As Covid re­search heats up, J&J re­tires a BAR­DA-fund­ed flu an­tivi­ral they worked on for 7 years

The last eight months have seen a resur­gence in an­tivi­rals as re­searchers, scram­bling for some­thing that might treat Covid-19, re­pur­posed ap­proved HIV drugs and racked the li­braries of small mol­e­cules on phar­ma and biotech’s shelves for any that could in­hib­it the nov­el virus. But yes­ter­day, J&J took an an­tivi­ral it had been test­ing for 7 years and for­mal­ly put it back on the shelf.

J&J an­nounced it was end­ing de­vel­op­ment of the ex­per­i­men­tal in­fluen­za drug pi­modi­vir af­ter an in­ter­im analy­sis of a Phase III study showed the drug was “very un­like­ly” to suc­ceed over stan­dard of care. The com­pa­ny halt­ed both that study, in hos­pi­tal­ized in­fluen­za A pa­tients, and an­oth­er one, in out­pa­tients. The de­ci­sions were made in con­sul­ta­tion with BAR­DA, which co-fund­ed the pro­gram.

“While our goal was to de­vel­op an in­no­v­a­tive new treat­ment op­tion for pa­tients at risk of res­pi­ra­to­ry in­fec­tions, un­for­tu­nate­ly these da­ta show that pi­modi­vir does not of­fer a ben­e­fit above the ex­ist­ing stan­dard of care,” James Mer­son, J&J’s in­fec­tious dis­ease R&D chief, said in a state­ment.

As re­searchers rush to find Covid-19 treat­ments, the set­back is a re­minder of the pit­falls of de­vel­op­ing an­tivi­ral drugs, where progress has been slow out­side chron­ic in­fec­tions like HIV and He­pati­tis C.

James Mer­son

As re­cent­ly as spring of 2017, then-glob­al R&D chief Bill Hait list­ed pi­modi­vir as one of 14 po­ten­tial block­busters for the phar­ma­ceu­ti­cal gi­ant. But by 2020, it was not ex­act­ly J&J’s most-watched as­set. They li­censed the drug from Ver­tex for $30 mil­lion plus mile­stones in 2014, back when the Boston biotech was piv­ot­ing from a small mol­e­cule an­tivi­ral en­gine to a small mol­e­cule cys­tic fi­bro­sis en­gine. But the com­pa­ny said lit­tle about the com­pound be­fore and af­ter Hait’s an­nounce­ment. “J&J picked up this one from Ver­tex in 2014,” we wrote in a 2017 sto­ry. “Not much has been heard about it since then.”

That spring, though, the com­pa­ny was about to an­nounce da­ta from a Phase IIa tri­al test­ing the drug in pa­tients with in­fluen­za. Un­like Tam­i­flu, Re­len­za and the ma­jor­i­ty of ap­proved in­fluen­za drugs, pi­modi­vir tar­get­ed a part of the RNA poly­merase, which the virus us­es to repli­cate, as op­posed to neu­raminidase, which the virus us­es to ex­it cells. Ide­al­ly, it could treat flu virus­es that had evolved re­sis­tance to oth­er drugs, pre­cip­i­tat­ing BAR­DA’s in­ter­est in the pro­gram. And the study showed that across about 270 pa­tients, those who re­ceived treat­ment saw low­er vi­ral loads than those on place­bo.

J&J sub­se­quent­ly launched two Phase III tri­als, both of which were ter­mi­nat­ed this week.

This is J&J’s sec­ond re­cent fail­ure in an­tivi­ral re­search, a field much of the in­dus­try had been leav­ing for years be­fore Covid-19 struck. In 2014, the phar­ma al­so spent $1.75 bil­lion to ac­quire the an­tivi­ral com­pa­ny Alios. But in 2018, they sus­pend­ed de­vel­op­ment of Alios’s lead RSV drug, tak­ing a $630 mil­lion im­pair­ment. In 2019, they wrote off an­oth­er $930 mil­lion, es­sen­tial­ly de­clar­ing the pro­gram a bust.

Late last year, the com­pa­ny al­so re­ceived a CRL on their Vi­iV-part­nered long-act­ing HIV an­tivi­ral, a set­back in a heat­ed race with Mer­ck.

J&J, of course, is now work­ing with BAR­DA on a dif­fer­ent prod­uct: A Covid-19 vac­cine. The ju­ry is still out on the can­di­date but the com­pa­ny has high hopes.

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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