No­vo bets on swift FDA re­view for oral di­a­betes drug semaglu­tide

The world’s top di­a­betes drug mak­er No­vo Nordisk is in a hur­ry. As part of its fourth-quar­ter re­sults on Fri­day, the com­pa­ny $NVO said it was plan­ning to use a pri­or­i­ty vouch­er to has­ten the FDA re­view process for its po­ten­tial block­buster oral GLP-1, semaglu­tide, a crit­i­cal com­po­nent of the Dan­ish drug­mak­er’s long-term growth strat­e­gy.

The com­pa­ny has spent near­ly a cen­tu­ry lean­ing on its ros­ter of in­jectable di­a­betes treat­ments, but as com­pe­ti­tion heats up and pric­ing pres­sure in the Unit­ed States in­ten­si­fies, No­vo is bet­ting on a pill to en­tice pa­tients who are averse to in­jec­tions or those who haven’t so far re­quired in­jec­tions to man­age their in­sulin lev­els. An es­ti­mat­ed 425 mil­lion peo­ple glob­al­ly suf­fer from di­a­betes, ac­cord­ing to the In­ter­na­tion­al Di­a­betes Fed­er­a­tion.

The drug, like oth­ers in its class, is a GLP-1 treat­ment that stim­u­lates in­sulin pro­duc­tion. Last year, late-stage da­ta showed No­vo’s pill out­per­formed a place­bo and in a head-to-head tri­al beat Boehringer In­gel­heim and Eli Lil­ly’s Jar­diance, an oral SGLT2-in­hibitor ap­proved back in late 2016. No­vo’s once-a-week in­jectable ver­sion of semaglu­tide — called Ozem­pic — was launched in the Unit­ed States last Feb­ru­ary and has now cap­tured 26% of the week­ly new-to-brand pre­scrip­tion mar­ket share, No­vo said on Thurs­day. Arch-ri­val Lil­ly’s once-week­ly block­buster in­jectable GLP-1 Trulic­i­ty is cur­rent­ly the mar­ket leader.

The GLP-1 pill will be sub­mit­ted for US re­view at the end of the first quar­ter of 2019, and No­vo will sub­mit a pri­or­i­ty re­view vouch­er in tan­dem, which should speed up the FDA process to six months, ver­sus the stan­dard 10 months.

If ap­proved, fo­cus will turn to the price of No­vo’s med­i­cine, as the soar­ing cost of drugs in the Unit­ed States trig­gers the ire of pa­tients and politi­cians alike. Anec­do­tal re­ports of di­a­bet­ics ra­tioning or fore­go­ing in­sulin have elicit­ed wide­spread crit­i­cism, and in re­cent years law­mak­ers across the aisle have pro­posed a raft of poli­cies to tack­le the larg­er is­sue of drug pric­ing, which is al­so con­sid­ered a top pri­or­i­ty by US vot­ers.

“We see risk ap­pre­hen­sion grows on GLP-1 pric­ing, no­tably around 2023E Vic­toza gener­ics, but al­so from US pay­ers as the class bal­loons and when oral semaglu­tide is launched at a low­er price point,” Jef­feries an­a­lysts wrote in a note on Fri­day.

A No­vo spokesper­son de­clined to com­ment on the com­pa­ny’s pric­ing plans for oral semaglu­tide. The drug is ex­pect­ed to gen­er­ate about $2.2 bil­lion in sales in 2024, ac­cord­ing to Eval­u­ate Phar­ma es­ti­mates.

Mean­while, No­vo is al­so nav­i­gat­ing a soup of Brex­it un­cer­tain­ty. The com­pa­ny is the biggest sup­pli­er of in­sulin to the UK, but with no clar­i­ty on Britain’s de­par­ture, the drug­mak­er has put to­geth­er a con­tin­gency plan. The prepa­ra­tions in­cludes stock­pil­ing ahead of March 29 — the ex­pect­ed date of Britain’s de­par­ture from the EU — and sched­uled month­ly air­freight slots be­tween April and Ju­ly 2019 to en­sure sup­ply isn’t dis­rupt­ed. In a state­ment mid-Jan­u­ary, No­vo said it would have dou­bled its UK stock to 16 weeks by the end of the month.

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.

Ted Love. HAVERFORD COLLEGE

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.

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).

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.

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.