Chris­t­ian Hogg Chi-Med

→ One of Chi-Med’s late-stage fa­vorites is grad­u­at­ing ear­ly from its Phase III study, hav­ing met its pri­ma­ry end­points at in­ter­im analy­sis. The Hong Kong-head­quar­tered biotech left out the num­bers in its brief state­ment, which not­ed that su­r­u­fa­tinib hit a PFS goal among pa­tients with ex­tra-pan­cre­at­ic neu­roen­docrine tu­mors. CEO Chris­t­ian Hogg has tapped the drug, along­side savoli­tinib, for ap­provals over the next two years to fol­low up on the land­mark OK for fruquin­tinib in Chi­na.

→ Am­gen $AMGN and Al­ler­gan $AGN have nabbed an OK to mar­ket their Her­ceptin copy­cat — chris­tened Kan­jin­ti — in the US for all ap­proved in­di­ca­tions of the Roche block­busters in­clud­ing HER2-over­ex­press­ing breast can­cer and gas­tric or gas­troe­sophageal junc­tion ade­no­car­ci­no­ma. “Kan­jin­ti is the sec­ond of four biosim­i­lars from Am­gen and Al­ler­gan’s col­lab­o­ra­tion to be ap­proved by the FDA,” David Nichol­son, Al­ler­gan’s chief re­search and de­vel­op­ment of­fi­cer, not­ed.

David Nichol­son Al­ler­gan

→ Last year, Sun Phar­ma­ceu­ti­cals en­tered the crowd­ed mar­ket for plaque pso­ri­a­sis with its IL-23 in­hibitor Ilumya. On Fri­day, the In­di­an drug­mak­er said the mon­o­clon­al an­ti­body — in-li­censed from Mer­ck $MRK back in 2014 for $80 mil­lion — cleared a mid-stage study in pa­tients with pso­ri­at­ic arthri­tis. The in­ter­im analy­sis re­vealed that over 71% of pa­tients treat­ed with the drug ex­pe­ri­enced a 20% im­prove­ment in joint and skin symp­toms, meet­ing the pri­ma­ry end­point of the study.

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

→ Ab­b­Vie is tout­ing new pos­i­tive da­ta com­par­ing their ag­ing block­buster Hu­mi­ra with their hoped-for block­buster upadac­i­tinib. Over 48 weeks a larg­er pro­por­tion of pa­tients tak­ing the ex­per­i­men­tal drug ex­pe­ri­enced clin­i­cal re­mis­sion than in the con­trol arm with Hu­mi­ra. Their drug brought in $20 bil­lion last year, top­ping the scales in the num­ber 1 slot.

→ Gilead has turned to Van­cou­ver-based Ab­Cellera for its lat­est dis­cov­ery deal. Ab­Cellera will use its know-how in “sin­gle-cell screen­ing of nat­ur­al im­mune sources” to find an­ti­body can­di­dates for Gilead to pur­sue in the in­fec­tious dis­ease field. The deal in­cludes an up­front and mile­stones.

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

The Wash­ing­ton Post man­aged to whip up the quick­est in­dus­try con­sen­sus I’ve ever seen that one of its re­porters was pur­vey­ing overblown non­sense with a sto­ry that Pfiz­er was sit­ting on da­ta sug­gest­ing that En­brel could be an ef­fec­tive treat­ment for Alzheimer’s. 

In cov­er­ing that bit of an­ti-Big Phar­ma fan­ta­sy — there are lots of rea­sons to go af­ter phar­ma, but this piece was lu­di­crous — I not­ed com­ments in the sto­ry from some promi­nent peo­ple in the field crit­i­ciz­ing Pfiz­er for not pub­lish­ing the da­ta. I sin­gled out Rudy Tanzi at Har­vard and then ap­plied some added crit­i­cism for the things he’s done to hype — in my opin­ion — high­ly ques­tion­able as­sump­tions. You can see it in the link.