As­traZeneca of­fers some mixed PhI­II re­sults for se­vere asth­ma, while Roche ri­val floun­ders

As­traZeneca post­ed some mixed — though gen­er­al­ly pos­i­tive — da­ta from two big Phase III stud­ies of ben­ral­izum­ab, its IL-5 con­tender in the high­ly com­pet­i­tive mar­ket for se­vere asth­ma. A high place­bo re­sponse se­ri­ous­ly erod­ed one set of late-stage da­ta. But the ther­a­py ap­pears head­ed to an ap­proval — even as Roche was prac­ti­cal­ly giv­en the kiss of death for a ri­val late-stage drug.

As­traZeneca put ben­ral­izum­ab through two Phase III stud­ies that col­lec­tive­ly re­cruit­ed more than 2,500 pa­tients. In the first of those, the CAL­I­MA tri­al with 1,306 pa­tients, 30 mg of ben­ral­izum­ab in­ject­ed every 4 and 8 weeks was able to re­duce ex­ac­er­ba­tion by 28% to 36% com­pared to a place­bo. In the sec­ond study, SIROC­CO with 1,209 pa­tients, the ex­ac­er­ba­tion rate dropped by a more com­pet­i­tive 48% to 51%.

As­traZeneca’s ben­ral­izum­ab tar­gets the IL-5 re­cep­tor rather than the mol­e­cule it­self, a dis­tinc­tion that the phar­ma gi­ant be­lieves will help it com­pete against the re­cent­ly ap­proved Nu­cala (Glax­o­SmithK­line’s mepolizum­ab) and Cinqair (Te­va’s reslizum­ab). The ju­ry is still out on that score, though.

Nu­cala was ap­proved on its abil­i­ty to re­duce ex­ac­er­ba­tions in asth­ma by tack­ling eosonophils, a prime bio­mark­er for risk in the tar­get­ed pop­u­la­tion. But GSK did not prove that the drug im­proved lung func­tion, while As­traZeneca’s team claims they did track amped up lung per­for­mance.

Eu­gene Bleeck­er MD

Pro­fes­sor Eu­gene Bleeck­er from the Cen­ter for Ge­nomics and Per­son­al­ized Med­i­cine, Wake For­est School of Med­i­cine, and lead au­thor of the SIROC­CO tri­al, had this to say:

Two drugs are cur­rent­ly ap­proved for the treat­ment of se­vere, un­con­trolled asth­ma (mepolizum­ab and reslizum­ab) but both tar­get the IL-5 mol­e­cule di­rect­ly, rather than the re­cep­tor. By tar­get­ing the IL-5 re­cep­tor, ben­ral­izum­ab de­pletes eosinophils di­rect­ly, and our stud­ies show that eosinophil counts were near­ly com­plete­ly de­plet­ed by week 4 of treat­ment.

The re­sults were pub­lished in The Lancet Res­pi­ra­to­ry Med­i­cine, which al­so con­clud­ed that Roche’s two Phase III stud­ies for le­brik­izum­ab fell far short of the bar on ef­fi­ca­cy. A sum­ma­ry con­demns the drug with slight crit­i­cism:

The find­ings sug­gest that the drug, which blocks IL-13, may not be suf­fi­cient to pro­vide clin­i­cal­ly mean­ing­ful im­prove­ments in re­duc­ing asth­ma ex­ac­er­ba­tions.

Roche con­clud­ed back in Feb­ru­ary that it had one suc­cess and one flop in Phase III, which amounts to a se­vere set­back on this high­ly com­pet­i­tive front.

There’s al­so plen­ty of com­pe­ti­tion ahead for all the re­main­ing play­ers. Re­gen­eron and Sanofi are in a Phase III asth­ma pro­gram for dupilum­ab, a po­ten­tial IL-4/IL-13 megablockuster head­ed for a like­ly ap­proval for use against atopic der­mati­tis. And No­var­tis re­cent­ly tout­ed mid-stage da­ta on an­oth­er eosinophilic drug, fe­vip­iprant,which is de­signed as an oral drug that could con­quer the whole mar­ket through an eas­i­er route of ad­min­is­tra­tion than these first-gen drugs.

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.