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. 

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.

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.

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.

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.

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.