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.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Therapists Marcela Ot'alora and Bruce Poulter are trained to conduct MDMA-assisted psychotherapy. In this reenactment, they demonstrate how they help guide and watch over a patient who is revisiting traumatic memories while under the influence of MDMA. (Photo: Multidisciplinary Association for Psychedelic Studies)

MD­MA, now in Phase III, shows promise as a PTSD treat­ment

The first time Lori Tipton tried MDMA, she was skeptical it would make a difference.

“I really was, at the beginning, very nervous,” Tipton said.

MDMA is the main ingredient in the club drug known as ecstasy or molly. But Tipton wasn’t taking pills sold on the street to get high. She was trying to treat her post-traumatic stress disorder by participating in a clinical trial.

After taking a dose of pure MDMA, Tipton lay in a quiet room with two specially trained psychotherapists. They sat next to her as she recalled some of her deepest traumas, such as discovering her mother’s body after Tipton’s mother killed two people and then herself in a murder-suicide.

Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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