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.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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