In­di­v­ior tight­ens grip on opi­oid ad­dic­tion mar­ket with Sublo­cade's new FDA ap­proval

The FDA has giv­en In­di­v­ior the OK to sell its month­ly in­jectable ver­sion of Sub­ox­one, shoring up the com­pa­ny’s ten­u­ous hold on the opi­oid ad­dic­tion mar­ket as com­pe­ti­tion looms near.

Scott Got­tlieb

The drug, to be mar­ket­ed as Sublo­cade (RBP-6000), is a month­ly in­jec­tion of buprenor­phine, which con­tains a mild opi­oid to help stymie with­draw­al for ad­dicts quit­ting opi­oid use. The med­i­cine is meant to be used as part of a treat­ment plan that in­cludes coun­sel­ing and psy­choso­cial sup­port.

The news doesn’t come as a sur­prise. Con­sid­er­ing the grow­ing ad­dic­tion to opi­oid-based painkillers and hero­in in the US, the FDA’s ad­vi­so­ry com­mit­tee made a strong rec­om­men­da­tion to ap­prove the drug ear­li­er this month. And ri­vals will be well re­ceived at the FDA.

“Every­one who seeks treat­ment for opi­oid use dis­or­der de­serves the op­por­tu­ni­ty to be of­fered the treat­ment best suit­ed to the needs of each in­di­vid­ual pa­tient, in com­bi­na­tion with coun­sel­ing and psy­choso­cial sup­port, as part of a com­pre­hen­sive re­cov­ery plan,” said FDA Com­mis­sion­er Scott Got­tlieb. “As part of our on­go­ing work in sup­port­ing the treat­ment of those suf­fer­ing from ad­dic­tion to opi­oids, the FDA plans to is­sue guid­ance to ex­pe­dite the de­vel­op­ment of new ad­dic­tion treat­ment op­tions. We’ll con­tin­ue to pur­sue ef­forts to pro­mote more wide­spread use of ex­ist­ing, safe and ef­fec­tive FDA-ap­proved ther­a­pies to treat ad­dic­tion.”

Max Her­rmann, Stifel

In­di­v­ior’s film ver­sion of this drug, which is dis­solved un­der the tongue or in­side the cheek, has been the mar­ket leader in this field for the past two decades. But the com­pa­ny’s grip on the mar­ket was com­pro­mised when gener­ics and oth­er com­peti­tors be­gan to creep on­to the scene. In Sep­tem­ber the com­pa­ny warned in­vestors that a US court rul­ing that cleared the way for a gener­ic ri­val had “sig­nif­i­cant­ly in­creased” the risk of new com­peti­tors. In a press re­lease back in Sep­tem­ber, In­di­v­ior said it could lose up to 80% of its mar­ket share “with­in a mat­ter of months” thanks to the new com­pe­ti­tion.

And then there’s Sub­ox­one’s brand­ed ri­val Viv­it­rol (made by Alk­er­mes), which re­cent­ly made its case for equal ef­fi­ca­cy to In­di­vor’s drug. This month­ly in­jec­tion works dif­fer­ent­ly than Sub­ox­one, block­ing the ef­fect of opi­oids. Alk­er­mes’ cen­tral brand­ing mes­sage is that Viv­it­rol is clean­er, con­tain­ing no opi­oids. But the drug al­so re­quires pa­tients to be detoxed en­tire­ly from opi­oids, which can prove prob­lem­at­ic for ad­dict­ed pa­tients.

Al­though not great news for com­peti­tors, this new ap­proval for In­di­v­ior could mean sig­nif­i­cant rev­enue for the com­pa­ny. Max Her­rmann, an an­a­lyst at Stifel, ex­pects the drug could cap­ture 30% of the broad­er buprenor­phine mar­ket. He ex­pects an­nu­al sales of about $700 mil­lion by 2021, while Jef­feries an­a­lysts ex­pect peak sales of $1.3 bil­lion by 2025.

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.

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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.

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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.

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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.

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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.