With No­var­tis and Roche gun­ning to carve up Eylea fran­chise, Re­gen­eron has an­oth­er PhI­II suc­cess sto­ry to tell

Work­ing fu­ri­ous­ly to stay ahead of two pow­er­house ri­vals in No­var­tis and Roche, Re­gen­eron to­day is run­ning out a promis­ing set of fresh top-line da­ta for its fran­chise drug Eylea. And one promi­nent an­a­lyst quick­ly re­ward­ed them with a pro­jec­tion of $700 mil­lion in added sales in 5 years.

Re­searchers led by chief sci­en­tif­ic of­fi­cer George Yan­copou­los say they hit the pri­ma­ry end­point in their Phase III study for se­vere non-pro­lif­er­a­tive di­a­bet­ic retinopa­thy, set­ting up a sup­ple­men­tal ap­pli­ca­tion at the FDA.

The block­buster drug had lit­tle prob­lem over­com­ing a place­bo in the Panora­ma study, with 58% in the drug arms scor­ing at least a two-step im­prove­ment in the di­a­bet­ic retinopa­thy sever­i­ty scale com­pared to on­ly 6% for the sham.

Re­gen­eron shares bumped up 2% in mid-morn­ing trad­ing on Mon­day.

An­a­lysts fo­cused on Re­gen­eron $REGN have been look­ing to the Panora­ma da­ta to give them a fresh set of num­bers they can use to com­pare Eylea with two ex­per­i­men­tal meds mov­ing up the pipeline: No­var­tis’ $NVS brolu­cizum­ab (RTH258) and Roche’s $RHH­BY RG7716.

As ex­pect­ed, Leerink’s Ge­of­frey Porges led the cheer­ing sec­tion for Re­gen­eron, where he’s been an un­abashed sup­port­er.

(T)his re­sult opens up a sig­nif­i­cant new mar­ket for Eylea, which could ex­pand the ad­dress­able pool of pa­tients in the broad­er di­a­bet­ic eye dis­ease in­di­ca­tion by 30-40% com­pared to the cur­rent DME-on­ly in­di­ca­tion. We an­tic­i­pate US ap­proval and launch for this in­di­ca­tion for Eylea in 2019E, and al­ready in­clude US sales es­ti­mates for Re­gen­eron of $200mm in 2019E, grow­ing to $700mm by 2023E. Over­all, our US Eylea sales es­ti­mate in 2019E of $4,397mm is 6% high­er than re­cent con­sen­sus, and our 2023E es­ti­mate of $4,992mm is 19% high­er than re­cent con­sen­sus, which sug­gests that con­sen­sus is not valu­ing this in­cre­men­tal in­di­ca­tion.

Re­gen­eron is field­ing a full slate of new tri­als in a dri­ve to stay out front, in­clud­ing a study of its own quar­ter­ly dos­ing reg­i­men. Late last year, though, Re­gen­eron and Bay­er were forced to halt work on a next-gen com­bo to suc­ceed Eylea af­ter it couldn’t beat the stan­dard bear­er in a mid-stage study.

No­var­tis has been par­tic­u­lar­ly ag­gres­sive with its block­buster fore­cast for brolu­cizum­ab, which it ex­pects will hit the mar­ket next year with an eas­i­er dos­ing sched­ule af­ter post­ing pos­i­tive da­ta com­pared to Eylea. And Roche, no slouch in the com­pe­ti­tion game, is mov­ing through the clin­ic with its own block­buster slay­er.

Di­a­bet­ic retinopa­thy of­ten starts as NPDR, a con­di­tion that af­fects more than a half mil­lion peo­ple in the US, ac­cord­ing to Re­gen­eron. As the ail­ment pro­gress­es in­to di­a­bet­ic retinopa­thy — a con­di­tion that af­flicts mil­lions — leaky blood ves­sels dis­tort vi­sion.

It’s hard to over­es­ti­mate the im­por­tance of this drug to Re­gen­eron. Even as the big biotech brings on new drugs with Sanofi, world­wide sales of Eylea hit close to $6 bil­lion last year, dwarf­ing any in­come it earned from the rest of its port­fo­lio com­bined.

“This is the first time a ther­a­py has demon­strat­ed it can re­verse dis­ease pro­gres­sion in pa­tients with mod­er­ate­ly se­vere to se­vere non-pro­lif­er­a­tive di­a­bet­ic retinopa­thy with­out di­a­bet­ic mac­u­lar ede­ma, in a tri­al specif­i­cal­ly de­signed to study this pop­u­la­tion,” said Yan­copou­los. “Pa­tients in the tri­al con­tin­ue to be eval­u­at­ed to de­ter­mine if Eylea can pre­vent pro­gres­sion to neo­vas­cu­lar vi­sion-threat­en­ing com­pli­ca­tions or di­a­bet­ic mac­u­lar ede­ma. We look for­ward to shar­ing one-year re­sults lat­er this year.”

George Yan­copou­los, Re­gen­eron R&D chief.

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.