Am­gen goes back to Rhode Is­land to build its first next-gen man­u­fac­tur­ing site in the US

In a bid to lead the way in de­vel­op­ing a new gen­er­a­tion of more ef­fi­cient bi­o­log­ics man­u­fac­tur­ing fa­cil­i­ties, Am­gen $AMGN is in­vest­ing $160 mil­lion in a new plant to be con­struct­ed on its Rhode Is­land base.

The phar­ma gi­ant $AMGN — head­quar­tered in Thou­sand Oaks, CA — has had a long his­to­ry with the 75-acre cam­pus in West Green­wich, RI, since in­her­it­ing it in the Im­munex ac­qui­si­tion in 2001. With the new op­er­a­tion, it plans to add around 150 man­u­fac­tur­ing po­si­tions to the 625-strong team. The state gov­ern­ment was hap­py to hear about that job cre­ation, in ad­di­tion to 200 tem­po­rary con­struc­tion and val­i­da­tion jobs, and has promised $9.5 mil­lion in tax cred­its to move things along.

Bob Brad­way

Flex­i­bil­i­ty is a hall­mark of this new de­sign, Am­gen says, which would al­low the com­pa­ny to re­spond to new de­mands more quick­ly and at low­er cost. The mod­u­lar de­sign means the equip­ment in­side the fa­cil­i­ty would be portable and dis­pos­able. One such plant has al­ready been up and run­ning in Sin­ga­pore since 2014.

Af­ter eval­u­at­ing glob­al lo­ca­tions for the project, Am­gen — led by CEO Bob Brad­way — fi­nal­ly de­cid­ed to dou­ble down on the re­sources it’s al­ready poured in­to the Rhode Is­land site, cit­ing the work­force, the qual­i­ty of liv­ing and the po­ten­tial to grow. While cost was not men­tioned, the cur­rent num­bers — both in cap­i­tal and hir­ing — is al­most half of what the com­pa­ny out­lined in Feb­ru­ary, when it an­nounced it would spend up to $300 mil­lion and hire up to 300 em­ploy­ees for a new fa­cil­i­ty.

Es­te­ban San­tos

“Am­gen has three decades of ex­pe­ri­ence in bi­o­log­ics man­u­fac­tur­ing, and we are proud of our track record of pro­vid­ing a re­li­able sup­ply of high-qual­i­ty med­i­cines for pa­tients around the world,” said Es­te­ban San­tos, ex­ec­u­tive vice pres­i­dent of op­er­a­tions.

The com­pa­ny al­so at­trib­uted the de­ci­sion to build the new plant on US soil to the fed­er­al tax re­form that, ac­cord­ing to an ear­li­er End­points analy­sis, re­duced its tax rate by 20-plus per­cent.

It is yet un­clear when the plant, which Am­gen says would take half the con­struc­tion time to build com­pared to a tra­di­tion­al one, will open. Mean­while, Am­gen is tout­ing its low op­er­at­ing cost and en­vi­ron­men­tal ben­e­fits, in­clud­ing re­duced wa­ter and en­er­gy con­sump­tions.

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.