In­sys pro­motes CFO to the helm as Saeed Mo­ta­hari hits the ex­it; Gele­sis gets OK to mar­ket weight loss treat­ment

An­drew Long

Saeed Mo­ta­hari is leav­ing In­sys Ther­a­peu­tics on the sec­ond an­niver­sary of his ap­point­ment as CEO. The Pur­due Phar­ma vet is suc­ceed­ed by his CFO, An­drew Long, who is step­ping up as the com­pa­ny strug­gles to stay afloat. A month ago, In­sys re­vealed that the strate­gic coun­sel it hired raised “sub­stan­tial doubt” about its abil­i­ty to con­tin­ue as a go­ing con­cern due to loss­es and un­cer­tain­ty as to whether it can gen­er­ate enough cash for its le­gal fees and set­tle­ments. Its for­mer ex­ec­u­tives are em­broiled in court for al­leged­ly brib­ing doc­tors to pre­scribe its po­tent, ad­dic­tive fen­tanyl spray Sub­sys off-la­bel. Mean­while, the drug­mak­er’s bil­lion­aire founder and for­mer chief John Kapoor is on tri­al for rack­e­teer­ing and con­spir­a­cy as­so­ci­at­ed with Sub­sys sales. In con­junc­tion with Long’s as­cent to the top, An­drece Hous­ley, the cur­rent cor­po­rate con­troller, will move up to fill its pre­vi­ous role. And In­sys has pro­mot­ed Venkat Goskon­da to CSO, over­see­ing what re­mains of the com­pa­ny’s R&D and man­u­fac­tur­ing ac­tiv­i­ties.

Gen­Script — the less­er known par­ent com­pa­ny of CAR-T dark horse Leg­end Biotech — has be­gun con­struc­tion of a com­mer­cial man­u­fac­tur­ing cen­ter spe­cial­iz­ing in plas­mids and virus­es man­u­fac­tur­ing. The Hong Kong-list­ed CRO ex­pects to build Chi­na’s first and largest hub for R&D of cell and gene ther­a­pies as well as an­ti­bod­ies, with ca­pac­i­ty for late-stage de­vel­op­ment and com­mer­cial pro­duc­tion. Lo­cat­ed in Zhen­jiang, the new 133,000-square-me­ter fa­cil­i­ty com­ple­ments a US site set to be­come op­er­a­tional soon.

→ The FDA has cleared a hy­dro­gel cap­sule de­vel­oped by PureTech af­fil­i­ate Gele­sis for mar­ket­ing as a pre­scrip­tion aid in weight man­age­ment. Made by cross-link­ing cel­lu­lose and cit­ric acid, Plen­i­ty is de­signed to swell up in the stom­ach so that peo­ple feel fuller be­fore meals and eat less. While it hit a goal of help­ing over­weight sub­jects lose at least 5% of their body weight, the piv­otal study failed on a co-pri­ma­ry on mean dif­fer­ence be­tween treat­ment and place­bo, but the low risk of tak­ing the prod­uct like­ly con­vinced reg­u­la­tors to give their green light.

Months af­ter re­port­ing pos­i­tive mid-stage de­pres­sion da­ta for its lead ex­per­i­men­tal pill, AXS-05, Ax­some $AXSM on Mon­day post­ed Phase II re­sults that showed the drug — a com­bi­na­tion of  dex­tromethor­phan (DM) and bupro­pi­on (BUP) — met the main goal as a smok­ing ces­sa­tion treat­ment. The da­ta “could add in­cre­men­tal up­side to the stock be­cause we don’t think that the Street has fac­tored smok­ing ces­sa­tion in­to its mod­els…the BUP com­para­tor arm in this Phase II falls with­in the ef­fi­ca­cy range of what has been used in reg­is­tra­tional tri­als for (GSK‘s) Zy­ban, the BUP monother­a­py that is cur­rent­ly ap­proved for smok­ing ces­sa­tion,” SVB Leerink’s Marc Good­man wrote in a note.

CNS-fo­cused EIP Phar­ma is bet­ting big on its lead ex­per­i­men­tal drug ne­flamapi­mod. The drug — which in­hibits the en­zyme p38 al­pha — is be­ing eval­u­at­ed in an on­go­ing proof-of-con­cept tri­al in pa­tients with ear­ly Alzheimer’s dis­ease, which is ex­pect­ed to read­out this fall. In the mean­time, the com­pa­ny has raised $11.2 mil­lion to ex­plore the use of the drug in de­men­tia with Lewy bod­ies and for the cog­ni­tive deficits in Hunt­ing­ton’s dis­ease — Phase II stud­ies for these new in­di­ca­tions are ex­pect­ed to com­mence in the sec­ond quar­ter. 

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.

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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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.