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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

Endpoints Premium

Premium subscription required

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

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,200+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Bris­tol My­ers Squibb gets re­view date for Op­di­vo com­bo in gas­tric can­cer, look­ing to over­turn Keytru­da's 3-year lead

The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.

The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.

Covid-19 claims an­oth­er PDU­FA vic­tim as Glax­o­SmithK­line push­es back planned PD-1 roll­out

Bristol Myers Squibb isn’t the only pharma giant that’s been standing in the FDA’s waiting line for site inspections.

GlaxoSmithKline is telling us today that their H2 2020 PDUFA deadline for the PD-1 drug dostarlimab — picked up in its Tesaro buyout — was pushed back due to a delay in the manufacturing site inspection needed for a regulatory decision. And that is forcing the company to revise its timeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,200+ biopharma pros reading Endpoints daily — and it's free.