As JP­Mor­gan mad­ness sub­sides, De­moc­rats will un­veil a leg­isla­tive pack­age to ad­dress drug price hikes

On the night be­fore the start of JP Mor­gan — a con­fer­ence where bio­phar­ma ex­ec­u­tives big and small waxed lyri­cal about in­no­va­tion, adorned with name badges fea­tur­ing a gold DNA cap­sule — Pres­i­dent Don­ald Trump tweet­ed his dis­plea­sure that drug­mak­ers were not hon­or­ing their promis­es to rein in prices. He wasn’t wrong. Da­ta sug­gest drug­mak­ers have re­turned to busi­ness as usu­al. And now, af­ter De­moc­rats clawed back con­trol of the House, they’re ex­pect­ed to un­veil a leg­isla­tive pack­age to­day to ad­dress what the White House has so far at­tempt­ed in vain to do: cut prices for pre­scrip­tion drugs.

At least three bills are be­ing tout­ed in the pack­age — in­clud­ing one re­vealed last No­vem­ber from Sen­a­tor Bernie Sanders and Rep­re­sen­ta­tive Ro Khan­na that as­serts Amer­i­cans should not pay more for pre­scrip­tion drugs than the me­di­an price in five ma­jor coun­tries, re­sem­bling a Trump ad­min­is­tra­tion pro­pos­al pre­sent­ed the pre­ced­ing month. Oth­er parts of the leg­is­la­tion pro­pos­es al­low­ing HHS to ne­go­ti­ate prices for Medicare Part D di­rect­ly with drug­mak­ers, in­stead of mid­dle­men like phar­ma­cy ben­e­fit man­agers — as well as im­port­ing med­i­cines at a low­er price from coun­tries such as Cana­da.

Last year, un­der pres­sure from the Trump ad­min­is­tra­tion and in re­sponse to pub­lic out­rage, a num­ber of high pro­file drug­mak­ers made pledges to freeze prices. Since then, the Trump ad­min­is­tra­tion has al­so in­tro­duced two pro­pos­als to tem­per prices. But de­spite in­ten­si­fy­ing po­lit­i­cal and me­dia scruti­ny, drug­mak­ers have re­turned to hikes on at least a por­tion of their port­fo­lio. That in turn has trig­gered an in­tense pub­lic back­lash, which is dri­ving this new leg­isla­tive on­slaught.

The phar­ma­ceu­ti­cal in­dus­try, along with its well con­nect­ed lob­by, has ve­he­ment­ly fought against pro­pos­als to im­port over­seas prices, sug­gest­ing such schemes will sti­fle in­no­va­tion and po­ten­tial­ly ush­er un­safe med­i­cines in­to the coun­try.

Stephen Ubl, CEO of PhRMA, at an End­points News event at the 2019 JP Mor­gan con­fer­ence Jeff Ru­mans for End­points News

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How­ev­er, da­ta show that de­spite the high cost of health­care, the Unit­ed States ac­tu­al­ly per­forms worse across var­i­ous health mea­sures ver­sus a num­ber of oth­er high-in­come na­tions. And Amer­i­cans them­selves are des­per­ate­ly seek­ing change: at­tack­ing drug price goug­ing is one of the few sub­jects that has wide­spread bi­par­ti­san sup­port. Ac­cord­ing to a re­cent Politi­co/Har­vard poll, an over­whelm­ing ma­jor­i­ty of Amer­i­cans ranked ad­dress­ing the cost of med­i­cines as a top pri­or­i­ty for the new Con­gress.

On Wednes­day, for­mer Lil­ly ex­ec­u­tive and HHS sec­re­tary Alex Azar tweet­ed: “For those lis­ten­ing in the phar­ma­ceu­ti­cal in­dus­try: The list price in­creas­es must stop. Prices must start com­ing down.”

But an­a­lysts are not as con­vinced po­lit­i­cal pres­sure will have the im­pact some an­tic­i­pate. Bern­stein’s Ron­ny Gal in a note in No­vem­ber 2018 wrote: “phar­ma does not have to be as nice to PO­TUS now that CMS has pol­i­cy ideas that are an­ti­thet­i­cal to in­dus­try in­ter­est…At the very least, threat­en­ing to raise prices gives in­dus­try a bar­gain­ing chip to ne­go­ti­ate some of these poli­cies away.” More re­cent­ly in Jan­u­ary, Cowen an­a­lysts pub­lished a sur­vey of US drug buy­ers — in­clud­ing HMOs, PBMs and hos­pi­tals who col­lec­tive­ly bought more than $42 bil­lion in drugs in 2017 — to as­cer­tain the mo­men­tum of US drug prices over the next 3 years.

“Re­spon­dents ex­pect U.S. brand drug prices will con­tin­ue to rise over the next 3 years, at a rate sim­i­lar to the past,” the an­a­lysts found.

When asked about the flur­ry of de­bate sur­round­ing the is­sue of pric­ing, Bio­Marin chief Jean-Jacques Bi­en­aime said “It’s not a re­al prob­lem; it’s all pol­i­tics” in an in­ter­view with Bloomberg on the eve of JP Mor­gan.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.