Go­ing gang­busters in atopic der­mati­tis, the FDA hands Sanofi and Re­gen­eron a fresh coup for their mega-block­buster star Dupix­ent

Just days af­ter Sanofi CEO Olivi­er Brandi­court proud­ly showed off the phar­ma gi­ant’s re­turn to growth with the stel­lar per­for­mance of Dupix­ent lead­ing the way, the French com­pa­ny and its long­time al­lies at Re­gen­eron laid claim to a fresh coup for the fran­chise, gain­ing a pri­or­i­ty re­view des­ig­na­tion at the FDA for ex­pand­ing the drug’s reach to ado­les­cents with mod­er­ate to se­vere atopic der­mati­tis.

The IL-4/IL-13 in­hibitor is now up for a speedy de­ci­sion by March 11, which will help keep the sales team forg­ing steadi­ly ahead as re­searchers con­tin­ue to push new in­di­ca­tions and a wider pa­tient pop­u­la­tion.

Olivi­er Brandi­court

Sanofi re­port­ed Q3 sales of $262 mil­lion for Dupix­ent, well ahead of fore­casts as the drug con­tin­ues to gain trac­tion among adults with AD. The li­on’s share of that mon­ey is com­ing from the US. That’s helped in­spire a bull­ish as­sess­ment from Leerink’s Ge­of­frey Porges, who is es­ti­mat­ing 2019 sales of $1.75 bil­lion — with peak sales stretch­ing past the $7 bil­lion mark.

Con­sen­sus for the peak is over the $5 bil­lion mark.

A full $2.5 bil­lion of Porges’ $7.5 bil­lion tal­ly is be­ing laid at the door of the asth­ma mar­ket, which the an­a­lyst con­clud­ed in late Oc­to­ber was like­ly af­ter Sanofi and Re­gen­eron won what he felt was the ide­al la­bel for that in­di­ca­tion — putting it in the lead to a ma­jor mar­ket.

The ag­gres­sive pos­ture with this drug un­der­scores the ab­solute and grow­ing im­por­tance of push­ing ground­break­ing new drugs in­to the mar­ket­place. These days, it’s not how many drug ap­provals you get, but whether your new drugs can earn bil­lions. And the big block­busters are still few and far apart.

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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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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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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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.
SpringWorks

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.

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.