Xavier Becerra, new HHS secretary, at his nomination hearing (Greg Nash/Pool via AP Images)

Drug­mak­ers brace for a pric­ing fight as Xavier Be­cer­ra is con­firmed as the next HHS sec­re­tary

By a ra­zor-thin mar­gin of 50-49, all Sen­ate De­moc­rats and Maine Re­pub­li­can Su­san Collins on Thurs­day con­firmed for­mer Cal­i­for­nia At­tor­ney Gen­er­al Xavier Be­cer­ra as the head of the De­part­ment of Health and Hu­man Ser­vices (HHS) — set­ting the stage for what may be ma­jor pric­ing bat­tles with the bio­phar­ma in­dus­try.

The par­ti­san di­vide over Be­cer­ra’s nom­i­na­tion came as De­moc­rats lined up be­hind Be­cer­ra’s tough stance against drug­mak­ers and for Oba­macare, among oth­er is­sues, while Re­pub­li­cans lam­bast­ed his lack of med­ical and sci­en­tif­ic ex­pe­ri­ence, as well as his tough stance against the phar­ma­ceu­ti­cal in­dus­try.

“I think we can all agree the price we’re pay­ing for some of these pre­scrip­tion drugs is far high­er than it should be. All you have to do is trav­el to an­oth­er coun­try to find we’re pay­ing way more,” Be­cer­ra said in his Sen­ate com­mit­tee hear­ing in Feb­ru­ary to re­view his nom­i­na­tion.

Aaron Kessel­heim, a pro­fes­sor of med­i­cine at Har­vard Med­ical School and a fac­ul­ty mem­ber in the Di­vi­sion of Phar­ma­coepi­demi­ol­o­gy and Phar­ma­coeco­nom­ics at Brigham and Women’s Hos­pi­tal, said he’s not con­cerned that Be­cer­ra is not a doc­tor; “be­ing a med­ical doc­tor trains you to have in­sight in­to pa­tient care, but it does not give you spe­cial in­sight in­to be­ing an ef­fec­tive HHS Sec­re­tary, as we learned from the dis­as­trous Tom Price ad­min­is­tra­tion.”

Aaron Kessel­heim

In terms of drug pric­ing, Kessel­heim said he thought Be­cer­ra could “right away take some steps to ad­dress Part B drug pric­ing, since right now Medicare en­gages in no over­sight of Part B prices; it just pays the ASP [av­er­age sales price] plus a small per­cent. This could in­clude ideas such as en­forc­ing ac­cu­rate re­port­ing of ASPs, re­duc­ing spend­ing on bi­o­log­ic drugs with biosim­i­lars by bring­ing them all un­der the same re­im­burse­ment code, shift­ing cer­tain drugs from Part B to Part D (with as­so­ci­at­ed lim­its on OOP [out of pock­et] costs), and in­sti­tut­ing the Med­PAC rec­om­men­da­tion to cre­ate a CM­MI [Cen­ters for Medicare & Med­ic­aid Ser­vices (CMS) In­no­va­tion Cen­ter] demon­stra­tion project to ne­go­ti­ate prices of Part B drugs. Ul­ti­mate­ly, he may need to de­vel­op the me­chan­ics of a sys­tem to ne­go­ti­ate fair drug prices based on their clin­i­cal ben­e­fits if such a ne­go­ti­a­tion process is ap­proved by Con­gress, since it will most nat­u­ral­ly be housed with­in CMS.”

As At­tor­ney Gen­er­al of Cal­i­for­nia, Be­cer­ra led the state to be­come the first in the na­tion to ban pay-for-de­lay agree­ments, which can de­lay the en­try of gener­ic drugs to mar­ket, and he de­feat­ed a chal­lenge to the law from the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines (AAM), the gener­ic phar­ma­ceu­ti­cal in­dus­try group.

“I took on a num­ber of these drug­mak­ers by go­ing be­hind the cur­tain on how they reached their pric­ing and we were able to prove there was col­lu­sion go­ing on,” he added in the Feb­ru­ary hear­ing. He al­so has sought to right the wrongs of the opi­oid epi­dem­ic.

The Fed­er­al Trade Com­mis­sion’s re­cent an­nounce­ment that it would crack down on phar­ma­ceu­ti­cal com­pa­nies’ merg­ers al­so plays right in­to Be­cer­ra’s work on an­titrust is­sues.

And his ad­vo­ca­cy for us­ing march-in rights to uni­lat­er­al­ly low­er drug prices in cas­es where the gov­ern­ment has in­vest­ed in their de­vel­op­ment (such as with Gilead’s Covid-19 drug remde­sivir) has al­so riled the in­dus­try.

“Ob­vi­ous­ly the use of march-in rights would be a huge deal,” Ben Ip­poli­to, res­i­dent schol­ar at the Amer­i­can En­ter­prise In­sti­tute, told End­points News. “I don’t know if that has a high enough ben­e­fit-to-cost ra­tio to take on or not, par­tic­u­lar­ly giv­en all the oth­er pri­or­i­ties they’ve al­ready got … and if Con­gress ends up work­ing on drug pric­ing leg­is­la­tion any­ways.”

Lau­ren Aron­son

He not­ed that any push to use march-in might push the bio­phar­ma in­dus­try away from de­vel­op­ing treat­ments that march-in rights could ap­ply to, “which seems like it un­der­mines the point of fund­ing the re­search.”

On the flip side, sev­er­al non­prof­its specif­i­cal­ly fo­cused on drug prices praised his con­fir­ma­tion and are prepar­ing for him to take ac­tion.

Lau­ren Aron­son, ex­ec­u­tive di­rec­tor of the Cam­paign for Sus­tain­able Rx Pric­ing, com­mend­ed Con­gress for Be­cer­ra’s con­fir­ma­tion and for his “pledg­ing to work across par­ty lines to low­er drug prices and hold Big Phar­ma ac­count­able.” David Mitchell, a can­cer pa­tient and founder of Pa­tients for Af­ford­able Drugs Now, al­so called Be­cer­ra’s con­fir­ma­tion “a win for pa­tients across the coun­try who are strug­gling with high drug prices.”

Stephen Ubl

Phar­ma in­dus­try groups, mean­while, pledged to work with Be­cer­ra.

Stephen Ubl, pres­i­dent and CEO of in­dus­try group PhRMA, said in a state­ment that the in­dus­try looks for­ward to work­ing with HHS “to help ad­dress our na­tion’s lead­ing pri­or­i­ties: get­ting COVID-19 un­der con­trol and im­prov­ing health care af­ford­abil­i­ty and ac­cess for all Amer­i­cans.”

AAM of­fered their con­grat­u­la­tions and said they look for­ward to work­ing with him “to ad­vance poli­cies that en­hance the com­pet­i­tive­ness of safe, ef­fec­tive, af­ford­able gener­ics and biosim­i­lars.”

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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