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February 28, 2020

Liftoff: Biohaven migraine drug gets FDA green light

PHOTO | Andrew Venditti Biohaven CEO Coric eyes a billion-dollar-plus market for Nurtec, shipments of which could begin as soon as Monday.
By Natalie Missakian

New Haven’s Biohaven Pharmaceuticals’ new migraine treatment has crossed the regulatory finish line and is headed to market after winning approval from the FDA late Thursday.

Biohaven CEO Vlad Coric, MD, said the drug, Nurtec (generic: rimegepant), a fast-acting dissolving pill aimed at stopping migraine attacks in progress, will start shipping to pharmacies early next week.

The approval is Biohaven’s first and marks a major victory for the young Elm City biotech, which was spun out of Yale in 2013 and is headquartered at 215 Church Street. 

“It’s an ecstatic feeling here and a thrilling day for the whole team at Biohaven. I wish you could’ve heard the cheers in the office after we got the call,” Coric told New Haven BIZ Friday morning. “It’s a big day for us and for patients with migraine.” 

The approval is also a boost for New Haven’s growing bioscience industry. Coric told NHB Biohaven is eyeing an expansion of its Elm City headcount and footprint as a result of the launch, although he did not provide specifics. The company now has 700 employees nationwide. 

The drug is part of a new class of migraine treatments known as CGRP receptor antagonists, which work by blocking a brain chemical that transmits pain. 

Biohaven Chief Commercial Officer William (BJ) Jones told investors on a conference call Friday that the company plans to hit the ground running with more than 500 sales reps already in place across the country. The company has spent the last year ramping up its commercial team ahead of the launch, he said.

“The team worked tirelessly well in advance to get this product manufactured, packaged and ready to ship out once we had that FDA approval letter,” he said. “We plan also to have our [sales] representatives out in the marketplace extremely soon. In fact, you can expect that to happen on Monday. They’ll be out actually leveraging our new product.”

The fledgling biotech has its work cut out for it. Its competitors include big pharma players like Amgen, Eli Lilly and Teva Pharmaceuticals. Those companies have all been approved for new CGRP migraine drugs in the last two years, but all require injection and focus on prevention.

Dublin-based Allergan, however, beat Biohaven to FDA approval in December with the first CGRP migraine drug in a pill form, which is being sold under the brand name Ubrevly. 

Coric said he was confident Biohaven’s Nurtec would stand out from the crowd, citing the drug’s “fast onset of action that lasts for two days.”  The pill dissolves quickly in a patient’s mouth, without the need for water. 

Coric said the biotech is prepared to outmaneuver its bigger competitors with a “robust commercial launch” that will leverage new avenues like social media and ecommerce to reach patients.

“There were rumors going around from our competitors that we were going to have 100 to 150 sales reps. This is a sales force five times larger than what people thought, and we’re doing it in a modern-day, smarter way,” Coric said. “We’re going to be smarter and quicker and that’s where I think we’re going to win.”

Analysts have predicted potential blockbuster status for the drug, pegging peak sales at $1.6 billion annually in 2025, Coric said. 

More than 37 million Americans suffer from migraine, according to the National Headache Foundation. Biohaven is targeting migraine sufferers who aren’t satisfied with their current treatment or who can’t take triptans like Imitrex, the standard drug used to stave off attacks, because of cardiovascular risks. (Unlike triptans, CGRP drugs do not constrict blood vessels.) 

“The approval of Nurtec ODT is exciting for people with migraine as it provides a new treatment option to help people regain control of their attacks and their lives,” headache foundation executive director Mary Franklin said in a statement.

Biohaven plans to supply the drug in packs of eight; patients will be instructed to take one 75-mg. pill per attack, with no more than one per day.  

The company has not disclosed pricing for the drug, but Coric said it would be in line with competitors’ and with the $4,200-$4,600 annual price-range target set for the new treatment by drug pricing watchdog ICER.

Contact Natalie Missakian at news@newhavenbiz.com

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