Bob Kramer, Emergent CEO

Emer­gent tossed near­ly 400M Covid-19 vac­cine dos­es in Bal­ti­more de­ba­cle, House re­port says

The ex­act num­ber of dos­es lost in the Emer­gent BioSo­lu­tions mishap at its Bal­ti­more plant has nev­er been ex­act­ly de­ter­mined. But a re­cent re­port from the US House se­lect sub­com­mit­tee on the coro­n­avirus cri­sis says that the com­pa­ny might have de­stroyed near­ly 400 mil­lion dos­es of Covid-19 vac­cines af­ter fail­ures to meet qual­i­ty stan­dards.

The re­port came to the de­ter­mi­na­tion via re­quests for in­ter­nal com­mu­ni­ca­tions be­tween Emer­gent ex­ec­u­tives, which the sub­com­mit­tee al­leges in­clud­ed ef­forts to hide ev­i­dence of con­t­a­m­i­na­tion in “an at­tempt to evade over­sight from gov­ern­ment reg­u­la­tors.”

“De­spite ma­jor red flags at its vac­cine man­u­fac­tur­ing fa­cil­i­ty, Emer­gent’s ex­ec­u­tives swept these prob­lems un­der the rug and con­tin­ued to rake in tax­pay­er dol­lars,” Rep. Car­olyn Mal­oney (D-NY) said in a state­ment. “Ul­ti­mate­ly, our re­port shows that Emer­gent’s man­u­fac­tur­ing fail­ures and de­cep­tive tac­tics led to the de­struc­tion of mil­lions of dos­es of des­per­ate­ly need­ed vac­cines. Emer­gent’s busi­ness prac­tices are sim­ply un­ac­cept­able, and I urge the fed­er­al gov­ern­ment to care­ful­ly con­sid­er fu­ture con­tracts in light of Emer­gent’s fail­ures.”

Orig­i­nal­ly, it was said that be­tween 75 mil­lion and 85 mil­lion dos­es of drug sub­stance was de­stroyed af­ter con­t­a­m­i­na­tion. The re­port finds that 400 mil­lion dos­es were de­stroyed be­tween April 2021 and Au­gust 2021. Emer­gent hid the ev­i­dence, the re­port al­leges, by re­mov­ing qual­i­ty-as­sur­ance hold tags from J&J batch­es that in­di­cat­ed that the con­tain­ers had qual­i­ty is­sues, in an ef­fort to avoid draw­ing at­ten­tion from FDA in­spec­tors. Emer­gent em­ploy­ees were wor­ried that the De­part­ment of Health and Hu­man Ser­vices was get­ting too in­volved in its op­er­a­tions af­ter the As­traZeneca-J&J mix­up.

The re­port al­so says that Emer­gent en­tered con­tracts with the two phar­mas de­spite its aware­ness that tech­ni­cal op­er­a­tions were not up to snuff for at least a few years.

“Our risk is high!” A note from a se­nior di­rec­tor of qual­i­ty said at one point. “We lack com­mer­cial GMP com­pli­ance ma­tu­ri­ty.”

The team at Emer­gent main­tains that there is noth­ing new in­clud­ed in the re­port, how­ev­er, and dis­putes the state­ment that 400 mil­lion dos­es of the vac­cine were de­ter­mined to me un­us­able, cit­ing the dif­fi­cul­ty that comes with es­ti­mat­ing the dosage equiv­a­lent of drug sub­stance that has not com­plet­ed the man­u­fac­tur­ing process.

“To equate these qual­i­ty con­trol ac­tions with a ‘dis­card­ed dose’ fig­ure dis­plays a lack of un­der­stand­ing re­gard­ing the bio­man­u­fac­tur­ing process,” the state­ment said.

The CD­MO main­tains that it nev­er know­ing­ly mis­led the FDA or any of the part­ners in­volved in the man­u­fac­tur­ing process. It al­so said that the first it heard of the sub­com­mit­tee’s re­port was through the me­dia.

“While it’s im­por­tant to an­a­lyze past de­ci­sions to in­form fu­ture plans – we must do so in the prop­er con­text and avoid the temp­ta­tion to Mon­day morn­ing quar­ter­back with the ben­e­fit of what we know to­day,” the state­ment says. “Emer­gent and our gov­ern­ment part­ners were at­tempt­ing to com­press in­to a few months the de­vel­op­ment and scale up of drug sub­stance man­u­fac­tur­ing process­es that nor­mal­ly take years. We were al­ways trans­par­ent with our pub­lic and pri­vate part­ners about our process and ca­pa­bil­i­ties and of­ten wel­comed BAR­DA, J&J and As­traZeneca per­son­nel on­site dai­ly.”

The re­port says the Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion was aware of de­fi­cien­cies that the com­pa­ny had high­light­ed at the Bayview site when it was award­ed $628 mil­lion in fund­ing back in May 2020. As­traZeneca per­son­nel raised con­cerns to Emer­gent in Ju­ly of 2020, not­ing that the site wasn’t pre­pared for com­mer­cial man­u­fac­tur­ing, and in­ter­nal J&J com­mu­ni­ca­tions said that the phar­ma was un­clear if Emer­gent would be good-to-go come game time.

“I am stat­ing very loud­ly that this work is NON-CGMP com­pli­ant. And a di­rect reg­u­la­to­ry risk,” an out­side con­sul­tant told Emer­gent in No­vem­ber 2020.

The re­port al­so found that in­ex­pe­ri­enced staff and high turnover led to vac­cine con­t­a­m­i­na­tion, as the staff that was work­ing wasn’t trained prop­er­ly, and had lit­tle pre­vi­ous phar­ma ex­pe­ri­ence.

In Feb­ru­ary, Emer­gent an­nounced that its trou­bled Bayview plant would get a $100 mil­lion up­grade, as it start­ed mak­ing sched­uled up­grades ear­ly, and ex­pect­ed to be back in op­er­a­tion in Q2 2022. The work will al­low for “ad­di­tion­al non-pan­dem­ic work be­ing done in Bayview down the road,” CEO Bob Kramer said, and help sup­port the strength­en­ing of J&J’s sup­ply chain.

Right now, Emer­gent has a sup­ply agree­ment for San­doz’s gener­ic Nar­can, and plans to launch a live ty­phoid vac­cine and cholera vac­cine. It al­so has a sup­ply deal with the US gov­ern­ment for its an­thrax vac­cine, the drug that kicked off the com­pa­ny’s re­la­tion­ship with the gov­ern­ment years ago.

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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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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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.