FDA of­fers No­var­tis a thumbs-up on En­brel biosim­i­lar as Am­gen plays of­fense/de­fense si­mul­ta­ne­ous­ly

On Fri­day, the FDA gave Am­gen a clean bill of health for its biosim­i­lar of Ab­b­Vie’s Hu­mi­ra. To­day, it’s Am­gen’s turn to watch a megablock­buster go un­der the biosim­i­lar gun, as the FDA of­fers a clear thumbs up to No­var­tis’ knock­off of the $9 bil­lion drug En­brel.

Two days ahead of a pan­el re­view, FDA in­sid­ers said that No­var­tis’ gener­ics di­vi­sion San­doz had of­fered all the da­ta need­ed to con­clude that the copy­cat was good for all in­di­ca­tions Am­gen sells En­brel for in the U.S. The FDA’s in­sid­er con­clu­sion:

“In con­sid­er­ing the to­tal­i­ty of the ev­i­dence, the da­ta sub­mit­ted by San­doz show that GP2015 is high­ly sim­i­lar to US-li­censed En­brel, notwith­stand­ing mi­nor dif­fer­ences in clin­i­cal­ly in­ac­tive com­po­nents, and that there are no clin­i­cal­ly mean­ing­ful dif­fer­ences be­tween GP2015 and US-li­censed En­brel in terms of the safe­ty, pu­ri­ty, and po­ten­cy of the prod­uct to sup­port the demon­stra­tion that GP2015 is biosim­i­lar to the US-li­censed En­brel in the stud­ied in­di­ca­tion of PsO. The Ap­pli­cant has al­so pro­vid­ed an ex­ten­sive da­ta pack­age to ad­dress the sci­en­tif­ic con­sid­er­a­tions for ex­trap­o­la­tion of da­ta to sup­port biosim­i­lar­i­ty to oth­er con­di­tions of use and po­ten­tial li­cen­sure of GP2015 for each of the in­di­ca­tions for which US-li­censed En­brel is cur­rent­ly li­censed and for which GP2015 is el­i­gi­ble for li­cen­sure.”

The de­ci­sion, which is like­ly to pave the way to a quick ap­proval, is a mir­ror re­flec­tion of the FDA’s view of Am­gen’s Hu­mi­ra biosim­i­lar, which threat­ens Ab­b­Vie’s $14 bil­lion fran­chise. But where Am­gen is fight­ing to get its biosim­i­lar on the mar­ket, it’s fight­ing tooth and nail against No­var­tis, wag­ing a le­gal war against No­var­tis’ de­vel­op­ment strat­e­gy, which stud­ied the drug on­ly for pso­ri­a­sis but is look­ing for an ap­proval on a full slate of in­di­ca­tions.

In this case, the FDA doesn’t have a prob­lem with in­di­ca­tion ex­trap­o­la­tion, as it is called, but de­pend­ing whether you’re play­ing of­fense or de­fense, it’s a flash point on the le­gal front.

These back-to-back biosim­i­lar ap­pli­ca­tions mark a new stage in the field. No­var­tis won a pi­o­neer­ing ap­proval for the first biosim­i­lar with Zarxio, a knock­off of fil­gras­tim, and has its eyes on Hu­mi­ra and oth­er ag­ing block­busters. The agency clear­ly has its doors open to these big play­ers who are threat­en­ing to top­ple some of the most lu­cra­tive drug fran­chis­es in the world. And the first wave of ap­pli­ca­tions are blaz­ing a trail for oth­ers to fol­low. But in the end, the near-term prospects for the field may be lim­it­ed if the com­pa­nies play­ing de­fense can pre­vail in the courts and pro­tect their patents for years to come.

The ju­ry is still out on that, but the FDA is mak­ing its po­si­tion crys­tal clear.

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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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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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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