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Biohaven’s calcitonin gene-related peptide (CGRP) therapy for acute and preventive treatment of migraine, NURTEC ODT, was approved by FDA for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021. In the first six weeks following launch, NURTEC ODT achieved the greatest week-over-week growth for new acute migraine treatments during that time period.In October 2021, Biohaven reported that that the treatment had generated $336m, with over 1m prescriptions filled. Now the market leader for new oral migraine therapies, NURTEC ODT accounted for approximately 61% of new-to-brand prescriptions (NBRx) for oral CGRP-targeting drugs in October 2021.
Biohaven was founded in New Haven, CT in 2013. In November 2015, the company appointed Vlad Coric, M.D., as CEO. Beginning his career in academia, Coric was an Associate Clinical Professor at Yale and Chief of Inpatient Services at the Yale Clinical Neuroscience Research Unit. Joining Bristol Myers Squibb (BMS) as Group Director, Clinical Research, in 2007, he worked across areas including neuroscience, oncology, immuno-oncology and virology. In 2017, Coric led Biohaven in its initial public offering on the New York Stock Exchange, cumulatively raising over $500m in financing. As well as overseeing the launch of NURTEC ODT, he has also expanded Biohaven’s pipeline to include assets in-licensed from BMS, AstraZeneca, and Yale University, among other institutions.
Dr. Coric sat down with Pharm Exec at the end of 2021 to assess NURTEC ODT’s swift and seismic impact on the migraine market.
PharmExec: There are lots of reports on how NURTEC ODT outstripped its expectations. Did that happen from your perspective, too?
Vlad Coric: When we first launched, there were a lot of naysayers. There were a lot of people saying that the migraine market was satisfied. But we’d talked to patients who’d been treated with the older meds and it was clear to us that they just weren’t satisfied. Of course, we knew the challenges that a little company like Biohaven would have competing against big pharma and companies such as AbbVie, but very early on in our trials, we started seeing something special. We were seeing patients like Ellie, who’s been on our meds for three years now, in physician’s associate school. She has not missed a single exam due to migraine the last three years at PA school. Before that, however, her migraines meant she would miss exams, and the stress of that led to sleep deprivation and that would bring on more migraines. Now, a week or so before her exams, Ellie takes NURTEC ODT every other day as a preventive. Then, after the exam period, she will just go back to using NURTEC ODT as she needs it. This minimizes the amount of drug in her system, it moves her away having to have a daily medicine and have this drug circulating in her body for months.
There are many others like Ellie, whose lives have been transformed. they had been on all the other treatments, the over-the-counter stuff, the prescription stuff. That’s when we knew we had something special and we went out there to tell people: This is going to be a paradigm shift; it is going to decrease disability and improve people’s lives. This is a big segment. There are nearly 40 million migraine sufferers in the US; there are one billion migraine sufferers worldwide. So, we from the early days we thought NURTEC ODT was going to be as big. While it has met our expectations, it has exceeded the expectations of most in this field because they didn’t see what we were seeing in our trials.
Having changed the paradigm, as you say, where do you go next? How do you keep ahead?
You have to continue to disrupt the area. We’re talking now with patients and doctors about customizing a patient’s migraine therapy with one simple pill. You can use it for acute or prevention, it is dual therapy. We believe that the best treatment for a patient is minimal dose. We have to empower patients, let them work with their doctor to customize what’s best for them. The need for speed is also real in migraine. The quick onset of a drug can give you backyour life. What is remarkable about NURTEC ODT is that we had patients getting back to normal in one hour. That’s an hour sooner than most of the competitive oral agents in this space, but to make that faster still, we developed an intranasal CGRP antagonist, zavegepant. The data from zavegepant showed that we can get people back to normal in 30 minutes. That speed of onset matters in patient’s lives. It might make the difference between getting to an appointment or missing it or allow you to get to work on time. The sooner you abate a migraine, the better.
Are you are reaching patients with NURTEC ODT that wouldn’t normally have gone to the doctor’s with their migraines?
Yes, that’s where we’ve been trying to move the field. Unlike those with very severe, chronic and much more frequent migraines, most patients will have less than six to eight migraine attacks per month. But people with lower frequency of migraine attacks tend to say, “This stinks, my day is shot, I’ll have to call in sick and today and I’m probably going to miss work tomorrow. I’ll have to make it up this weekend. And I’ll try to make do with what I can get at the pharmacy because I don’t want the side effects or the needles that you get with some of the prescription drugs.” But let’s say someone has three to four of these episodes per month. It interferes with their family and work life; they’re missing six to eight days per month from lost workdays and then having to make up for it. A lot of over-the-counter treatments are very good for mild migraines, but not for moderate to severe. With NURTEC ODT, patients and their doctors can take control of migraine by using our simple pill for both acute and prevention. So, we’re seeing about a third of patients coming into therapy now that haven’t been on an Rx before. That’s a very important number, because you usually don’t see new people coming into an Rx this early in a drug launch.
The latest salvo fired in the migraine marketing wars has seen Eli Lilly begin enrolling patients in a head-to-head study comparing its Emgality injection to NURTEC ODT. What is your take on this study?
First of all, we don’t need a trial like that to show if the patients prefer oral intervention. As a physician, I’ve learned over the years the patients always prefer an oral over a needle. Actually, you lose patient access when you get to needle-based approaches. But Lilly is trying to come up with an alternate storyline to get people more focused on their needle-based injection. I don’t view their study as lending anything scientifically or clinically important to the field. There’s very limited real science that’s going to come out of that study; it’s more of a marketing tactic than anything else.
There is no other current CGRP agent that has both the acute and preventive indication of NURTEC ODT. Because with the simple oral dose our drug enters the body so quickly, there is a quick effect. The preventive effects are seen by the end of the first week of treatment. Lilly is looking at the 12-week time point in their study. But that is missing the point that patients want treatments to be simple to use; they want to pop it in their mouths and get a quick response. They want their migraine to go away and they don’t want any new problems. Traditionally, in this space, other meds have given a lot of side effects. And as far as needle-based approaches go, when you’re in pain, the last thing you want is an injection, right? Unless you really, really need it. Generally speaking, patients want to reach for something that they can control and can quickly administer without a needle.
How has NURTEC ODT’s success changed your standing and your place in the industry? And what is next for Biohaven?
NURTEC ODT proved that our small team can develop a drug in this field that can disrupt the market and be differentiated from those from the much larger companies out there, those who have stuck to the old model of “one medicine for acute and a different one for prevention.” Not only did our reputation and our market cap increase, but it also underlined our commitment to neuroscience. Now we will take our expanded resources and look into other diseases like Spinocerebellar ataxia, amyotrophic lateral sclerosis (ALS), and other pain disorders. Hopefully we can go on to change the paradigm in those areas too.