December 4, 2018
Bioscience Notebook

Biohaven sees stock soar on migraine med results, launches China subsidiary

Photo | Biohaven
Photo | Biohaven
Donnie McGrath, chief of corporate strategy and business development at Biohaven, will helm the company's China subsidiary.

Biohaven Pharmaceutical Holding Co. Ltd.'s stock jumped more than 25 percent Monday afternoon after the company reported positive results in a Phase 3 trial of its fast-dissolving migraine drug, rimegepant.

The results bolster the company's plan to file for FDA approval to market the drug during the second half of 2019. Biohaven also plans to seek approval for a standard tablet version of the drug.

Biohaven's shares closed at $42.62 Monday afternoon and were trading at $42.59 as of Tuesday morning.

The company said the orally-dissolving tablet met its primary endpoints — freedom from pain and most bothersome symptoms (such as nausea or sensitivity to light or sound) two hours after a single dose — in the study of 1,375 migraine patients.

It also provided rapid onset of pain relief, separating from a placebo in as little as 15 minutes, the company said. Additionally, a greater percentage of patients returned to normal functioning after an hour compared to those who took the placebo.

Rimegepant is part of a new class of drugs known as calcitonin gene-related peptide (CGRP) receptor antagonists, which work to stop migraines by blocking a brain chemical that transmits pain.

It is billed as an alternative for migraine sufferers with heart conditions, who are unable to take Imitrex and other migraine drugs that constrict blood vessels.

The orally-dissolving formula uses Zydis ODT technology licensed from New Jersey-based Catalent Inc.

"We expect approval in the first half of 2020," Needham analyst Alan Carr, who lives in North Branford, said in a note to clients after the announcement.

He said the fast onset and convenience will help differentiate rimegepant from a similar migraine drug being developed by competitor Allergan, which expects to file for FDA approval early next year.

In a separate announcement last week, Biohaven said it is setting up a subsidiary in China to commercialize its late-stage neuro drugs in Asia-Pacific markets.

The wholly owned subsidiary, called BioShin, will be based in Shanghai and helmed by Biohaven Chief of Corporate Strategy and Business Development Donnie McGrath, a former Bristol Myers-Squibb executive, Biohaven said last week.

In a statement, McGrath said the subsidiary positions Biohaven to capitalize on recent changes in the regulatory landscape as well as multiple financing alternatives in China, which are making the country attractive for U.S. biotechs.

"I am very excited about the potential of Biohaven's product development portfolio in China, and Asia more broadly," he said.

Joining McGrath are two other former BMS execs: Karl Lintel, tapped as chief operating officer, and Elaine Hawkings, named head of clinical operations. Lintel formerly headed BMS China while Hawkings led the pharma giant's Asia Pacific clinical operations.

Zoey Wang, a physician entrepreneur with pharmaceutical experience in China and Europe, will be general manager, Biohaven said.

"It is estimated that almost 90 million individuals in China alone suffer from migraine and we believe that some of these individuals could benefit from new treatment options such as rimegepant and BHV-3500," said Biohaven CEO Vlad Coric, referring to the company's two cutting-edge migraine drugs.

Bioshin plans to submit its first Investigational New Drug (IND) application to the China Food and Drug Administration by the end of the year.

Biohaven is also developing treatments for Alzheimer's disease, obsessive-compulsive disorder, generalized anxiety disorder and other neurological conditions, and is seeking federal approval for a new version of a drug to treat amyotrophic lateral sclerosis (ALS), popularly known as Lou Gehrig's Disease.

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