target this toxic plaque of peptide that is like the plaques are bad in the arteries, in the heart, also around the brain. And here we are able to gradually decrease this plaque burden that is affecting the neurons and causing Alzheimer's disease. I think this is significant. I think this is writing history.

TYLER MATHISEN: Mr. Vounatsos, let me ask you a question that may have been implicit in your earlier answers but I'd like to ask it nonetheless. All families, most families, have been struck by this disease as mine has. This is not a cure. You say this slows the progression of the plaques and of the disease. Am I right to assume then that if it slows the progression of the disease, it extends life and extends quality of life and, and do you know by how long or how much that's number one and then, since I asked the word how, used the phrase how much, how much does it cost per patient per year?

VOUNATSOS: You know we are still at the beginning of learning in terms of efficacy of this type of compound. We have five years data on our long-term extension study and we continue to see benefits. So, the clinical trials were conducted for 18 months on the active substance and then, you know in real life, we will have much more data in order to be in a better position to best inform. The critical question that you ask, how long should I stay on therapy? Is the elimination of the plaque, the time where I should stop therapy? Today, we don't know. On our long-term extension data, after five years, we continue to see benefits so much more to come.

MATHISEN: So basically I interpret your answer then as saying, we are gathering information, we don't know how long life might be extended with the use of this drug, but that that certainly is an outcome that you could look forward to. Correct me if, if that interpretation is wrong. Number two, what is the cost per patient per year or what do you think it is likely to be?

VOUNATSOS: So, we have seen some level of evidence in terms of activity of daily living and we believe that the patient should be able to conduct to have to live a more normal life independently before moving to an institution which is the case of more than 100,000 patients, you know, every year in the US which is a terrible situation. So hopefully what we have seen in some of the data is that activity of daily living and cognition could be improved. This has to be confirmed with the next trial and real-life data. The price is set at $56,000 a year, during the normal year after lengthy engagement obviously this is important with scientific leaders, pharmaco-economists, payers, private and public payers. These are in line with our pricing principle. This is after two decades of having no innovation. This will allow sustainability of continuing to invest in our rich pipeline that goes beyond Alzheimer’s, Parkinson's, ALS, stroke, neuropathic pain and many more. So, we believe this is a fair price. We'll be working very closely with Medicare that is covering 80%, we believe approximately of the epidemiology, in order to secure sustainability of the system. And, and monitor very closely, the dramatization. Moreover, we are committed not to take any price increase during the next four years.

TIRRELL: Michel, it's Meg Tirrell. On the, the price, you know, STAT News has a story out by Adam Feuerstein and Damian Garde saying this could be the most lucrative drug in pharmaceutical history. RBC says the sales opportunity here potentially $46 billion per year but that same analyst, Brian Abrahams, also saying that the price could come back to bite Biogen because it's about four times higher than what many expected you to price this drug at. Are you expecting pushback from payers? Could this be a moment, like my colleagues at STAT News pointed out like Sovaldi, that drug for Hepatitis C that was so huge in its first year that it overwhelmed the payer system. What do you expect in terms of reimbursement?

VOUNATSOS: You know Meg, and we're engaging with Medicare and we're engaging with the private payers since quite a long time. Do you know that today the cost of Alzheimer's is 600 billion to the US in terms of direct and indirect cost. So, it is time without having really a treatment that addresses a defined pathophysiology of the disease, it is really time now that we invest some resources to treatment.

TIRRELL: And I understand also Biogen is investing in helping people get diagnosed with Alzheimer's. I mean this could really change the face of brain health treatment for a lot of folks. Looking through your press release, you're establishing partnerships with CVS for more screening, LabCorp and the Mayo Clinic for more diagnostics. I mean we often see this, Hepatitis C is another example, that when there's a new drug, the pharmaceutical industry tries to help diagnose more patients, it's good for your bottom line and if the drug helps them, it's good for the patients. What do you expect in terms of accessing patients with Alzheimer's here?

VOUNATSOS: Well, if you read the report and other reports, it's clearly documented that there are some bottlenecks, including infrastructure. Infrastructure is not yet ready and one company cannot do it well, cannot do it alone. So, we will do everything we can in order to support the awareness, the diagnosis and the patient journey towards treatment and monitoring of the treatment also for the underserved population, we want this launch to be the most equitable launch. We've learned from the last pandemics and you know that the incidence is higher for the Latinx, for the African American Black population, and we want to give the same chance as a patient living in Boston today.

TIRRELL: Alright Michel Vounatsos, we appreciate you being with us on this historic day. Thanks again.

VOUNATSOS: Thank you.

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