FDA en­dors­es Bavar­i­an Nordic's mon­key­pox vac­cine, mark­ing world's first ap­proval

In 2003, sci­en­tists traced the mon­key­pox virus to a pa­tient’s pet prairie dog in Marsh­field, Wis­con­sin. Al­to­geth­er, forty-sev­en con­firmed and prob­a­ble cas­es of mon­key­pox were re­port­ed from six US states — mark­ing the first in­stance that an out­break was record­ed out­side of Africa, af­ter a ship­ment of 800 small mam­mals from Ghana were im­port­ed to Texas. On Tues­day, the first vac­cine for the dis­ease — which can be fa­tal — was ap­proved by the FDA.

Mon­key­pox is a rare virus trans­mit­ted to hu­mans from an­i­mals such as ro­dents and pri­mates, and is pri­mar­i­ly na­tive to Africa near trop­i­cal rain­forests. It is sim­i­lar to hu­man small­pox — which was erad­i­cat­ed in 1980 — so most of the glob­al pop­u­la­tion is now vul­ner­a­ble, al­though old­er small­pox vac­cines are shown to have a high de­gree of suc­cess of pro­tect­ing hu­mans from mon­key­pox.  Mean­while, an on­go­ing mon­key­pox out­break in Nige­ria — which has spread to the UK, Is­rael, and Sin­ga­pore — has demon­strat­ed a spike in hu­man-to-hu­man trans­mis­sion, caus­ing trep­i­da­tion.

Bavar­i­an Nordic’s vac­cine, Jyn­neos, was en­dorsed by the US drug reg­u­la­tor to pro­tect against both small­pox and mon­key­pox dis­ease — and was de­vel­oped in part­ner­ship with the US gov­ern­ment. The sub­cu­ta­neous in­jec­tion is based on a live, at­ten­u­at­ed vac­cinia virus — which can­not be repli­cat­ed but is strong enough to in­duce an im­mune re­sponse.

The vac­cine was test­ed in 22 clin­i­cal tri­als — in­clud­ing two late-stage stud­ies — en­com­pass­ing 7871 in­di­vid­u­als aged 18 through 80 years who re­ceived at least one dose (7109 small­pox vac­cine-naïve and 762 small­pox vac­cine-ex­pe­ri­enced in­di­vid­u­als). In pa­tients who had pre­vi­ous­ly been giv­en ACAM2000 (the oth­er FDA-ap­proved small­pox vac­cine), Jyn­neos’ im­pact was com­pa­ra­ble.

The ap­proval for mon­key­pox was based on sur­vival da­ta de­rived from lethal mon­key­pox virus stud­ies in non-hu­man pri­mates. Over­all sur­vival in var­i­ous mod­els ranged from 80% to 100% of Jyn­neos-vac­ci­nat­ed an­i­mals com­pared to 0-40% in con­trol an­i­mals, the Den­mark-based biotech said.

As part of its ap­proval, the com­pa­ny has been giv­en a Pri­or­i­ty Re­view Vouch­er (PRV) — which it in­tends to sell. PRV’s are valu­able as they give the own­er-drug­mak­er the VIP treat­ment in the queue to get its prod­ucts re­viewed, and have them sold for hun­dreds of mil­lions of dol­lars in re­cent years.

Bavar­i­an Nordic has giv­en the Unit­ed States 28 mil­lion dos­es of the vac­cine for emer­gency use, and it has a decade-long con­tract in place with BAR­DA to re­plen­ish and po­ten­tial­ly ex­pand the stock­pile. The vac­cine is al­so ap­proved in Eu­rope and Cana­da to pro­tect against small­pox.

Al­though mon­key­pox is much milder than small­pox, it can be fa­tal — killing be­tween 1% and 10%, of in­fect­ed pa­tients, with most deaths oc­cur­ring in younger age groups, ac­cord­ing to the WHO.

So­cial im­age: AP Im­ages

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Roger Perlmutter, Merck R&D chief (YouTube)

Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.