Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

No­vavax is pulling out of its Covid-19 vac­cine deal with Gavi, the Vac­cine Al­liance, a glob­al part­ner­ship tasked with en­sur­ing vac­cine ac­cess in low­er-in­come coun­tries, fol­low­ing an al­leged con­tract vi­o­la­tion.

The Mary­land-based com­pa­ny claimed on Fri­day that Gavi failed to pur­chase at least 350 mil­lion dos­es of its pro­tein-based vac­cine Nu­vax­ovid by the end of the year, per an ad­vanced pur­chase agree­ment. Gavi, the World Health Or­ga­ni­za­tion and the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions (CEPI) are co-lead­ers of CO­V­AX, an ef­fort to en­sure that all par­tic­i­pat­ing coun­tries, re­gard­less of in­come lev­els, have ac­cess to vac­cines.

Gavi paid No­vavax $350 mil­lion last year and an­oth­er $350 mil­lion in ear­ly 2022 as part of the agree­ment, ac­cord­ing to the com­pa­ny’s Q1 re­port. How­ev­er, No­vavax said it has on­ly re­ceived or­ders for 2 mil­lion dos­es from Gavi this year.

While Gavi was not im­me­di­ate­ly avail­able for com­ment, the or­ga­ni­za­tion has re­port­ed­ly de­nied a breach of con­tract. A spokesper­son told Reuters on Tues­day that “it is clear that No­vavax will not be able to meet its com­mit­ment to man­u­fac­ture” the dos­es un­der agree­ment by the end of the year.

“No­vavax has been ready to meet our com­mit­ment to man­u­fac­ture and de­liv­er dos­es for the CO­V­AX fa­cil­i­ty. Giv­en that vac­ci­na­tion rates in de­vel­op­ing coun­tries re­main be­low tar­gets set by pub­lic health au­thor­i­ties, our hope was that the No­vavax vac­cine might help to di­ver­si­fy the avail­able CO­V­AX vac­cine port­fo­lio and of­fer an abil­i­ty to ad­dress key lo­gis­ti­cal and up­take chal­lenges through our vac­cine’s re­frig­er­a­tor sta­bil­i­ty and more tra­di­tion­al vac­cine tech­nol­o­gy,” a No­vavax spokesper­son said in a state­ment on Tues­day.

No­vavax said on Fri­day that it gave a writ­ten no­tice to Gavi ter­mi­nat­ing the deal, “ef­fec­tive im­me­di­ate­ly.” The spokesper­son said No­vavax “val­ues its re­la­tion­ship with Gavi” and hopes to ne­go­ti­ate a new agree­ment.

The com­pa­ny’s stock $NVAX was down more than 12% on Tues­day af­ter­noon, trad­ing at around $16.56 per share.

The news comes as Nu­vax­ovid sales num­bers con­tin­ue to dis­ap­point, lead­ing CEO Stan­ley Er­ck to low­er his full-year sales guid­ance the last two quar­ters. The vac­cine won FDA au­tho­riza­tion back in Ju­ly, be­com­ing the first pro­tein-based Covid vac­cine in the US, af­ter suf­fer­ing de­lay af­ter de­lay for its EUA fil­ing. It’s al­so on the WHO’s emer­gency use list, and won au­tho­riza­tions as a boost­er this month in Cana­da and the UK.

The vac­cine raked in $626 mil­lion last quar­ter, though Er­ck low­ered his full-year sales ex­pec­ta­tions to $2 bil­lion, the low­er end of a $2 bil­lion to $2.3 bil­lion range pro­ject­ed in Q2.

Dur­ing the com­pa­ny’s Q2 call, Er­ck told in­vestors and an­a­lysts that low­er-than-ex­pect­ed de­mand from CO­V­AX con­tributed to his low­er­ing of full-year sales guid­ance.

“Glob­al­ly and par­tic­u­lar­ly with re­spect to CO­V­AX, there was a surge of sup­ply and when cou­pled with chal­lenges CO­V­AX had with the dis­tri­b­u­tion in­to low- and mid­dle-in­come coun­tries, this lim­it­ed the need for them to or­der con­tract­ed prod­uct from us and oth­er vac­cine man­u­fac­tur­ers,” he said.

While the Ac­cess to Med­i­cine Foun­da­tion not­ed “in­dus­try-wide” progress in its lat­est bi­en­ni­al re­port, the or­ga­ni­za­tion re­port­ed that low-in­come coun­tries re­main “wide­ly over­looked” when it comes to drug and vac­cine ac­cess.

“If the pan­dem­ic is to be a turn­ing point in the fight for eq­ui­table ac­cess to med­i­cine, com­pa­nies must now scale their ef­forts to cov­er more prod­ucts in their port­fo­lios, and in a greater num­ber of coun­tries,” the foun­da­tion said in a news re­lease.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (ROMUALD MEIGNEUX/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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