US sen­a­tors, ac­tivists chas­tise Gilead­'s Tru­va­da pric­ing, spot­light­ing CDC patents on drug's use as HIV pre­ven­tion pill

Once up­on a time, Gilead was the pur­vey­or of im­pos­si­bly high-priced, but fan­tas­ti­cal­ly ef­fec­tive, he­pati­tis C drugs. Now at­ten­tion has turned to its HIV pill, Tru­va­da, which the CDC re­port­ed­ly has some patents on. In a let­ter to the HHS, a cadre of US sen­a­tors un­der­scored their con­cern that the drug — which is ap­proved to pre­vent HIV — could be in­fring­ing up­on gov­ern­ment patents and is be­ing sold at a price that makes it un­af­ford­able for many Amer­i­cans.

Tru­va­da — emtric­itabine/teno­fovir diso­prox­il fu­marate — 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%.

Ac­cord­ing to a coali­tion of HIV/AIDs ac­tivists — the PrEP4All Col­lab­o­ra­tion — 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. The chief bar­ri­er is price: “Gilead charges $1600 per month for pills that cost as lit­tle as $6 per month abroad, mean­ing that some in­sur­ers do not cov­er it and in­di­vid­u­als can­not af­ford to pay for it out of pock­et,” ac­cord­ing to an analy­sis by Yale Law School, which has part­nered with PrEP4All.

In March, the Yale Glob­al Health Jus­tice Part­ner­ship pub­lished a re­port that found CDC sci­en­tists were the first to de­ter­mine that the drugs that com­prise Gilead’s Tru­va­da 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 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.

“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.”

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 ear­li­er this month.

In a let­ter post­ed ear­li­er in April, the PrEP4All Col­lab­o­ra­tion high­light­ed that Gilead has “con­sis­tent­ly in­creased the price of the drug, for both pre­ven­tion and treat­ment, since its in­tro­duc­tion” and that the CDC patents rep­re­sent a po­ten­tial “mul­ti-bil­lion dol­lar fund­ing stream” via roy­al­ty pay­ments that could fund a uni­ver­sal PrEP pro­gram to dra­mat­i­cal­ly re­duce the num­ber of new HIV in­fec­tions in the coun­try and/or com­pell Gilead $GILD to dra­mat­i­cal­ly low­er the price of PrEP.

Gilead ap­pears to po­ten­tial­ly be mar­ket­ing a pre­scrip­tion drug for us­es that are patent­ed by the US gov­ern­ment, sev­en US Sen­a­tors wrote in a let­ter pub­lished on Wednes­day.

“We would like to know what steps have been tak­en to en­sure that any us­ages by pri­vate com­pa­nies of gov­ern­ment-held patents are prop­er­ly li­censed and that any po­ten­tial in­fringe­ments are act­ed up­on… 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, seek­ing doc­u­ments on the sta­tus of ne­go­ti­a­tions be­tween the gov­ern­ment and Gilead, among oth­er re­quests.

“There are no on­go­ing ne­go­ti­a­tions be­tween Gilead and HHS with re­spect to the patents owned by the gov­ern­ment,” the com­pa­ny spokesper­son said, adding that Gilead is in dis­cus­sion with the gov­ern­ment to de­ter­mine the best way to broad­en ac­cess to Tru­va­da for PrEP.

Mean­while, the US De­part­ment of Jus­tice is re­view­ing the gov­ern­ment PrEP patent, ac­cord­ing to a re­port by the Wash­ing­ton Post, which cit­ed a re­tired CDC sci­en­tist who was among agency staff speak­ing with a DoJ lawyer last week.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, hand­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.