Gilead­'s sto­ried hep C fran­chise will now in­clude a gener­ic drug op­er­a­tion

Faced with a dwin­dling stream of rev­enue for its he­pati­tis C fran­chise amid an on­go­ing na­tion­al de­bate on drug pric­ing, Gilead has come up with an un­con­ven­tion­al plan.

Through a new sub­sidiary named Asegua Ther­a­peu­tics, Gilead will sell gener­ic ver­sions of the he­pati­tis C com­bo drugs Ep­clusa and Har­voni at a price of $24,000 — a frac­tion of the list prices of the drugs, which cost $75,000 and $94,500 re­spec­tive­ly for a 12-week reg­i­men.

John Mil­li­gan

While pro­vid­ing a pain­less cure for he­pati­tis C was a ma­jor suc­cess in biotech, it turned out to be a bit of a mixed sto­ry for Gilead, which saw the huge, prof­itable mar­ket quick­ly shrink as the pa­tient pop­u­la­tion got small­er and cheap­er ri­vals emerged from Mer­ck and Ab­b­Vie. Chair­man John Mar­tin and CEO John Mil­li­gan — the duo cred­it­ed for ex­e­cut­ing this break­through — al­so en­dured end­less crit­i­cism for their ag­gres­sive strat­e­gy, which trig­gered a con­tro­ver­sy that nev­er re­al­ly went away.

Nei­ther Mil­li­gan nor Mar­tin will over­see the launch of these gener­ic drugs, sched­uled for Jan­u­ary of 2019, as they are both step­ping down at the end of the year. But to hear Mil­li­gan tell it, this ini­tia­tive is an at­tempt to solve a com­plex prob­lem they have ob­served for the past five years: Even though re­bates have shaved more than 60% off the av­er­age price paid for their hep C cures, these dis­counts are “ef­fec­tive­ly in­vis­i­ble” and “ac­cess to these cures has been lim­it­ed.”

Over the past sev­er­al months, we have searched for a vi­able path to re­duce the list price of our brand­ed HCV med­ica­tions so that their cost to pay­ers is more eas­i­ly un­der­stood. Un­for­tu­nate­ly, ex­ist­ing con­tracts with in­sur­ers, to­geth­er with laws as­so­ci­at­ed with gov­ern­ment pric­ing poli­cies, make it un­ac­cept­ably dif­fi­cult to quick­ly low­er the list price to re­flect the dis­count­ed cost of our med­ica­tions.

Set­ting up their own gener­ic op­er­a­tion, Mil­li­gan writes, is “the fastest way to low­er list prices for our HCV cures with­out sig­nif­i­cant dis­rup­tion to the health­care sys­tem and our busi­ness, as a bridge to longer term so­lu­tions aimed at re­duc­ing pa­tients’ out-of-pock­et med­ica­tion costs.”

Specif­i­cal­ly, this could save Medicare pa­tients up to $2,500 in out-of-pock­et costs in the Part D set­ting, as well as “sub­stan­tial sav­ings” to state man­aged Med­ic­aid plans.

Ep­clusa and Har­voni both con­tain so­fos­bu­vir, the orig­i­nal hep C med­i­cine that Gilead sells as So­val­di. In the first half of 2018, their com­bined sales reg­is­tered at $1.7 bil­lion, com­pared with $4.8 bil­lion dur­ing the same pe­ri­od in 2017.

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 have vowed not to let politics get in the way of 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 health agencies under his purview — including the FDA — of their rulemaking 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.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#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)

#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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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.

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.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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