No­var­tis rais­es the temp on Eylea ri­val­ry with head-to-head tri­al win for Beovu in di­a­bet­ic mac­u­lar ede­ma

Re­gen­eron’s an­ti-VEGF Eylea has long dom­i­nat­ed its mar­ket, but com­peti­tors are look­ing to de­throne the king — par­tic­u­lar­ly No­var­tis’ late­com­er Beovu. Ham­pered by pri­or safe­ty con­cerns, No­var­tis has set Eylea di­rect­ly in its sights with a pair of non-in­fe­ri­or­i­ty stud­ies for Beovu that could help it get over the line in mac­u­lar ede­ma.

No­var­tis’ Beovu matched Re­gen­eron’s an­ti-VEGF Eylea a year af­ter treat­ment at im­prov­ing di­a­bet­ic mac­u­lar ede­ma pa­tients’ eye­sight in the drug’s sec­ond head-to-head swing at the mar­ket leader, No­var­tis said Tues­day.

In the Phase III Kestral tri­al — a com­ple­ment to the pri­or Kite study — pa­tients re­ceiv­ing a 6-mg dose of Beovu every three months saw sim­i­lar im­prove­ments in eye­sight, in­clud­ing cen­tral sub­field thick­ness, com­pared with pa­tients dosed with 2 mgs of Eylea, No­var­tis said.  In a 12-week fol­low-up pe­ri­od, Beovu con­tin­ued to match Eylea’s re­sults in im­prov­ing pa­tients’ eye­sight.

The top-line Kestral re­sults come with­in months of the ear­ly Kite study read­out, which al­so showed Beovu matched Eylea’s ef­fi­ca­cy in di­a­bet­ic mac­u­lar ede­ma. Eylea is the easy mar­ket leader in mac­u­lar ede­ma, where Beovu is cur­rent­ly chas­ing an FDA ap­proval. No­var­tis’ drug hit the mar­ket back in Oc­to­ber 2019, scor­ing an FDA ap­proval in wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD).

Chas­ing Eylea and its $1.32 bil­lion in third-quar­ter sales will be no easy task for No­var­tis, par­tic­u­lar­ly af­ter an un­for­tu­nate Beovu la­bel up­date back in Sep­tem­ber added in­for­ma­tion on reti­nal vas­culi­tis and reti­nal vas­cu­lar oc­clu­sion, which can cause blind­ness. It’s not quite a black-box warn­ing, but it could be enough to de­ter physi­cians will­ing to give the new­er drug a shot; No­var­tis has said it’s con­vened a pan­el of ex­perts to ex­am­ine the prob­lem.

In the mean­time, the Swiss phar­ma said there were no new safe­ty sig­nals in the Kestral study, back­ing up its sta­ble safe­ty da­ta from the Kite study. Both Beovu and Re­gen­eron are de­liv­ered by in­trav­it­re­al in­jec­tion di­rect­ly in­to the eye.

On top of its pur­suit of mac­u­lar ede­ma, No­var­tis is al­so hop­ing to take Beovu in­to reti­nal vein oc­clu­sion and pro­lif­er­a­tive di­a­bet­ic retinopa­thy as it hunts a mar­ket Eylea has long dom­i­nat­ed. The drug snared $51 mil­lion in sales in the third quar­ter and has bagged ap­provals in 46 coun­tries as of Sep­tem­ber.

Pri­or to the new safe­ty flags, No­var­tis tout­ed Beovu’s less oner­ous dos­ing reg­i­men, which re­quires month­ly in­jec­tions for the first three months of treat­ment be­fore switch­ing over to a once-every-12-weeks sched­ule. Eylea, mean­while, re­quires the month­ly in­jec­tion through month three with fol­low-up in­jec­tions need­ed every eight weeks.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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