Gilead scraps a PhII/III study ear­ly as drug flops against ul­cer­a­tive col­i­tis

Just as Gilead $GILD was look­ing to buoy ex­pec­ta­tions in its R&D prospects, the big biotech had been hit with a set­back on its late-stage pipeline. The com­pa­ny says it’s scrap­ping a Phase II/III ul­cer­a­tive col­i­tis study of its an­ti-MMP9 an­ti­body GS-5745 af­ter track­ing in­suf­fi­cient ef­fi­ca­cy to keep it in the clin­ic.

Ge­of­frey Porges, Leerink

The Da­ta Mon­i­tor­ing Com­mit­tee made the call af­ter re­view­ing the ex­pe­ri­ences of 150 pa­tients in the study, which was sup­posed to re­cruit 1,600 pa­tients al­to­geth­er. Gilead signed off on the de­ci­sion af­ter agree­ing with their con­clu­sion.

Gilead isn’t giv­ing up on the drug. It’s still pur­su­ing a Phase III study of the an­ti­body for gas­tric can­cer, with a com­bo tri­al un­der­way with nivolum­ab as well. Gilead says it will al­so keep push­ing on Crohn’s dis­ease, rheuma­toid arthri­tis and cys­tic fi­bro­sis. But an­a­lysts — most of whom weren’t ex­pect­ing big things for this drug to be­gin with — are start­ing to write off the drug af­ter it flailed in this first late-stage tri­al.

“De­spite these low ex­pec­ta­tions, the bad news does come as an­oth­er blow to the sen­ti­ment about the com­pa­ny’s R&D prospects and in­vestor sen­ti­ment,” not­ed Leerink’s Ge­of­frey Porges. “GS-5745 was one of the five proof-of-con­cept mol­e­cules in phase 2 de­vel­op­ment ex­pect­ed to read-out in H216 that of­fered op­por­tu­ni­ty for some off­set to Gilead’s in­creas­ing­ly chal­lenged core busi­ness­es. While it is still pos­si­ble that this pro­gram could cre­ate val­ue in ei­ther Crohn’s or gas­tric can­cer, in­vestors are un­like­ly to give it much cred­it af­ter this ear­ly dis­con­tin­u­a­tion.”

Jef­feries’ Bri­an Abra­hams took the news with a grain of salt. He’s turn­ing his at­ten­tion to oth­er drugs that may prove far more ex­cit­ing, in­clud­ing fil­go­tinib, mo­melo­tinib, GS-9620, bicte­gravir, sim­tuzum­ab and 4997.

Gilead has been turn­ing to some high dol­lar deals to help main­tain in­vestors’ en­thu­si­asm as its gang­buster hep C rev­enue has be­gun to fade. Late last year the team at Gilead quick­ly stepped in to fill Ab­b­Vie’s shoes on an au­toim­mune col­lab­o­ra­tion with Gapala­pa­gos, pay­ing $725 mil­lion up­front to part­ner on fil­go­tinib. An­oth­er $1.35 bil­lion in mile­stones is on the ta­ble.

Gilead’s shares are down slight­ly in af­ter-mar­ket trad­ing.

Some an­a­lysts have been clam­or­ing for a ma­jor ac­qui­si­tion to help right the ship, which they could eas­i­ly af­ford out of their pile of cash re­serves, but RBC’s Michael Yee hasn’t de­tect­ed much des­per­a­tion among Gilead’s ex­ec­u­tive crew — yet. Yee al­so doesn’t ex­pect any kind of cor­po­rate split.

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.