Gilead says a net­work of sup­pli­ers and dis­trib­u­tors sold tens of thou­sands of fake ver­sions of its HIV meds

Gilead has ac­cused a net­work of unau­tho­rized drug sup­pli­ers and dis­trib­u­tors of sell­ing coun­ter­feit ver­sions of its HIV meds, some of which end­ed up in US phar­ma­cies, ac­cord­ing to court doc­u­ments un­sealed Tues­day.

Over the last two years, Gilead says the dis­trib­u­tor de­fen­dants sold 85,246 bot­tles of Gilead meds (in­clud­ing its HIV meds Bik­tarvy and De­scovy) with coun­ter­feit doc­u­men­ta­tion — some of which had tam­pered bot­tles, or con­tained an en­tire­ly dif­fer­ent drug.

The com­pa­ny first learned of the coun­ter­feit meds back in Au­gust 2020, when White Cross Phar­ma­cy in Cal­i­for­nia re­port­ed to Gilead and Safe Chain (one of the de­fen­dants) that a pa­tient re­turned a bot­tle of Bik­tarvy with for­eign med­ica­tion in­side, ac­cord­ing to a com­plaint filed in Ju­ly. The com­pa­ny has since re­ceived mul­ti­ple com­plaints from pa­tients and phar­ma­cies about bot­tles of Gilead HIV meds that, when opened, were filled with the wrong drug.

As part of an on­go­ing in­ves­ti­ga­tion and in co­or­di­na­tion with law en­force­ment, Gilead ex­e­cut­ed seizures at 17 lo­ca­tions in nine states, con­fis­cat­ing thou­sands of coun­ter­feit Gilead-la­beled meds.

While the bot­tles are au­then­tic-look­ing, their seals or la­bels had been tam­pered with and, in some cas­es, their doc­u­men­ta­tion had been faked. Fed­er­al law re­quires all pre­scrip­tion drugs to come with a “pedi­gree,” or a doc­u­ment track­ing every sale from sell­er to sell­er, all the way back to the man­u­fac­tur­er. Gilead says in some cas­es, the de­fen­dants dis­trib­uted bot­tles with fal­si­fied pedi­grees, claim­ing to trace the coun­ter­feits back to an au­then­tic source.

In many cas­es, the bot­tles were filled with a gener­ic painkiller, or high-dose tablets of the an­tipsy­chot­ic Sero­quel. The lat­ter can cause se­da­tion or drowsi­ness, and though new pa­tients are rec­om­mend­ed to start on 50 mg a day for many con­di­tions, 300 mg tablets were dis­cov­ered in the coun­ter­feit Gilead bot­tles.

One pa­tient who un­know­ing­ly took the an­tipsy­chot­ic af­ter re­ceiv­ing a coun­ter­feit bot­tle of Bik­tarvy was un­able to speak or walk af­ter­ward, Gilead said in the com­plaint.

“Pa­tient safe­ty is our first pri­or­i­ty, and our ac­tions were in­stru­men­tal in re­mov­ing coun­ter­feit HIV med­ica­tions from the US sup­ply chain and pro­tect­ing in­di­vid­u­als who re­ly on our med­ica­tions,” Lori May­all, Gilead’s head of an­ti-coun­ter­feit­ing and brand pro­tec­tion, said in a state­ment.

The US Dis­trict Court in East­ern New York has or­dered all de­fen­dants in the case to stop sell­ing Gilead-brand­ed med­ica­tion, the phar­ma gi­ant said on Wednes­day.

In Au­gust, Gilead is­sued a pub­lic warn­ing that coun­ter­feit ver­sions of Bik­tarvy and De­scovy had made their way in­to some US phar­ma­cies. The com­pa­ny said gen­uine bot­tles had been tam­pered with fake foil in­duc­tion seals — those “lift-and-peel” stick­ers you see on bot­tle open­ings — or la­bels, and con­tained the wrong tablets.

Bik­tarvy won ap­proval for the treat­ment of HIV back in 2018. A year lat­er, Gilead spent a pri­or­i­ty re­view vouch­er to clear De­scovy for the treat­ment and pre­ven­tion of HIV, just be­fore gener­ics to its block­buster Tru­va­da were set to hit the mar­ket in 2020.

Au­then­tic Bik­tarvy pills are pur­plish-brown and cap­sule-shaped, with the num­bers “9883” writ­ten on one side, and the let­ters “GSI” on the oth­er, Gilead said. De­scovy tablets are blue and rec­tan­gu­lar, with the num­bers “225” on one side and “GSI” on the oth­er.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Anderson, incoming Bayer CEO (David Paul Morris/Bloomberg via Getty Images)

Bay­er taps Roche's Bill An­der­son to lead phar­ma gi­ant as CEO

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.