Biohaven has created a wholly owned subsidiary in Shanghai. BioShin will develop and commercialize Biohaven’s migraine and neurology assets in China and other markets in the Asia-Pacific region.
BioShin plans to file its first IND application to the China Food and Drug Administration before the end of this year—within a month, in other words. The New Haven, Connecticut-based biotech revealed phase 3 data for its oral CGRP inhibitor rimegepant in March, saying it was teeing up for a 2019 filing. All told, just over 19% of patients on rimegepant were pain-free two hours after dosing, compared to 14% of the placebo group, but these numbers are similar to those put up by Allergan’s CGRP med ubrogepant. For comparison, about 20% of patients on ubrogepant were pain-free at two hours, compared to 12% in the placebo group.
Although Biohaven looked to have pulled ahead of Allergan at the announcement of its trial results back in August, ubrogepant might still reach the market first as Allergan indicated last month that it was on track for an NDA filing in the first quarter of 2019.
Biohaven is also advancing a sublingual version of riluzole, a drug for amyotrophic lateral sclerosis, as well as a prodrug of riluzole called troriluzole for a number of other indications, including Alzheimer’s, obsessive-compulsive disorder, generalized anxiety disorder and spinocerebellar ataxia.
Biohaven’s chief of corporate strategy and business development, Donnie McGrath, will head up BioShin as its CEO. In his role as vice president of business development and head of global search and evaluation at Bristol-Myers Squibb, McGrath oversaw the Big Pharma’s venture investment program, which included investments in Asia.
Joining McGrath will be a pair of BMS alums—Karl Lintel, M.D., the chief commercial officer, and Elaine Hawkings, who will lead clinical operations. Zoey Wang, who has worked in China and Europe with Sanofi and Novartis, is also joining the team.
"I am very excited about the potential of Biohaven's product development portfolio in China, and Asia more broadly," McGrath said in a statement. "An abundance of recent developments in China, including changes in the regulatory landscape, a new rare-disease policy, and multiple alternatives available to finance the company makes forming an Asia-Pacific subsidiary an attractive option as we seek to rapidly advance our product candidates in the Asia-Pacific market. I believe that the positive data from Biohaven's phase 3 program for rimegepant, and the potential of our other late-stage product candidates, has enabled BioShin to attract the top talent we need to execute on our strategy in Asia."