Un­der fire for Tru­va­da US pric­ing at House hear­ing, Gilead chief O'­Day touts R&D costs, as­serts gov­ern­ments patents are void

Gilead chief Daniel O’Day spent more than three hours de­fend­ing the $2000 month­ly price of its HIV pre­ven­tion pill, Tru­va­da, at a US House com­mit­tee on over­sight and re­form hear­ing Thurs­day, in re­sponse to a tsuna­mi of rage from AIDS ac­tivists, law­mak­ers and pa­tients re­gard­ing its pric­ing pol­i­cy.


Im­age: Daniel O’Day at the hear­ing. C-SPAN

Tru­va­da — emtric­itabine/teno­fovir diso­prox­il fu­marate (TDF/FTC) — was ap­proved in 2004 to treat HIV. In 2012, it was sanc­tioned by the FDA as a pre­ven­ta­tive treat­ment or PrEP (pre-ex­po­sure pro­phy­lax­is), in which in­di­vid­u­als at high risk for HIV take med­i­cines dai­ly to low­er their chances of con­tract­ing the in­fec­tion. Ac­cord­ing to the CDC, dai­ly PrEP re­duces the risk of get­ting HIV via sex­u­al in­ter­course by more than 90%.

A coali­tion of HIV/AIDs ac­tivists — the PrEP4All Col­lab­o­ra­tion — es­ti­mates that few­er than 10% of at-risk in­di­vid­u­als in the Unit­ed States re­ceive Tru­va­da as PrEP, and in­fec­tion rates re­main high (rough­ly 38,700 Amer­i­cans be­came new­ly in­fect­ed with HIV in 2016, ac­cord­ing to US gov­ern­ment es­ti­mates) par­tic­u­lar­ly among peo­ple of col­or and men who have sex with men. Gilead sells Tru­va­da for PrEP at about $1,600 to $2,000 per month in the Unit­ed States, while gener­ic ver­sions are avail­able else­where for as lit­tle as $6 per month, ad­vo­ca­cy or­ga­ni­za­tion Health GAP said in its tes­ti­mo­ny to the com­mit­tee: “While un­der-uti­liza­tion of PrEP is caused by mul­ti­ple fac­tors, it is clear that price is a bar­ri­er that in­hibits broad ac­cess.”

In March, the Yale Glob­al Health Jus­tice Part­ner­ship pub­lished a re­port that found CDC sci­en­tists were the first to de­ter­mine that the drugs Gilead’s Tru­va­da com­pris­es could be used to pre­vent HIV trans­mis­sion. As such, the agency was grant­ed a patent in 2015 that cov­ers HIV PrEP with a com­bi­na­tion of emtric­itabine and teno­fovir diso­prox­il fu­marate, the two drugs that make up Tru­va­da. Two oth­er patents were grant­ed lat­er. The Yale analy­sis con­clud­ed that Tru­va­da ap­peared to in­fringe the CDC’s patents for PrEP and that the US gov­ern­ment could as­sert the patents and seek mon­e­tary dam­ages.

“Gilead bore the risk and cer­tain­ly the vast ma­jor­i­ty of the cost of re­search and clin­i­cal stud­ies to demon­strate Tru­va­da’s ef­fi­ca­cy and safe­ty as part of com­bi­na­tion HIV ther­a­py,” a Gilead spokesper­son told End­points News last month. “The HHS patents on the drug’s use for PrEP were filed more than a year af­ter the drug had been dis­cussed by sci­en­tists for PrEP, had been rec­om­mend­ed and even pre­scribed off-la­bel by physi­cians for pre­ven­tion of HIV in­fec­tions, and ap­peared in guide­lines pub­lished by the CDC and oth­er health care or­ga­ni­za­tions for post-ex­po­sure pro­phy­lax­is (PEP) and PrEP. As such, the gov­ern­ment did not in­vent PrEP, Tru­va­da or Tru­va­da for PrEP and its patents should not have been grant­ed.”

O’Day on Thurs­day re­it­er­at­ed Gilead’s po­si­tion on Tru­va­da’s patents — in pre­pared tes­ti­mo­ny, he ref­er­enced in­stances in which sci­en­tists had re­searched use of the drug for PrEP, be­fore the CDC filed its patent ap­pli­ca­tion in 2006. Gilead has not chal­lenged the CDC patents be­cause the Fos­ter City, CA-based com­pa­ny val­ues the “col­lab­o­ra­tive re­la­tion­ship” with the agency, he told law­mak­ers.

In April, a cadre of US sen­a­tors in a let­ter to the US gov­ern­ment asked why Gilead was mar­ket­ing Tru­va­da for us­es patent­ed by the US gov­ern­ment. “Al­though Sec­re­tary Azar has stat­ed that ne­go­ti­a­tions are on­go­ing, Gilead has re­port­ed­ly reached no agree­ment with the gov­ern­ment that would al­low them to make use of these patent­ed meth­ods,” they wrote. At the time, a Gilead spokesper­son told End­points News that there were “no on­go­ing ne­go­ti­a­tions be­tween Gilead and HHS with re­spect to the patents owned by the gov­ern­ment.”

How­ev­er, a Wash­ing­ton Post re­port sug­gest­ed that the US De­part­ment of Jus­tice is re­view­ing the gov­ern­ment PrEP patent, cit­ing a source.

Gilead gen­er­at­ed glob­al Tru­va­da sales of near­ly $3 bil­lion last year, of which about $2.6 bil­lion came from the Unit­ed States. A gener­ic ver­sion of Tru­va­da is sold by My­lan $MYL in high-in­come Eu­ro­pean coun­tries and Aus­tralia, and the CDC is col­lect­ing a “small” roy­al­ty on those sales, af­ter the gener­ic drug­mak­er un­suc­cess­ful­ly chal­lenged the CDC patent in the Eu­ro­pean Patent Of­fice, STAT re­port­ed in April.

Ear­li­er this month, Gilead $GILD agreed to al­low one gener­ic drug­mak­er Te­va $TE­VA to be­gin sell­ing a copy­cat ver­sion of the drug by 2020 — about one year ahead of three oth­er com­pa­nies who have at­tempt­ed to launch their own ver­sions (Am­neal, Au­robindo and My­lan). A coali­tion of AIDS ac­tivists al­so dis­rupt­ed Gilead’s an­nu­al gen­er­al meet­ing of share­hold­ers, with de­mands that Gilead stop ob­struct­ing ac­cess to Tru­va­da.

“Typ­i­cal­ly, with on­ly one gener­ic on the mar­ket, its price is on­ly set about 20% low­er than the brand name drug. Te­va can ex­pect to be­come PrEP4All’s next tar­get if they don’t launch their own pa­tient as­sis­tance pro­grams. This sweet­heart deal with Te­va is like­ly un­con­sti­tu­tion­al, as are the deals keep­ing the oth­er three gener­ics off the mar­ket un­til 2021,” HIV ac­tivist and PrEP4All co-founder Pe­ter Sta­ley wrote in a Face­book post.

One day lat­er, Gilead notched a deal to pro­vide the CDC with up to 2.4 mil­lion bot­tles of the HIV-pre­ven­tion pill an­nu­al­ly for unin­sured Amer­i­cans at risk for HIV.  The do­na­tion, which ex­tends up to 2030, will tran­si­tion to its im­proved HIV drug De­scovy if it is ap­proved for use as PrEP. At the time, Gilead ac­knowl­edged that on­ly about 200,000 of the es­ti­mat­ed 1.1 mil­lion Amer­i­cans at risk for HIV cur­rent­ly re­ceive Tru­va­da for PrEP.

On Thurs­day, Health GAP chas­tised the CDC deal:

Gilead’s do­na­tion pro­gram is de­cep­tive and in­suf­fi­cient in sev­er­al ways. First, it pro­vides free TDF/FTC and sub­se­quent TAF/FTC for 200,000 unin­sured peo­ple, which is ad­mit­ted­ly use­ful, but Gilead will con­tin­ue to charge full price for the re­main­ing 800,000 to 900,000 el­i­gi­ble for PrEP. In essence, in terms of po­ten­tial mar­ket earn­ings, Gilead has of­fered a 20% price re­duc­tion off its list price of $20,000 per pa­tient per year. The net price for all PrEP users, es­pe­cial­ly af­ter they have been switched to the patent- and da­ta-pro­tect­ed TAF/FTC will be $16,000 per per­son per year times 800,000 users equals $12.8 bil­lion per year. Ad­di­tion­al­ly, Gilead will most cer­tain­ly re­ceive a ma­jor tax break on the do­na­tion val­ue of the do­nat­ed PrEP, which might al­so add as much as $1 bil­lion a year to their bot­tom line.

Alexan­dria Oca­sio-Cortez

At the hear­ing, O’Day em­pha­sized that since 2000, Gilead has spent $6 bil­lion on HIV/AIDS re­search, and has ef­fec­tive­ly rel­e­gat­ed the dis­ease from a death sen­tence to a man­age­able con­di­tion.

De­mo­c­ra­t­ic rep­re­sen­ta­tive Alexan­dria Oca­sio-Cortez told O’Day that the com­mit­tee wasn’t out to ques­tion his char­ac­ter, but the in­cen­tive sys­tem in the Unit­ed States that has en­gen­dered the norm of as­tro­nom­i­cal drug pric­ing.

“I’m not here to vil­i­fy the work that you’ve done, be­cause you are re­spond­ing to set of in­cen­tives,” she said. “You could re­sign to­day, and there will still be some­one that would oc­cu­py this seat, us­ing the same in­cen­tives, mak­ing the same de­ci­sions […] So this isn’t about you, this is about the sys­tem of in­cen­tives that we have set up […] I don’t blame you, I blame us.”

Jim Jor­dan

Mean­while, the rank­ing Re­pub­li­can on the com­mit­tee, Jim Jor­dan, ac­cused his De­mo­c­ra­t­ic col­leagues of cru­ci­fy­ing Gilead.

“Folks are alive to­day be­cause of the work you’ve done, and we’re go­ing to beat you up,” he said to O’Day.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi preps an­oth­er round of lay­offs as new ex­ecs look to slim down the glob­al phar­ma in an on­go­ing re­or­ga­ni­za­tion — re­port

Sanofi is reportedly once again sharpening up the budget axe as the pharma giant prepares to chop more jobs.

Reuters reports this morning that Sanofi has its sights set on cutting 1,680 jobs in Europe, where the unions have been combating rounds of cutbacks at the Paris-based player. Sanofi itself hasn’t said anything about these cuts, as the company looks to discuss a 3-year plan with staff representatives.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.