China

BioHaven hopes to soothe Chinese headaches with Shanghai subsidiary

Capitalizing on the burgeoning biopharma interest in China, neuro-focused drug developer BioHaven $BHVN is setting up shop in Shanghai with a subsidiary called BioShin that will be tasked with shepherding the Connecticut-based company’s arsenal of late-stage migraine and neurology products in markets across the Asia-pacific region.

Vlad Coric

BioHaven, which earlier this week said it had submitted a US application to market a sublingual formulation of the ALS drug riluzole, is gearing up to report key data from a pivotal late-stage trial testing its acute migraine drug, rimegepant, before the end of the year in the United States. The company’s interest is China is not unexpected, given that large swathes of the region’s immense population suffer from migraine and other central nervous system disorders, although patients have not benefited from the heady pace of medical innovation their US counterparts have enjoyed.

“Almost 90 million individuals in China alone suffer from migraine and could ultimately benefit from our late-stage migraine development platform,” said BioHaven chief Vlad Coric.

Once a breeding ground for scientists that emigrated to the United States, China is now attracting top researchers and entrepreneurial talent back to its shores as financial incentives, governmental support, industrial infrastructure, regulatory reforms and a large, ageing population provide the ideal backdrop for rapid drug discovery and development.

Donnie McGrath

BioShin will be led by Donnie McGrath, a former Bristol-Myers $BMY exec who has served as BioHaven’s chief of corporate strategy and business development since 2017, along with fellow ex-Bristol-Myers exec Karl Lintel who has been appointed COO. With the support of BioHaven, BioShin can further build its team and “raise capital from both the private and public markets in mainland China and Hong Kong,” McGrath said in a statement on Wednesday.

BioShin is expected to submit an application to evaluate rimegepant in human trials in China next quarter, and additional INDs for other investigational drugs are also planned for submission in 2019. Meanwhile, in the United States, positive Phase III rimegepant data will allow BioHaven to submit an application to market the as-needed oral CGRP treatment for migraine in mid-2019, trailing behind Allergan $AGN that has recently reiterated it is on track to submit its application for a rival oral CGRP by the first quarter of next year.

The multi-billion dollar US migraine market is already replete with injectable medications from Teva $TEVA, Eli Lilly $LLY, and one from Amgen $AMGN and Novartis $NVS, which are all designed to be used as preventative treatments and are curiously priced identically. For those patients who still experience migraine attacks despite preventative anti-CGRP therapy, acute, as-needed treatments will still be required, which is where rimegepant and Allergen’s rival ubrogepant could come handy. If approved, the two acute drugs could potentially also be used in combination with their anti-CGRP injectable rivals.


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