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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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