Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zag­ger took the helm of UC Davis spin­out Evolve Biosys­tems sev­er­al months ago, the com­pa­ny billed it­self as a pro­bi­ot­ic mak­er.

How­ev­er, she be­lieves the com­pa­ny’s Evi­vo sup­ple­ment de­signed to help in­fants de­vel­op a healthy gut mi­cro­bio­me is “so much more” — and that, she said, calls for a re­brand.

Evolve has, well, evolved in­to In­fi­nant Health, the com­pa­ny an­nounced on Mon­day. The new name is a mash-up of the words “in­fant” and “in­fi­nite,” rep­re­sent­ing the com­pa­ny’s goal of ex­pand­ing be­yond in­fant care. While its sole prod­uct, Evi­vo, is in­tend­ed for new­borns, In­fi­nant is “quick­ly de­vel­op­ing” an op­tion for kids through the age of two.

“It isn’t just about the ba­by at birth, it’s re­al­ly about tak­ing care of the ba­by, as a fe­tus and all the way through un­til the mi­cro­bio­me of the ba­by at the age of two be­comes a lit­tle bit more adult-like,” Zag­ger said.

Evi­vo launched back in 2017 to ad­dress the 97% of ba­bies who are miss­ing a key ben­e­fi­cial gut bac­te­ria, In­fi­nant said at the time. While ba­bies are sup­posed to re­ceive a bac­te­ria called B. in­fan­tis from moth­ers at birth, re­search sug­gests that fac­tors such as C-sec­tions, for­mu­la feed­ing and even side ef­fects of an­tibi­otics can lead to a de­ple­tion of the so-called “good bac­te­ria,” ac­cord­ing to the com­pa­ny. With­out it, harm­ful bac­te­ria dom­i­nate the gut, which can raise the risk for con­di­tions such as eczema or obe­si­ty.

The sup­ple­ment is avail­able as an oil for use via feed­ing tube in the neona­tal in­ten­sive care unit (NICU) or as a pow­der to be mixed in­to breast milk.

“When I think about, you know, the brand and what we stand for, we are all about bring­ing ba­bies back to na­ture’s most in­tend­ed state,” Zag­ger said.

Na­ture is a key theme in the re­brand. The new lo­go fea­tures black let­ter­ing and gold bub­bles. Those metal­lic col­ors are sym­bol­ic of the pe­ri­od­ic ta­ble, she said, adding that it’s all about the mes­sag­ing. The com­pa­ny’s of­fice al­so fea­tures a 50-foot moss wall and wa­ter­falls.

Back in 2014, reg­u­la­tors is­sued a warn­ing against us­ing cer­tain di­etary sup­ple­ments af­ter the death of a pre-term in­fant who took Sol­gar’s pro­bi­ot­ic ABC Dophilus. Sol­gar lat­er is­sued a vol­un­tary re­call.

“In con­sid­er­ing the use of any di­etary sup­ple­ment, clin­i­cians should con­sid­er that the FDA does not reg­u­late these prod­ucts as drugs,” the CDC said in a warn­ing.

The mi­cro­bio­me space has seen a good deal of ac­tiv­i­ty late­ly, as sev­er­al star­tups look to use spores from bac­te­ria to re­store the prop­er mi­cro­bial bal­ance need­ed to main­tain health and fight in­fec­tions like C. dif­fi­cile, a lead­ing cause of hos­pi­tal-ac­quired in­fec­tions in the US. En­terome land­ed a $40 mil­lion deal with Nestlé Health Sci­ence just a cou­ple months ago. How­ev­er, the field hasn’t been spared from biotech’s re­cent hard times, with Vedan­ta Bio­sciences and Finch Ther­a­peu­tics among those en­act­ing lay­offs ear­li­er this year.

“For me, as a mom of two, putting some­thing syn­thet­ic in­side of my ba­by’s bel­lies was nev­er any­thing I was will­ing to do, but some­thing that was borne out of na­ture and the way na­ture re­al­ly in­tend­ed the ba­bies to come in­to the world is some­thing I would be wild­ly ex­cit­ed about and want­i­ng to do,” Zag­ger said about the prod­uct, which is de­signed to mim­ic a bac­te­ria that’s nor­mal­ly pro­duced nat­u­ral­ly.

In­fi­nant has se­cured some big-name back­ers, in­clud­ing the Bill & Melin­da Gates Foun­da­tion and J&J’s ven­ture arm, the John­son & John­son De­vel­op­ment Cor­po­ra­tion.

“We think we’ve got a bit of the mod­ern day peni­cillin,” Zag­ger said. “We’re look­ing for­ward to the fu­ture.”

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.

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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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.

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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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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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.

Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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