Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mount­ing its coun­ter­feit drug law­suit, nam­ing two “king­pins” and a com­plex net­work of con­spir­a­tors who al­leged­ly sold im­i­ta­tion bot­tles of its HIV meds, some of which end­ed up in US phar­ma­cies.

The phar­ma gi­ant on Wednes­day pro­vid­ed an up­date on what it called a “large-scale, so­phis­ti­cat­ed coun­ter­feit­ing con­spir­a­cy,” ac­cus­ing two new de­fen­dants of “lead­ing and or­ches­trat­ing” a scheme to sell hun­dreds of mil­lions of dol­lars in il­le­git­i­mate drugs pos­ing as meds such as Bik­tarvy and De­scovy.

Two Flori­da men, Lazaro Rober­to Her­nan­dez and Ar­man­do Her­rera, were named as “king­pin de­fen­dants” in re­cent­ly un­sealed court doc­u­ments and ac­cused of set­ting up and con­trol­ling a se­ries of “fly-by-night” whole­salers to sell the coun­ter­feit meds.

Ann Don­nel­ly

Back in Au­gust, US Dis­trict Judge Ann Don­nel­ly froze the as­sets of more than 50 new­ly named de­fen­dants, ac­cord­ing to the un­sealed doc­u­ments, in­clud­ing Her­nan­dez and Her­rera.

Gilead first filed suit back in Ju­ly 2021, and ear­li­er this year al­leged that de­fen­dants have sold more than 85,000 bot­tles of coun­ter­feit Gilead meds. The de­fen­dants al­leged­ly sold au­then­tic-look­ing bot­tles, pur­chased il­le­gal­ly from pa­tients, with coun­ter­feit doc­u­men­ta­tion, ac­cord­ing to a new com­plaint. In some cas­es, those bot­tles con­tained com­plete­ly dif­fer­ent drugs, ei­ther a gener­ic painkiller or high-dose tablets of the an­tipsy­chot­ic Sero­quel.

The an­tipsy­chot­ic can cause se­da­tion, drowsi­ness and oth­er se­ri­ous prob­lems when tak­en in com­bi­na­tion with oth­er drugs or at high dos­es. One pa­tient who un­know­ing­ly took the an­tipsy­chot­ic af­ter re­ceiv­ing a coun­ter­feit bot­tle of Bik­tarvy was un­able to speak or walk af­ter­ward, Gilead said in its first com­plaint.

While fed­er­al law re­quires pre­scrip­tion drugs to come with a pedi­gree, or a doc­u­ment track­ing every sale, de­fen­dants al­leged­ly dis­trib­uted bot­tles with fal­si­fied pedi­grees that claimed to trace the coun­ter­feits to an au­then­tic source.

“Gilead will con­tin­ue to work close­ly with the U.S. Food and Drug Ad­min­is­tra­tion (FDA), phar­ma­cies and the De­part­ment of Jus­tice to re­move coun­ter­feit and tam­pered med­ica­tion from cir­cu­la­tion and to pre­vent fu­ture dis­tri­b­u­tion of coun­ter­feit med­ica­tions,” the com­pa­ny said in a state­ment on Wednes­day.

Bik­tarvy was ap­proved for the treat­ment of HIV back in 2018, and Gilead spent a pri­or­i­ty re­view vouch­er a year lat­er to get De­scovy on the mar­ket for both treat­ment and pre­ven­tion. The drugs earned Gilead $2 bil­lion and $397 mil­lion in the US last quar­ter, re­spec­tive­ly.

“In­di­vid­u­als who be­lieve they have been dis­pensed a coun­ter­feit Gilead med­ica­tion should im­me­di­ate­ly re­port the med­i­cine to their health­care provider, phar­ma­cy and Gilead Prod­uct Qual­i­ty Com­plaints,” Gilead said Wednes­day.

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

Gilead has is­sued a list of trust­ed dis­trib­u­tors, in­clud­ing the big firms Car­di­nal Health, Amerisource­Ber­gen and McKesson.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.