FDA hits Leo Phar­ma with a CRL for what the biotech says are ques­tions about the 'de­vice com­po­nen­t' of eczema can­di­date

Af­ter toil­ing away for the last few years on a mon­o­clon­al an­ti­body to com­pete with Dupix­ent in atopic der­mati­tis, Leo Phar­ma has been hit with a com­plete re­sponse let­ter from the FDA.

The agency has “re­quest­ed ad­di­tion­al da­ta re­lat­ing to a de­vice com­po­nent of tralok­inum­ab,” Leo said on Thurs­day, but the biotech didn’t share any fur­ther de­tails on the de­vice or what went wrong. Com­pa­ny spokesper­son Hen­rik Kyn­dlev de­clined to pro­vide more in­for­ma­tion via email, but said Leo is “look­ing for­ward to meet with the FDA to clar­i­fy de­tails about the re­quest.”

As for the safe­ty and ef­fi­ca­cy of the drug, Leo was on the de­fen­sive: “FDA did not re­quest any new da­ta on the clin­i­cal ef­fi­ca­cy or safe­ty of the drug prod­uct for­mu­la­tion of tralok­inum­ab,” the com­pa­ny said in a state­ment.

It’s worth not­ing that drug­mak­ers hit with a CRL of­ten ob­scure in­for­ma­tion about the con­tents of those let­ters in pub­lic state­ments, in many cas­es omit­ting the agency’s safe­ty and ef­fi­ca­cy con­cerns, ac­cord­ing to a study pub­lished in The BMJ in 2015. In that analy­sis, just 14% of com­pa­nies’ press re­lease state­ments af­ter a CRL ac­tu­al­ly matched the con­cerns con­tained in the let­ters, which aren’t made pub­lic.

Kyn­dlev de­clined to share a copy of the CRL with End­points “as it is an on­go­ing reg­u­la­to­ry process,” but reaf­firmed that the FDA’s re­quest is “on­ly re­lat­ed to the de­vice com­po­nent.”

Tralok­inum­ab comes from As­traZeneca’s pipeline, where it flopped in three Phase II­Is for asth­ma pa­tients be­fore Pas­cal So­ri­ot gave it the boot. Leo put down $115 mil­lion for rights to the mon­o­clon­al an­ti­body plus an­oth­er der­ma­tol­ogy can­di­date back in 2016 — promis­ing up to $1 bil­lion in mile­stones — and set out to de­vel­op it as an atopic der­mati­tis ther­a­py.

The Dan­ish biotech an­nounced tralok­inum­ab swept up pos­i­tive re­sults for all pri­ma­ry and sec­ondary end­points in three Phase III tri­als in De­cem­ber 2019, but some were skep­ti­cal of the tim­ing. Ever­core ISI’s Umer Raf­fat said it ap­peared that Leo had been sit­ting on the re­sults for about a year, which is nev­er a good sign.

Leo’s com­mu­ni­ca­tions team, how­ev­er, told End­points that Raf­fat was wrong about the year­long de­lay, adding that the tri­als were sched­uled to wrap up in a se­ries and they were wait­ing for the full da­ta, which weren’t avail­able for analy­sis un­til No­vem­ber 2019.

While it’s stan­dard pro­ce­dure in the in­dus­try to re­port da­ta by tri­al as they be­come avail­able, the spokesper­son said Leo didn’t re­lease any hard da­ta to avoid dam­ag­ing their chances of get­ting the da­ta pub­lished in a peer-re­viewed jour­nal.

Leo sub­mit­ted the BLA for tralok­inum­ab back in Ju­ly, and says it was hand­ed a tar­get ac­tion date in Q2 2021.

Ear­li­er this month, Leo read out long-term da­ta from an open-la­bel ex­ten­sion tri­al dubbed ECZ­TEND. In a two-year co­hort of pa­tients who com­plet­ed 52 weeks of tralok­inum­ab treat­ment in par­ent Phase III stud­ies ECZ­TRA 1 and 2 and at least 56 weeks in ECZ­TEND, 93.8% achieved at least a 50% im­prove­ment in Eczema Area and Sever­i­ty In­dex score (EASI-50). A to­tal of 82.5% achieved EASI-75, and 59.8% achieved EASI-90, ac­cord­ing to Leo.

Tralok­inum­ab tar­gets IL-13, which Leo says plays a key role in the im­mune process be­hind atopic der­mati­tis signs and symp­toms. Dupix­ent, the gi­ant in the field, blocks both IL-13 and IL-4. Eli Lil­ly snagged its own IL-13 con­tender, le­brik­izum­ab, in the $1.1 bil­lion Der­mi­ra buy­out. That can­di­date is now in Phase III.

Ear­li­er this month, the FDA ex­tend­ed its re­view pe­ri­od for Ab­b­Vie’s Rin­voq in atopic der­mati­tis, re­quest­ing “an up­dat­ed as­sess­ment of the ben­e­fit-risk pro­file,” ac­cord­ing to the drug­mak­er.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.