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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,400+ biopharma pros reading Endpoints daily — and it's free.

Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.