Draw­ing Shire par­al­lel, Flem­ming Ørn­skov mulls IPO for Gal­der­ma; Rei­s­tone shows re­sults from eczema study with JAK1 block­er

Two years ago, Flem­ming Ørn­skov took up a new chal­lenge as CEO of Gal­der­ma with the ex­pec­ta­tion he would work the mag­ic like he did with Shire — cul­mi­nat­ing in the rare dis­ease biotech’s $62 bil­lion sale to Take­da — with the pure-play der­ma­tol­ogy out­fit fresh­ly spun out of Nestlé.

Now that the ship is steady, he’s seem­ing­ly set­ting his sights on an IPO.

In an in­ter­view with Bloomberg, Ørn­skov said he’s ac­cel­er­at­ing re­search spend­ing while re­cruit­ing more der­ma­tol­o­gists and med­ical spe­cial­ists to the com­pa­ny. The strat­e­gy, he added, is sim­i­lar to Shire’s in the sense that he would dou­ble down on the sci­ence and shift to cut­ting-edge, high-risk prod­ucts that can com­mand high prices — even as Gal­der­ma con­tin­ues to bring in rev­enue through its con­sumer aes­thet­ic and skin care prod­ucts such as Cetaphil mois­tur­iz­ers.

The pipeline is high­light­ed by nemolizum­ab, an an­ti-IL-31 an­ti­body po­si­tioned for atopic der­mati­tis, pruri­go nodu­laris and rosacea. And Ørn­skov ap­pears un­fazed about steer­ing straight in­to a crowd­ed space.

“When I start­ed as CEO at Shire, rare dis­eases was a min­i­mal part of the busi­ness,” he said. “Even my board was prob­a­bly skep­ti­cal.”

Gal­der­ma’s cur­rent own­ers, led by the in­vest­ment firm EQT, are aim­ing for a val­u­a­tion of up to $22 bil­lion, Bloomberg re­port­ed cit­ing in­sid­ers. — Am­ber Tong

Rei­s­tone fin­ish­es an­oth­er JAK1 block­er study — this time in AD

Shang­hai biotech Rei­s­tone Bio­phar­ma re­vealed pos­i­tive re­sults to­day from a Phase II study in­volv­ing a top­i­cal oint­ment with JAK1 block­er SHR0302.

The study, which looked at the oint­ment in adults and ado­les­cents with mild-to-mod­er­ate atopic der­mati­tis, had all three dosages (0.5%, 1% and 2%) meet the study’s pri­ma­ry end­point of eczema im­prove­ment based on im­proved per­cent­age change of a pa­tient’s Eczema Area and Sever­i­ty In­dex (EASI) score from base­line ver­sus place­bo at week 8.

This is not the on­ly in­di­ca­tion in the works for Rei­s­tone’s JAK1 block­er — back in Au­gust, the Chi­nese firm fin­ished an­oth­er Phase II study test­ing the drug in pa­tients with patchy hair loss.

SHR0302 oint­ment was gen­er­al­ly well-tol­er­at­ed at all dos­es.

“We are pleased to see the pos­i­tive re­sults from this study of a new top­i­cal ther­a­py,” said Rei­s­tone co-founder and CEO Min Ir­win. “We be­lieve this top­i­cal for­mu­la­tion will be an in­valu­able ad­di­tion to the SHR0302 port­fo­lio.” — Paul Schloess­er

Chi­na’s Chance Phar­ma­ceu­ti­cals rais­es $30M for drug pipeline and man­u­fac­tur­ing fa­cil­i­ty

Chi­nese biotech Chance Phar­ma­ceu­ti­cals fin­ished a Se­ries C round for $30 mil­lion, the com­pa­ny said in a state­ment to­day.

With the Se­ries C led by new in­vestor La­pan Cap­i­tal along­side oth­er new and ex­ist­ing in­vestors, the $30 mil­lion is to ad­vance Chance’s pipeline of in­hala­tion ther­a­pies, start new busi­ness col­lab­o­ra­tions and as­sist in the build­ing of their man­u­fac­tur­ing fa­cil­i­ty.

The last fundrais­ing was a Se­ries B in June 2020, amount­ing to just over $707,000.

“We are op­ti­mistic about the mar­ket po­ten­tial of trans­for­ma­tive in­hala­tion ther­a­pies,” com­ment­ed La­pam Cap­i­tal chair­man Zhi­hua Yu. — Paul Schloess­er

ATAI an­nounces pre­ci­sion psy­chi­a­try biotech in part­ner­ship with Duke spin­out

Ger­man biotech ATAI an­nounced the launch of pre­ci­sion psy­chi­atric play­er PsyPro­tix to­day, formed in a part­ner­ship with Duke Uni­ver­si­ty biotech spin­out Chymia. The biotech will fo­cus on de­vel­op­ing ther­a­peu­tics for treat­ment-re­sis­tant de­pres­sion (TRD) and oth­er men­tal health in­di­ca­tions, ac­cord­ing to a state­ment.

PsyPro­tix’s goal is to fo­cus on metabolom­ic mech­a­nisms and un­der­ly­ing de­pres­sion symp­toms for cer­tain pa­tients, with the goal of de­riv­ing more tai­lored and po­ten­tial­ly cus­tomiz­able treat­ments for each in­di­vid­ual pa­tient.

“This emerg­ing tech­nol­o­gy adapts to the vari­abil­i­ty of con­di­tions, such as de­pres­sion, with the aim of al­low­ing pa­tients with psy­chi­atric dis­or­ders to po­ten­tial­ly be di­ag­nosed and treat­ed more ac­cu­rate­ly and ef­fi­cient­ly ac­cord­ing to their spe­cif­ic needs,” said ATAI CSO and co-founder Srini­vas Rao. — Paul Schloess­er

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.