Re­gen­eron, Sanofi talk up po­ten­tial block­buster fran­chise as Dupix­ent sweeps in rhi­nos­i­nusi­tis PhI­II

A busy clin­i­cal team at Re­gen­eron $REGN and Sanofi $SNY has out­lined an­oth­er seg­ment on the al­ler­gic in­flam­ma­to­ry map that they plan to build their Dupix­ent king­dom up­on.

In two Phase III tri­als, in­ves­ti­ga­tors say, the mega-block­buster hope­ful de­liv­ered a clean sweep over chron­ic rhi­nos­i­nusi­tis with nasal polyps, clear­ing ob­struc­tion and shrink­ing ab­nor­mal tis­sue growth at a much high­er rate than place­bo.

Bri­an Sko­r­ney

The “in­cre­men­tal­ly pos­i­tive” re­sults, as Baird an­a­lyst Bri­an Sko­r­ney puts it, come days ahead of an ex­pect­ed reg­u­la­to­ry de­ci­sion on the mod­er­ate-to-se­vere asth­ma ap­pli­ca­tion, which Sanofi and Re­gen­eron sent in af­ter Dupix­ent hit key end­points in a Phase III a year ago.

While an­a­lysts were more skep­ti­cal of the drug’s com­mer­cial po­ten­tial in asth­ma due to com­pe­ti­tion from both ex­ist­ing (GSK’s Nu­cala) and up­com­ing ri­vals (teze­pelum­ab from As­traZeneca and Am­gen), in this case Sko­r­ney is more in­ter­est­ed in the fact that Dupix­ent beat the cur­rent stan­dard of care — oft-in­ef­fec­tive cor­ti­cos­teroid fol­lowed by ex­pen­sive surgery.

Dupix­ent’s demon­strat­ed abil­i­ty to sig­nif­i­cant­ly re­duce symp­toms in a heav­i­ly pre-treat­ed pa­tient pop­u­la­tion in which more than half of the pa­tients had pre­vi­ous­ly un­der­gone surgery, and near­ly 75% had used cor­ti­cos­teroids, should dri­ve strong com­mer­cial up­take in this in­di­ca­tion where there re­mains a sig­nif­i­cant un­met need.

George Yan­copou­los

SI­NUS-24 and SI­NUS-52 en­rolled 276 and 448 pa­tients, re­spec­tive­ly. At 24 weeks, pa­tients in the two tri­als who re­ceived a com­bo of Dupix­ent and cor­ti­cos­teroid nasal spray ex­pe­ri­enced a 51% and 57% im­prove­ment in nasal con­ges­tion/ob­struc­tion sever­i­ty, ver­sus 15% and 19% in the two place­bo (plus nasal spray) arms. In the drug arms, pa­tients’ nasal polyps score — which mea­sures the size of their polyps — shrunk by an av­er­age of 27% and 33%, while those on place­bo saw 4% to 7% in­creas­es.

Those are the co-pri­ma­ry end­points, with p < 0.0001; the part­ners say Dupix­ent al­so scored on key sec­ondary end­points, from “demon­strat­ing a sig­nif­i­cant re­duc­tion in the need for sys­temic cor­ti­cos­teroids or surgery” to “im­prove­ments in smell and chron­ic rhi­nos­i­nusi­tis symp­toms.”

John Reed

Track­ing a pre-spec­i­fied group of pa­tients who al­so has asth­ma — a com­mon predica­ment among chron­ic rhi­nos­i­nusi­tis suf­fer­ers — re­searchers al­so note an im­prove­ment in lung func­tion and asth­ma con­trol.

“With these da­ta, Dupix­ent has now been shown to ad­dress this in­flam­ma­tion across the com­plete air­way, which man­i­fests in the up­per res­pi­ra­to­ry tract as polyps and con­ges­tion, and in the low­er air­way as asth­ma,” said Re­gen­eron pres­i­dent and CSO George Yan­copou­los, who led the de­vel­op­ment team cred­it­ed for the IL-4/IL13 an­ti­body.

Add that to eczema, where the drug land­ed its first big OK, and it makes three Type 2 or al­ler­gic in­flam­ma­to­ry dis­eases where Dupix­ent has “demon­strat­ed sig­nif­i­cant late-stage ef­fi­ca­cy,” he said in a state­ment.

Ge­of­frey Porges, Leerink

That con­text is key for Ge­of­frey Porges of Leerink, who main­tains that de­spite the strength of the da­ta and the clear po­ten­tial ben­e­fit, “the great­est boost from nasal poly­po­sis will be from in­cre­men­tal share gains in oth­er co-mor­bid atopic/al­ler­gic con­di­tions.” He ex­plains:

Bar­ri­ers to adop­tion in this in­di­ca­tion will be the high cost and con­tin­u­ing bur­den of treat­ment ( ~$36,000/year and bi­week­ly in­jec­tions) and the dif­fer­ent physi­cian pop­u­la­tion (ENT sur­geons) treat­ing polyps, who may not be in­cen­tivized to treat with a bi­o­log­ic agent ver­sus pro­ce­dure. To the ex­tent some of these pa­tients are iden­ti­fied and in the care of al­ler­gists al­ready, they may be more ac­ces­si­ble for Dupix­ent, but sur­geons are like­ly to be slow­er con­vert­ers to in­jectable treat­ment.

“(W)e look for­ward to work­ing with reg­u­la­to­ry au­thor­i­ties around the world to make Dupix­ent an op­tion for peo­ple liv­ing with this chron­ic con­di­tion,” added John Reed, glob­al head of R&D at Sanofi.

Porges es­ti­mates reg­u­la­to­ry fil­ings in 2019 and FDA ap­proval, if it is to come, in 2020.

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

Endpoints Premium

Premium subscription required

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