Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Am­gen is the lat­est phar­ma com­pa­ny to ap­pear on the radar of Sen­ate Fi­nance Com­mit­tee Chair Ron Wyden (D-OR), who is in­ves­ti­gat­ing the way phar­ma com­pa­nies are us­ing sub­sidiaries in low- or ze­ro-tax coun­tries to low­er their tax bills.

Bob Brad­way

Like its peers Mer­ck, Ab­b­Vie and Bris­tol My­ers Squibb, Wyden notes how Am­gen us­es its Puer­to Ri­co op­er­a­tions to con­sis­tent­ly pay tax rates that are sub­stan­tial­ly low­er than the U.S. cor­po­rate tax rate of 21%, with an ef­fec­tive tax rate of 10.7% in 2020 and 12.1% in 2021.

“As a re­sult of these arrange­ments, there ap­pears to be a sub­stan­tial dis­crep­an­cy be­tween where Am­gen gen­er­ates pre­scrip­tion drug sales and where Am­gen books prof­its from those drug sales. In 2021, Am­gen gen­er­at­ed 70% of its sales in the Unit­ed States yet re­port­ed just 28% of its pre­tax in­come in the Unit­ed States,” Wyden wrote in a let­ter yes­ter­day to Am­gen CEO Robert Brad­way. “Sad­ly, it ap­pears that ex­ploit­ing sub­sidiaries in Puer­to Ri­co and oth­er low tax ju­ris­dic­tions has been a long­stand­ing prac­tice for Am­gen.”

The let­ter comes as the soon-to-be-signed-in­to-law In­fla­tion Re­duc­tion Act pro­vides that, in ad­di­tion to the drug ne­go­ti­a­tion mea­sures, cor­po­ra­tions with more than $1 bil­lion in prof­its over the pre­vi­ous three years would be re­quired to pay tax­es of at least 15% of their world­wide “book” prof­its, which is ex­plained fur­ther by the In­sti­tute on Tax­a­tion and Eco­nom­ic Pol­i­cy.

Am­gen has al­so found trou­ble with the IRS, with the WSJ re­port­ing that the IRS has claimed that Am­gen un­der­re­port­ed its tax­able in­come by near­ly $24 bil­lion from 2010 to 2015 and is seek­ing $10.7 bil­lion in back tax­es and penal­ties.

Bris­tol My­ers, mean­while, could al­so face near­ly $1.4 bil­lion in back tax­es the IRS be­lieves it evad­ed pay­ing as part of a scheme to move its patent rights from the US to an Irish sub­sidiary.

Among his 13 re­quests for Am­gen, Wyden asks the com­pa­ny to ex­plain how it gen­er­at­ed more than 70% of its sales in the US, but just 28% of its pre-tax in­come in the US. He al­so sin­gles out the com­pa­ny’s megablock­buster En­brel, which in 2021 brought in more than $4 bil­lion from US sales com­pared to just $113 mil­lion in the rest of the world.

“For all prof­its at­trib­ut­able to En­brel-re­lat­ed in­tel­lec­tu­al prop­er­ty rights from 2018 – 2021, please pro­vide a de­tailed list of coun­tries where Am­gen paid tax­es,” he wrote.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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