Nestlé puts $200M more be­hind a treat­ment for peanut al­ler­gy

Aim­mune’s pa­tients won’t ever be able to eat much or even most of their can­dy, but every time they open a cap­sule, they’ll be con­sum­ing a prod­uct Nestlé helped pro­duce.

Since the im­munother­a­py com­pa­ny com­plet­ed its Phase II stud­ies, Nestlé has be­come one of its largest back­ers. They in­vest­ed $145 mil­lion in 2016 and $98 mil­lion in 2018. And to­day, days af­ter Aim­mune won FDA ap­proval for their peanut al­ler­gy drug Pal­forzia, Nestlé an­nounced a $200 mil­lion eq­ui­ty in­vest­ment. They will now have in­vest­ed $473 mil­lion and com­mand 19.9% of the com­pa­ny.

Baird’s Bri­an Sko­r­ney es­ti­mat­ed that the new cash, along with their cred­it fa­cil­i­ty with KKR, should give Aim­mune a $450 mil­lion reser­voir and re­solve any ques­tions about whether they’ll have the ca­pac­i­ty to com­mer­cial­ize Pal­forzia.

It “is more than enough to fund the launch of Pal­forzia and get to a point that set­tles the bull/bear launch de­bate,” he wrote in a note to in­vestors.

Sep­a­rate­ly, Aim­mune an­nounced an ex­clu­sive, $10 mil­lion li­cens­ing agree­ment for Xen­cor’s XmAb7195, a hu­man­ized an­ti­body de­signed to treat the un­der­ly­ing mech­a­nisms be­hind al­ler­gic re­ac­tion.

Aim­mune’s val­ue has in­creased by over a third since Nestlé’s ini­tial in­vest­ment, in large part thanks to Pal­forzia’s suc­cess. The drug is no cure — pa­tients won’t be able to eat But­terfin­gers, let alone Reese’s — but it’s the first thing ap­proved to low­er the risk of an ex­treme al­ler­gic re­ac­tion. Al­ler­gic chil­dren take a cap­sule with es­ca­lat­ing amounts of peanut pow­der and sprin­kle it on their food over the course of sev­er­al months. Giv­ing peanut pow­der to kids with peanut al­ler­gies can, un­sur­pris­ing­ly, cause sub­stan­tial re­ac­tions and some pa­tients dis­con­tin­ue, but at the end of a 12-month Phase III tri­al the re­sults were clear: 67% of pa­tients who re­ceived the drug could tol­er­ate eat­ing around 2 peanuts, ver­sus 4% of place­bo.

That da­ta, along­side a pa­tient pop­u­la­tion of up to 1.6 mil­lion peo­ple, led an­a­lysts to project over $1 bil­lion in peak sales. The com­pa­ny has since an­nounced a price of $10,680, more than twice what some an­a­lysts pro­ject­ed. Sko­r­ney ex­pects it will still re­ceive wide re­im­burse­ment.

Still, the drug has not evad­ed crit­i­cism. In ad­di­tion to its side ef­fects, crit­ics note that Aim­mune will es­sen­tial­ly be charg­ing over $10,000 for peanut flour that, with slight al­ter­ation, is large­ly iden­ti­cal to the flour found on su­per­mar­ket shelves. Some al­ler­gists al­ready use that, some­times with sub­stan­tial ef­fect.

Hugh Win­dom Win­dom Al­ler­gy

“They are just pack­ag­ing up what we al­ready do, in a gold-plat­ed cap­sule,” Hugh Win­dom, an al­ler­gist in Sara­so­ta, FL, told NPR last year. Oth­er al­ler­gists say they need the stan­dard­ized prod­uct and dos­ing reg­i­men Pal­forzia pro­vides.

Pal­forzia, though, may soon not be alone. DBV Tech­nolo­gies is de­vel­op­ing a patch that’s ex­pect­ed to be less ef­fec­tive but al­so less dan­ger­ous. They with­drew their FDA sub­mis­sion in De­cem­ber of 2018 over man­u­fac­tur­ing and qual­i­ty con­trol ques­tions but re­sub­mit­ted in Au­gust and they ex­pect a de­ci­sion this year.

An ap­proval could put com­pet­i­tive pres­sure on Aim­mune to ex­pand their pipeline. That could lead to more deals like to­day’s li­cens­ing agree­ment with Xen­cor. XmAb7195 — now re­named AIMab7195 — in­ter­acts with IgE cells that can dri­ve an im­mune re­sponse. Aim­mune plans to test it as an ad­ju­vant to Pal­forzia and oth­er im­munother­a­pies.

They al­so have an egg and a tree nut im­munother­a­py in de­vel­op­ment.

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.

Dan Skovronsky, Eli Lilly CSO

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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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Eli Lilly CSO Dan Skovronsky (file photo)

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The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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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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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.

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AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

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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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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

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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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#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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