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.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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