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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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