Nestlé ups its bet on Aim­mune’s peanut al­ler­gy drug to $276M as NDA fil­ing looms, ri­val­ry in­ten­si­fies

Nestlé Health Sci­ence is up­ping its bet on Aim­mune Ther­a­peu­tics by $98 mil­lion $AIMT, with its now $276 mil­lion stake in the com­pa­ny giv­ing it 19% of the biotech’s eq­ui­ty.

Al­lied on Aim­mune’s peanut al­ler­gy med, Nestlé is bet­ting big on the biotech af­ter the Phase III ef­fi­ca­cy da­ta point­ed to an NDA fil­ing with the FDA next month. Their time­line projects a po­ten­tial mar­ket launch in H2 of next year.

Greg Be­har

In its Q3 re­view a few days ago the com­pa­ny said it had gained new da­ta to back up the safe­ty pro­file of their treat­ment, AR101, de­signed to build tol­er­ance to peanuts among a pa­tient group suf­fer­ing from a se­vere al­ler­gy.

Once again, said Aim­mune, about 1 in 5 of the pa­tients tak­ing the drug dropped out of the study, match­ing a dropout rate tracked dur­ing the PAL­ISADE tri­al. A much small­er num­ber of place­bo pa­tients al­so stopped treat­ment in the ear­li­er piv­otal tri­al, rais­ing some ques­tions about the ad­verse events tracked in the tri­al.

None of that, though, has blunt­ed Nestlé’s ap­petite for Aim­mune shares, though. Their $98 mil­lion — at $30.27 a share — adds to the $255 mil­lion bankroll the com­pa­ny en­joyed at the end of Q3, putting them in po­si­tion to roll out their new ther­a­py next year, if the FDA proves oblig­ing on that score and no nasty sur­pris­es await in­vestors.

Bri­an Sko­r­ney

Baird’s Bri­an Sko­r­ney, by the way, re­cent­ly out­lined his ex­pec­ta­tions for back-to-back Ad­Coms for AR101 and DBV Ther­a­peu­tics’s ri­val Vi­askin Peanut ther­a­py. An­a­lysts have pitched prospec­tive peak sales for AR101 at or a bit above the $1 bil­lion block­buster mark.

The two com­pa­nies are al­so ex­tend­ing their col­lab­o­ra­tion pact by 2 years.

“The im­mi­nent U.S. reg­u­la­to­ry fil­ing for AR101 and the an­tic­i­pat­ed launch to fol­low in the com­ing year will be great news for peo­ple with peanut al­ler­gy, who need ro­bust, re­li­able pro­tec­tion from ac­ci­den­tal-ex­po­sure re­ac­tions,” says Nestlé Health Sci­ence CEO Greg Be­har. “This col­lab­o­ra­tion ex­em­pli­fies Nestlé Health Sci­ence’s com­mit­ment to food al­ler­gy and our ex­cite­ment to con­tin­ue an al­liance with a lead­ing in­no­va­tor in the de­vel­op­ment of food al­ler­gy ther­a­peu­tics.”

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.

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.

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.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.