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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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J&J ad­comm live blog: J&J faces ques­tions on old­er adults, asymp­to­matic in­fec­tion, long-term im­mu­ni­ty

The FDA adcomm has advanced to the free-for-all question stage of the hearing and, as they did for Moderna and Pfizer, committee members are raising questions about the lingering issues surrounding the vaccine.

In J&J’s case, one of those unknowns is a group of participants who appeared to respond worse to the vaccine: those over 60 with comorbidities. In that group, the vaccine was only 42% effective at stopping disease starting 28 days after vaccination.