Do­nat­ed glob­al­ly since 2005, No­var­tis' flat­worm treat­ment Egat­en wins FDA nod — and a PRV

No­var­tis $NVS has the fix for all your par­a­sitic flat­worm needs. The Swiss drug­mak­er de­vel­oped a hu­man treat­ment for fas­ci­o­lia­sis in part­ner­ship with the WHO af­ter for­mu­lat­ing a sim­i­lar med­i­cine for do­mes­tic live­stock who are al­so vul­ner­a­ble to the ne­glect­ed trop­i­cal dis­ease, which has cropped up in more than 70 coun­tries. Since 2005, the drug­mak­er has been do­nat­ing the drug — Egat­en — glob­al­ly, and on Wednes­day, the med­i­cine was ap­proved by the FDA.

Fas­ci­o­lia­sis is caused by two species of leaf-shaped par­a­sitic flat­worms fol­low­ing in­ges­tion of lar­vae in con­t­a­m­i­nat­ed wa­ter or food — main­ly raw or un­der­cooked veg­e­ta­tion — and the lar­vae ma­ture in­to adult worms in the liv­er. Ac­cord­ing to the WHO, the in­fec­tion is present in do­mes­tic an­i­mals in al­most every coun­try where cat­tle and sheep are reared, and where live­stock is af­fect­ed, hu­mans usu­al­ly are too. The agency es­ti­mates at least 2.4 mil­lion peo­ple are in­fect­ed glob­al­ly, with sev­er­al mil­lion at risk. Rare cas­es of the in­fec­tion in the Unit­ed States have been doc­u­ment­ed, and trans­mis­sion due to im­port­ed con­t­a­m­i­nat­ed pro­duce could oc­cur, as seen in Eu­rope, the CDC has cau­tioned.

Mw­ele­cela Male­cela

Since 2005, No­var­tis has do­nat­ed rough­ly 4 mil­lion tablets of Egat­en (tri­claben­da­zole), val­ued at $41 mil­lion, fa­cil­i­tat­ing the treat­ment of around 2 mil­lion peo­ple with fas­ci­o­lia­sis in more than 30 coun­tries, No­var­tis said last Ju­ly as it re­newed its com­mit­ment to do­nate the drug till De­cem­ber 2022. This pledge in­cludes the do­na­tion of 600,000 tablets an­nu­al­ly, which are ex­pect­ed to reach 300,000 pa­tients per year.

The drug is rec­og­nized in the WHO’s mod­el list of es­sen­tial med­i­cines, and is made avail­able by the agency dur­ing epi­demics and for pe­ri­od­ic use in en­dem­ic coun­tries. For in­stance, an out­break in north­ern Iran in 1989 and 1991 af­fect­ed more than 10,000 peo­ple, and oth­ers have oc­curred in Al­ge­ria, Cu­ba and France, ac­cord­ing to the Na­tion­al Or­ga­ni­za­tion for Rare Dis­or­ders.

In the US, the CDC has long al­so con­sid­ered the one-day treat­ment the drug of choice, mak­ing it avail­able thus far in case of an in­fec­tion un­der a spe­cial (in­ves­ti­ga­tion­al) pro­to­col. But health reg­u­la­tors’ full en­dorse­ment of the drug for use in pa­tients six years and old­er is ex­pect­ed to fa­cil­i­tate drug li­cens­ing and im­port to af­fect­ed coun­tries when need­ed, No­var­tis said, adding that the ap­proval al­so trig­gered the award of a pri­or­i­ty re­view vouch­er.

“This FDA de­ci­sion…re­moves a ma­jor hur­dle in ex­pand­ing treat­ment to coun­tries where it is most need­ed,” said Mw­ele­cela Male­cela, di­rec­tor of the de­part­ment of con­trol of ne­glect­ed trop­i­cal dis­eases at the WHO.

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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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.

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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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

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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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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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: 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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