Japan­ese bil­lion­aire Mik­i­tani takes full con­trol of Rakuten As­pyr­i­an; HOX Ther­a­peu­tics taps Karl Kee­gan as CEO

→ Hav­ing in­fused $150 mil­lion in­to Rakuten As­pyr­i­an weeks ago, Hi­roshi “Mick­ey” Mik­i­tani is step­ping up his con­trol on the biotech he’s been chair­ing since 2016. The Japan­ese bil­lion­aire, known for build­ing a leg­endary e-tail­er from scratch, is tak­ing over the CEO role so that Miguel Gar­cia-Guz­man can con­tin­ue to build the pho­toim­munother­a­py pipeline as CSO and vice chair­man. As the San Diego-based com­pa­ny turns the cor­ner on a Phase III study, it’s al­so ap­point­ed Takashi Toraishi, who was man­ag­ing its Japan of­fices, as COO to over­see clin­i­cal tri­als and com­mer­cial­iza­tion.

→ With Jack­ie Fouse gone to take the reins of Agios, Der­ma­vant Sci­ences — a der­ma­tol­ogy fo­cused unit of Vivek Ra­maswamy’s Roivant Sci­ences — has hired in­dus­try vet­er­an Todd Za­vod­nick as its CEO, as the com­pa­ny pre­pares to be­gin a late-stage tri­al of its lead ex­per­i­men­tal drug, tap­inarof. Za­vod­nick comes with over two decades of ex­pe­ri­ence, hav­ing worked at ZEL­TIQ Aes­thet­ics be­fore it was ac­quired by Al­ler­gan $AGN as well as Gal­der­ma, among oth­er firms.

→ Can­cer biotech HOX Ther­a­peu­tics has ap­point­ed new CEO Karl Kee­gan to lead its en­try in­to the clin­ic. In a ca­reer span­ning prod­uct de­vel­op­ment at SmithK­line Beecham, in­vest­ment an­a­lyst in Lon­don and CFO/cor­po­rate de­vel­op­ment roles at Pharm­ing, Vec­tura and Shield Ther­a­peu­tics, the com­pa­ny notes, he’s amassed sig­nif­i­cant ex­pe­ri­ence in fi­nanc­ing com­pa­nies, busi­ness de­vel­op­ment and cor­po­rate M&A. He is now ex­pect­ed to bring it all to the ta­ble at Guild­ford, UK-based HOX, which is fo­cused on a type of “con­trol” genes cen­tral to em­bryo­ge­n­e­sis called HOX.

→ Se­r­i­al en­tre­pre­neur Pe­ter Suz­dak is out at Rex­ahn Phar­ma­ceu­ti­cals, pass­ing the pres­i­dent and CEO ba­ton to Dou­glas Swirsky. Swirsky, who joined the can­cer drug de­vel­op­er at the be­gin­ning of the year, will car­ry on be­ing CFO. A for­mer in­vest­ment banker, Swirsky was chief ex­ec­u­tive at Gen­Vec for four years un­til it was sold to In­trex­on.

→ Af­ter a decade with Thomas Van­Cott at the helm, ABL is turn­ing a new leaf by pro­mot­ing chief com­mer­cial of­fi­cer Jar­lath Keat­ing to pres­i­dent and CEO. While Keat­ing is a re­cent hire, he’s a vet­er­an of the con­tract re­search and man­u­fac­tur­ing ser­vice in­dus­try, hav­ing held com­mer­cial roles at Mil­li­pore­Sig­ma and tech­ni­cal roles at Lon­za Bi­o­log­ics. His ap­point­ment, the com­pa­ny says, is a “clear re­flec­tion of ABL’s com­mit­ment to a long-term glob­al ex­pan­sion strat­e­gy.”

→ Four new ex­ecs are com­ing on board Flag­ship-seed­ed Sig­ilon Ther­a­peu­tics’ pur­suit of the Holy Grail in di­a­betes: get­ting stem cells to trans­form in­to in­sulin pro­duc­ing pan­cre­at­ic be­ta cells with­out trig­ger­ing a se­vere im­mune re­ac­tion. Deya Cor­zo has joined as CMO af­ter work­ing up her clin­i­cal tri­al mus­cles at So­journix, uniQure, Cel­gene, Take­da and Sanofi/Gen­zyme; Vi­a­Cyte vet Olivia Kel­ly is named VP of islet cell ther­a­py re­search; Martha Rook is jump­ing from Mil­li­pore­Sig­ma to be­come head of man­u­fac­tur­ing; and Vanya Sagar, for­mer­ly of Bio­gen, will be VP of HR.  

Agenus’ $AGEN in-house mid-stage check­points and can­cer vac­cines may still have a long path to com­mer­cial­iza­tion, but the Lex­ing­ton, MA-based biotech wants to be sure it’s ready for it. Jen­nifer Buell is now chief op­er­at­ing of­fi­cer, a role that com­bines all three po­si­tions she’s held in her five years at the com­pa­ny: She has a broad man­date cov­er­ing re­search, clin­i­cal de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial op­er­a­tions. Al­li­son Jeynes-El­lis, bio­phar­ma vet and Avil­lion CEO, has been ap­point­ed as a board di­rec­tor.  

El­liot Ehrich

Kevin For­rest has brought in a new part­ner from 5AM Ven­tures — where he used to be a prin­ci­pal — to his team at Ex­pan­sion Ther­a­peu­tics. El­liot Ehrich, the new­ly mint­ed CMO, had re­cent­ly joined the ven­ture firm af­ter a 17-year run at Alk­er­mes that cul­mi­nat­ed in the top R&D and med­ical role. His ex­pe­ri­ence in dri­ving drug as­sets from ear­ly re­search through ap­proval will be “in­stru­men­tal” for Ex­pan­sion, CEO For­rest says, which is still in dis­cov­ery stage with its RNA-tar­get­ing small mol­e­cule med­i­cines de­signed to treat a set of ge­net­ic dis­eases called ex­pan­sion re­peat dis­or­ders.

→ As Asha Das makes an abrupt de­par­ture from Toca­gen to tend to “un­fore­seen and im­me­di­ate per­son­al mat­ters,” it’s tapped a board mem­ber to fill in as the act­ing CMO. Lori Kunkel, who has three CMO stints from Loxo On­col­o­gy, Phar­ma­cyclics and Pro­te­olix un­der her belt, will take charge of ad­vanc­ing Toca­gen’s Phase III high grade glioma pro­gram and the rest of its pipeline un­til the San Diego-based biotech finds a per­ma­nent hire.

→ Now that As­cle­tis has some­what stead­ied its po­si­tion on the Hong Kong Stock Ex­change — al­beit not an en­vi­able one, cur­rent­ly trad­ing around half of its de­but price — it’s ready to move on with a new CFO on the team. Lin­di Tan brings 15 years of as a health­care an­a­lyst, with stints at SeaTown Hold­ings and Temasek.  

Mer­ck vet Joel Lebowitz has joined Schrödinger as CFO at a time the com­pu­ta­tion­al drug dis­cov­ery shop is dou­bling down on big bio­phar­ma part­ner­ships, marked by a joint ven­ture with WuXi AppTec launched days ago. Lebowitz, who spent much of his time at the phar­ma gi­ant eval­u­at­ing the port­fo­lio and do­ing pipeline val­u­a­tion, will al­so play a key role in busi­ness de­vel­op­ment.

→ Af­ter a decade at now trou­bled Idera, Louis Ar­cu­di is mov­ing on to his next CFO role. The sea­soned ex­ec will be en­ter­ing Mil­len­do Ther­a­peu­tics with Michael Yeh, an alum­ni of So­bi and Bio­gen who’s just been ap­point­ed VP of med­ical af­fairs.

→ Ox­nard, CA-based CURE Phar­ma has tapped ven­ture cap­i­tal­ist Alex Katz to over­see its fi­nan­cial func­tions as CFO. Katz, a for­mer man­ag­ing part­ner for ff Ven­ture Cap­i­tal and Dif­fer­en­tial Ven­ture Part­ners, has been work­ing with the drug de­liv­ery in­no­va­tor as an ad­vis­er.

→ On the heels of a much an­tic­i­pat­ed up­date that keeps the con­tro­ver­sy burn­ing over NK­TR-214/Op­di­vo, Nek­tar $NK­TR an­nounced it has re­cruit­ed Genen­tech vet Wei Lin to spear­head its on­col­o­gy pro­grams. As SVP of clin­i­cal de­vel­op­ment, Lin will have over­sight not just on NK­TR-214 com­bo tri­als but al­so the rest of the I/O pipeline.

→ We fi­nal­ly know where Lisa Suen­nen is head­ed af­ter a sur­pris­ing ex­it from GE Ven­tures.  Man­att Phelps & Phillips, a lead­ing law and con­sult­ing firm with a health-fo­cused branch, an­nounced Suen­nan will head up its dig­i­tal and tech­nol­o­gy busi­ness­es and as well as the firm’s ven­ture cap­i­tal fund from its San Fran­cis­co of­fice.

De­nali CMO Ca­r­ole Ho has tak­en a board seat at Beam Ther­a­peu­tics, the base edit­ing biotech found­ed by CRISPR trail­blaz­ers Feng Zhang, David Liu and J Kei­th Joung.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

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.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

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.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

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.

Ab­b­Vie touts new da­ta for Hu­mi­ra suc­ces­sor; Gilead inks dis­cov­ery deal

→ 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.

Turns out, Rudy Tanzi did­n't see much of a sto­ry about a hid­den link be­tween En­brel and Alzheimer's ei­ther

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. 

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.

Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.

Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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