J&J may be late to the pso­ri­a­sis drug mar­ket par­ty, but it’s plan­ning to make a splash with guselkum­ab

J&J has reaped the fi­nal har­vest of Phase III da­ta it is tak­ing to reg­u­la­tors in search of a block­buster ap­proval for their pso­ri­a­sis con­tender guselkum­ab.

J&J is wide­ly ex­pect­ed to use this lat­est batch of re­li­ably pos­i­tive da­ta to clean up on ma­jor ap­provals at the FDA and EMA. But its fa­vor­able late-stage com­par­isons with Hu­mi­ra may not count for so much these days, as the phar­ma gi­ant is bring­ing up the rear of a pa­rade of new drugs that got to the mar­ket first.

No­var­tis’ Cosen­tyx got out ahead 18 months ago and the Swiss phar­ma gi­ant has fol­lowed with 4-year da­ta track­ing a sol­id suc­cess — 43.5% — in keep­ing skin cleared over the long haul. Eli Lil­ly backed its new drug Taltz in a ma­jor cam­paign last fall. And then Valeant am­bled across the fin­ish line with bro­dalum­ab — now dubbed Siliq — two weeks ago. Their drug, picked up at a dis­count from a dis­ap­point­ed As­traZeneca, al­so comes with a black box warn­ing on sui­ci­dal think­ing that will al­most cer­tain­ly squeeze its slice of the mar­ket down to a sliv­er.

Now comes J&J, a glob­al pow­er­house, with a con­tender it be­lieves is al­ready po­si­tioned for suc­cess.

As we saw in the first Phase III, VOY­AGE 1, guselkum­ab hand­i­ly outscored a place­bo on two mea­sures of com­plete or near-com­plete skin clear­ance in VOY­AGE 2. And once again their IL-23 drug slapped aside Hu­mi­ra, with guselkum­ab ver­sus adal­i­mum­ab achiev­ing an IGA 0/1 score of 84% ver­sus 67.7% and a PASI 90 of 70% com­pared to 46.8%, re­spec­tive­ly.

“The re­sults were re­mark­ably sim­i­lar, which is what you want to see,” Philippe Sza­pary, VP for der­ma­tol­ogy and gas­troen­terol­o­gy in J&J’s Im­munol­o­gy Clin­i­cal De­vel­op­ment unit, tells me about his Phase III stud­ies. “It’s very re­as­sur­ing to see such amaz­ing con­sis­ten­cy.”

J&J’s third Phase III study look­ing at pa­tients trans­ferred to guselkum­ab af­ter an in­ad­e­quate re­sponse to their oth­er pso­ri­a­sis drug Ste­lara al­so looked good. The state­ment notes:

Pa­tients who switched to guselkum­ab con­sis­tent­ly showed greater im­prove­ment in their pso­ri­a­sis be­tween weeks 28 and 40, com­pared with pa­tients who con­tin­ued to re­ceive Ste­lara, hav­ing twice as many of­fice vis­its with at least a 2 point im­prove­ment in IGA from week 16, the study’s pri­ma­ry end­point, and an IGA score of 0 or 1.

J&J gained a new ap­proval for Ste­lara last fall, adding Crohn’s to the la­bel as the com­pa­ny looked to keep its per­for­mance in block­buster ter­ri­to­ry. The new Nav­i­gate study al­so po­si­tions J&J to keep about 30% of pso­ri­a­sis pa­tients who don’t re­spond well to Ste­lara in the fold, so to speak.

In­ves­ti­ga­tors al­so reaped a sat­is­fy­ing pro­file on safe­ty, with a some­what bet­ter set of da­ta on ad­verse ef­fects com­pared to Hu­mi­ra, which re­mains a big play­er in this field as Ab­b­Vie con­tin­ues to fight off biosim­i­lar com­pe­ti­tion. There is al­so one more pso­ri­a­sis drug wait­ing in the wings. Sun Phar­ma gained con­trol of Mer­ck’s MK-3222, but it isn’t ex­pect­ed to hit the mar­ket any­time soon.

The next step is to keep gath­er­ing da­ta with ex­ten­sion stud­ies that will take the 1800 pa­tients en­rolled for VOY­AGE 1 and 2 out about five years. With a tar­get ly­ing up­stream of IL-17 and TNF, he adds, in­ves­ti­ga­tors are hope­ful that guselkum­ab will con­tin­ue to per­form well against com­pe­ti­tion long af­ter it ar­rives on the mar­ket.

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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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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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.

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.

Plagued by de­lays, As­traZeneca HQ costs soar to £750M as it edges to­ward 2020 com­ple­tion

In the lat­est up­date on As­traZeneca’s de­lay-prone HQ project, the phar­ma gi­ant re­vealed that the cost of con­struc­tion has swelled to £750 mil­lion ($956 mil­lion) — more than dou­ble the orig­i­nal es­ti­mate in 2013.

The move-in date is still in 2020, a spokesper­son con­firmed, af­ter As­traZeneca pushed pro­ject­ed com­ple­tion from 2016 to 2017, and then to the spring of 2019. While the ini­tial plan called for a £330 mil­lion (then $500 mil­lion) in­vest­ment, the cost bal­looned to £500 mil­lion ($650 mil­lion), and more in the most re­cent up­date.