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.”

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Back-to-back piv­otal fail­ures force Ther­a­vance to lay off 270 staffers, prune R&D fo­cus

If it all went well, Q3 was supposed to be harvest time for Theravance.

Both of its lead drugs — the pan-JAK inhibitor izencitinib and blood pressure drug ampreloxetine — were slated for crucial readouts. The biotech was, as SVB Leerink analyst Geoffrey Porges put it, “entering the most important period of validation events in its history.”

Instead, izencitinib flopped a key Phase IIb trial in ulcerative colitis, putting the J&J partnership around it in jeopardy. A month later, Theravance is reporting that the Phase III trial testing ampreloxetine in symptomatic neurogenic orthostatic hypotension is also a failure, imploding the company’s entire pipeline and forcing a rethink on R&D strategy.

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Boston skyline (Shutterstock)

Boston, the Bay Area and San Diego dom­i­nate the life sci­ences re­al es­tate mar­ket. Where to next?

With strong competition for life sciences real estate in key clusters — greater Boston, San Francisco and San Diego — where will the industry look to expand next? That’s the question that real estate company JLL sought to answer in its latest report, released on Wednesday.

JLL scored US biotech hubs on a variety of criteria to come up with this year’s ranking, including talent, industry depth, innovation and lab real estate dynamics. Unsurprisingly, they found that last year’s top three clusters remain unchanged. JLL predicts that these core clusters will be “immovable” for the foreseeable future, comparing them to the Silicon Valley of biotech.

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