Vas Narasimhan (Credit: AP)

No­var­tis nabs FDA ap­proval for hyped Eylea ri­val

As Re­gen­eron’s Eylea stares down po­ten­tial slow-death-by-gener­ics, No­var­tis has nabbed a wide­ly ex­pect­ed FDA ap­proval for its own wet mac­u­lar de­gen­er­a­tion in­jec­tion, Beovu (brolu­cizum­ab).

No­var­tis has been eye­ing Re­gen­eron patent ex­pi­ra­tion with the leer­ing in­ten­si­ty of a prowl­ing tiger. Be­fore be­com­ing CEO in 2017, Vas Narasimhan iden­ti­fied brolu­cizum­ab as one of four big late-stage drugs to watch, and in 2018 he named it one of the “core 5” in his list of 25 block­busters.

The chunk the Swiss gi­ant may carve out of Eylea’s $5 bil­lion rev­enue shrank short­ly af­ter that 2018 pro­jec­tion as Re­gen­eron stum­bled its way in­to a sur­prise FDA ap­proval to ad­min­is­ter over 12 weeks.

To­day’s FDA ap­proval is al­so for a 12-week dose. It was won off two head-to-head, ran­dom­ized phase III clin­i­cal tri­als that found “non-in­fe­ri­or­i­ty” for brolu­cizum­ab against Eylea (afliber­cept) af­ter year one. In HAWK, pa­tients re­ceiv­ing brolu­cizum­ab im­proved on eye tests by 6.6 let­ters for a 6 mg dose and 6.1 let­ters for a 3 mg dose com­pared with 6.9 mg.  In the HAR­RI­ER study, pa­tients re­ceiv­ing 6 mg of brolu­cizum­ab im­proved by 6.9 let­ters com­pared with 7.6 let­ters for afliber­cept. The two tri­als cov­ered a com­bined 1817 pa­tients.

No­var­tis tout­ed the drug as the first to of­fer both greater flu­id res­o­lu­tion than afliber­cept and that can be pre­scribed with a three-month dos­ing in­ter­val im­me­di­ate­ly af­ter a three-month load­ing phase.

Baird an­a­lyst Bri­an Sko­r­ney, though, wrote the an­nounce­ment looked “meh,” He ar­gued Beovu was un­like­ly to make a huge im­pact on Eylea giv­en sim­i­lar ef­fi­ca­cy and dosage, and what ap­pears to mar­gin­al­ly worse safe­ty da­ta.

“Al­though the in­tro­duc­tion of a com­pet­i­tive prod­uct should re­sult in some mar­ket share loss, we be­lieve con­cerns that it is lead­ing Eylea sales over a cliff are over­done, es­pe­cial­ly in light of this la­bel,” Sko­r­ney wrote.

Eylea’s patents will be­gin to ex­pire in 2023 in the US and 2025 in Eu­rope, al­though the US in­tel­lec­tu­al prop­er­ty es­tate will re­main in­to 2032.

Wet mac­u­lar de­gen­er­a­tion, al­so known as age-re­lat­ed mac­u­lar de­gen­er­a­tion, is the lead­ing cause of vi­sion loss and blind­ness in peo­ple over 65 in North Amer­i­ca, Eu­rope, Aus­tralia and Asia.

Re­gen­eron, cog­nizant of Eylea’s long-loom­ing patent ex­pi­ra­tion, signed a bil­lion-dol­lar R&D part­ner­ship with Al­ny­lam this year to ex­plore RNAi ther­a­pies, in­clud­ing for wet AMD. In­flam­ma­some, a new Boehringer In­gel­heim part­ner, is de­vel­op­ing mol­e­cules for wet AMD treat­ment.

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.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Glax­o­SmithK­line scraps a LAG3 study, mark­ing an­oth­er fail­ure for the pipeline af­ter a crit­i­cal set­back

Another gap has appeared in GlaxoSmithKline’s pipeline.

Friday morning the Australian biotech Immutep put out word that Hal Barron’s R&D group at GSK had decided to scrap a Phase II proof-of-concept study in ulcerative colitis for their anti-LAG3 therapy GSK2831781. According to the biotech, the program didn’t survive an interim review.

The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

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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.