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.

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.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ 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.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ 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 55,100+ 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 55,100+ biopharma pros reading Endpoints daily — and it's free.

H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.