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.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,700+ biopharma pros reading Endpoints daily — and it's free.

Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,700+ biopharma pros reading Endpoints daily — and it's free.

Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,700+ biopharma pros reading Endpoints daily — and it's free.

It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 59,700+ biopharma pros reading Endpoints daily — and it's free.

Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.