Third time’s the charm as Heron wins FDA nod for non-opi­oid anes­thet­ic Zyn­relef

With an aim to re­duce the use of opi­oids in the post-op set­ting, Heron Ther­a­peu­tics on Thurs­day an­nounced that it fi­nal­ly won FDA ap­proval — af­ter two pri­or CRLs — for its long-last­ing lo­cal anes­thet­ic, which is a com­bi­na­tion of bupi­va­caine and the NSAID meloxi­cam.

Heron will price the drug, known com­mer­cial­ly as Zyn­relef, some­where be­tween 22% and 28% less than its di­rect com­peti­tor, Paci­ra Bio­sciences’ Ex­par­el (bupi­va­caine li­po­some in­jectable sus­pen­sion), Heron CEO Bar­ry Quart told End­points News in an in­ter­view.

CEO Bar­ry Quart

“We’re not look­ing at how we’re priced ver­sus the com­peti­tor. What we’re pre­dom­i­nate­ly in­ter­est­ed in is at what price we can get max­i­mum ac­cess to the prod­uct as hos­pi­tals are con­strained,” Quart said.

That 22-28% dis­count could prove to be a ma­jor ad­van­tage for Zyn­relef, ac­cord­ing to Wall Street biotech an­a­lysts. Leerink ex­pects peak sales for Zyn­relef to be more than $500 mil­lion by 2025, and a re­cent sur­vey from the bank in Jan­u­ary showed how a 25% dis­count could in­crease the num­ber of hos­pi­tals will­ing to use the drug.

Ever­core ISI an­a­lysts not­ed Thurs­day a “some­what (but not en­tire­ly)” sur­pris­ing move by the FDA to lim­it the la­belled in­di­ca­tions for the ap­proval to bunionec­to­my, open hernior­rha­phy and to­tal knee arthro­plas­ty rather than grant­i­ng a broad­er la­bel. But the com­pa­ny notes there is a speedy path for­ward to fur­ther broad­en the la­bel to ad­dress more pa­tients.

Zyn­relef has been re­ject­ed twice by the FDA — first in May 2019, for man­u­fac­tur­ing con­cerns, and then again last year for con­cerns re­lat­ed to quan­ti­fy­ing the ex­po­sure to cer­tain ex­cip­i­ents used in the drug.

“It’s tak­en a while, but it’s def­i­nite­ly worth all the ef­fort to get this im­por­tant prod­uct out to pa­tients,” Quart said. “The first CRL was pre­dom­i­nate­ly re­lat­ed to man­u­fac­tur­ing ques­tions and we pro­vid­ed the in­for­ma­tion the agency need­ed. Un­for­tu­nate­ly, dur­ing the re­view [af­ter the first CRL], the agency asked for some ad­di­tion­al in­for­ma­tion re­lat­ed to ex­cip­i­ents in the prod­uct. We ba­si­cal­ly got stuck right at a point where the FDA was mak­ing pub­lic their in­ac­tive in­gre­di­ent data­base so they were very rigid about mak­ing sure they had all of the in­for­ma­tion on these in­ac­tive in­gre­di­ents.”

Quart al­so said he an­tic­i­pates rel­a­tive­ly fast up­take of the drug as hos­pi­tals look to re­duce their use of opi­oids, par­tic­u­lar­ly af­ter surg­eries, when pa­tients of­ten use just a frac­tion of the opi­oids that they re­ceive with a pre­scrip­tion. About 90,000 Amer­i­cans died from opi­oid-re­lat­ed over­dos­es in 2020, which com­pares with about 70,000 in 2019.

For hos­pi­tals with ex­pe­ri­ence with the prod­uct, Quart said he ex­pects to see “rapid up­take,” but there’ll be a group of hos­pi­tals that take longer to de­ter­mine whether or not to put Zyn­relef on their for­mu­la­ries.

“We don’t re­al­ly look at it in terms of mar­ket share for opi­oids,” he said. “What we look at is the need to re­duce or elim­i­nate the need for opi­oids. In our clin­i­cal stud­ies in the pack­age in­sert, you’ll see that we were able to elim­i­nate the need for opi­oids in over 50% pa­tients hav­ing a her­nia pro­ce­dure, and about 30% of pa­tients hav­ing a bunionec­to­my, which is a very painful pro­ce­dure.”

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.