Sanofi, As­traZeneca mark big leap to­ward fil­ing of RSV drug in 2022, with safe­ty da­ta in hand to chal­lenge Synagis

The last big piece of the da­ta pack­age that Sanofi and As­traZeneca need­ed to file their RSV an­ti­body with the FDA is now in.

In a Phase II/III tri­al in­volv­ing ba­bies who were born preterm or had chron­ic lung dis­ease or con­gen­i­tal heart dis­ease, the part­ners said, nir­se­vimab showed a sim­i­lar safe­ty and tol­er­a­bil­i­ty pro­file com­pared to Synagis — the stan­dard and on­ly drug cur­rent­ly avail­able for the same group. They are eye­ing a fil­ing in the first half of 2022.

Like Synagis, nir­se­vimab is an in­tra­mus­cu­lar in­jec­tion de­signed to pre­vent se­ri­ous low­er res­pi­ra­to­ry tract in­fec­tion by res­pi­ra­to­ry syn­cy­tial virus. The dif­fer­ence? While Synagis must be giv­en month­ly for the en­tire RSV sea­son, nir­se­vimab’s ex­tend­ed half-life means one dose can last the whole win­ter.

“Giv­en the typ­i­cal RSV sea­son lasts near­ly five months, there is a po­ten­tial ad­van­tage to pro­vid­ing a pre­ven­ta­tive op­tion that could help pro­tect all in­fants with one dose for the en­tire sea­son,” said Joseph Do­ma­chowske, pri­ma­ry in­ves­ti­ga­tor of the tri­al, dubbed MED­LEY.

In­ves­ti­ga­tors as­sessed safe­ty by mon­i­tor­ing the side ef­fects among 925 in­fants in the tri­al for close to a year af­ter they were dosed. Sanofi and As­traZeneca didn’t break down the ex­act num­ber of ad­verse events in ei­ther the nir­se­vimab or Synagis arm.

In­fants were giv­en the an­ti­bod­ies right be­fore they en­ter their first RSV sea­son — or at birth if they were born dur­ing it.

Al­though the MED­LEY tri­al had ze­roed in on those at high­est risk, Sanofi and As­traZeneca have much broad­er am­bi­tions.

Ear­li­er this year, they teased topline da­ta sug­gest­ing that nir­se­vimab pro­tect­ed ba­bies for the en­tire sea­son, cut­ting low­er res­pi­ra­to­ry tract in­fec­tions in both healthy preterm and term in­fants. Pre­vi­ous re­sults from a Phase IIb tri­al fo­cused on preterm in­fants sug­gest­ed the re­duc­tion of med­ical­ly at­tend­ed RSV in­fec­tions was as big as 70% over place­bo.

“RSV is the ma­jor re­main­ing pe­di­atric in­fec­tious dis­ease with no pre­ven­ta­tive op­tion avail­able to all in­fants,” said Jean-François Tou­s­saint, glob­al head of R&D at Sanofi Pas­teur. “We be­lieve nir­se­vimab has the po­ten­tial to be­come an im­por­tant and in­no­v­a­tive rou­tine im­mu­niza­tion for all in­fants – those born pre­ma­ture­ly or at term, healthy or with health con­di­tions.”

Un­der a €645 mil­lion al­liance inked back in 2017, As­traZeneca is in charge of de­vel­op­ment through ini­tial ap­provals as well as man­u­fac­tur­ing, while Sanofi spear­heads com­mer­cial­iza­tion. As­traZeneca had since di­vest­ed US rights to Synagis to So­bi (Ab­b­Vie is mar­ket­ing the drug in the rest of the world).

SVB Leerink an­a­lyst Ge­of­frey Porges has fore­cast a block­buster mar­ket for the drug, pre­dict­ing that it will eclipse Synagis’ $1.4 bil­lion in sales.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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