Gilead, Gala­pa­gos re­port com­pet­i­tive num­bers for first big PhI­II read­out for fil­go­tinib in rheuma­toid arthri­tis

Gilead $GILD and its part­ners at Gala­pa­gos $GLPG of­fered their first cut of Phase III da­ta for fil­go­tinib, their late-stage can­di­date for dis­rupt­ing the rheuma­toid arthri­tis mar­ket. And while they may have come in nu­mer­i­cal­ly a lit­tle be­hind their big ri­val at Ab­b­Vie, re­searchers seem to have gained a good safe­ty pro­file and some com­pet­i­tive num­bers that help jus­ti­fy Gilead’s $725 mil­lion up­front near­ly 3 years ago.

John McHutchi­son

Look­ing at a snap­shot of the da­ta, 100 mg fil­go­tinib hit a 57.5% mark for ACR20 at 12 weeks and 66% for 200 mg. At the 24 week mark, that trans­lat­ed to 54.9% and 69.4%. The clin­i­cal re­mis­sion rate was 25.5% and 22.4% at 12 weeks, 26.1% and 30.6% at 24 weeks.

That was all much bet­ter than the place­bo arms in this study — hit­ting the pri­ma­ry and the key sec­on­daries in sight. Fil­go­tinib, though, is the drug that Ab­b­Vie $AB­BV aban­doned to stick with upadac­i­tinib (ABT-494), which in one Phase III hit with 71% of pa­tients achiev­ing ACR20 and 29% achiev­ing clin­i­cal re­mis­sion at week 12.

Gilead’s shares jumped 2.3% on the news in af­ter-mar­ket trad­ing while Gala­pa­gos saw its stick surge 18% on Wednes­day.

This isn’t a head-to-head study, of course, but these days it may as well be. 

Upadac­i­tinib, like oth­er JAK in­hibitors such as Eli Lil­ly’s baric­i­tinib, has had some safe­ty is­sues to con­tend with. In this study of fil­go­tinib, the com­pa­nies gave them­selves high marks on safe­ty, with no tri­al deaths to re­port; 3.4, 5.2 and 4.1% of the pa­tients in the place­bo, 100mg and 200mg groups re­port­ing a se­ri­ous ad­verse event. There was “one case of non-se­ri­ous reti­nal vein oc­clu­sion in the fil­go­tinib 200 mg group and no re­ports of deep ve­nous throm­bo­sis or pul­monary em­bolism.”

There were two big MACE events, but they were split be­tween the drug and place­bo arms.

Leerink’s Ge­of­frey Porges sized up the press re­lease and says this one could be a game chang­er, with an im­proved 80% chance of suc­cess at the FDA.

At least based on the com­pa­nies’ press re­lease last night, this hy­poth­e­sis is in­deed valid and sup­ports the no­tion that while fil­go­tinib may not be the first of these drugs to mar­ket (like­ly the last), it might be the best.

Jef­feries’ Michael Yee was quick to re­mark:

The good news is this is the first pos­i­tive study and helps to de-risk the ini­tial read­outs for the fran­chise and looks pret­ty clean. We see this as a mod­est but good cat­a­lyst for GILD giv­en re­cent stock per­for­mance over the last few months and some frus­trat­ed in­vestor sen­ti­ment. The next ma­jor read­outs are in H1:19, al­though the key big­ger pic­ture read­out that Street will want to know in time is the Phase II/III UC male tox­i­c­i­ty study which is still en­rolling, and GILD is work­ing hard to ac­cel­er­ate en­roll­ment which may in­clude open­ing it up to oth­er in­di­ca­tions and lots more sites.

“These ini­tial Phase III da­ta sup­port the po­ten­tial of fil­go­tinib, in com­bi­na­tion with se­lect dis­ease mod­i­fy­ing drugs, to help pa­tients with ac­tive rheuma­toid arthri­tis who do not ad­e­quate­ly re­spond to cur­rent bi­o­log­ic dis­ease mod­i­fy­ing agents,” says Gilead CSO John McHutchi­son. “These da­ta are par­tic­u­lar­ly en­cour­ag­ing as we look ahead to Phase 3 re­sults from the on­go­ing FINCH 1 and 3 tri­als, which are ex­plor­ing fil­go­tinib in oth­er pop­u­la­tions of pa­tients with rheuma­toid arthri­tis.”

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ 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 55,200+ 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 55,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,200+ 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.