Ab­b­Vie, Sanofi-backed Prin­cip­ia of­fers an $86M IPO af­ter burn­ing through $148M for pipeline work

It’s time for some new biotech IPOs to test the wa­ters on Nas­daq. With some sub­stan­tial back­ing from Sanofi and Ab­b­Vie, Prin­cip­ia Bio­Phar­ma out of South San Fran­cis­co is get­ting ready to roll the dice on an IPO on Nas­daq. 

The biotech start­up — a clas­sic, pipeline-fo­cused ef­fort that’s spent $148 mil­lion to get to this stage — has pen­cilled in an $86 mil­lion raise on its S-1 and of­fered up some in­ter­im Phase II da­ta to help re­as­sure in­vestors that it’s on to some­thing re­al. This new of­fer­ing will test in­vestors’ ap­petite for risk, af­ter a long slate of drug de­vel­op­ers went pub­lic in the lead-up to the sum­mer lull.

Mar­tin Babler

Their lead drug is a BTK in­hibitor for au­toim­mune dis­eases dubbed PRN1008. In a Phase II study for rare cas­es of a chron­ic skin con­di­tion called pem­phi­gus, re­searchers say they tracked a 54% rate of dis­ease con­trol for 26 pa­tients on low-dose cor­ti­cos­teroids — with pa­tients on low-dose cor­ti­cos­teroids ver­sus a stan­dard high-dose for steroids — and an 80% con­trol rate at day 85 for 20 evalu­able pa­tients. That study is con­tin­u­ing.

The pre­lim­i­nary da­ta set up a Phase III which the com­pa­ny plans to launch lat­er this year.

Their oth­er top drug is PRN2246, an­oth­er BTK in­hibitor for mul­ti­ple scle­ro­sis and oth­er CNS ail­ments which is al­lied with Sanofi. So far, they’ve gath­ered on­ly bio­mark­er da­ta from healthy pa­tients to un­der­score its ac­tiv­i­ty. That’s in­cred­i­bly ear­ly-stage still, but Sanofi has high­light­ed the al­liance as one of its most promis­ing as top ex­ecs try to make a case that they can de­vel­op sig­nif­i­cant new drugs with­out Re­gen­eron by its side.

Sanofi paid $40 mil­lion in cash to part­ner on their drug, adding $15 mil­lion this year out of a po­ten­tial $765 mil­lion ini­tial­ly laid out in mile­stones. Ab­b­Vie paid out an­oth­er $15 mil­lion in cash last sum­mer, adding $667 mil­lion for a de­vel­op­ment deal on oral im­muno­pro­tea­some in­hibitors — with the S-1 of­fer­ing the first fi­nan­cial de­tails on that deal.

CEO Mar­tin Babler — a sales and mar­ket­ing vet­er­an out of Genen­tech — picked up a $1.2 mil­lion pay pack­age for last year, based on a $374,000 an­nu­al salary plus stock op­tions. And the rest of the ex­ec­u­tive team in­cludes some prin­ci­pal play­ers with CVs tied to Genen­tech par­ent Roche.

Most of the eq­ui­ty cur­rent­ly is divvied up among a group of ven­ture back­ers, with Mor­gen­thaler, New Leaf, Or­biMed and GSK’s SR One each hold­ing 16.8% of the eq­ui­ty. Bak­er Broth­ers and Sofinno­va Ven­ture fol­low with 12.3% each. Babler has 4.7% of the stock.

Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

John Hood [file photo]

UP­DAT­ED: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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