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.

Brian Kaspar. AveXis via Twitter

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Martin Shkreli [via Getty]

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ZHEN SU — Mer­ck Serono’s Se­nior Vice Pres­i­dent and Glob­al Head of On­col­o­gy
EL­LIOTT LEVY — Am­gen’s Se­nior Vice Pres­i­dent of Glob­al De­vel­op­ment
CHRIS BOSHOFF — Pfiz­er On­col­o­gy’s Chief De­vel­op­ment Of­fi­cer

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