Help want­ed: New CEO to run Gilead as John Mil­li­gan steps down

Gilead $GILD CEO John Mil­li­gan is out.

In a com­plete­ly un­ex­pect­ed an­nounce­ment, the big biotech com­pa­ny re­port­ed right af­ter the mar­ket close Wednes­day evening that Mil­li­gan will re­main in his po­si­tion un­til the end of the year, as the board looks for his suc­ces­sor.

He’s step­ping down, but Mil­li­gan clear­ly has an­oth­er ca­reer chap­ter in mind.

“It has been an hon­or to work at Gilead for my en­tire pro­fes­sion­al ca­reer and, now that the com­pa­ny is on sol­id foot­ing for the fu­ture, the Board and I have agreed it is a good time to turn the reins over to a new leader,” said Mil­li­gan in a state­ment. “I’m look­ing for­ward to a well-de­served break and will then move on to new and dif­fer­ent op­por­tu­ni­ties.”

Al­so out is Chair­man John Mar­tin, who pre­ced­ed Mil­li­gan at the helm. He plans to leave once the new CEO ar­rives.

The up­com­ing change at the top has big im­pli­ca­tions, notes Leerink’s Ge­of­frey Porges, who’s been watch­ing this com­pa­ny for years. His note:

These an­nounce­ments come as a sur­prise to in­vestors giv­en Dr. Mil­li­gan’s 28-year ca­reer at Gilead and his rel­a­tive­ly short 2-year stint in the long-await­ed CEO po­si­tion, and no in­ter­nal suc­ces­sor has been iden­ti­fied. These an­nounce­ments clear­ly sig­nal a de­ci­sion by the com­pa­ny’s board to “go in a dif­fer­ent di­rec­tion” and while we don’t be­lieve the or­der­ly de­par­tures sug­gest any im­me­di­ate is­sue, the ba­sis for these changes and their im­pli­ca­tions are like­ly to dom­i­nate in­vestor con­ver­sa­tions about the com­pa­ny for sev­er­al months. In­vestor chat­ter is like­ly to switch from “what’s Gilead go­ing to buy” to “who’s Gilead go­ing to hire,” and giv­en the com­pa­ny’s mixed hir­ing record, the ap­pointee may not nec­es­sar­i­ly be an in­di­vid­ual with im­me­di­ate in­dus­try or in­vestor cred­i­bil­i­ty. Cer­tain­ly these tran­si­tions con­firm our view that de­spite the ob­vi­ous need for sig­nif­i­cant new pipeline and prod­uct op­por­tu­ni­ties, Gilead won’t be mak­ing any ma­jor strate­gic moves for po­ten­tial­ly a year or more.

To­geth­er, Mar­tin and Mil­li­gan made biotech his­to­ry at Gilead. They led the team that pro­vid­ed a pain­less cure for he­pati­tis C, cre­at­ing a huge, if tem­po­rary, mega-mar­ket to prof­it from. And they con­tin­ued to dom­i­nate the HIV space, of­fer­ing new block­buster com­bi­na­tion drugs that re­main the stan­dard ther­a­py in the field over ca­reers that spanned decades.

Faced with the de­cline of the hep C fran­chise, Mil­li­gan ag­gres­sive­ly snapped up Kite to be­come a leader in CAR-T, buy­ing new tech­nolo­gies along the way.

Mar­tin and Mil­li­gan al­so en­dured end­less crit­i­cism for their ag­gres­sive pric­ing strat­e­gy, par­tic­u­lar­ly when they priced their he­pati­tis C drug at $84,000, trig­ger­ing out­rage from Wash­ing­ton DC to the Bay Area. That con­tro­ver­sy nev­er re­al­ly died out, leav­ing the in­dus­try with the worst rep it’s ever had.

They’ll be missed by in­vestors, but not by every­one.

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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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

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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Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

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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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.