HHS Secretary Xavier Becerra (AP Photo/Patrick Semansky)

HHS lines up near­ly $700M in sup­ply deals to com­bat mon­key­pox and stock up on a small­pox treat­ment

The De­part­ment of Health and Hu­man Ser­vices is dou­bling down on ef­forts to se­cure more dos­es of Bavar­i­an Nordic’s mon­key­pox vac­cine and Chimerix’s small­pox treat­ment as the CDC re­veals that few peo­ple have com­plet­ed their full vac­cine se­ries.

BAR­DA an­nounced on Mon­day that it’s shelling out $11 mil­lion to Michi­gan-based Grand Riv­er Asep­tic Man­u­fac­tur­ing, which agreed ear­li­er this month to per­form fill and fin­ish ser­vices for Bavar­i­an Nordic’s mon­key­pox vac­cine Jyn­neos.

Rochelle Walen­sky

Jyn­neos re­mains the on­ly vac­cine that’s specif­i­cal­ly ap­proved by the FDA to pre­vent mon­key­pox — and though it’s a two-dose vac­cine, CDC di­rec­tor Rochelle Walen­sky said in a White House brief­ing on Fri­day that 97% of shots that have been de­liv­ered so far have been first dos­es.

“While we are en­cour­aged by the scale-up, there are many peo­ple el­i­gi­ble for sec­ond dos­es, and very few of the dos­es ad­min­is­tered so far are record­ed [as] sec­ond dos­es,” she said dur­ing the brief­ing. “I’d like to take this mo­ment to em­pha­size that this is a two-dose vac­cine and it is im­por­tant to re­ceive the sec­ond dose in the se­ries.”

As part of BAR­DA’s Ju­ly con­tract for 5 mil­lion vials of Jyn­neos, Bavar­i­an Nordic agreed to al­low a US-based man­u­fac­tur­er to fill and fin­ish 2.5 mil­lion vials.

“We con­tin­ue to build on our ef­forts to se­cure and make safe and ef­fec­tive vac­cines read­i­ly avail­able,” HHS Sec­re­tary Xavier Be­cer­ra said in a state­ment. “This new agree­ment so­lid­i­fies a do­mes­tic man­u­fac­tur­ing ca­pa­bil­i­ty that will bring us more vac­cine soon­er to end this out­break.”

Mean­while, BAR­DA struck a deal with Chimerix for up to 1.7 mil­lion dos­es of its small­pox treat­ment Tem­bexa. An ini­tial $115 mil­lion will grant the US gov­ern­ment 319,000 dos­es, but the 10-year con­tract has ad­di­tion­al op­tions worth an­oth­er $551 mil­lion, plus post-mar­ket­ing ac­tiv­i­ties worth $13 mil­lion. Over­all, the con­tract is worth up to $680 mil­lion.

Back in May, Chimerix agreed to sell its Tem­bexa rights to Emer­gent BioSo­lu­tions, which has of­fered $225 mil­lion up­front and mile­stones that could reach $100 mil­lion.

How­ev­er, the clos­ing of that deal is de­pen­dent on “BAR­DA’s ap­proval of a pre-no­va­tion agree­ment be­tween Chimerix and EBS,” ac­cord­ing to a news re­lease.

“Our col­lab­o­ra­tion with BAR­DA for the de­vel­op­ment of TEM­BEXA has pro­vid­ed the Unit­ed States gov­ern­ment with a sec­ond ther­a­peu­tic op­tion to en­sure the fed­er­al gov­ern­ment’s readi­ness for a po­ten­tial small­pox emer­gency,” Chimerix CEO Mike Sher­man said.

While there’s no treat­ment ap­proved for mon­key­pox in the US, an­tivi­rals such as Tem­bexa and Siga’s Tpoxx may be used, ac­cord­ing to the NIH.

The US is al­so ramp­ing up ship­ments of Siga’s Tpoxx treat­ment which was shown to clear 10 of 25 mon­key­pox pa­tients’ le­sions by day 7, and 23 pa­tients’ le­sions by day 21, ac­cord­ing to da­ta pub­lished by JA­MA

In the hopes of stretch­ing the US sup­ply of Jyn­neos, the FDA a cou­ple of weeks ago cleared most peo­ple for in­tra­der­mal in­jec­tions, which are more dif­fi­cult to ad­min­is­ter cor­rect­ly but re­quire much less vac­cine. While of­fi­cials claimed the new route of ad­min­is­tra­tion would ex­pand sup­ply by five-fold, vac­cine clin­ics have re­port­ed­ly strug­gled to squeeze a full five dos­es out of each vial.

Dur­ing the press brief­ing, White House mon­key­pox re­sponse co­or­di­na­tor Robert Fen­ton said clin­ics are ex­tract­ing be­tween 4.5 to 5 dos­es per vial.

So far, 1.1 mil­lion vials of vac­cine have been made avail­able, and 75% of ju­ris­dic­tions are ad­min­is­ter­ing dos­es in­tra­der­mal­ly while about 20% are work­ing to get there, Fen­ton said. As of Aug, 23, 207,000 dos­es had been ad­min­is­tered.

This sto­ry has been up­dat­ed to clar­i­fy that the Chimerix deal is in­tend­ed to pre­pare for a po­ten­tial small­pox emer­gency. 

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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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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As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.

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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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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