Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is ex­pe­ri­enc­ing some buy­er’s re­morse two years af­ter throw­ing down $2.6 bil­lion for Aim­mune Ther­a­peu­tics and its peanut al­ler­gy pill Pal­forzia.

CEO Mark Schnei­der an­nounced on Tues­day that Nestlé is “ex­plor­ing strate­gic op­tions” for Pal­forzia fol­low­ing low­er-than-ex­pect­ed de­mand. A com­pa­ny spokesper­son de­clined to con­firm whether a po­ten­tial sale is in con­sid­er­a­tion.

“The re­view is ex­pect­ed to be com­plet­ed in the first half of 2023. Go­ing for­ward, Nestlé Health Sci­ence will sharp­en its fo­cus on Con­sumer Care and Med­ical Nu­tri­tion,” the com­pa­ny said in a news re­lease.

Pal­forzia, es­sen­tial­ly peanut pow­der in a pill, be­came the first FDA-ap­proved treat­ment for peanut al­ler­gy back in 2020. The idea is to ex­pose pa­tients to small but grad­u­al­ly in­creas­ing amounts of peanut pow­der to build up re­sis­tance to the al­ler­gen. In a Phase III tri­al, chil­dren on Pal­forzia had a 67% chance of avoid­ing a se­vere re­ac­tion to 600 mg of peanut pro­tein, or about two peanuts, com­pared to 4% for place­bo pa­tients.

Nestlé se­cured a mi­nor­i­ty stake in Aim­mune back in 2017, then wait­ed for an FDA ap­proval be­fore swoop­ing in for a $2.6 bil­lion takeover in the fall of 2020. Pri­or to that, the com­pa­ny had pur­chased more than $470 mil­lion worth of stock.

De­spite a slow roll­out, par­tial­ly due to the pan­dem­ic, Schnei­der had high hopes for the drug. An­a­lysts pegged sales pro­jec­tions of over $1 bil­lion. How­ev­er, the chief ex­ec­u­tive not­ed in an in­vestor call on Tues­day that the drug has proven to be more “niche ther­a­py” than block­buster.

The clo­sure of al­ler­gists’ of­fices in ear­ly 2020 con­tributed to a slow roll­out, Schnei­der said, as well as the fre­quen­cy of re­quired doc­tor’s vis­its. While the CEO stressed that the ther­a­py is safe, the risk of ana­phy­lac­tic shock means pa­tients must spend con­sid­er­able time in a doc­tor’s of­fice when es­ca­lat­ing dos­es. Both pa­tient re­ten­tion and al­ler­gist adop­tion has been low­er than ex­pect­ed, he added.

Mean­while, ad­vo­cates stand be­hind Pal­forzia as the “on­ly FDA-ap­proved ther­a­py for the ap­prox­i­mate­ly 1.2 mil­lion kids with peanut al­ler­gies,” ac­cord­ing to the Asth­ma and Al­ler­gy Foun­da­tion of Amer­i­ca.

“Im­por­tant­ly, Pal­forzia is cov­ered by many in­sur­ance plans where­as non-FDA ap­proved ther­a­pies of­ten have high out-of-pock­et costs that lim­it ac­cess to those who can af­ford it.  We hope that Pal­forzia con­tin­ues to be an op­tion for peo­ple and fam­i­lies man­ag­ing food al­ler­gies,” pres­i­dent and CEO Ken­neth Mendez told End­points News via email.

Nestlé’s stock $NSR­GY was down about 2% on Tues­day morn­ing, pric­ing around $117 per share.

This ar­ti­cle has been up­dat­ed to in­clude com­ment from the Asth­ma and Al­ler­gy Foun­da­tion of Amer­i­ca. 

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.