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.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

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