Re­gen­eron makes a block­buster case for its PhI­II drug pipeline

While Bio­gen is strug­gling to get its pipeline to per­form, Re­gen­eron ex­ecs put on a demon­stra­tion to­day on how a biotech com­pa­ny with a sec­ond-tier R&D bud­get can per­form bet­ter on the late-stage front than much big­ger com­pa­nies spend­ing much more on re­search. And it led off with bull­ish re­marks on a pair of would-be block­busters, in­clud­ing their top Phase III drug dupilum­ab.

Dur­ing their sec­ond quar­ter re­view, the ex­ec­u­tive team not­ed:

— Sar­ilum­ab is up for an Oc­to­ber 30 PDU­FA date at the FDA, with a re­cent Eu­ro­pean fil­ing at the EMA to fol­low up on. Peak sales es­ti­mates top $1 bil­lion for this drug, which beat megablock­buster Hu­mi­ra in a head-to-head study on rheuma­toid arthri­tis. This will like­ly be the sec­ond drug part­nered with Sanofi to hit the mar­ket – the first was the PC­SK9 drug Pralu­ent, which has had a slow up­take since its in­tro­duc­tion.

— It’s dupilum­ab, though, that is get­ting the full red car­pet treat­ment at Re­gen­eron. The IL-4/IL-13 block­ing drug – al­so part­nered with Sanofi – is ex­pect­ed to get ap­proved in the first half of 2017. Most an­a­lysts note that with stel­lar Phase III da­ta from a slate of atopic der­mati­tis stud­ies, along with the FDA’s break­through drug des­ig­na­tion to help speed things along, that ap­proval is like­ly to land ear­ly. Peak sales es­ti­mates tend to hov­er around $2.5 bil­lion a year, mak­ing it a con­tender to be­come a top 2017 drug. Some op­ti­mistic sell-siders have pushed their peak es­ti­mates to $4 bil­lion or $5 bil­lion.

R&D chief George Yan­copou­los

“Dupilum­ab is re­al­ly a fran­chise un­to it­self,” says R&D chief George Yan­copou­los in the Q2 call with an­a­lysts to­day. The pos­i­tive da­ta in atopic der­mati­tis has spurred their be­lief that the drug has “huge” po­ten­tial. There’s al­ready sig­nif­i­cant pent­up de­mand from pa­tients who ei­ther don’t re­spond to cur­rent­ly avail­able reme­dies or can’t tol­er­ate them, says Re­gen­eron’s ex­ec­u­tive team. There’s al­so no oth­er com­pe­ti­tion in the late-stage pipeline to con­tend with.

“This re­al­ly has a chance to pro­vide some­thing to pa­tients that don’t have any oth­er al­ter­na­tives at this point,” says Yan­copou­los. And the com­pa­ny is push­ing ahead in asth­ma and oth­er in­di­ca­tions, look­ing to push the bound­aries on its fran­chise po­ten­tial.

— Then there’s REGN 2810, a PD-1 check­point drug al­so part­nered with Sanofi which is al­ready in a pos­si­ble piv­otal study. This is part of an­oth­er am­bi­tious col­lab­o­ra­tion deal with Sanofi, which is look­ing to fi­nal­ly get things go­ing in the can­cer are­na.

Re­gen­eron al­so has a brand new al­liance of its own with Adicet and its CEO, Aya Jakobovits, who earned a big en­dorse­ment from Yan­copou­los.

“We re­al­ly be­lieve in peo­ple and we be­lieve in syn­er­gies,” says the R&D chief, tout­ing a match-up on Adicet’s off-the-shelf ap­proach to de­vel­op­ing cell ther­a­pies. “We have had a long­stand­ing in­ter­est to work with Aya Jakobovits. We have enor­mous re­spect for her and her ca­pa­bil­i­ties.”

Be­yond that, though, Yan­capou­los wasn’t say­ing much about the tech­nol­o­gy and what dis­tin­guish­es it from ri­vals in the field.

— And fi­nal­ly there’s fas­inum­ab (REGN475), an an­ti-NGF pain drug for os­teoarthri­tis, which is up against some com­pe­ti­tion af­ter Pfiz­er and Eli Lil­ly got things go­ing again af­ter a long pause to as­sess safe­ty is­sues. Pa­tients had a bad habit of blow­ing out their joints af­ter tak­ing the drug, and de­vel­op­ers had to be care­ful to ex­clude pa­tients at risk.

Put it all to­geth­er, and Re­gen­eron’s rel­a­tive­ly mod­est $1.5 bil­lion R&D bud­get – aug­ment­ed by Sanofi – is out­per­form­ing most of its peers, and many much larg­er com­pa­nies that have yet to nail down a suc­cess­ful R&D strat­e­gy.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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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.”

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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.

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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.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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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.