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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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