Ab­b­Vie-Al­ler­gan com­plete, but crit­ics con­tin­ue to raise an­ti-com­pet­i­tive con­cerns

The Ab­b­vie-Al­ler­gan mega-merg­er may now be com­plete, but its crit­ics haven’t had their last say.

In a 7-page let­ter to the Fed­er­al Trade Com­mis­sion, Cal­i­for­nia At­tor­ney Gen­er­al Xavier Be­cer­ra called in­to ques­tion the reme­dies the fed­er­al agency im­posed to solve the an­ti-trust con­cerns in­trin­sic in the $63 bil­lion deal.

Xavier Be­cer­ra

He said the agency did not fol­low its own “best prac­tices” when it comes to the merg­er. Yet even these prac­tices — now com­mon­place in some form or an­oth­er — have con­sis­tent­ly failed to cur­tail an­ti-com­pet­i­tive and price-rais­ing po­ten­tial, Be­cer­ra ar­gued, and should be stud­ied thor­ough­ly in an ef­fort to come up with new fix­es.

“It is wide­ly rec­og­nized that phar­ma­ceu­ti­cal merg­ers that bur­den the pub­lic in the form of high­er prices, few­er drug choic­es, drug short­ages, or oth­er an­ti­com­pet­i­tive ef­fects, must not be al­lowed,” he wrote. “This rais­es the ques­tion of whether, and to what ex­tent, merg­ers that are ap­proved sub­ject to di­vesti­tures re­store the lost com­pe­ti­tion from those merg­ers.”

Di­vesti­tures, in which one com­pa­ny sells off as­sets that would com­pete with oth­er as­sets in the merged com­pa­ny, have be­come the com­mon rem­e­dy for mo­nop­oly con­cerns that have emerged out of an in­creas­ing­ly con­sol­i­dat­ing phar­ma­ceu­ti­cal in­dus­try. Af­ter Bris­tol My­ers Squibb bought Cel­gene, for in­stance, the FTC con­di­tioned ap­proval of the deal on Bris­tol My­ers di­vest­ing Ote­zla, Cel­gene’s an­ti-in­flam­ma­to­ry drug, be­cause Bris­tol My­ers had their own an­ti-in­flam­ma­to­ry drug in the works, al­beit one that used a very dif­fer­ent mech­a­nism. Am­gen bought it for $13.4 bil­lion.

As the FTC re­viewed the Al­ler­gan-Ab­b­Vie deal, though, con­sumer ad­vo­cates ques­tioned both the gen­er­al wis­dom of di­vesti­tures in phar­ma merg­ers and specif­i­cal­ly how they were be­ing ap­plied to this deal. Those were most no­tably put in a sting­ing dis­sent from the FTC rul­ing clear­ing the merg­er, in which com­mis­sion­er Ro­hit Chopra called the pol­i­cy to have com­pa­nies di­vest over­lap­ping drugs “nar­row, flawed, and in­ef­fec­tive.” “It miss­es the big pic­ture,” he wrote, “al­low­ing phar­ma­ceu­ti­cal com­pa­nies to fur­ther ex­ploit their dom­i­nance, block new en­trants, and harm pa­tients in need of life-sav­ing drugs.”

To con­sum­mate the deal, the FTC made Al­ler­gan sell off an ex­per­i­men­tal an­ti-in­flam­ma­to­ry com­pound called brazikum­ab that might com­pete with Ab­b­Vie’s ap­proved Skyrizi. This, Be­cer­ra said, was against FTC guide­lines that call for com­pa­nies to sell off on-mar­ket prod­ucts be­cause ex­per­i­men­tal drugs have a “high rate of fail­ure.” Prod­ucts are al­so sup­posed to be sold to an ex­pe­ri­enced com­pa­ny ready to com­pete. The FTC, though, al­lowed Ab­b­Vie to di­vest the pan­cre­at­ic en­zyme Zen­Pep to Nestlé, “mak­er of choco­lates, bot­tled wa­ter and ba­by food.”

More broad­ly, Be­cer­ra said, there is lit­tle ev­i­dence that di­vesti­tures have been a suc­cess­ful tac­tic. He cit­ed FTC stud­ies showed di­vesti­tures had a 35% fail­ure rate, even when suc­cess is de­fined by the “ex­treme­ly broad and gen­er­ous de­f­i­n­i­tion” of one post-merg­er sale or, for pipeline drugs, sim­ply that the prod­uct was trans­ferred. He al­so cit­ed stud­ies sug­gest­ing the di­vesti­tures don’t pre­vent price in­creas­es.

The at­tor­ney gen­er­al called for a study that would an­a­lyze how well-di­vest­ed on-mar­ket drugs were sold and if pipeline drugs were brought to mar­ket; mea­sures that could be tak­en to guard against the “op­por­tunis­tic se­lec­tion” of di­vesti­ture buy­ers that are less like­ly to ef­fec­tive­ly de­vel­op or mar­ket drugs, such as — in Be­cer­ra’s view — Nestlé; and the role of phar­ma­cy ben­e­fit man­agers who, by cre­at­ing tiered for­mu­las, can block even the best di­vesti­tures from com­pet­ing.

Ul­ti­mate­ly, he of­fered, the FTC might have to do for phar­ma what they of­ten do for oth­er in­dus­tries: im­pose lim­its on what com­pa­nies can do af­ter the merg­er to en­sure the po­ten­tial suc­cess of the di­vest­ed and now ri­val prod­uct.

“Such a rem­e­dy could be es­sen­tial for the suc­cess of drug di­vesti­tures like Brazikum­ab, which is a pipeline drug that, once and if it gets to mar­ket, would need to com­pete against Ab­b­Vie’s in­cum­bent drug for PBM for­mu­la­ry ac­cess,” he wrote.

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Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

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While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

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With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

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Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.