Cu­ria nets con­tract for cannabi­noid can­di­date and taps a new pres­i­dent of man­u­fac­tur­ing

The CD­MO Cu­ria, fresh off an ex­pan­sion a year ago, is scal­ing up man­u­fac­tur­ing for a can­di­date from an Aus­tralian biotech.

In­can­nex Health­care, a biotech cen­tered on pro­duc­ing cannabi­noid-based med­i­cines and psy­che­del­ic ther­a­pies, is us­ing Cu­ria Glob­al to fur­ther de­vel­op and man­u­fac­ture a GMP-grade in­haled drug prod­uct for the treat­ment of con­cus­sion and trau­mat­ic brain in­jury orig­i­nal­ly de­vel­oped by the biotech.

The can­di­date, dubbed IHL-216A, com­bines cannabid­i­ol and isoflu­rane to treat con­cus­sions and oth­er trau­mat­ic brain in­juries. The in­tent is to im­prove re­cov­ery time and de­crease the im­pact of the in­jury on the qual­i­ty of life.

As Cu­ria ex­pands, it will add API site in up­state New York; In bat­tle against food al­ler­gies, Al­ladapt to build site to prep for PhI­II tri­als

The deal with Cu­ria, for which fi­nan­cial de­tails were not dis­closed, will have the com­pa­ny scale up the fill-fin­ish man­u­fac­ture of IHL-216A in com­pli­ance with cGMP. Cu­ria will al­so gen­er­ate da­ta on the qual­i­ty and sta­bil­i­ty of the can­di­date to sup­port fu­ture reg­u­la­to­ry fil­ings.

The first man­u­fac­tured batch will be used in the Phase I clin­i­cal tri­al, which will com­mence once feed­back on the can­di­date’s de­vel­op­ment plan is re­ceived from the FDA, which is set to con­clude in Q3 2022.

Preview

来源: Endpts

Steve Lichter

In ad­di­tion to the deal, Cu­ria has named a new pres­i­dent for its man­u­fac­tur­ing op­er­a­tion. The com­pa­ny is tap­ping Niall Con­don, ef­fec­tive im­me­di­ate­ly, as cur­rent pres­i­dent Steve Lichter re­tires. He’ll be re­spon­si­ble for the de­liv­ery of Cu­ria’s com­mer­cial man­u­fac­tur­ing ser­vices and prod­ucts, in­clud­ing APIs and oth­er drug prod­ucts.

“The CD­MO in­dus­try is dy­nam­ic, and Cu­ria is unique­ly po­si­tioned to serve cus­tomers with its in­no­v­a­tive port­fo­lio of so­lu­tions and prod­ucts span­ning R&D through man­u­fac­tur­ing. I’m look­ing for­ward to meet­ing its tal­ent­ed com­mu­ni­ty of col­leagues and mak­ing an im­pact for our cus­tomers and the pa­tients they serve,” Con­don said.

Con­don has ex­ten­sive ex­pe­ri­ence in the man­u­fac­tur­ing field as he re­cent­ly served as head of API and OSD man­u­fac­tur­ing at Vi­a­tris, which was formed through the merg­er of My­lan and Pfiz­er’s Up­john. Be­fore that, he was a se­nior vice pres­i­dent at Pfiz­er, where he helped build the Up­john Di­vi­sion. He al­so spent over 30 years at Pfiz­er in roles of in­creas­ing re­spon­si­bil­i­ty in man­u­fac­tur­ing and oth­er op­er­a­tions.

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