Robert Fos­ter Con­traVir

→ As hoped, Cel­gene $CELG and its part­ners at Ac­celeron $XL­RN have se­cured pri­or­i­ty re­view for their red blood cell boost­ing drug, lus­pa­ter­cept, which has been pegged to even­tu­al­ly gen­er­ate peak sales of $2 bil­lion. The bi­o­log­ic has been de­vel­oped to man­age ane­mia re­sult­ing from myelodys­plas­tic syn­drome (MDS) as well as be­ta tha­lassemia. The FDA ex­pects to make its de­ci­sion on the be­ta-tha­lassemia in­di­ca­tion by De­cem­ber 4, while the MDS in­di­ca­tion will be dealt with by April 4, 2020. The Eu­ro­pean re­view of the drug is al­so un­der­way, the com­pa­nies said on Tues­day.

→ Au­rinia’s $AUPH largest share­hold­er is skep­ti­cal that the com­pa­ny’s lead­er­ship team is up to task com­mer­cial­iz­ing its lead drug, vo­closporin, as the Cana­di­an biotech revs up late-stage stud­ies in lu­pus and dry eye dis­ease. Ko­rea-based Iljin has nom­i­nat­ed three in­de­pen­dent di­rec­tors to the eight-mem­ber board in an at­tempt to rein in in­sid­ers who they say have been plac­ing self-in­ter­ests above those of in­vestors. Chief among the three nom­i­nees is Robert Fos­ter, the ex-CEO of Isotech­ni­ka whom Iljin cred­its for the dis­cov­ery of vo­closporin. The oth­er two, Soon-Yub (Samuel) Kwon and Myeong-Hee Yu, bring reg­u­la­to­ry and sci­en­tif­ic ex­per­tise, re­spec­tive­ly. CEO Pe­ter Green­leaf — re­cent­ly ap­point­ed af­ter stints at Cere­cor, Su­cam­po and Med­Im­mune — and chair­man George Milne have pre­vi­ous­ly urged in­vestors to re­ject Iljin’s nom­i­na­tions.

Robert Ian­none Linkedin

→ In April, the chief med­ical of­fi­cer of the em­bat­tled biotech Im­munomedics $IM­MU Robert Ian­none said he was leav­ing the com­pa­ny to work in Penn­syl­va­nia to be “close to his fam­i­ly.” On Mon­day, it was re­vealed that the for­mer As­traZeneca $AZN ex­ec­u­tive is head­ed to Jazz Phar­ma­ceu­ti­cals $JAZZ, where he will lead glob­al R&D.

→ Peanut al­ler­gy drug mak­er Aim­mune $AIMT pre­sent­ed da­ta from a rollover 28-week study on Tues­day that fol­lowed its land­mark piv­otal study. The re­sults sug­gest­ed that its treat­ment, AR101, can help pa­tients tol­er­ate high­er dos­es of peanut pro­tein, thus re­in­forc­ing the ra­tio­nale for con­tin­ued dai­ly dos­ing of AR101 be­yond one year, as test­ed in the late-stage PAL­ISADE tri­al. An FDA ap­proval de­ci­sion for AR101 is ex­pect­ed in Jan­u­ary 2020.

John Oyler BeiGene

→ In a sign of Chi­na’s grow­ing in­flu­ence on glob­al biotech, BeiGene chief John Oyler has been elect­ed to BIO’s board of di­rec­tors as well as the or­ga­ni­za­tion’s health sec­tion gov­ern­ing board.

→ Cam­bridge, Mass­a­chu­setts-based Strand Ther­a­peu­tics — which is fo­cused on gene ther­a­pies — has se­cured a $6 mil­lion seed round led by Play­ground Glob­al with par­tic­i­pa­tion from Alexan­dria Ven­ture In­vest­ments, AN­RI, and a group of pri­vate in­vestors. “This cap­i­tal will be in­stru­men­tal to build­ing out and scal­ing Strand’s mR­NA pro­gram­ming tech­nol­o­gy,” said Ja­cob Be­craft, the com­pa­ny’s co-founder and CEO, in a state­ment.

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.