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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.