Guard­ing a $2 bil­lion fran­chise op­er­a­tion, Gilead hus­tles up its sN­DA for De­scovy. But will it work?

Gilead has two years to go as it works to tran­si­tion pa­tients from Tru­va­da to De­scovy be­fore the old­er drug sees an on­slaught of gener­ics slice and dice the mar­ket.

But they aren’t wast­ing a day.

The big biotech said to­day that they will use a pri­or­i­ty re­view vouch­er to hus­tle along the sup­ple­men­tal ap­pli­ca­tion to sell the drug to re­duce the risk of in­fec­tion among a vul­ner­a­ble HIV-neg­a­tive pop­u­la­tion. That will cut the re­view time down from 10 months to 6.

Ge­of­frey Porges

The news fol­lows a rel­a­tive­ly suc­cess­ful Phase III tri­al com­par­ing the two drugs, which has drawn con­sid­er­able scruti­ny and some doubts as to just how lu­cra­tive this may prove in the longterm. The Phase III da­ta an­nounced a month ago were ac­tu­al­ly just non-in­fe­ri­or, though Gilead made much of the sta­tis­ti­cal­ly in­signif­i­cant nu­mer­i­cal su­pe­ri­or­i­ty re­sults for their new brand.

Why? Gilead has a cou­ple of bil­lion dol­lars in rev­enue it won’t want to give up to the gener­ics — but it may have to.

Here’s SVB Leerink’s Ge­of­frey Porges on the Phase III head-to-head:

This re­sult sets the stage for Gilead to ac­tive­ly tran­si­tion the >$2bn in cur­rent PrEP (pre-ex­po­sure pro­phy­lax­is) rev­enue for Tru­va­da to De­scovy. The dif­fer­ences be­tween Tru­va­da and De­scovy re­main mod­est, and it is dif­fi­cult to tell how much of the tran­si­tion will stick af­ter the in­tro­duc­tion of gener­ic Tru­va­da in 2021. At this stage pay­ing ~$18,000 per year, for a 1% dif­fer­ence in Bone Min­er­al Den­si­ty and a 2-4mL/min dif­fer­ence in re­nal func­tion might chal­lenge the gen­eros­i­ty of post-2020 gov­ern­ment and pri­vate pay­ers, but Gilead has more than two years to es­tab­lish the case for De­scovy.

Jef­feries’ Michael Yee, though, has been more sup­port­ive, not­ing small im­prove­ments make a big dif­fer­ence over the long, long run pa­tients use HIV meds.

Gilead has long had one of the most ag­gres­sive drug de­vel­op­ment shops in the in­dus­try, which ex­plains the PRV use for a sup­ple­men­tal ap­pli­ca­tion. 


Im­age: Er­ic Ris­berg AP

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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