Chicago-area biotech sends 2nd drug to India’s regulators; Penny stock player spins out

Phar­mazz is on its way to In­dia’s drug reg­u­la­tor for the sec­ond time as its in­ves­ti­ga­tion­al treat­ment passed muster in a Phase III study in pa­tients with acute is­chemic stroke.

The Chica­go sub­urbs-based biotech said its drug so­vateltide led to bet­ter im­prove­ment than place­bo on cer­tain mea­sure­ments of neu­ro­log­i­cal out­comes.

So­vateltide led an im­prove­ment of ≥2 points on mRS and an in­crease of ≥6 points on NIHSS at day 90 in the tri­al of 158 adults in In­dia. The mod­i­fied Rankin scale looks at the de­gree of de­pen­dence in the dai­ly ac­tiv­i­ties of peo­ple post-stroke event, and the NIH stroke scale mea­sures the stroke-re­lat­ed neu­ro­log­ic deficit.

Phar­mazz ex­pects to sub­mit the drug for ap­proval in In­dia “short­ly.” The 12-year-old biotech said the drug, li­censed from Mid­west­ern Uni­ver­si­ty in Down­ers Grove, IL, was well tol­er­at­ed and had no drug-re­lat­ed ad­verse events. Phar­mazz is al­so test­ing the drug in pa­tients with Alzheimer’s.

The com­pa­ny al­ready has one ap­proved drug in In­dia. The coun­try’s reg­u­la­tor green­lit Ly­faquin, or cen­thaquine, in May 2020 for pa­tients with hy­po­v­olemic shock. Cen­thaquine is al­so in clin­i­cal tri­als in pa­tients with acute res­pi­ra­to­ry syn­drome due to Covid-19, sep­tic shock and oth­er con­di­tions. — Kyle LaHu­cik 

Pen­ny stock biotech spins out PhI­II can­cer can­di­date in­to new com­pa­ny

Citius Phar­ma­ceu­ti­cals, a pen­ny stock biotech, be­lieves its shares are un­der­val­ued. And ex­ecs are hop­ing split­ting the com­pa­ny in­to two will change that.

New Jer­sey-based Citius plans to spin off I/ON­TAK — a Phase III re­com­bi­nant fu­sion pro­tein that com­bines the in­ter­leukin-2 (IL-2) re­cep­tor bind­ing do­main with diph­the­ria tox­in frag­ments — in­to a new, pub­licly-trad­ed com­pa­ny. The rest of the pipeline, in­clud­ing an ex­per­i­men­tal an­tibi­ot­ic lock so­lu­tion named Mi­no-Lok, will re­main at Citius.

“As Citius pre­pares for the com­mer­cial­iza­tion of its two late-stage prod­uct can­di­dates, I/ON­TAK and Mi­no-Lok, we be­lieve that the mar­ket has not ad­e­quate­ly val­ued the po­ten­tial of our re­cent I/ON­TAK li­cens­ing agree­ment,” Leonard Mazur, chair­man and CEO, said in a state­ment.

The yet-un­named new com­pa­ny will be a pure-play on­col­o­gy-fo­cused drug­mak­er, he added, while Citius re­tains a di­ver­si­fied port­fo­lio.

Citius li­censed I/ON­TAK from In­dia’s Dr. Red­dy’s Lab back in Sep­tem­ber. It is a re­for­mu­lat­ed ver­sion of ON­TAK, which was pre­vi­ous­ly FDA-ap­proved for a rare form of non-Hodgkin lym­phoma but ul­ti­mate­ly with­drawn due to man­u­fac­tur­ing is­sues. — Am­ber Tong

Switzer­land’s Helsinn builds R&D hub in US as it ramps up clin­i­cal work

Hav­ing of­fi­cial­ly un­veiled its new fo­cus on tar­get­ed can­cer ther­a­pies ear­li­er this year, Helsinn — the Swiss phar­ma that built its name on sup­port­ive can­cer care — is build­ing a new R&D hub in the US to sup­port the strat­e­gy.

The new unit, to be housed at its US sub­sidiary, will be tasked with the clin­i­cal work around a grow­ing pipeline, Helsinn said.

The first of those will be in­fi­gra­tinib, the FGFR ty­ro­sine ki­nase in­hibitor it li­censed from Bridge­Bio. As part of an up­dat­ed deal, the de­vel­op­ment re­spon­si­bil­i­ty is mov­ing from Bridge­Bio to Helsinn. — Am­ber Tong