A lucid approach to migraine: Vlad Coric, Biohaven

Biohaven’s calcitonin gene-related peptide (CGRP) therapy for the acute and preventive treatment of migraine, NURTEC ODT, was approved by the 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 after launch, NURTEC ODT saw the strongest week-over-week growth for new acute migraine treatments during this period. In October 2021, Biohaven reported that the treatment had generated $336 million, with over one million prescriptions filled. Now the market leader in new oral migraine therapies, NURTEC ODT accounted for approximately 61% of brand new prescriptions (NBRx) for oral medications targeting CGRP in October 2021.

Biohaven was founded in New Haven, CT in 2013. In November 2015, the company named Vlad Coric, MD as CEO. Beginning his career in academia, Coric served as an Associate Clinical Professor at Yale and Chief of Inpatient Services at Yale’s Neuroscience Clinical Research Unit. Joining Bristol Myers Squibb (BMS) as Group Director, Clinical Research in 2007, he has worked in areas including neuroscience, oncology, immuno-oncology and virology. In 2017, Coric led Biohaven in its IPO on the New York Stock Exchange, raising over $500 million in total funding. In addition to overseeing the launch of NURTEC ODT, he also expanded Biohaven’s pipeline to include licensed assets from BMS, AstraZeneca and Yale University, among other institutions.

Dr. Coric sat down with Pharmaceutical Director end of 2021 to assess the rapid and seismic impact of NURTEC ODT on the migraine market.

PharmExec: There are many reports of how NURTEC ODT exceeded its expectations. Did this happen from your point of view as well?

Vlad Coric: When we launched, there were a lot of naysayers. There were a lot of people saying that the migraine market was satisfied. But we had spoken to patients who had been treated with older drugs and it was clear to us that they were simply unhappy. Of course, we knew the challenges a small company like Biohaven would face against big pharma and companies like AbbVie, but very early in our trials we started to see something special. We were seeing patients like Ellie, who has been on our meds for three years now, at the Associate Physicians School. She hasn’t missed a single exam because of migraine in the past three years at PA school. Before that, however, her migraines meant she missed exams, and the resulting stress led to sleep deprivation, leading to more migraines. Now, about a week before her exams, Ellie takes NURTEC ODT every other day for prevention. Then, after the exam period, she will resume using NURTEC ODT as needed. This minimizes the amount of medication in his system, keeps him away from having daily medication and circulating that medication through his body for months.

There are many more like Ellie, whose life has been transformed. they had taken all the other treatments, over-the-counter products, prescription drugs. 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 will reduce disabilities and improve people’s lives. It’s a big segment. There are nearly 40 million migraine sufferers in the United States; there are a billion migraine sufferers in the world. So from the start we thought that NURTEC ODT was going to be that big. While it met our expectations, it exceeded most expectations in this area because they didn’t see what we were seeing in our testing.

After changing the paradigm, as you say, where do you go next? How do you stay one step ahead?

You must continue to disturb the region. We are currently discussing with patients and physicians the possibility of personalizing a patient’s migraine treatment with a simple pill. You can use it acutely or in prevention, it is a dual therapy. We believe that the best treatment for a patient is a minimum dose. We need to empower patients, let them work with their doctor to personalize what works best for them. The need for speed is also real in migraine. The rapid onset of medicine can restore your life. What is remarkable with NURTEC ODT is that we had patients who returned to normal within an hour. That’s an hour earlier than most competing oral agents in this space, but to make it even faster, we’ve developed an intranasal CGRP antagonist, zavegepant. Data from zavegepant has shown that we can get people back to normal in 30 minutes. This speed of onset matters in the lives of patients. It can mean the difference between making or missing an appointment or getting to work on time. The sooner you reduce a migraine, the better.

Are you reaching patients with NURTEC ODT who would not normally go to the doctor with their migraines?

Yeah, that’s where we tried to move the pitch. Unlike those who suffer from very severe, chronic and much more frequent migraines, most patients will have fewer than six to eight migraine attacks per month. But people with a lower frequency of migraine attacks tend to say, “It stinks, my day is screwed up, I’m going to have to call in sick today and I’m probably going to be off work tomorrow.” I’ll have to catch 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 a month. It interferes with their family and professional life; they miss six to eight days a month of lost workdays and then have to make up for that. Many over-the-counter treatments are very good for mild migraines, but not for moderate to severe migraines. With NURTEC ODT, patients and their doctors can take control of migraine using our simple acute and preventative pill. So we see about a third of patients entering therapy now who have never received an Rx before. This is a very important number, because you don’t usually see new people entering 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 comparative study comparing its Emgality injection to NURTEC ODT. What is your opinion on this study?

First, we do not need such a trial to show whether patients prefer an oral intervention. As a doctor, I have learned over the years that patients always prefer an oral route to a needle. In effect, you lose patient access when adopting needle-based approaches. But Lilly is trying to come up with an alternative scenario for people to focus more on their needle-based injection. I do not consider their study to contribute anything scientifically or clinically important to the field. There is very little actual scientific data that will come out of this 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 medicine enters the body so quickly, there is a rapid effect. The preventive effects are visible from the end of the first week of treatment. Lilly looks at the 12 week time point in their study. But this misses the point that patients want treatments to be easy to use; they want to put it in their mouth 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 drugs have given a lot of side effects. And when it comes to needle-based approaches, 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 achieve something they can control and deliver quickly without a needle.

How has the success of NURTEC ODT changed your position and place in the industry? And what is the next step for Biohaven?

NURTEC ODT has proven that our small team can develop a drug in this area that can disrupt the market and differentiate itself from those of much larger companies, those that stuck to the old model of “one drug for treble and another “. for prevention. Not only has our reputation and market capitalization increased, but it has also underlined our commitment to neuroscience. Now we’ll use our expanded resources and look at other diseases like spinocerebellar ataxia, amyotrophic lateral sclerosis (ALS), and other pain disorders. Hopefully we can continue to shift the paradigm in these areas as well.

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