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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.