Bio­phar­ma com­pa­nies pledge $1B to fund an­tibi­otics R&D as field shriv­els; Four biotechs hunt $797M+

→ As promised, a group of some 20 bio­phar­ma com­pa­nies have pooled close to $1 bil­lion to fund new re­search in an­tibi­otics — a field that has been dy­ing of late. Small mar­gins and tiny mar­kets have killed off a slate of play­ers in the field and drove out most of the big or­ga­ni­za­tions. Now Eli Lil­ly, Pfiz­er and oth­ers hope to foot the bill for a group of 2 to 4 new an­tibi­otics in the next 10 years. Pfiz­er alone pledged $100 mil­lion for the in­dus­try ef­fort. “With the AMR Ac­tion Fund, the phar­ma­ceu­ti­cal in­dus­try is in­vest­ing near­ly $1 bil­lion to sus­tain an an­tibi­ot­ic pipeline that is on the verge of col­lapse, a po­ten­tial­ly dev­as­tat­ing sit­u­a­tion that could af­fect mil­lions of peo­ple around the world,” said David Ricks, Eli Lil­ly CEO and pres­i­dent of IF­P­MA.

Here’s the list of back­ers: Almi­rall, Am­gen, Bay­er, Boehringer In­gel­heim, Chugai, Dai­ichi Sankyo, Ei­sai, Eli Lil­ly and Com­pa­ny, Glax­o­SmithK­line, John­son & John­son, LEO Phar­ma, Lund­beck, Menar­i­ni, Mer­ck, MSD, No­var­tis, No­vo Nordisk, No­vo Nordisk Foun­da­tion, Pfiz­er, Roche, Sh­iono­gi, Take­da, Te­va, and UCB.

→ A slate of biotechs are seiz­ing the mo­ment to raise ever-larg­er sums from their pub­lic de­buts. They in­clude:

  • Re­lay Ther­a­peu­tics, which is de­vel­op­ing small mol­e­cule ther­a­pies for sol­id tu­mors. The Cam­bridge, MA-based biotech set terms for a $250 mil­lion IPO by of­fer­ing 14.7 mil­lion shares be­tween $16 and $18 — con­fer­ring a ful­ly di­lut­ed mar­ket val­ue of $1.5 bil­lion at the mid­point.
  • San Diego-based Po­sei­da Ther­a­peu­tics in­creased its pro­posed deal size by 49%, shoot­ing to in­fuse $224 mil­lion in­to its CAR-T pipeline for mul­ti­ple myelo­ma.
  • NK cell play­er Nkar­ta reck­oned that in­vestors will pour in as much as 43% more than what it orig­i­nal­ly pen­ciled in, now plan­ning for a $215 mil­lion float around a pre­clin­i­cal pitch. The pro­posed range is $16 to $17, with a mar­ket val­ue of $519 mil­lion at the mid­point.
  • French NASH play­er In­ven­ti­va, which raised the pro­posed range to $13.40 – $15.40. The goal now is to bring in $108 mil­lion for the sec­ondary list­ing.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Evotec inks li­cense agree­ment with J&J; On­colyt­ic virus biotech prices $15M IPO

Drug discovery and development player Evotec entered another licensing deal with Big Pharma — this time with J&J’s Janssen.

The companies put out word that they entered into a strategic collaboration and license agreement with each other that focuses on targeted immune-based cancer therapies, to be commercialized by Janssen.

According to a statement, the collaboration will hinge on Evotec’s integrated drug discovery and manufacturing capabilities. During the pre-clinical R&D phase, the companies will collaborate closely — and then Janssen will take on full responsibility for both clinical development and commercialization.