As mon­key­pox quick­ly spreads, a hand­ful of biotechs spring to ac­tion

At the be­gin­ning of the week, many peo­ple hadn’t ever heard of mon­key­pox. By Fri­day, that all changed — and now a hand­ful of biotech com­pa­nies are reap­ing the ben­e­fits.

Emer­gent Bioso­lu­tions’ $EBS stock jumped more than 10% on Fri­day, four days af­ter the com­pa­ny plumped down $225 mil­lion for the rights to Chimerix’s small­pox vac­cine. Chimerix’s stock $CM­RX was up more than 3.8% on Fri­day. And Bavar­i­an Nordic $BVN­RY — which closed a $119 mil­lion deal with BAR­DA to pro­vide the US gov­ern­ment with freeze-dried dos­es of the Jyn­neos vac­cine — was up near­ly 2.5%.

The news comes just a cou­ple days af­ter the first mon­key­pox case was de­tect­ed in the US, and on Fri­day the CDC re­vealed it’s mon­i­tor­ing at least six oth­er Amer­i­cans af­ter they came in close con­tact with an in­fect­ed trav­el­er ear­li­er this month. Cas­es are surg­ing in Eu­rope, where Spain has now iden­ti­fied 30 cas­es, and neigh­bor­ing Por­tu­gal has re­port­ed 23.

Make no mis­take, though: The cur­rent sit­u­a­tion is noth­ing like Covid, ac­cord­ing to Nor­man Bay­lor, who once di­rect­ed the FDA’s Of­fice of Vac­cines Re­search and Re­view and now serves as a con­sul­tant.

“The good news is we have a vac­cine. Re­mem­ber with Covid, we had noth­ing. We were start­ing from scratch,” he said.

Mon­key­pox has been around since 1958, when two out­breaks oc­curred in colonies of re­search mon­keys (hence the name). How­ev­er, the first hu­man case wasn’t re­port­ed un­til over a decade lat­er in the De­mo­c­ra­t­ic Re­pub­lic of Con­go. The US saw an out­break back in 2003, af­ter re­ceiv­ing a ship­ment of an­i­mals from Ghana, which was con­tained with test­ing and vac­ci­na­tion, ac­cord­ing to the CDC.

Be­cause mon­key­pox is sim­i­lar to (but milder than) small­pox, cur­rent­ly ap­proved small­pox vac­cines like Chimerix’s Tem­blex should of­fer some pro­tec­tion against mon­key­pox, ac­cord­ing to Daniel Ku­ritzkes, chief of in­fec­tious dis­eases at Brigham and Women’s Hos­pi­tal in Boston. In fact, most old­er adults are al­ready vac­ci­nat­ed (rou­tine vac­ci­na­tion end­ed in 1972 af­ter the dis­ease was erad­i­cat­ed in the US).

Even though a large pop­u­la­tion re­mains un­vac­ci­nat­ed, both Bay­lor and Ku­ritzkes doubt that the US will need to roll out a wide­spread vac­cine cam­paign to con­tain the cur­rent out­break.

Nev­er­the­less, BAR­DA is pay­ing Bavar­i­an Nordic $119 mil­lion to ex­er­cise op­tions for a freeze-dried stock­pile of Jyn­neos, which cov­ers both mon­key­pox and small­pox. Ad­di­tion­al op­tions for an­oth­er 13 mil­lion dos­es through 2024 and 2025 would add up to $180 mil­lion.

Paul Chap­lin, CEO of Bavar­i­an Nordic, said in an in­ter­view with End­points News that the com­pa­ny has had a long-stand­ing re­la­tion­ship with BAR­DA and is ready for what­ev­er comes next.

BAR­DA’s new op­tion for the Jyn­neos vac­cine is part of a years-old col­lab­o­ra­tion with Bavar­i­an Nordic to cre­ate a vac­cine with a longer shelf-life. So the new deal is quite co­in­ci­den­tal con­sid­er­ing what’s hap­pen­ing in the world, Chap­lin said.

How­ev­er, he was quick to em­pha­size that Bavar­i­an Nordic has an im­me­di­ate stock­pile and the ca­pa­bil­i­ty to pro­duce more. It has over a mil­lion dos­es in stock cur­rent­ly for BAR­DA, most of which is stored at their fa­cil­i­ty in Den­mark.

The com­pa­ny usu­al­ly sells Jyn­neos on an on­go­ing ba­sis, typ­i­cal­ly man­u­fac­tur­ing for or­der as there hasn’t been much in­ter­est in stock­pil­ing for small­pox. How­ev­er, Chap­lin said he ex­pects to be­gin sup­ply­ing EU coun­tries in the com­ing days and is man­u­fac­tur­ing more dos­es as we speak, though he didn’t dis­close any of the de­tails.

“I think gov­ern­ments are tak­ing the emer­gence of new in­fec­tious dis­eases ex­treme­ly se­ri­ous­ly. So I think that’s one thing, which is a pos­i­tive sign,” he said. “There are a num­ber of gov­ern­ments, Cana­da, the Unit­ed States, and ac­tu­al­ly a few coun­tries in Eu­rope [that] have ac­tu­al­ly pre­vi­ous­ly pur­chased Jyn­neos to stock­pile.”

Mean­while, Emer­gent snagged the rights to Tem­bexa, a small­pox treat­ment for all ages that was ap­proved in 2021, with an an­tic­i­pat­ed BAR­DA con­tract in the wings. The com­pa­ny is ea­ger for a come­back af­ter a re­port from the US House se­lect sub­com­mit­tee re­vealed that around 400 mil­lion Covid-19 vac­cine dos­es were like­ly tossed due to cross con­t­a­m­i­na­tion prob­lems at its Bal­ti­more plant.

Should the US need to roll out vac­cines, the re­al ques­tion will be who gets them first, Bay­lor said. British au­thor­i­ties re­cent­ly prompt­ed health­care work­ers and oth­ers who were ex­posed to get vac­ci­nat­ed, ac­cord­ing to a Reuters re­port.

“The sup­ply is not enough to roll out to every­body,” he said. “That would re­al­ly need some dis­cus­sion, and we’re not at that point yet.”

Aa­dia Rana, an as­so­ciate pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Al­aba­ma-Birm­ing­ham, told End­points that it’s un­clear whether those who have been vac­ci­nat­ed against small­pox in the past will need to be re­vac­ci­nat­ed. How­ev­er, William Schaffn­er, an in­fec­tious dis­ease ex­pert from Van­der­bilt Uni­ver­si­ty, point­ed out that small­pox vac­cines can pro­vide long-term pro­tec­tion. Like any vac­cine, though, pro­tec­tion di­min­ish­es over time.

“I am re­al­ly quite con­fi­dent that the pub­lic health au­thor­i­ties in the US and Cana­da and in Eu­rope will rather quick­ly bring these var­i­ous chains of trans­mis­sion to a close and it’s an ex­ot­ic event,” Schaffn­er said. “It’s an­oth­er in­di­ca­tion that we live to­geth­er on a very small globe, and that strange in­fec­tions can ap­pear very dis­tant­ly, and all of a sud­den show up in your neigh­bor­hood.”

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.

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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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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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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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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Fed­er­al claims court rules in fa­vor of Gilead in CDC Tru­va­da patent case

Gilead pulled a win last week in its ongoing patent battle with the CDC over the HIV drug Truvada for pre-exposure prophylaxis (PrEP).

The US Court of Federal Claims ruled on Nov. 21 that the government breached certain agreements with Gilead by failing to promptly notify the company of its patent applications for Truvada for PrEP, according to documents unsealed on Wednesday.

The issue traces back to around 2004 when Truvada won an accelerated approval to treat HIV. Because HIV is known to develop resistance to therapy, patients at the time were often required to take more than one drug at a time. Truvada combines Gilead’s prior HIV drugs, Emtriva and Viread, making life easier for patients who were taking separate pills daily. Shortly after, the CDC and Gilead struck up a partnership to research Truvada’s use as a preventative measure prior to exposure.