Months af­ter Re­gen­eron se­cured FDA ap­proval for 12-week Eylea reg­i­men, No­var­tis buys speedy US re­view for its ri­val

Vas Narasimhan

No­var­tis’ brolu­cizum­ab could do to Re­gen­eron’s Eylea what the flag­ship eye treat­ment did to Roche’s Lu­cen­tis, some ex­perts have pre­dict­ed. Vas Narasimhan has shout­ed from the rooftops the promise of brolu­cizum­ab even be­fore his el­e­va­tion to No­var­tis chief. On Mon­day, No­var­tis came one step clos­er to launch­ing its chal­lenge to Re­gen­eron’s for­mi­da­ble block­buster, se­cur­ing a speedy re­view for brolu­cizum­ab for use in wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), set­ting it up for ap­proval by the end of this year.

Wet AMD is the lead­ing cause of se­vere vi­sion loss and le­gal blind­ness in peo­ple over the age of 65 in North Amer­i­ca, Eu­rope, Aus­tralia and Asia, im­pact­ing an es­ti­mat­ed 20 to 25 mil­lion peo­ple glob­al­ly.

Last Au­gust, the FDA al­lowed Re­gen­eron $REGN to start mar­ket­ing a 12-week reg­i­men for Eylea for wet AMD pa­tients, ver­sus the orig­i­nal bi-month­ly reg­i­men. Brolu­cizum­ab is al­so a 12-week reg­i­men, al­though No­var­tis $NVS has ar­gued piv­otal tri­al da­ta sug­gests the drug was “con­sis­tent­ly su­pe­ri­or” to its Re­gen­eron ri­val, which gen­er­at­ed more than $4 bil­lion in net US sales last year. 

No­var­tis se­cured the quick re­view af­ter sub­mit­ting a pri­or­i­ty re­view vouch­er. The mar­ket­ing ap­pli­ca­tion was large­ly based on da­ta from two late-stage stud­ies: the HAWK and HAR­RI­ER tri­als, in which the drug met the main goal by show­ing it was as ef­fec­tive as Eylea in im­prov­ing vi­su­al acu­ity af­ter two years of treat­ment. Key sec­ondary end­points as­sess­ments al­so showed sig­nif­i­cant­ly few­er brolu­cizum­ab pa­tients with dis­ease ac­tiv­i­ty and reti­nal flu­id, ver­sus Eylea, No­var­tis said.  

“Giv­en up­com­ing com­pe­ti­tion from brolu­cizum­ab, we sense that (Re­gen­eron) man­age­ment is open to pro­vid­ing dis­counts or re­bates if nec­es­sary to main­tain Eylea’s com­pe­ti­tion in case brolu­cizum­ab pro­vides at­trac­tive fi­nan­cial terms,” Cowen’s Yaron Wer­ber wrote in a note last month.

Yaron Wer­ber

“With Roche’s faricimab com­ing in 2022/23 and Eylea biosim­i­lars in Eu­rope in 2025, the fran­chise is go­ing to be fac­ing pres­sure,” he added in a note pub­lished in Feb­ru­ary.

Mean­while, Al­ler­gan’s $AGN abic­i­par is al­so in the mix for pa­tients with wet AMD, hav­ing demon­strat­ed non-in­fe­ri­or­i­ty to Lu­cen­tis giv­en every 8 or 12 weeks in a pair of Phase III tri­als. But the rate of in­traoc­u­lar in­flam­ma­tion ob­served abic­i­par-treat­ed pa­tients in the MAPLE study were sig­nif­i­cant­ly high­er than the rate ob­served in Lu­cen­tis and Eylea, which could lim­it its suc­cess as a re­al play­er, SVB Leerink an­a­lysts wrote in a note ear­li­er in April.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'Fac­to­ry of the Fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “Factory of the Future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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