Run­ning be­hind Bris­tol My­ers and J&J, Bay­er inch­es for­ward in the next-gen blood thin­ner race

Over the week­end, Bay­er took an in­ter­me­di­ate step in its quest to chase down Bris­tol My­ers Squibb and J&J in the next-gen­er­a­tion blood thin­ner race.

In a Lancet pa­per pub­lished Sun­day de­tail­ing a Phase II safe­ty and dose-find­ing study, Bay­er’s ex­per­i­men­tal drug asun­dex­i­an re­duced the num­ber of bleed­ing events by 67% com­pared to Eliquis, a stan­dard of care. Bay­er’s next steps are to wrap up an­oth­er Phase II, fi­nal­ize the dose and push it in­to a Phase III study, like­ly by the end of this year, lead au­thor Manesh Pa­tel told End­points News.

“We feel good about the dos­ing, and we ac­tu­al­ly feel good about the fact that the high­er dose al­so has sim­i­lar rates of bleed­ing,” Pa­tel, a pro­fes­sor at Duke Uni­ver­si­ty, said. “It’s en­cour­ag­ing that it’s small num­bers, and you don’t want to over­in­ter­pret.”

When pa­tients use blood thin­ners, some­times the an­ti­co­ag­u­la­to­ry as­pects of the med­i­cine don’t just re­duce ex­cess clot­ting, but nor­mal clot­ting as well, Pa­tel said. This study aimed to ex­am­ine how asun­dex­i­an af­fect­ed the rates of such events.

It did not, Pa­tel and the pa­per stressed, look at the ef­fi­ca­cy of the drug in dif­fer­en­ti­at­ing be­tween rates of clot­ting events com­pared to stan­dard of care, which will like­ly be the fo­cus of the up­com­ing piv­otal study. Pa­tel al­so not­ed that the to­tal num­ber of bleed­ing events in the Phase II tri­al was low­er than ex­pect­ed.

Bay­er ran­dom­ized 755 pa­tients about even­ly in­to three sep­a­rate arms: a 20 mg asun­dex­i­an dos­ing arm, a 50 mg asun­dex­i­an dose co­hort and the Eliquis con­trol arm. Al­most all pa­tients, 753, were evalu­able at the end.

Pool­ing the two asun­dex­i­an arms to­geth­er, Bay­er ob­served four bleed­ing events across the 503 pa­tients, com­pared to six bleed­ing events in the 250 in­di­vid­u­als tak­ing Eliquis. As such, the com­pa­ny was able to de­ter­mine a 67% re­duc­tion in bleed­ing events be­tween the two drugs.

The study en­rolled pa­tients old­er than 45 with atri­al fib­ril­la­tion, though the av­er­age age of par­tic­i­pants was 73.7 years old. Near­ly 3 in 10 pa­tients al­so had chron­ic kid­ney dis­ease.

Asun­dex­i­an is a Fac­tor XIa in­hibitor, part of the same drug class as Bris­tol My­ers and J&J’s next-gen can­di­date, mil­vex­i­an. The part­ners here have a leg up on Bay­er in at least one area, hav­ing com­plet­ed a Phase II study ob­serv­ing a low­er rate of ve­nous throm­boem­bolism af­ter knee surgery with­out in­creas­ing risk of bleed­ing.

Fac­tor Xa in­hibitors, such as Eliquis and Xarel­to, can come with a fa­tal risk of bleed­ing, hence the push to­ward Fac­tor XIa. BMS and J&J are al­so aim­ing to launch their Phase III study for post-knee surgery VTE some­time this year.

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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