Pascal Soriot, AstraZeneca CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

UP­DAT­ED: UK says it won't pur­chase As­traZeneca's Covid treat­ment due to 'in­suf­fi­cien­t' Omi­cron da­ta — re­ports

Weeks af­ter ev­i­dence sug­gest­ed cur­rent Omi­cron sub­vari­ants may be less sus­cep­ti­ble to As­traZeneca’s pro­phy­lac­tic Covid-19 treat­ment Evusheld, the UK has re­port­ed­ly de­cid­ed against buy­ing dos­es for now.

The UK’s De­part­ment of Health said it won’t pro­cure Evusheld dos­es due to “in­suf­fi­cient da­ta on the du­ra­tion of pro­tec­tion of­fered by Evusheld in re­la­tion to the omi­cron vari­ant,” ac­cord­ing to the BMJ, a peer-re­viewed trade jour­nal pub­lished by the British Med­ical As­so­ci­a­tion.

Evusheld, which is a com­bi­na­tion of tix­agevimab and cil­gav­imab, will now be eval­u­at­ed by the Na­tion­al In­sti­tute for Health and Care Ex­cel­lence (NICE). How­ev­er, that re­port isn’t ex­pect­ed un­til next April, ac­cord­ing to the BBC, which was among the first to re­port the news. Mean­while, As­traZeneca said it will “seek fur­ther dis­cus­sions” with the UK.

‘This is dis­ap­point­ing news for im­muno­com­pro­mised pa­tients in the UK who con­tin­ue to have a dis­pro­por­tion­ate­ly high risk of in­fec­tion and hos­pi­tal­i­sa­tion from COVID-19, many of whom will now be forced to con­tin­ue shield­ing for an­oth­er win­ter, whilst vul­ner­a­ble peo­ple in many oth­er coun­tries are of­fered the pro­tec­tion of Evusheld. We will be seek­ing fur­ther dis­cus­sions with gov­ern­ment,” an As­traZeneca spokesper­son told End­points News in an email.

The drug was au­tho­rized in the US back in De­cem­ber, based on da­ta that sug­gest­ed re­cip­i­ents saw pro­tec­tion through six months. In a pri­ma­ry analy­sis, re­cip­i­ents saw a 77% re­duced risk of Covid in­fec­tion com­pared to place­bo, ac­cord­ing to the FDA.

In June, feel­ing pres­sure from Omi­cron sub­vari­ants, the FDA up­dat­ed the Evusheld fact sheet to rec­om­mend re­peat dos­ing every six months with 300 mg.

“Non­clin­i­cal da­ta and phar­ma­co­ki­net­ic mod­el­ing sug­gest that ac­tiv­i­ty against these sub­vari­ants [BA.2, BA.2.12.1, BA.4, and BA.5] may be re­tained for six months at drug con­cen­tra­tions achieved fol­low­ing an Evusheld dose of 300 mg of tix­agevimab and 300 mg cil­gav­imab,” reg­u­la­tors not­ed at the time.

How­ev­er, Ju­ly cor­re­spon­dence in the New Eng­land Jour­nal of Med­i­cine sug­gest­ed that cur­rent Omi­cron sub­vari­ants may be less sus­cep­ti­ble to As­traZeneca’s block­buster drug. The re­searchers from Japan, the Uni­ver­si­ty of Wis­con­sin, Johns Hop­kins and Ic­ahn School of Med­i­cine at Mount Sinai wrote that Eli Lil­ly’s bebtelovimab ap­peared to be ef­fec­tive across three dif­fer­ent Omi­cron sub­lin­eages – BA.2.12.1, BA.4, and BA.5.

“How­ev­er, in clin­i­cal use, these vari­ants may be less sus­cep­ti­ble to com­bi­na­tion ther­a­py with casiriv­imab and imde­vimab and with tix­agevimab and cil­gav­imab,” the re­searchers wrote.

As­traZeneca coun­tered back in Ju­ly that “stud­ies have shown that Evusheld neu­tral­izes all known vari­ants of con­cern, in­clud­ing BA.4/5.” And on the com­pa­ny’s Q2 call, ex­ecs main­tained that “ef­fi­ca­cy is re­main­ing very ro­bust.”

Iskra Re­ic

“The main lim­i­ta­tion of our study is the lack of clin­i­cal da­ta on the ef­fi­ca­cy of these mon­o­clon­al an­ti­bod­ies and an­tivi­ral drugs for the treat­ment of pa­tients in­fect­ed with BA.2.12.1, BA.4, or BA.5 sub­vari­ants,” re­searchers not­ed in the NE­JM piece.

Sales for Evusheld and the com­pa­ny’s Covid-19 vac­cine Vaxzevria were down last quar­ter com­pared to Q1 2022, com­ing in at $445 mil­lion and $451 mil­lion, re­spec­tive­ly. While CEO Pas­cal So­ri­ot ex­pects Vaxzevria sales will con­tin­ue to fall this year, he thinks Evusheld will grow.

“We are pleased to see strong de­mand, in­creased de­mand for Evusheld, be­cause it is clear that it’s re­al­ly im­por­tant to pro­tect the im­muno­com­pro­mised pa­tients … due to the fact that they are not able to de­vel­op the im­mune re­sponse af­ter vac­ci­na­tion,” Iskra Re­ic, ex­ec­u­tive VP of vac­cines and im­mune ther­a­pies, said on the Q2 call. “We do be­lieve that de­mand will con­tin­ue.”

The UK’s De­part­ment of Health and So­cial Care has not re­spond­ed to a re­quest for com­ment as of press time.

This sto­ry has been up­dat­ed to in­clude com­ment from As­traZeneca. 

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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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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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.